You see a video, a product catches your eye, and an “add to cart” button is already blinking in the corner of the screen. A few seconds later the order is placed, paid for, and on its way — all without leaving the app. That’s how TikTok Shop works: a closed-loop model in which the path from watching a piece of content to completing a purchase has been cut to the bare minimum. That very immediacy is its greatest strength and, at the same time, the source of its most serious concerns.

A platform that in 2017 drew around 72 million monthly users now attracts more than 1.5 billion — and between 11 and 15 million in Poland alone. TikTok has stopped being merely a place for entertainment and has turned into a powerful advertising and sales engine, combining influencer marketing, algorithmic personalization, and the emotional purchasing impulse. For businesses, it is a new and remarkably effective retail space. For consumers, it is an environment in which it grows ever harder to tell an authentic recommendation from an ad, or a fleeting enthusiasm from a considered decision.

That is precisely why TikTok Shop has landed at the center of lawmakers’ attention. While its model is not unlawful, the platform’s operation intersects with an entire web of regulation: from consumer law and the ban on “dark patterns,” through the EU’s DSA and DMA, data protection and safeguards for minors, all the way to advertising, media, and electronic communications law. This article shows where the convenience of one-tap shopping ends and the protection of the buyer’s free will begins.

What makes the TikTok Shop platform innovative?

Today, an effective marketing strategy is becoming an increasingly important priority for sellers. In Poland, monopolies in sales are relatively rare. Many competing companies operate in most industries. When purchasing products, consumers must choose from hundreds, or even thousands, of options offered by different brands. The scale of this phenomenon is evidenced by the fact that in the fourth quarter of 2025, over 2.9 million active businesses operated in Poland alone, the largest group of which were those associated with the retail sector. Meanwhile, buyers generally do not want to spend much time thoroughly analyzing goods available on the market. They are often guided by the opinions of other users, brand recognition, or media coverage. Therefore, in an information society based on the dynamic development of social media, tailoring advertising to current consumer needs and behaviors becomes crucial for running a business. Authentic and credible recommendations from trusted creators are becoming more important, and for many buyers, they are more persuasive than formulaic television commercials.

Considering the above arguments, many companies are making changes to their advertising strategies, for example, opting for influencer marketing. Online creators typically publish aesthetically and thematically consistent content that captures the interest of users with similar preferences and tastes. A business partnering with an influencer who shares similar values gains the opportunity to reach a large group of potential consumers, made up of the influencer’s followers. TikTok has become the dominant platform enabling the implementation of the marketing model described above. In 2017, the application had approximately 72 million monthly active users, and according to data from 2026, this number has increased to approximately 1.54 billion. In Europe alone, TikTok has already reached over 200 million users, and in Poland, the number ranged from 11 to 15 million. The average time spent on the platform is 70 minutes per day, which translates to approximately 35 hours per month. These statistics also indicate the continued growth of TikTok’s popularity, confirming the future of using social media for advertising and promotional purposes.

The development of influencer marketing significantly changed existing marketing practices, and its increasing prevalence led to the transformation of the TikTok app from a social media platform into an advertising system. The effective and profitable collaboration between media and advertising prompted the platform to take the next step in its development, combining these two sectors. Users were offered the opportunity to completely simplify the purchasing process. Previously, consumers only saw product advertisements, which attracted their attention and prompted them to search for sales offers. However, this pattern left them time to consider whether a purchase was truly necessary or necessary. It was also likely that, despite their interest in the product, they would eventually forget about the advertised product, and therefore their desire to purchase it.

The solution to the marketing strategy described above turned out to be a new feature presented by TikTok: TikTok Shop. The innovative nature of this tool is based on a closed-loop model, meaning the purchasing process takes place within a single app. Users first encounter content promoting a specific item. They then have the option to immediately purchase it by adding the advertised item to their shopping cart in the bottom corner of the app. TikTok acts as an intermediary for payment, shipping, and the entire order process. In this way, the app has evolved not only into a profitable advertising system but also an online store, becoming a marketplace platform that mediates payment, logistics, and order fulfillment.

The origins of TikTok Shop

Initially, the online shopping phenomenon developed through e-commerce. Its popularity contributed to the diversification of online sales into several business models: B2C, B2B, and C2C. The former involves a relationship between a business and an individual customer (examples include online stores such as Zalando, Zara, and IKEA). B2B refers to transactions between businesses, while C2C refers to sales between individuals, such as on platforms like Vinted, OLX, and Allegro.

These e-commerce models typically control the sales process independently. Their profits largely come from consumers who shop by searching for specific products they need. Entrepreneurs compete with each other through marketing activities aimed at convincing consumers of the quality of their products and building brand recognition.

In the next stage, the development of social media, and consequently influencer marketing, contributed to the emergence of a completely new type of buyer, one driven by impulse. Online creators present a specific lifestyle on their profiles in a significantly idealized form, which attracts the attention of their followers and becomes a role model. The desire to emulate the creator they follow can manifest itself both in their behavior and in the possessions they possess. The influencer thus becomes a person who inspires and encourages the purchase of a given product. Even if, from a rational perspective, the buyer doesn’t need the product, they often decide to purchase it under the influence of influencer marketing.

Additionally, a new branch of e-commerce has emerged, known as discovery commerce . This model relies on the discovery and purchase of new items while actively browsing social media. Highly advanced algorithms select content for users that aligns with their tastes or interests, in order to evoke certain emotions that then transform into a strong purchasing impulse. Social media platforms, recognizing this profitable sector, have contributed to the development of social commerce, including TikTok Shop. This solution capitalizes on users’ fleeting enthusiasm and allows them to complete their order without leaving the app. The entire process, from advertising content to payment and shipping, is handled by TikTok, which can limit the time available for rational purchase consideration.

What exactly does the purchasing process look like on TikTok Shop?

TikTok Shop is not a separate app, but a new feature added to the TikTok platform. There’s no need to create a new account or install a new app. This solution provides access to a wide group of potential consumers, as every existing TikTok user over the age of 18 can familiarize themselves with the new feature. This solution gives businesses multiple ways to reach consumers. The platform offers a separate tab, “Shop,” where users can search for specific products using filters and categories, or browse recommended items based on their activity on the platform.

Products offered by sellers using the TikTok Shop service can also be viewed on the “For You Page” tab. This is the subpage most frequently visited by users. This option is especially useful when a company decides to use influencer marketing. A creator posts a video promoting a selected product, and buyers are immediately presented with a purchase button at the bottom of the page. Consumers can also directly access the profiles of brands and creators to find the products they offer or promote.

The latest feature, TikTok Live, is gaining popularity. Before the live stream begins, the seller or influencer adds products available in the TikTok Shop. During the live stream, the host can showcase products, communicate with users, and answer their questions via chat. This can increase the credibility of the product and the seller, as well as encourage consumers to make a purchase, which they can do without interrupting the stream.

The very process of posting ads on TikTok Shop helps build consumer trust. Becoming a seller requires thorough verification, which the TikTok platform conducts to protect users from unreliable and fictitious businesses.

The first step to becoming a seller is to log in to your TikTok Seller Center account using your email address, phone number, or existing TikTok account. You’ll also need to fill out an application form with information that proves your seller credentials, such as your company name, address, and contact information.

After successful verification, the seller completes their store profile, adding a description, name, logo, seller details, addresses, customer service information, and tax information. It’s also necessary to configure payment and delivery methods, including the shipping address, available delivery methods, order processing time, and return policy. Connecting the store dashboard to a regular TikTok account is also crucial. This allows for tagging offered products in live videos, etc. The seller then has the option to publish their product, including the title, description, price, available models, and inventory. The platform also allows businesses to add listings by importing a product catalog from another sales platform.

After a consumer makes a purchase, the seller receives a sale notification in the TikTok Seller Center. The seller is then responsible for packaging and shipping the item to the user, which can be done manually or using external order processing systems.

Distance selling and consumer rights

The TikTok Shop platform offers the option of concluding a sale via a distance contract. This does not require the parties to be physically present at the same time, but rather requires at least one means of distance communication (Act of 30 May 2014 on consumer rights, Article 2). Therefore, when making a purchase through the TikTok Shop, consumer rights are governed by national and European Union law.

In Poland, the primary legal act regulating these activities is the Act of May 30, 2014, on Consumer Rights. Article 12 requires businesses to clearly inform consumers in distance contracts, including the method and deadline for contract execution, the total price including taxes, the right to withdraw from the contract, the complaint procedure, and the seller’s identifying information. The TikTok Shop platform is therefore obligated to provide the required information to the user before finalizing the order via the app. An important regulation is also included in Article 17 of the aforementioned Act and concerns the requirement to design the interface in a way that confirms the consumer’s awareness of the obligation to pay. In the case of platforms that allow order completion via a “button,” it must be clearly marked, e.g., “I buy with an obligation to pay” or “I buy and pay.” Otherwise, the contract is not concluded. The requirements described above are referred to as ” button ” solution ” and are intended to protect consumers from accidentally concluding paid contracts. Alternative obligations also arise from the Directive of the European Parliament and of the Council of 25 October 2011 on consumer rights.

The Consumer Rights Act also implements the EU Commodity Directive (2019/771), introducing uniform standards for the conformity of goods with the contract. A trader is liable for any lack of conformity of goods with the contract upon delivery and for two years from the date the discrepancy is discovered. The Act also governs basic consumer claims in the event of non-conformity, including repair or replacement of the goods, and if this is not possible, a price reduction or withdrawal from the contract.

Given that the sales strategy on the TikTok Shop platform relies on recommendation algorithms and influencer marketing, the Omnibus Directive (EU) 2019/2161 of November 27, 2019, plays a significant role in consumer empowerment. Its regulations introduce the obligation to provide information about the lowest price, disclose whether reviews were published by verified consumers, and indicate whether the seller is a business or an individual. The Omnibus Directive therefore increases consumer awareness and allows consumers to make more rational and manipulation-free purchasing decisions.

Digital Services Act Regulation

Due to their global nature, online platforms reach hundreds of millions of users. Content published through them can reach a very wide audience, thus influencing social, political, and economic relations. Massive social networking sites, therefore, go beyond simply providing entertainment or communication services and digital space, and are beginning to shape the reality around us.

The strong influence of individual platforms on current international relations has initiated more stringent oversight, including through the provisions of Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on the single market for digital services and amending Directive 2000/31/EC (Digital Services Act – DSA). Based on this regulation, TikTok was recognized by the European Commission as a Very Large Online Platform (VLOP). This status is granted to portals with monthly active users exceeding 10% of the EU population. TikTok exceeded the threshold and was classified as a VLOP in 2023.

Platforms deemed globally influential are not solely responsible for removing illegal content. They are also required to counteract the negative consequences that may arise from their operation. Among the most important responsibilities of very large online platforms (VLOPs) is the identification and assessment of systemic risks and the potential implementation of proportionate mitigation measures. Impacts on fundamental rights, democratic processes, the protection of minors, public safety, and the dissemination of illegal content are particularly scrutinized. Once a specific risk is identified, measures are planned to counteract its escalation, such as modifying the user interface or changing certain advertising practices. In emergency situations, the European Commission has the authority to require VLOP providers to assess the platform’s impact on the development of the crisis, implement specific mitigation measures, and submit periodic reports on the effectiveness of these actions. Very large online platforms are also required to undergo an annual independent audit of compliance with the Digital Services Act (DSA) and regularly publish comprehensive reports on their activities. The aim of this action is to ensure transparency of the platform’s operation towards users and supervisory authorities.

The DSA also regulates advertising by introducing the requirement to maintain a public ad repository. This repository should include, among other things, the ad’s content, advertiser, funding entity, broadcast time, and the number of recipients. This solution is intended to ensure transparency in advertising messages and enable social and scientific analysis of platforms’ promotional activities. Restrictions have also been imposed on recommendation systems. This means that VLOPs are required to provide users with at least one way to display content that is not based on profiling, meaning it does not use user activity history or data. To monitor platforms’ compliance with the EU regulation, it is also possible to impose a requirement to share data on, for example, the performance of recommendation algorithms with the European Commission, national digital service coordinators, or verified researchers.

TikTok, however, is not subject only to the obligations of very large online platforms. It is subject to all regulations provided for in the Digital Services Act. According to Article 26, each advertisement must be clearly identified as promotional material and indicate the advertiser, the funding entity, and the mechanism by which it was tailored to the user. This restriction is particularly useful for the TikTok Shop platform, where sponsored content is commonly created in the manner of regular content published by creators. Limiting the phenomenon of so-called hidden advertising through the provisions described above aims to increase user awareness.

One of the DSA’s key goals is also the protection of minors. When designing their services, platforms are required to consider a high level of protection for minors and their privacy. It is prohibited to display advertisements based on the profiling of minors when the platform has knowledge of the user’s minor status. The goal is to limit the use of children’s data for marketing purposes and reduce the risk of addictive use of the app.

The European Commission has also become concerned about potential negative consumer behavior resulting from the increasing transformation of large social media platforms into e-commerce portals. Complex profiling algorithms, influencer marketing, and instant purchases can encourage users to make impulsive decisions or even become dependent on purchasing processes. Articles 25 and 27 of the Consumer Protection Act (DSA) mitigate this risk. Designing web interfaces that manipulate or complicate consumer decision-making – so-called dark patterns – is prohibited. Examples of unacceptable solutions include hiding options that are less favorable to the business, making it difficult to unsubscribe from services, or designing buttons that encourage a specific choice. Users should also be fully aware of how the recommendation system works; therefore, platforms are required to clearly present its main parameters and the possibility of changing the content suggestion method.

Tamper protection and dark patterns

A key premise of the TikTok Shop platform is the immediacy of purchases. While this solution is very beneficial for businesses and, typically, consumers, it can lead to abuse. Sales without leaving the app, a simplified order completion process, and algorithmic personalization of recommended products seem to provide greater convenience when shopping online. However, some activities can be classified as ” dark patterns”, manipulations used to mislead users and influence their decisions. Because the practices described above can lead to impulsive behavior and distort consumer will, they may be treated as unfair market practices and subject to criminal penalties.

The Act of 23 August 2007 on Counteracting Unfair Market Practices defines an unfair market practice as a sale that is contrary to good practice and significantly distorts or may distort the market behavior of the average consumer before, during or after the conclusion of a product agreement , in particular a misleading market practice and an aggressive market practice (Act of 23 August 2007 on Counteracting Unfair Market Practices, Article 4). The main grounds for considering a market practice misleading include the dissemination of false information or truthful information in a potentially misleading manner. Such misleading information typically concerns the existence of a product, its type or availability, price, the method of price calculation, or the existence of a special price advantage.

To encourage immediate purchases, sellers pressure buyers with messages suggesting limited availability or a limited-time promotion for a specific product. Examples of such messages include phrases like “100 people are viewing the product,” “offer ends in 2 hours,” or “only 4 items left.” This practice is not illegal and is one of the most common marketing mechanisms. Problems arise when the website or portal is programmed to continually extend promotions, the offer doesn’t actually expire after the specified date, or the counter restarts upon page refresh.

Misleading practices, such as suggesting the limited nature of a permanently available offer, and aggressive practices, such as exerting time pressure, may result in legal consequences. In addition to the aforementioned Act of 23 August 2007 on Combating Unfair Commercial Practices, this issue is also regulated by Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market. This directive distinguishes between misleading commercial practices and aggressive commercial practices. Together, they constitute unfair commercial practices, which include, in particular, actions that are contrary to the requirements of professional diligence and that significantly distort or are likely to significantly distort the economic behavior of the average consumer who reaches or is targeted by the practice, or the average member of a group of consumers if the commercial practice is targeted at a specific group of consumers (Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (“Unfair Commercial Practices Directive”), Chapter 2, Article 5, paragraph 2).

Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 (Omnibus Directive) is also intended to combat various manifestations of the “dark patterns” phenomenon. It requires sellers to disclose the lowest price for a product within the last 30 days. This is intended to prevent the practice of artificially inflating prices and then announcing sales. The practice of fake reviews has also been curbed by introducing an obligation to disclose whether and how reviews posted on sales websites are verified. The Omnibus Directive also introduced the requirement to indicate on marketplace platforms whether the seller is a private individual or a professional entrepreneur, so that consumers are aware of who they are buying from.

The European Union has also introduced restrictions related to the design of digital services, contained in Regulation 2022/2065 on the Digital Single Market (DSA). As a result, online platform providers cannot design, organize, or operate their online interfaces in a way that misleads, manipulates, or otherwise interferes with or limits the ability of service users to make free and informed decisions. The regulation therefore directly addresses the fight against “dark patterns,” i.e., website design practices that deliberately use deceptive techniques, such as pre-selected consents or difficult unsubscribes.

The President of the Office of Competition and Consumer Protection (UOKiK) has broad authority to protect consumers from the unfair commercial practices mentioned above. Under the Act of 16 February 2007 on Competition and Consumer Protection, one of his powers is to protect the collective interests of consumers, including through provisions counteracting unfair market practices. If necessary, the UOKiK President may initiate proceedings against a business, ordering it to cease the unfair practice, or requiring the seller to remedy the effects of the violation. Should a business fail to comply with the guidelines, he may impose a fine of up to 10% of the business’s turnover in the previous year.

The number of legal acts, including EU documents, regulating unfair commercial practices reflects the considerable interest in this issue among both legislators and consumer protection authorities. TikTok Shop, as a social commerce model, is not illegal. It utilizes mechanisms combining influencer marketing, personalization, and emotional impact on the recipient, but the design of the user interface is crucial for this platform. The popularity of mass sales portals has contributed to the increasing use of “dark patterns” by businesses over the past few years. For this reason, the European Union and the Office of Competition and Consumer Protection (UOKiK) are increasingly rigorously monitoring sales tactics and issuing new legal acts to protect consumers and their free will when making purchases.

Influencer Marketing and Advertising Law

The effectiveness of influencer marketing stems from combining advertising with the ability to make an immediate purchase. Affiliate links, product tags, or direct purchase buttons, such as those on the TikTok Shop platform, are displayed beneath posts, videos, or other promotional materials. This purchasing model has proven effective by significantly simplifying the ordering process, thus reducing the time consumers spend considering the rationale behind the transaction.

The popularity of the marketing strategy described above stems from its perception by users, who perceive it as authentic and credible. Influencers present promoted products in a natural way, integrating them into their daily routine. However, if the material does not solely reflect the creator’s personal opinion but is created after receiving a benefit in return, it is considered commercial communication. This means it is subject to legal regulations on advertising and consumer protection. In Poland, influencers should clearly label advertising content in accordance with the Recommendations of the President of the Office of Competition and Consumer Protection. These regulations are intended to prevent misleading users.

Only content regarding a product that the influencer purchased independently and for which they did not receive remuneration or other benefits can be marked as a private opinion. Such material contains genuine feelings and opinions and therefore does not constitute advertising under the law and is not subject to advertising law. This is the most credible and reliable form of review for potential consumers, as it was created by a person not under any obligation to the manufacturer.

A manufacturer may enter into an agreement with an influencer to promote a product in exchange for a free product, financial benefit, or other form of remuneration. This creates legally regulated advertising. It may take the form of a post, report, or live broadcast in which the creator demonstrates how they use the product and its positive properties. Due to the natural presentation of the product as an everyday element, the recipient may have difficulty distinguishing a genuine recommendation from commercial content. The Act of August 23, 2007, on Counteracting Unfair Market Practices, classifies the act of concealing a promotional message as a misleading omission. Failure to clearly indicate the commercial nature of the material may hinder consumers’ proper assessment of the message and directly influence their purchasing decisions.

Another common advertising strategy is to feature a product integrated into published content without directly promoting it, for example, by placing it in the background of the material. This phenomenon is called product placement. Activities covered by advertising and consumer protection law also include, among others, affiliate and partner links, ambassador programs, and partner competitions. In Poland, these practices must contain clear, understandable to the average recipient, and visible advertising labels from the very beginning, such as “advertisement,” “paid collaboration,” or “sponsored content.” The Office of Competition and Consumer Protection (UOKiK) also recommends the use of two-level labeling, meaning that, in addition to the information contained in the content, the platform’s functionality must also be used to announce the paid collaboration. Detailed guidelines can be found in the Recommendations of the President of the UOKiK regarding the labeling of advertising content by influencers. Material is considered advertising content not only when the influencer receives monetary compensation in exchange for its creation. The same obligation applies when promoting your own business, receiving a free product or service, or obtaining a sales commission via an affiliate link or discount code (Recommendations of the President of the Office of Competition and Consumer Protection regarding the marking of advertising content by influencers).

In the event of non-compliance with the Recommendations of the President of the Office of Competition and Consumer Protection regarding the labeling of advertising content by influencers, pursuant to the Act of 16 February 2007 on Competition and Consumer Protection, the Office of Competition and Consumer Protection (UOKiK) conducts proceedings against entrepreneurs using practices that violate the collective interests of consumers. Actions may be taken against advertisers, influencers, and marketing agencies. Therefore, responsibility for incorrect labeling of advertising content rests not only with the creator publishing the material but also with all entities participating in organizing the promotional campaign. One of the sanctions that the President of the UOKiK has the right to impose is a financial penalty. Incorrectly labeled promotional material can also be considered surreptitious advertising. Due to the dynamic development of influencer marketing, the proper creation of marketing content is currently widely subject to UOKiK scrutiny. Therefore, it is worth clearly and understandably labeling sponsored publications, among other things, to avoid significant financial penalties.

Personal data protection

TikTok Shop, as a hybrid social network and e-commerce platform, processes a significant amount of data related to both user activity and purchasing processes. The app’s operation is based on audience profiling and matching the most relevant content. Therefore, the platform’s operations are subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (GDPR).

In addition to user data such as name, surname, contact details, shipping addresses, and payment information, media platforms also collect information that allows for behavioral analysis. Time spent browsing specific products, interactions with ads, and the history of items added to carts or wish lists allow the TikTok Shop platform to create a personalized recommendation system based on past activity. This phenomenon creates so-called behavioral advertising, a marketing strategy based on user profiling using advanced algorithms to predict future purchasing decisions. The concept of profiling refers to the automated processing of personal data, particularly for the purpose of predicting a user’s economic situation, personal preferences, interests, health, and location.

According to the GDPR, profiling is permissible, but it also comes with a number of obligations. Platforms are obligated to transparently inform users about, among other things, the purposes of profiling, the legal basis for data processing, the consequences of the actions taken, and their rights, including the right to object to profiling. Data of minors is particularly protected. Due to the growing popularity of the TikTok app among young users, it was necessary to subject it to special regulations in this regard. In the area of information society services, the processing of data of children over 16 years of age is lawful. An exception is made for situations in which a person with parental authority or guardianship provides prior consent. However, EU member states may introduce a lower age limit in their laws, but it must be at least 13 years old, as is the case in Poland, for example. To ensure that platforms enforce their obligations related to the protection of minors, they should use appropriate age verification mechanisms. In practice, however, this solution requires further improvement due to the common practice of users providing false data during registration.

The President of the Office of Competition and Consumer Protection (UOKiK) plays a crucial role in protecting users, especially the collective interests of consumers. He is authorized to take action against entrepreneurs who engage in unfair market practices, design manipulative interfaces, and so on. Personal data protection, however, falls primarily within the remit of the Office for Personal Data Protection (UODO), which oversees compliance with the GDPR and the secure processing of information by companies and institutions. Due to its global influence, TikTok has attracted increasing attention from EU authorities in recent years and is becoming the subject of more frequent inspections. Due to the platform’s European headquarters being located in Ireland, the relevant supervisory authority is the Irish Data Protection Commission (DPC). For example, in 2025, this institution imposed a fine of €530 million on ByteDance, the app’s owner. The fine was imposed on the transfer of user data from the European Economic Area to China in violation of the GDPR and the failure to demonstrate data protection at the level guaranteed in the EU.

The GDPR is supplemented by Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications), which regulates, in addition to the processing of personal data, the confidentiality of electronic communications, also known as ePrivacy. Due to the scope of its regulations, the provisions of this directive have particular relevance to the TikTok Shop application. The platform uses numerous tracking technologies, such as cookies and mobile device advertising identifiers, to monitor user activity. Information may be stored on a user’s device or accessed only after obtaining prior consent. Exceptions are made only for technologies strictly necessary to provide the service requested by the user, such as remembering a shopping cart. An additional ePrivacy regulation was also envisaged, the purpose of which was to replace the current directive and harmonize the personal data protection rules applicable in all EU Member States. The changes were to include, among other things, simplifying the rules regarding cookies. However, the project encountered legislative difficulties and was not adopted by decision of the European Commission.

Abuse of Market Power and the Digital Markets Plan

The dynamic expansion of the largest digital platforms’ influence has led to the need to adapt competition law to the new situation, particularly in the digital market. To this end, the European Union adopted Regulation (EU) 2022/1925 of the European Parliament and of the Council of 14 September 2022 on contestable and fair markets in the digital sector and amending Directives (EU) 2019/1937 and (EU) 2020/1828 (Digital Markets Act – DMA). The Act introduces the concept of a gatekeeper. This term refers to an entrepreneur with an influential position in the internal market, through which business users reach end users. A gatekeeper provides a core platform service and maintains an established market position.

The dominant position of a gatekeeper is also associated with a number of obligations. Among other things, the practice of self-preferencing, which involves favoring one’s own products or services over the offers of other businesses using the platform, is prohibited. In the case of TikTok Shop, this could involve using recommendation algorithms to increase the visibility of products promoted by individual sellers, without applying objective and fair advertising criteria. This type of favoritism and limiting the reach of individual entities could lead to a distortion of fair competition between businesses using TikTok Shop for sales purposes.

By decision of the European Commission, BytaDance Ltd. was granted gatekeeper status solely for the operation of the TikTok application as a social media platform. The DMA regulations governing the gatekeeper position do not apply directly to TikTok Shop, but they may impact the rules for recommending products and using entrepreneurs’ data.

Media law and audiovisual regulations

Audiovisual materials are the primary tool for promoting and selling products on the TikTok Shop marketplace. Therefore, the app’s operations are also subject to scrutiny for compliance with media law and regulations governing audiovisual media services. The dominant role in this regard is played by Directive 2010/13/U of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation, or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive – AVMSD) and the Broadcasting Act of 29 December 1992, which implements it into Polish law. As a result of the amendment to the Act of 11 August 2021, the regulations have been extended to video-sharing platforms, including the TikTok app.

Video-sharing platforms are primarily obligated to implement appropriate measures to protect minors from harmful content that could negatively impact their moral, mental, or physical development. These provisions have been implemented into Polish law through Article 47e of the Broadcasting Act, which mandates, among other things, the marking of potentially inappropriate content with special graphics for young viewers. These regulations are particularly important for the TikTok Shop platform due to the constantly growing number of underage users. Posting content that spreads hatred and discrimination is also prohibited.

TikTok Shop, a hybrid social media platform and e-commerce platform, is often used to publish so-called audiovisual commercial communications—images used to directly or indirectly promote goods, services, or individuals (Directive 2010/13/U of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services, Article 1). Article 9 of the AVMSD requires member states to ensure that such communications are easily recognizable, thus prohibiting hidden audiovisual commercial communications. The use of subliminal techniques or the inclusion of discriminatory content would also be illegal. The National Broadcasting Council (KRRiT) is responsible for ensuring compliance with audiovisual law. Its remit includes, among other things, overseeing the activities of video-sharing platform providers.

The sales method used by TikTok Shop may seem analogous to teleshopping, offerings directly to consumers to deliver goods or services in exchange for payment. This modern form of interactive audiovisual commerce (live shopping) bears numerous similarities to traditional teleshopping. The mechanisms of both aforementioned sales methods involve presenting the product, its specific features, available options, and generally encouraging the recipient to purchase. However, teleshopping is targeted at a general, anonymous audience who may only be interested in the recommended product. Meanwhile, TikTok Shop relies on advanced algorithms that target promotional content to users who, based on their previous activity, have shown interest in similar content.

Platform liability under e-commerce regulations

The original act regulating the legal liability of online platforms in the European Union was Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce). Its foundation was the so-called safe harbor principle, i.e., the principle of limited liability of online intermediaries. According to this principle, hosting service providers and online platforms were not liable for content or goods published by users, provided they had no actual knowledge of the illegal nature of the content or goods or services or, upon obtaining such knowledge, promptly removed any infringements. Furthermore, the directive did not impose a general obligation on platforms to monitor content published by users.

However, the ongoing development of digital platforms has made it necessary to amend the current liability model. Regulation (EU) 2022/2065 – Digital Services Act (DSA) – came into effect on February 17, 2024. This regulation does not eliminate the principle of limited liability but significantly expands monitoring obligations, especially for very large online platforms (VLOPs). One of the key obligations introduced under the new regulations is the Know Your Business Customer (KYBC) principle. This regulation aims to increase the safety of consumers shopping online by limiting sales conducted by dishonest or anonymous traders. Before enabling sales through its platform, an online platform must collect and verify basic data identifying the seller. The required information includes, among others, the trader’s name, registered office address, contact details, registration number in the relevant register of traders, and the trader’s payment account details. In the event of refusal to provide the specified data or providing it falsely, the platform should prevent the trader from conducting sales until the situation is resolved.

A problematic issue related to the TikTok Shop app is defining the platform’s responsibility for transactions conducted by sellers using it. Although TikTok Shop formally acts as an online intermediary, it can be argued that its operating mechanism goes beyond passive hosting. A recommendation system using algorithms, promoting offers, and providing marketing and analytical tools to sellers are the mechanisms TikTok Shop uses to shape consumer behavior and purchasing decisions. The platform’s influence on the visibility of offers and the order fulfillment process may support assigning it broader responsibilities in overseeing the online sales process.

Regulations on electronic communications, including the European Electronic Communications Code and the Polish Electronic Communications Law

The TikTok Shop platform does not constitute an electronic communications service under European Union law, but its operations provide for various forms of electronic communication. TikTok Shop’s use of push notifications, in-app messages, and marketing communications requires the platform to comply with regulations governing electronic marketing and the protection of user privacy in electronic communications. The primary legal acts regulating these aspects are Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (EECC) and the Act of 12 July 2024 – Electronic Communications Law.

The primary function of TikTok Shop is to enable entities to sell goods through the social media platform. Article 2 of the European Electronic Communications Code defines an electronic communications service as the transmission of signal transmissions or the provision of interpersonal communications services. The mere ability to exchange messages between users or with sellers does not automatically qualify the TikTok Shop platform as a provider of electronic communications services, as this is not its core competency and does not constitute its core business. However, because electronic communications are primarily used for marketing purposes, it is obligated to comply with regulations governing direct marketing and the protection of user privacy.

Push notifications, messages sent directly to users’ mobile devices, are an increasingly popular marketing solution. TikTok Shop uses them to provide information about order status, discounts, time-limited campaigns, or the launch of live shopping. Transactional notifications regarding order fulfillment, shipping, or payment status are typically part of the contract and do not require marketing consent. However, notifications encouraging potential consumers to make a purchase are classified as direct marketing and, in accordance with electronic communications law, require prior user consent.

The practice of using automated calling systems and electronic means of communication for advertising purposes without the user’s prior consent is also prohibited. Users should be clearly informed about the purpose of receiving marketing communications, the data controller, and the possibility of withdrawing consent, which should not result in any negative consequences. With respect to the TikTok Shop platform, the above position means that it is unlawful to send promotional content to users solely based on the fact that they have an account on the app.

TikTok Shop is the clearest example of how thin the line between entertainment, advertising, and commerce has become – a one-tap purchase woven into a stream of content is now as effortless as liking a video. Yet that convenience comes at a price: the closed-loop model and algorithmic personalization shrink the time left for rational reflection, while responsibility for protecting the consumer shifts increasingly away from the buyer and onto the platform and the legislator. EU and national regulations – from consumer law, through the DSA and DMA, data protection and safeguards for minors, all the way to media and electronic communications law – form a web meant to counterbalance the platform’s power and restore the buyer’s awareness of their own choices. TikTok Shop thus remains a dual phenomenon: on one hand a groundbreaking innovation in digital commerce, on the other a test of whether the law can keep pace with a technology that sells faster than we can think.

Artykuł A Store in Your Pocket, the Law in the Background: TikTok Shop Under the Regulators’ Lens pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Biostimulants in aesthetic medicine – current regulatory challenges for manufacturers, distributors and clinics

The aesthetic medicine market is currently one of the fastest-growing healthcare segments in Europe. Particularly dynamic growth is observed in so-called tissue biostimulants, preparations used to stimulate the body’s natural regenerative processes. While traditional fillers dominated just a few years ago, today both manufacturers and physicians are increasingly turning to preparations containing poly-L-lactic acid (PLLA), calcium hydroxyapatite, polynucleotides, and collagen preparations, whose mechanism of action is based on the stimulation of tissue regeneration processes rather than solely on mechanical effects.

The growing popularity of these products, however, raises a number of legal questions. These concern not only their qualification as medical devices, but primarily the manner of communicating their properties and permissible forms of promotion. In practice, manufacturers, importers, distributors, and aesthetic medicine clinics increasingly face the dilemma of drawing the line between providing reliable product information and advertising, which is subject to stringent legal restrictions.

This issue has become particularly important following the entry into force of the Act of April 7, 2022, on Medical Devices and the issuance of the Regulation of the Minister of Health on the Advertising of Medical Devices. Polish legislators have decided to introduce some of the most detailed regulations regarding the advertising of medical devices in Europe. These restrictions directly impact the activities of manufacturers, distributors, importers, healthcare providers, and marketing agencies serving the aesthetic medicine industry.

At the same time, it’s important to remember that advertising medical devices does not operate in isolation from other legal regulations. Businesses must consider not only the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and the Medical Devices Act, but also regulations on consumer protection, combating unfair market practices, combating unfair competition, personal data protection, and sometimes regulations governing the practice of medical professions and healthcare activities. Consequently, a single marketing campaign may be subject to simultaneous assessment under several different legal regimes.

Particular difficulties arise with products used exclusively by individuals with appropriate professional qualifications. In practice, most biostimulants are administered via injection by a physician or other qualified medical professional. This raises the question of whether products intended exclusively for professional use can be advertised at all, and if not, how can businesses legally present information about their offerings on websites, social media, or at industry conferences.

The purpose of this study is to present practical aspects of applying regulations regarding the advertising of medical devices, using tissue biostimulants as an example. Particular attention will be paid to the boundary between advertising and information, the obligations of manufacturers and distributors, the most common marketing errors, and compliance solutions that can reduce the risk of violating applicable regulations.

Biostimulants – why do they raise so much legal controversy?

From a legal perspective, biostimulants constitute one of the most interesting categories of medical devices. Their specificity lies in the fact that, although formally subject to regulations specific to medical devices, their method of use, risk profile, and patient perception often resemble medicinal products more than traditional medical devices.

In market practice, patients often fail to recognize the difference between a medicinal product and a biostimulant. Both types of products are administered in a doctor’s office, require medical qualifications, involve intervention in the body, and may cause adverse reactions. Therefore, for the average consumer, the difference between a medicinal product and a medical device remains almost invisible.

From the perspective of EU law, however, what matters most is not the method of administration or the site of use, but the mechanism by which the principal intended action is achieved. The MDR is based on a fundamental distinction between medicinal products and medical devices. If the principal action is achieved by pharmacological, immunological, or metabolic means, the product will generally be classified as a medicinal product. However, if the mechanism of action is based on other properties – for example, physical or mechanical – the product may be classified as a medical device, even if its use leads to long-term biological effects.

This very boundary has been the subject of numerous interpretational disputes for years. In the case of biostimulants, the preparation does not replace natural processes occurring in the body nor does it produce a therapeutic effect through a pharmacological mechanism. Its purpose is to create conditions enabling the activation of natural regenerative processes, such as stimulating fibroblasts to produce collagen or rebuilding the extracellular matrix. It is this mechanism that causes most currently available biostimulants to be classified as medical devices.

This does not mean, however, that all products marketed as “biostimulants” automatically fall into the same regulatory category. Legal classification is determined by a case-by-case analysis of the specific product, its intended use, and the mechanism of action specified by the manufacturer. In practice, there are also products that, despite similar aesthetic applications, may be subject to different legal regimes, including regulations concerning medicinal products, cosmetics, and medical devices.

This is fundamental for subsequent marketing communications. Already at the product qualification stage, the manufacturer should consider the target audience, the information that can be conveyed to recipients, and the advertising restrictions that will apply. Mistakes made at this stage often result in the need to redesign the entire marketing strategy after the product has been launched.

Can biostimulants be advertised? Limitations under the Medical Devices Act and the MDR Regulation

One of the most frequently asked questions by manufacturers, importers, and healthcare providers is whether biostimulants can be advertised to a broad audience. The answer to this question is ambiguous and requires consideration of both the provisions of the EU MDR Regulation, the Polish Medical Devices Act, and implementing regulations governing advertising.

In practice, a certain pattern can be observed. Many entrepreneurs equate the fact that a product has been legally introduced to the market with the ability to freely promote it. However, this assumption is incorrect. Approval of a medical device for marketing does not automatically mean that the manufacturer or distributor can use any marketing tools. On the contrary, the more specialized the product and the greater the risk associated with its use, the greater the restrictions on its communication.

In the case of biostimulants, it is particularly important that the vast majority of these products are intended for use only by individuals with appropriate professional qualifications. Treatments using them require medical qualification, maintaining appropriate aseptic conditions, and injections performed in accordance with medical knowledge. Therefore, the recipient of the product is not the patient, but a medical professional who then uses the product while providing healthcare services or aesthetic medicine treatments.

This circumstance is of fundamental importance from the perspective of advertising law.

Advertising of medical devices is not advertising of consumer products.

The Medical Devices Act adopts different assumptions than the regulations governing the advertising of ordinary consumer goods. The legislator’s goal was not to create freedom in marketing activities, but to ensure that decisions regarding the use of medical devices are made primarily based on medical knowledge, not advertising messages.

For this reason, the legislator decided to introduce numerous restrictions on both the content of advertising and its target audience. In practice, this means that, already at the design stage of a marketing campaign, entrepreneurs should answer three fundamental questions:

• who is the actual user of the product,
• to whom the message is addressed,
• whether the information provided is of a promotional nature or purely informational.

Only a combined analysis of these elements allows us to assess the compliance of the planned communication with applicable regulations.

The intended use of the product is crucial.

In practice, there’s a common misconception that advertising opportunities are determined solely by how a product is sold. This isn’t the correct approach.

The manufacturer’s intended use of the product and the user group specified in the technical documentation and instructions for use are of much greater importance. If the manufacturer has specified that the product should only be used by professionals, this also influences the assessment of the admissibility of directing marketing messages to individuals without medical qualifications.

This is precisely the situation with most biostimulants. These products are intended for procedures requiring appropriate professional training, knowledge of anatomy, aseptic techniques, and the ability to recognize contraindications. From a regulatory perspective, it would be difficult to justify extensive advertising campaigns aimed at the general public when the product itself cannot be used independently by the average consumer.

This doesn’t mean, however, that businesses cannot provide any information regarding such products. On the contrary, the law permits the provision of information about medical devices, but the line between information and advertising requires individual assessment.

Advertising and information – why is the distinction so important?

In practice, the vast majority of disputes concerning medical device advertising do not focus on obvious promotional campaigns. Much more often, the problem arises with materials that businesses define as “informational,” while from the perspective of regulatory authorities, they may be considered advertising.

Importantly, neither the MDR nor the Medical Devices Act provide a legal definition of medical device advertising. However, the lack of a statutory definition does not imply any freedom of interpretation. Case law and doctrine assume that the nature of a message is primarily determined by its actual purpose, not the name given to it by the trader.

If the primary purpose of the message is to increase interest in the product, build a positive image of the product or encourage its purchase or use, there is a high probability that the message will be classified as advertising, regardless of whether it contains a direct call to purchase.

In practice, this means that even seemingly neutral materials may be considered advertising if they are prepared in a way that highlights only the advantages of the product, ignores its limitations or uses characteristic marketing techniques.

Is the manufacturer’s website itself an advertisement?

This is one of the most frequently asked questions in the practice of law firms advising manufacturers of medical devices.

There is no single universal answer to this question.

The mere presence of product information on a website does not constitute advertising. A website can function as a product catalog, a database of technical documentation, or a platform for communicating with medical professionals. However, if the product’s presentation goes beyond providing objective information and begins to utilize typical marketing mechanisms, the risk of such communication being classified as advertising significantly increases.

For example, posting instructions for use, declarations of conformity, technical data, or information on how to use a product on a website will generally be informative. However, a situation in which the same website includes slogans such as “revolutionary rejuvenation method,” “the most effective biostimulator available on the market,” “instant lifting effect,” or “spectacular results guaranteed” should be assessed differently. In such cases, the message goes beyond neutral information and begins to serve a promotional purpose.

Therefore, designing websites for medical device manufacturers requires close collaboration between marketing departments and legal and regulatory affairs departments . In practice, even seemingly minor changes in product presentation can result in a different legal classification for the entire message.

The boundary between advertising and information – practical problems of producers and aesthetic medicine clinics

While the distinction between advertising and information seems intuitive, in practice it is one of the most problematic issues related to the functioning of the medical device market. This stems primarily from the fact that contemporary marketing communication rarely takes the form of classic television or print advertising. Businesses much more frequently utilize websites, social media, newsletters, podcasts, webinars , expert blogs, and educational materials. Each of these forms can—depending on how it is prepared—be considered both neutral information and advertising.

In practice, there is no single element that automatically determines the classification of a given message. Supervisory authorities and courts analyze all the circumstances, taking into account the content of the message, its form, presentation, audience, and the actual purpose of the publication. This means that even a message containing only truthful information may be considered advertising if its primary purpose is to encourage the purchase or use of a product.

For this reason, businesses should move away from the simple question: “Are we allowed to publish this information?” and instead ask themselves: “How will the average recipient perceive this message?” It is the recipient’s perspective, not the business’s intention, that will in many cases determine the legality of the message.

Website – an entrepreneur’s business card or an advertising tool?

The first place where doubts arise is almost always the manufacturer’s, distributor’s, or clinic’s website. For many businesses, it is their primary channel of communication with the market, yet it is also one of the most frequently scrutinized elements during inspections conducted by regulatory authorities.

The mere presence of information about a medical device on a website is not prohibited. Businesses have the right to present information about the products offered, their properties, methods of use, technical documentation, and instructions for use. However, problems arise when the presentation method goes beyond providing objective information.

A good example is comparing two descriptions of the same product.

The first one could be as follows:

“A preparation intended for the reconstruction of tissue volume in accordance with the instructions for use. The product is intended for use by qualified medical professionals.”

This description is for informational purposes only. It is limited to presenting the product’s intended use and user group.

The following message should be assessed differently:

“The most innovative biostimulator on the market. It instantly rejuvenates the skin and provides a spectacular lifting effect after just one treatment.”

Although both messages refer to the same product, the second employs typical marketing tactics. It uses evaluative terms (“the most innovative,” “spectacular effect”), promises of effectiveness, and suggests a competitive advantage. This type of message is difficult to consider as neutral technical information.

In practice, this means that entrepreneurs should analyze not only the content of the information, but also the way it is expressed. Often, it is individual marketing terms that determine the overall nature of the message.

Newsletters and mailings to customers

Another tool increasingly used by manufacturers and distributors is newsletters and emails directed to customers. Again, not every message can be considered advertising.

If a newsletter contains information about changes in regulations, new regulatory requirements, announcements from supervisory authorities, or changes to product instructions, it will generally serve an informative purpose. However, messages whose primary purpose is to increase sales of a specific product should be assessed differently.

For example, a message titled “Changes to MDR requirements for technical documentation” would be educational in nature. An email with the slogan “Discover the most effective biostimulant available on the market – order today” would undoubtedly serve an advertising function.

This does not, of course, prohibit commercial communication. However, entrepreneurs should remember that such communication is subject to all restrictions applicable to advertising medical devices.

Webinars and training – education or product promotion?

The significant increase in the popularity of webinars organized by medical device manufacturers has also led to this form of communication starting to attract the attention of supervisory authorities.

Organizing training for doctors and other medical professionals is nothing unusual. On the contrary, in many cases, proper user training is an essential element in ensuring the safe use of a device.

The problem arises, however, when a webinar described as a “scientific training” actually focuses almost exclusively on promoting one product, highlighting its advantages while omitting limitations, contraindications, and alternative methods of treatment.

In practice, it is worth adopting the principle that the more educational the material is, the greater the emphasis should be on presenting objective medical knowledge, and not only information beneficial to the manufacturer.

Scientific conferences

Similar problems apply to industry conferences. Sponsorship of scientific events by medical device manufacturers is common practice and raises no objections in itself. However, risks arise when the scientific component is subordinated to marketing objectives.

In practice, particular caution should be exercised when presenting research results for a specific product. Results should be presented honestly, taking into account methodological limitations and the full clinical context. Selectively presenting only favorable data may be viewed as misleading.

LinkedIn – professional communication can also be advertising

Many content creators assume that since LinkedIn is primarily a professional platform, the content published there is strictly business-related. However, this assumption is far-fetched.

If a LinkedIn entry is limited to information about participation in a conference, obtaining a certificate, a scientific publication or organizational changes in the company, it is generally difficult to attribute an advertising nature to it.

However, if a publication contains incentives to use a specific product, comparisons with competitive products, promises of specific clinical effects or highlights the advantages of a product in order to increase sales, it may be considered advertising, regardless of the fact that it was published on a professional website.

LinkedIn is increasingly being used as a marketing platform for the healthcare market. Therefore, communications conducted via this platform should also be subject to the company’s internal compliance procedures.

Social media – the biggest challenge for the biostimulant market

Social media has completely transformed the way patients make decisions. Just a dozen or so years ago, the primary source of information was a doctor’s consultation and manufacturer-provided materials. Today, many patients primarily seek information on Instagram, TikTok, Facebook, and YouTube, guided by the opinions of influencers , physicians with educational profiles, and other users’ testimonials.

For entrepreneurs, this represents a huge marketing opportunity, but also significant regulatory risk. Traditional regulations regarding medical device advertising were designed with press, radio, and television advertising in mind. Modern online communication is much more dynamic and often combines elements of education, personal branding, and product promotion. As a result, assessing the legality of a specific message requires a case-by-case analysis of its actual purpose and context.

Instagram – where does education end and advertising begin?

Instagram remains the most important communication channel used by aesthetic medicine clinics and physicians performing biostimulant treatments. This platform relies primarily on visual communication, which inherently has a stronger impact on audiences than traditional product descriptions.

From a legal perspective, however, it cannot be assumed that every post about a procedure constitutes advertising. Physicians have the right to conduct educational activities, explain the mechanisms of individual procedures, discuss indications and contraindications, and comment on scientific publications. Such activities contribute to increasing patient awareness and should not, in and of themselves, be equated with advertising.

The line is crossed when communication begins to focus on promoting a specific medical device or building its commercial appeal. This applies particularly to publications containing marketing slogans, incentives for procedures, information about price promotions, comparisons with competing products, or emphasizing the exceptional effectiveness of a specific product without providing the full medical context.

In practice, it is worth adopting the rule that the more a post resembles advertising material prepared by a marketing agency, the greater the risk of it being classified as an advertisement for a medical device.

TikTok – short form does not exempt from responsibility

Just a few years ago, few medical device manufacturers considered TikTok a business communication tool. Today, the situation is completely different. More and more clinics are publishing short videos demonstrating treatment procedures, patient reactions, and the aesthetic effects achieved after using specific products.

The specific nature of this platform, however, means that the message is necessarily simplified. A video lasting several dozen seconds rarely allows for the presentation of contraindications, possible side effects, or limitations of the product’s use. As a result, there is an increased risk of creating a one-sided image of the product, highlighting only its benefits.

From a compliance perspective , businesses should therefore exercise particular caution when preparing materials published on platforms based on short audiovisual forms. Merely shortening the message does not exempt them from ensuring its compliance with regulations on advertising medical devices.

Influencer Marketing – New Regulatory Risk

influencers remains one of the most dynamically developing areas of marketing. This phenomenon has also impacted the aesthetic medicine market. Increasingly, individuals with significant social media followings are publishing treatment reports, presenting their recovery processes, and describing their own experiences using specific products.

From a legal perspective, such collaboration requires special caution. Even if the influencer doesn’t mention a specific product, the way the treatment is presented can lead to increased interest in a specific technology or manufacturer. If the publication is created as part of a commercial collaboration, additional obligations arise under regulations regarding labeling advertising content and consumer protection.

In practice, the producer should remember that responsibility for the legality of the message is not always limited solely to the influencer. Depending on the cooperation model, the entrepreneur initiating the campaign may also be responsible for the manner in which marketing communications are conducted.

Doctor as a product ambassador

The use of physicians’ authority to promote medical products remains a particularly sensitive issue. Public trust in medical professionals means their statements have a much greater impact than traditional advertising messages.

This doesn’t mean, however, that doctors cannot publicly comment on the technologies they use. On the contrary, sharing medical knowledge, clinical experience, and research results is a crucial element in the development of medical science and practice. The problem arises only when a doctor’s statement ceases to be expert-based and begins to serve a marketing function.

The risk increases especially when a physician appears in manufacturer-produced materials, uses promotional language, or explicitly encourages consumers to choose a specific product. In such cases, the regulatory authority may determine that the use of the medical profession’s authority serves to increase the product’s commercial appeal, which requires assessment from the perspective of regulations governing the advertising of medical devices.

Before – after photos – an effective marketing tool or a source of risk?

One of the most distinctive elements of communication in aesthetic medicine is photographs depicting the patient’s appearance before and after the procedure. From a marketing perspective, this is an extremely effective tool for influencing potential clients. However, from a legal perspective, its use raises a number of concerns.

Firstly, such materials often lead the recipient to believe that the treatment will provide a guaranteed result. However, the results of medical procedures depend on numerous individual factors, such as the patient’s health, age, biological predispositions, and adherence to post-treatment recommendations . Presenting single, spectacular results can lead to unrealistic expectations.

Secondly, publishing patient photos requires compliance with regulations on personal data protection and the protection of personal rights. Consent to perform a procedure does not constitute consent to the dissemination of the image. The provider should obtain separate, informed, and voluntary consent covering the publication of photographs in specific communication channels.

Third, it’s important to remember that even properly obtained patient consent doesn’t eliminate the risk of a publication being considered an advertisement for a medical device. If a photo is used to promote a specific product or increase interest in a specific procedure, the entire message should be assessed in light of advertising regulations.

In practice, this means that the use of ” before – after ” photography requires simultaneous analysis from the perspective of medical device law, personal data protection, civil law, and consumer protection regulations. Failure to consider even one of these aspects can lead to significant legal risk.

Misleading advertising – why can a truthful message also violate the law?

One of the most common mistakes made by businesses operating in the medical device market is the belief that because all information contained in an advertisement is truthful, the message is automatically legal. However, this assumption is far-fetched and is not supported by either the EU MDR or national regulations regarding medical device advertising.

Assessing the legality of advertising is not limited to verifying the veracity of individual claims. Equally important are the manner in which they are presented, the context of the overall message, and the potential impact on the recipient’s decisions. Advertising can be misleading not only by providing false information, but also by selectively presenting facts, omitting important limitations, or emphasizing only the positive aspects of a product’s use.

This is why Article 7 of the MDR should be considered one of the key regulations governing the marketing communications of medical device manufacturers. This provision prohibits the use of texts, names, trademarks, images, symbols, or other markings that could mislead the user or patient regarding the intended purpose, safety, or performance of the device. This prohibition applies not only to labels and instructions for use but also to advertising materials and other forms of market communication.

In practice, this means that an entrepreneur should analyze each message not only in terms of compliance with the product’s technical documentation, but also from the perspective of how the average recipient might interpret the information presented.

Not only falsehood, but also silence

One of the most frequently underestimated aspects of advertising is the responsibility for omitting information that is important to the recipient. Businesses typically focus on avoiding false claims, much less on analyzing the consequences of omitting specific information.

Imagine an advertisement for a biostimulator in which the manufacturer presents excellent aesthetic results achieved after the treatment. All photographs are authentic, and the description of the effects reflects the actual experiences of selected patients. At the same time, the advertisement contains no information about the need for medical qualification, possible contraindications, the risk of side effects, or the body’s varied response to treatment.

Formally, none of the claims presented are false. Nevertheless, the recipient may be misled into thinking that achieving the presented effect is typical, predictable, and practically guaranteed. Consequently, the message may be considered misleading because it creates unrealistic expectations regarding the product’s performance.

A similar risk arises when using terms such as “safe,” “non-invasive,” “natural,” or “side-effect-free.” Even if a product has a high safety profile, using such phrases can imply an absence of risk, which is difficult to reconcile with clinical reality.

Can we use the terms “best”, “most effective” or “revolutionary”?

Marketing language often relies on the use of evaluative terms. Advertisements feature phrases such as “market leader,” “the most innovative product,” “the best rejuvenation technology,” or “a breakthrough in aesthetic medicine.” In the consumer goods sector, this type of communication is common. However, when it comes to medical devices, much greater caution is required.

First, an entrepreneur should have objective evidence to support any comparative or evaluative claim. Second, even the existence of scientific research does not always justify the use of terms suggesting absolute superiority over all competing solutions. In medical practice, the effectiveness of therapy depends on many factors, including the patient’s qualifications, the physician’s experience, and individual biological conditions.

From a compliance perspective, a much safer solution is to use a description based on clinical trial results and technical parameters of the product, instead of using general marketing slogans.

Practice of supervisory authorities – the growing importance of digital communication

Recent years have seen a significant increase in supervisory authorities’ interest in online communications. While previously, oversight activities focused primarily on traditional advertising materials, they now also analyze websites, social media profiles, newsletters, videos published on streaming platforms , and collaborations with influencers.

This trend is consistent with a broader trend observed at the EU level, where increasing emphasis is being placed on countering manipulative marketing practices and ensuring a high level of protection for consumers using healthcare services. Consequently, businesses should assume that online communications are subject to the same scrutiny as traditional forms of advertising.

The Polish Office of Competition and Consumer Protection and consumer protection – the second pillar of responsibility

Although the primary legislation regulating the advertising of medical devices remains the Medical Devices Act, businesses cannot limit their analysis solely to this legal regime. Consumer protection regulations also apply, in particular the Act on Combating Unfair Market Practices and the Act on Competition and Consumer Protection.

From the perspective of the President of the Office of Competition and Consumer Protection (UOKiK), the impact of a message on the average consumer is of particular importance. If a communication exploits emotions, raises unjustified expectations, or suggests characteristics that the recipient is unable to independently verify, it may be considered a practice that violates the collective interests of consumers.

In practice, this means that a single marketing campaign may be assessed simultaneously by different authorities under different legal frameworks. Manufacturers should therefore design their marketing activities to ensure compliance not only with medical device regulations but also with consumer protection and fair competition regulations.

Compliance instead of reaction after inspection

Experience in recent years shows that a significant number of violations are not the result of deliberate actions by businesses, but rather a lack of appropriate internal procedures. Marketing materials are often prepared by external advertising agencies that are intimately familiar with the mechanisms of selling consumer products but lack experience in the regulated sector.

compliance systems that encompass the entire marketing communications process is becoming increasingly important . Every piece of content – whether it’s an Instagram post, a product brochure, a webinar , or a YouTube video – should be reviewed not only by the marketing department but also by those responsible for regulatory and legal matters.

This approach allows for the identification of risks before the material is published, reducing the likelihood of initiating administrative proceedings, disputes with supervisory authorities and negative image consequences.

The most common mistakes of manufacturers, importers, distributors and clinics – what to avoid in practice?

Recent experience shows that most violations of regulations regarding medical device advertising do not result from deliberate disregard for applicable regulations. Quite the opposite – entrepreneurs operating in the aesthetic medicine market typically strive to conduct their business in compliance with the law, but they encounter difficulties resulting from ambiguous regulations and the dynamic development of modern communication channels. Marketing of medical products is increasingly conducted via social media, educational platforms, and industry events, whereas existing regulations were primarily designed with traditional forms of advertising in mind.

In practice, however, there are several recurring mistakes that occur regardless of the size of the company and which should be taken into account when designing a marketing strategy.

Mistake No. 1 – Equating commercial information with neutral information

One of the most common misconceptions is that material doesn’t constitute advertising solely because a business owner has designated it as “information.” This approach is unsupported by applicable law.

The nature of a message is assessed based on its actual function, not the name given by the author. If the material highlights the benefits of a specific product, builds its market appeal, or is intended to encourage the recipient to choose a specific product, there is a high probability that it will be classified as an advertisement, even if it does not contain a classic call to purchase.

An example would be an article published on the manufacturer’s website titled “Modern Skin Regeneration Possibilities.” If the majority of the text is devoted to a single product, highlights its advantages over the competition, and leads to a contact form allowing purchase of the product or registration for training, it’s difficult to consider such material solely educational.

In practice, entrepreneurs should remember that supervisory authorities analyze not only the content of the publication, but also its location, method of presentation and connection with the entrepreneur’s business activity.

Mistake #2 – Copying Cosmetic Product Marketing

The aesthetic medicine market is developing in parallel with the cosmetics market, resulting in many marketing activities being mutually inspired. However, from a regulatory perspective, this approach can lead to serious problems.

Cosmetics marketing relies primarily on building emotions, visual appeal, and creating a specific lifestyle. Meanwhile, communication regarding medical devices is subject to much more stringent requirements. Using identical marketing techniques for products covered by the MDR may lead to violations of advertising regulations, especially if the message ignores the limitations imposed by the product’s intended use or its method of use.

In practice, this means that the marketing department of a medical device manufacturer should not automatically use solutions used in cosmetic campaigns, even if they seem effective from a business point of view.

Mistake No. 3 – overexposing the effects of the treatment

Marketing materials for biostimulants often focus almost exclusively on aesthetic effects. Images depicting wrinkle smoothing, facial contour improvement, or increased skin firmness undoubtedly attract audiences and enhance the message’s appeal.

The problem, however, is that the results of aesthetic medicine treatments are individual. They depend on the patient’s age, health, skin condition, previous medical procedures, lifestyle, and the experience of the practitioner. Presenting individual, exceptionally positive results without proper context can lead to unrealistic expectations on the part of potential patients.

From a compliance perspective , it is much safer to present information about the mechanism of action of the product and its intended use than to focus all communication on spectacular visual effects.

Mistake No. 4 – Ignoring contraindications and limitations of use

Another common mistake is presenting a product solely through the lens of its benefits. Marketing materials often emphasize the product’s effectiveness, innovation, and safety, while failing to mention situations in which its use may be inadvisable.

Meanwhile, reliable communication regarding medical devices should also include information about contraindications, limitations of use, and the need for medical qualification. This doesn’t mean, of course, that every advertisement must include full instructions for use, but omitting all information regarding potential risks could lead to accusations of misleading consumers.

Mistake #5 – Lack of cooperation between marketing and legal departments

In many companies, marketing materials are prepared by external creative agencies or marketing departments that lack specialized knowledge of medical device regulations. Only then does the completed material reach the legal department, often just prior to publication.

affairs specialists and lawyers at the marketing campaign design stage. This avoids the need for later material withdrawal or costly modification.

Mistake #6 – Lack of social media procedures

Many companies have extensive procedures for approving product catalogs and printed materials, yet they don’t regulate the rules for publishing content on social media. Yet, it’s short posts on Instagram, Facebook, and LinkedIn that are currently published most frequently and have the greatest impact on a company’s image.

The lack of internal guidelines leads individual employees to publish content at their own discretion, often unaware of the legal consequences of using specific phrases or photographs. In practice, it’s worth developing separate policies for online communication, covering topics such as product presentation, use of photographic materials, publishing coverage of industry events, and collaborating with physicians and influencers.

Compliance practices – how to organize legal marketing communications?

Compliance system shouldn’t be limited to merely responding to emerging issues. Its primary goal is to prevent violations by establishing transparent rules for preparing and approving marketing materials.

In practice, a growing number of medical device manufacturers are implementing multi-stage approval procedures involving marketing departments, regulatory affairs specialists, quality control departments, and lawyers. This model allows for the assessment of a material not only in terms of its marketing appeal but also its compliance with the product’s technical documentation, instructions for use, and applicable regulations.

Maintaining documentation of the approval process is also particularly important. In the event of an audit, the company should be able to demonstrate that the materials were prepared in accordance with internal procedures and reviewed by appropriately qualified individuals. Archiving subsequent versions of materials, legal opinions, and publication decisions can be of significant evidentiary value.

In practice, a well-functioning compliance system shouldn’t be perceived as an obstacle to marketing activities. On the contrary, properly designed procedures enable legally secure communication, reducing the risk of administrative sanctions and disputes with supervisory authorities, while building trust with customers and business partners.

European perspective – why will the importance of compliance systematically grow?

Polish regulations on medical device advertising are currently among the most detailed in the European Union. However, this does not mean that businesses operating in the domestic market can limit themselves solely to knowledge of the provisions of the Medical Devices Act and the Regulation of the Minister of Health. The functioning of the medical devices market is increasingly determined by the practice of applying the MDR, the positions of EU bodies, and the actions of national regulatory authorities in individual member states.

The MDR does not contain comprehensive regulations on the advertising of medical devices. It focuses primarily on product safety, manufacturers’ obligations, conformity assessment, and the rules for placing devices on the market. At the same time, Article 7 of the MDR establishes the general principle that all communication about a device – regardless of its form – must not mislead users or patients about the product’s intended purpose, properties, safety, or efficacy.

In practice, this provision serves a much broader purpose than the classic ban on misleading advertising. It constitutes a specific interpretative principle that should be considered when assessing every form of communication conducted by a manufacturer or distributor. Increasingly, supervisory authorities are moving away from formalistic analysis of individual advertising slogans and focusing on the overall perception of the message by the average user.

At the same time, the activities of Medical Device Coordination Group (MDCG) highlights the growing importance of transparent information provided to users of medical devices. Although MDCG documents are not legally binding, in practice they guide the interpretation of MDR provisions by national authorities and notified bodies. Increasing emphasis is being placed on ensuring consistency between a device’s technical documentation, instructions for use, and market communications.

It can be predicted that in the coming years, marketing control will encompass not only traditional advertising but also recommendation algorithms of online platforms, message personalization, the use of artificial intelligence in marketing, and automated advertising profiles. The development of new technologies is blurring the lines between information, advertising, and educational content.

For manufacturers, this means moving away from a one-time approach to assessing marketing materials. Implementing ongoing compliance procedures that enable ongoing assessment of communications’ compliance with rapidly evolving regulatory requirements will be much more effective.

Practical checklist compliance before publishing marketing materials

In practice, most violations can be avoided by implementing simple verification procedures. Before publishing material regarding a medical device, it’s important to answer the following questions:

First, is the product intended for use by laypeople or exclusively by professionals? The answer to this question determines the acceptable scope of communication and the target audience.

Secondly, is the planned material truly informative, or is its primary purpose to increase interest in the product? When in doubt, it’s worth adopting a more cautious approach and evaluating the message according to advertising principles.

Third, are all claims regarding product properties supported by technical documentation, instructions for use, and conformity assessment results? Marketing departments should not independently make new claims regarding product effectiveness or safety.

Fourthly, does the material use evaluative terms such as “best”, “most effective”, “revolutionary” or “guaranteed effect”, the validity of which could be questioned by the supervisory authority?

Fifth, does the message include product use restrictions, the need for medical qualification, and other information relevant to user safety?

Sixth, does the publication contain photographs or recordings of patients? If so, it is necessary to verify not only compliance with regulations on advertising medical devices, but also the basis for processing personal data, the scope of consent granted, and the protection of personal rights.

Seventh, was the material reviewed by those responsible for regulatory and legal matters? In practice, even minor linguistic changes can significantly alter the legal assessment of the entire message.

Eighth, does the entrepreneur have documentation confirming the material approval process? In the event of an audit, the ability to demonstrate organizational diligence can be crucial to assessing the entrepreneur’s actions.

Summary

The development of the biostimulator market is one of the most dynamic areas in contemporary aesthetic medicine. These products respond to growing patient expectations for natural tissue regeneration methods, while simultaneously posing entirely new regulatory challenges for manufacturers, importers, distributors, and healthcare providers.

Contrary to popular belief, the biggest problem today isn’t the mere ability to advertise. The key challenge remains the ability to communicate effectively, while simultaneously providing accurate product information and complying with stringent legal requirements. The line between information and advertising is becoming increasingly blurred, especially in the digital environment, where communication occurs via social media, educational platforms, and artificial intelligence tools.

From the perspective of entrepreneurs, this means a shift in thinking about medical device marketing. Instead of treating compliance as a final stage of reviewing advertising materials, it’s worth viewing them as an integral element of the process of designing market communication. Early involvement of legal, regulatory, and quality specialists not only reduces the risk of administrative sanctions but also builds brand credibility and audience trust.

It can be expected that the requirements for communication transparency will systematically increase in the coming years. The development of artificial intelligence, data-driven marketing, and message personalization will force supervisory authorities to increasingly scrutinize not only the content of advertisements but also their distribution and impact on audience decisions. In this environment, competitive advantage will be achieved not by those businesses that conduct the most aggressive marketing communications, but by those that manage to combine innovation with regulatory responsibility.

Artykuł Biostimulants under the microscope of the law – where does information end and prohibited advertising of medical devices begin? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The Polish dietary supplements market is facing the most significant regulatory overhaul in years. The draft amendment to the Act on Food and Nutrition Safety and the Act on the State Sanitary Inspectorate introduces a series of far-reaching changes that will substantially alter the way supplements are notified, monitored, advertised, and supervised in Poland. While the reform does not formally introduce a pre-market authorization system, it undeniably strengthens the position of regulatory authorities and increases the compliance burden imposed on businesses operating in the sector.

The amendment, expected to enter into force six months after publication, reflects both domestic concerns regarding the rapid expansion of the supplements market and the broader European trend toward stricter food safety oversight. For manufacturers, importers, distributors, and marketing agencies, the proposed changes may require a complete reassessment of internal procedures, legal risk management, and commercial strategy.

The reform arrives at a time when the Polish dietary supplements market continues to expand at an exceptional pace. Poland has become one of the largest supplement consumers in the European Union, both in terms of total market value and per capita spending. According to market estimates, the sector exceeded PLN 7 billion in value in 2024 and is expected to continue growing steadily over the coming years. The scale of the market alone has become a challenge for regulators. Between 2017 and 2020, more than 62,000 supplement notifications were submitted to the Chief Sanitary Inspectorate (GIS), while the number of products listed in official registers exceeded 29,000.

At the same time, authorities increasingly pointed to systemic weaknesses in the existing framework. Under the current rules, a business may place a dietary supplement on the market immediately after submitting a notification to GIS, even if doubts exist regarding the product’s composition or classification. The authorities may initiate explanatory proceedings, but the product can still remain commercially available during the investigation. In practice, this system has often been criticized for providing insufficient preventive control and allowing potentially problematic products to circulate before any meaningful assessment takes place.

Another major concern involved the widespread use of aggressive advertising strategies. For years, the dietary supplements industry has been accused of blurring the line between supplements and medicinal products. Many advertisements indirectly suggested therapeutic effects or implied that supplements could substitute proper medical treatment or balanced nutrition. Regulators and pharmaceutical companies repeatedly argued that existing penalties were too low to deter large market participants from engaging in questionable promotional practices.

The lack of a centralized digital supervision system also contributed to inefficiencies. The notification process relied partly on outdated administrative mechanisms, resulting in difficulties with document verification, inconsistent communication, and lengthy proceedings. The new amendment seeks to address these concerns through digitalization, stricter procedural obligations, and substantially higher financial sanctions.

One of the most visible changes introduced by the reform is the mandatory use of the e-Sanepid platform for all supplement notifications. Until now, notifications could be submitted either electronically or in paper form, and businesses had some flexibility regarding the form and timing of submission. Under the new rules, however, the process becomes fully digitized. Notifications will only be accepted through the e-Sanepid system and will require either a qualified electronic signature or a trusted electronic profile.

This change may appear largely technical at first glance, but in reality it significantly increases the formalization of the entire notification process. For large companies with developed compliance departments, adapting to electronic communication systems is unlikely to create serious difficulties. Smaller businesses, however, may face operational and financial challenges connected with digital authentication tools, procedural monitoring, and document management requirements.

The amendment also changes the moment at which the notification obligation arises. Previously, the law referred both to products already introduced to the market and those merely intended for future introduction. The new wording removes the reference to “intended introduction,” meaning that the obligation will arise only once the product is actually being placed on the market. Although this clarification simplifies the legal interpretation of the obligation, it also narrows the flexibility businesses previously enjoyed when planning product launches.

Perhaps the most consequential aspect of the reform concerns explanatory proceedings and scientific opinions. Under the current framework, businesses could effectively delay proceedings indefinitely by postponing the submission of required scientific documentation. While the law imposed certain deadlines on the authorities themselves, it did not establish sufficiently strict obligations for the notifying entity. This created situations where proceedings remained unresolved for years, significantly limiting the effectiveness of supervision.

The amendment introduces a much stricter procedural regime. Once GIS requests a scientific opinion regarding a product’s classification or compliance, the business will have only 14 days to submit an application to a scientific institution or to the President of the Office for Registration of Medicinal Products. Furthermore, the scientific opinion itself must generally be issued within six months, with an absolute maximum period of twelve months in exceptional cases.

The most significant innovation is the introduction of a legal presumption against the entrepreneur. If the entity fails to submit the application for an opinion within the required 14-day period, the law will automatically presume that the proposed classification of the product is incorrect and that the product does not meet the requirements applicable to its category. In practical terms, procedural inactivity itself may lead to negative legal consequences.

This fundamentally changes the balance between businesses and regulatory authorities. Previously, delaying the process often worked in favor of companies by allowing products to remain on the market while proceedings continued. Under the new rules, inaction may immediately weaken the entrepreneur’s legal position. Businesses will therefore need to implement much stricter internal monitoring systems to ensure compliance with procedural deadlines.

The amendment additionally prohibits businesses from circumventing the procedure by repeatedly submitting notifications for identical products. Once proceedings are initiated, companies will no longer be able to submit another notification concerning a product with the same qualitative and quantitative composition. Similarly, withdrawing a notification will not allow the entrepreneur to restart the process with the same formula at a later stage. These restrictions are intended to eliminate procedural abuse and prevent companies from avoiding regulatory scrutiny through repeated filings.

Another major reform concerns transparency and the expansion of the public product register maintained within the SEPIS system. The current register already contains certain information regarding notified products, but the scope of publicly available data remains relatively limited. The new system significantly broadens the amount of information accessible to consumers and competitors alike.

Under the amendment, the register will include the product name, form of the product, qualitative composition, information regarding active substances, details concerning explanatory proceedings, and information about prohibited ingredients. Although quantitative composition data and certain identifying information regarding the reporting entity will remain confidential, the reform nevertheless represents a substantial increase in market transparency.

From the consumer protection perspective, this may be viewed as a positive development. Consumers will gain easier access to information about supplement composition and regulatory status, potentially allowing for more informed purchasing decisions. However, from the business perspective, the new transparency rules create considerable reputational risks. Information regarding ongoing explanatory proceedings may become publicly visible long before any final administrative decision is issued. As a result, companies may face reputational damage even in situations where no violation is ultimately confirmed.

The reform also updates the broader inspection framework to align Polish law with Regulation (EU) 2017/625 on official controls. Although the regulation has already been directly applicable across the European Union since 2019, several references in Polish legislation still pointed to repealed EU acts. The amendment therefore modernizes the legal terminology and adapts national provisions to the currently binding European framework.

Importantly, however, the changes do not significantly expand the substantive powers of sanitary authorities. The amendment primarily introduces terminological adjustments, extending references from “official food controls” to “official controls and other official activities.” Sanitary authorities will continue to possess extensive powers during inspections, including access to facilities, examination of production processes and documentation, and collection of samples for laboratory testing.

The reform does, however, expand the situations in which businesses must bear the costs of inspections and administrative activities. In addition to existing obligations related to violations, follow-up inspections, and border sanitary controls, businesses will now also be required to cover costs associated with official activities performed at their own request, such as the issuance of certain documents. While this change may appear relatively modest compared to other parts of the reform, it nevertheless contributes to the overall increase in operational costs for market participants.

One of the most controversial elements of the amendment concerns advertising and marketing practices. The reform significantly broadens the scope of administrative liability related to the promotion and presentation of dietary supplements. Previously, penalties focused primarily on incorrect product labeling. Under the new rules, liability will explicitly extend to advertising, online promotion, social media activities, and the overall presentation of products.

Most importantly, the amendment introduces severe sanctions for advertising or presenting a supplement before notifying GIS. This is likely to have a major impact on digital marketing strategies commonly used in the supplements industry. Influencer campaigns, online pre-launch promotions, teaser advertisements, and social media product announcements may all potentially fall within the scope of the new sanctions if conducted before formal notification.

The amendment also reinforces existing prohibitions against suggesting that a balanced diet cannot provide sufficient nutrients or implying medicinal properties of supplements. Although these prohibitions already existed under current law, the reform significantly strengthens enforcement mechanisms by attaching much higher financial penalties to violations.

Indeed, the increase in administrative penalties represents one of the most dramatic aspects of the reform. Under the current framework, the maximum administrative fine generally amounts to thirty times the average monthly salary. The amendment raises this threshold to one hundred times the average salary, increasing potential penalties by more than 330 percent.

Based on current economic indicators, maximum fines could exceed PLN 800,000. Such amounts are clearly intended to function as genuinely deterrent sanctions rather than symbolic administrative measures. For large corporations with extensive marketing operations, these penalties may significantly alter risk calculations related to aggressive advertising or borderline compliance practices.

For businesses operating in the supplements sector, the cumulative impact of these changes may be substantial. Compliance costs are likely to increase considerably. Companies may need to invest in legal advisory services, digital infrastructure, scientific assessments, employee training, and enhanced compliance monitoring systems. Marketing departments in particular will face increased scrutiny and will need to carefully verify advertising content before publication.

The reform may also contribute to market consolidation. Large, well-established companies are generally better positioned to absorb increased compliance costs and adapt to stricter regulatory requirements. Smaller businesses, startups, and niche supplement brands may struggle with the financial and administrative burden created by the new framework. As a result, the amendment could unintentionally reduce market diversity and strengthen the competitive position of major industry players.

From the perspective of public authorities, the reform aims to improve the efficiency and credibility of food safety supervision. Digitalization through e-Sanepid and SEPIS is expected to accelerate administrative processes, improve data analysis capabilities, and strengthen market oversight. The introduction of strict procedural deadlines should also reduce the risk of excessively lengthy proceedings and administrative disputes.

At the same time, the implementation of these systems will require significant investments in technological infrastructure and administrative capacity. The effectiveness of the reform will therefore depend not only on the wording of the legislation itself, but also on the practical ability of GIS and related institutions to manage the new digital environment efficiently.

Ultimately, the amendment does not formally transform dietary supplements into products requiring prior authorization before market entry. Businesses will still be able to introduce supplements through a notification-based system rather than a licensing procedure. Nevertheless, the practical reality of operating in the sector is likely to change considerably.

The reform substantially increases the procedural obligations imposed on businesses, strengthens enforcement tools available to authorities, raises financial exposure connected with non-compliance, and introduces far greater transparency into the market. While these changes may improve consumer protection and market oversight, they also create new operational and reputational risks for entrepreneurs.

For companies active in the supplements industry, the coming months may therefore become a critical period of preparation. Businesses that fail to adapt quickly to the new regulatory environment may face not only financial penalties, but also significant disruptions to their commercial operations and marketing strategies.

Artykuł Dietary Supplements Under Tightened Scrutiny: How the 2026 Reform Could Reshape the Polish Market pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

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Artykuł KG Legal initiates debt enforcement procedures, acting on behalf of a Swedish creditor against the Polish entrepreneur pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.