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.

Jan K., a literature enthusiast with an extraordinary fondness for Polish children’s poetry, finally managed to find a very rare book after a long search – an edition of Julian Tuwim’s “Locomotive,” which he purchased without hesitation from a used bookstore in Maryland, USA, via the online platform AbeBooks. The ease and simplicity of the solution – clicking the “BUY NOW” button, which would soon bring his dream book to him – combined with the bargain price for such a sought-after rarity in the reading community, filled Jan K. with optimism. From that moment on, he simply waited for the Polish Post to knock on his door and deliver him the publication he considered the opportunity of a lifetime. Perhaps it would have been, had Jan K. considered the key issues surrounding importing goods from the USA and the associated costs.

In analyzing the above case, it is crucial to focus on the fundamental concepts related to consumer rights and obligations, which have legal implications – and which can be reduced to the following questions: who does Jan K. become and what does he do in this regard? Given the dynamic growth of global e-commerce between the European Union and the United States, current regulations impose on consumers the role of participants in trade in goods. Under the Union Customs Code, and as confirmed by the case law of the Court of Justice of the European Union (CJEU), goods mean any product that has a measurable monetary value and, as such, may constitute the subject of a commercial transaction. Therefore, every shipment of goods is subject to customs supervision upon crossing the EU border (Article 134, point 1 of Regulation 952/2013 establishing the Union Customs Code), which also includes customs control (Article 5, point 3 thereof), which refers to specific verification activities performed by customs and tax authorities, such as a search of the goods. This procedure may also involve the risk of a customs debt (Article 5, point 18, ibid.), which would impose on the debtor (Article 5, point 19, ibid.) the obligation to pay the applicable shipping charges. Furthermore, raising the issue of a customs representative – in the form of direct or indirect representation (Article 18, point 1, ibid.), Poczta Polska could potentially become this representative.

Returning to Jan K.’s case, since the book meets the definition of a commodity, the consumer effectively becomes an importer of non-EU goods. The American sales platform was therefore merely a tool enabling the transaction and payment, acting solely as an intermediary between the seller and the buyer. Therefore, the consumer bears all legal responsibility for the authenticity of the documents submitted to Poczta Polska for clearance. Returning to reality, Jan K. should pay attention to important legal aspects when purchasing a unique reading item. It’s worth starting by separating the price of the goods from the shipping costs.

Higher mathematics – calculating customs value

If additional fees related to importing goods from the US to Poland are not included in the price, you should calculate how much you will actually pay for shipping, as the final customs value is made up of several additional fees. Shipping to the EU must first be added to the product price. Customs duty, which varies depending on the product type, is added to this amount (this information is available, for example, in the Polish ISZTAR tariff system or the European TARIC). This amount becomes our VAT base, and the tax is calculated from it. Estimating the total cost of goods, including import, significantly helps in making rational consumer decisions and can save our wallets, sometimes unprepared for additional financial burdens.Play

When tariffs work and when they don’t

Is Jan K. rightly happy about his bargain, or will he first have to contend with the customs system? Until now, a fairly favorable rule existed, according to which shipments up to €150 worth were completely duty-free. However, July 1, 2026, introduces a revolution in this area – the duty exemption is replaced by a flat-rate duty mechanism of €3 for each item, representing a group of goods of the same type, and therefore classified under the same CN code. Although from a customs perspective, the seller would be the customs debtor, the Ministry of Finance emphasizes that how this cost is calculated depends on the business policy of the given platform. Many American platforms add the flat-rate duty to the final price in the basket or in the shipping costs. Additional fees may also be related to the seller’s shipping terms – the seller may declare that they will cover import duties (DDP), or the buyer may be responsible for this, and may be charged a surcharge (DAP). Failure to establish clear shipping terms often results in the buyer being required to pay, a fact that only becomes apparent upon delivery. For this reason, Jan K. should verify the terms he agrees to and what additional costs are included in the price.

The IOSS and OSS procedures may provide some stability in terms of fees. IOSS, which applies to purchases of physical goods, including those from the US, is aimed at non-EU entities that conduct distance selling of imported goods (SOTI) and have established an intermediary that is an active VAT payer in Poland. Currently, this system is used by the vast majority of large platforms in the US, such as Amazon, eBay, Etsy, and Shopify, although additional verification is always helpful. EU and non-EU OSS, on the other hand, are primarily useful for digital services (e-books, games), telecommunications and broadcasting services (internet-based television signal delivery), and other intangible services (e.g., educational services). However, a key aspect of the IOSS system, which we will discuss in more detail in the context of purchases on US platforms, is the value threshold – if the actual value of a physical book is within €150, the platform will collect Polish VAT directly during the payment transaction. However, if this value were higher than EUR 150, IOSS cannot be used and the parcel is subject to the standard customs procedure requiring declaration on the SAD H1 document in the AIS-IMPORT system (i.e. use of the VAT E-Commerce system).

Where is the Polish Post Office in all this?

Article 19 of the Customs Law is a treasure trove of knowledge on the proper conduct of customs procedures – it regulates, among other things, the procedure for presenting goods and filing customs declarations in postal traffic handled by a designated operator. This is where Poczta Polska SA comes in, fulfilling this role, thus acting as a link between the e-consumer and the foreign operator. As mentioned earlier, anyone can appoint a customs representative, acting directly or indirectly. However, in the case of shipments imported from countries such as the USA, there is a certain institutional facility known as tacit (implicit) customs representation.

This mechanism works simply: if the actual value does not exceed €150, the designated operator, i.e., Poczta Polska, will be authorized by law to file a customs declaration on behalf of and for the benefit of the recipient (unless the consumer objects to the notification of arrival). What does this mean in practice? The platform simply adds Polish VAT at the time of purchase. If it uses the IOSS system, the customs declaration in the e-commerce system is submitted using the simplified H7 customs declaration, and the consumer receives the parcel from the Poczta Polska postman at no additional charge upon delivery. If the platform is not equipped with IOSS, VAT must be calculated and collected upon the goods’ arrival in the EU, which means the consumer pays VAT under the general rules upon delivery.

What if the shipment value exceeds €150? The problem of verifying whether the platform uses IOSS resolves itself somewhat. In this case, the platform loses its customs supplier status and assumes only accounting obligations, and therefore, customs and tax duties are settled within the scope of full customs declarations in the national AIS-IMPORT system in the importing country. Poczta Polska does not have an implied power of attorney in this case – the recipient receives a notification and must submit the required documents within 14 days, grant Poczta Polska a customs power of attorney, or otherwise perform customs clearance on their own.

Cooperation with Poczta Polska – proper documents for conscientious service

Courier companies are becoming increasingly popular, ensuring efficient delivery and clear communication. However, when importing goods from a non-EU country, additional fees may be charged. Poczta Polska often proves to be a more cost-effective alternative, but it requires a complete set of documents. This list includes: confirmation of the type and value of the goods; proof of payment: shipping costs, insurance, and any discount information; recipient details and additional documents such as certificates and permits (in transactions between private parties, a “declaration regarding the goods contained in the shipment” in the case of gifts). Importantly, the better the description of the parcel, the less chance of additional complications, such as the need to clarify the contents, prepare corrections, or delays.

Polish Post’s negative dictionary

Since we’ve touched on customs situations that can prove particularly problematic, we should mention Poczta Polska’s blacklist of goods – or rather, its negative vocabulary. This list lists goods for which Poczta Polska does not perform customs clearance under the VAT E-commerce package; customs clearance is handled independently. These primarily include: goods shipped as commercial samples, medicines and medical devices (high risk of shipment detention), food (possible additional inspections), plant and animal products (often subject to separate sanitary regulations), weapons, collectibles and counterfeits (intellectual property rights), electronics with batteries (frequent transport requirements), alcohol and tobacco products (tax regime and quantity restrictions). These goods therefore require special care and adherence to formal requirements, not to mention the need for full customs clearance using the SAD H1 import document.

Other (this time favorable) exceptions

Goods that deviate from the rule regarding proper customs clearance can also have a positive impact on the consumer. These special situations include, among other things, customs duty exemption. Under Article 203(3) of Implementing Regulation 2015/2447, non-Union goods that originally had EU status are exempt from import duties as a result of being exported from outside the EU and then re-imported within three years and released for free circulation. Another example, although going beyond sales on foreign sales platforms, are gifts with an actual value of up to €45 – they are completely exempt from customs duty if they are a private-to-private, occasional, free-of-charge, and appropriately marked package (excise goods do not apply here).

How will all this work in practice? The case of Jan K.

To this end, let’s consider two scenarios: in the first, Jan K. managed to snag his dream book for only €50, as it didn’t stand out from the catalog of books available at the second-hand bookstore. In the second, Jan K. paid €300 for “Lokomotywa” (The Locomotive), as it was a collector’s edition, practically unavailable in the current reading market. The AbeBooks platform, like most major American platforms, uses the IOSS system. What path will a consumer of the American sales platform have to take to enjoy their desired book?

Scenario 1: Locomotive below €150

The customs value is immediately apparent – Polish VAT was added to the price of the goods, and payment was made via the AbeBooks platform, while imports at the border are VAT-exempt. Although the flat-rate customs duty of €3 per item should have been paid through the platform, Jan K. should be aware that this amount could have been included in the price of the book itself or in the shipping costs. The parcel was shipped from the USA, and the seller marked it with the platform’s IOSS identification number. Jan K. did not object, so Poczta Polska became the tacit customs representative and processed the clearance automatically, using a simplified H7 customs declaration in the e-commerce system. The parcel was not classified as a collector’s item, which was due to the seller’s precise and detailed descriptions. A Poczta Polska postman delivered the parcel to Jan K., and from that moment on, he was able to immerse himself in Tuwim’s poetry.

Scenario 2: “Locomotive” above €150

Now let’s analyze a slightly less favorable option for Jan K.: Here, customs duty and VAT are not included in the book’s price, which initially pleased Jan K. The seller shipped the package, but because it was shipped from the United States, the carrier must submit an Entry Summary Declaration (ENS) and lodge it with the appropriate customs office before the goods arrive. An ENS would not be necessary only if the sale was made from common transit countries that have concluded agreements with the EU on the recognition of security and safety inspections conducted in these exporting countries, namely Norway, Liechtenstein, and Switzerland. When the package reaches Poland, customs and tax systems block its further route, and it is placed under customs supervision. Poczta Polska sent the importer, Jan K., a paper notification (although electronic notification is also possible) about the shipment being held for customs clearance. A terrified Jan K. tried to find out what was happening with his parcel and why it had been detained. He finally discovered that Poczta Polska was not his customs representative. After controlling his emotions, he gathered the necessary documentation, which included proof of purchase, payment confirmation with a breakdown of the price of the goods themselves, shipping fees, and item description, as well as a signed power of attorney, and sent it to Paczka Polska. Poczta Polska, which had become Jan K.’s active representative, processed customs clearance using the AIS-IMPORT system, using full import customs declarations on the SAD H1 document. The customs and tax office then assessed fees: customs duty based on the CN customs classification and VAT based on the tax base, which is the combined price of the goods, transportation fees, and customs duties. This process was successful, the parcel was returned to postal service, and the postman knocked on Jan K.’s door – the importer’s enthusiasm was somewhat lower than in Scenario 1, as he had already incurred customs and VAT costs before beginning the reading.

What if the package arrives damaged?

The complications continue: the package was damaged, and we don’t know who to contact. Since the introduction of the Tax Explanations on July 1, 2021, autonomous tax law creates a legal fiction under which the electronic interface operator is considered a B2C supplier, the platform is therefore obligated to tax and settle the transaction. This solution is primarily beneficial to officials, who find it more convenient to collect VAT from a large platform than from hundreds of smaller sellers. On the other hand, it creates a certain ambiguity – as we established above, the platform is still merely an intermediary under civil law. Why do we see a discrepancy here? Because of the issue of tortious liability.

If the “Locomotive” purchased by Jan K. were lost or destroyed before delivery, from July 2021, the consumer would have to direct warranty or non-performance claims to the Maryland antiquarian bookstore, not the AbeBooks platform (if the damage occurred during transport, i.e., before formal release by customs). It should undergo a qualification process as defective goods, and if approved, the American seller is to make a price adjustment, which will reduce the overall customs value, automatically including the costs of customs duty and VAT. For goods over €150 or of collector’s value, the loss or destruction of a package in the warehouse results in a customs debt, and Poczta Polska becomes the debtor. If damage to goods worth less than €150 occurred during transport by Poczta Polska, after legal qualification and removal of the goods from customs supervision, the postal operator is obligated to pay the VAT, along with default interest.

Despite the many scenarios, one important rule stands out – the platform itself very rarely pays compensation. Based on US court decisions (such as the Bolger vs. Amazon.com, LLC case, in which Angela Bolger suffered serious bodily injury after a laptop battery purchased through Amazon exploded), it can be assumed that the chance of obtaining compensation increases essentially only if the platform controlled the physical delivery process. Or rather, if this can be proven in court. Platform uniqueness, as Janger and Twerski called it in their renowned 2023 analysis, is increasingly being raised as a serious problem for consumer protection and rational risk management. American sales platforms hide behind formal definitions of “sale” and “title,” but in practice, these explanations have little application. This absurdity is particularly evident in models such as FBA (Fulfillment by Amazon), where the platform stores, packages, and ships the goods, and claims the right to substitute without consulting the consumer. The fiction of a “recognized supplier” exists under VAT law, yet remains free from civil liability.

Cost-related catches – what to watch out for so as not to overpay

As the example above shows, the issues of cost and financial responsibility are often ambiguous, so it’s important to understand what additional fees we might be exposed to. Distinguishing the price of the goods from transportation fees, customs duties, and VAT is the first, but not the last, point at which we should consider how much importing goods purchased on an American marketplace will actually cost us. In addition to the components of the customs value, we must also consider other possible fees, such as the cost of insuring the imported goods, loading and handling fees associated with their transport to the national border or a Polish port.

The principle that “determinations of charges for transport costs must be unambiguous, precise, and separate for domestic and international sections” is one of the key aspects of EU customs law. Why is this so important? According to Articles 71 and 72 of the UCC, foreign and domestic sections are treated differently – the customs value of goods increases upon entry into the customs union, whereas within the EU, costs are not included in this value. However, the Act introduces a condition here, specifically a clear separation of goods and transport costs (which is why this had to be clearly stated in Scenario 2 of Jan K. in Jan K.’s documents for Poczta Polska). If only one transport amount appears on the invoice, the customs authority has the right to include 100% of the transport costs in the customs value. This trap, known as the cascading effect, is likely to occur in transactions on online marketplaces, as confirmed by the Supreme Administrative Court’s rulings in this case.

The customs authorities’ reasoning can be traced to the Supreme Administrative Court’s judgment of March 17, 1999 (SA/ Sz 1731/98). In this case, the Spanish wine seller failed to divide costs and sections into foreign and domestic, and the transaction itself resulted in two sets of invoices for different amounts (the second set of invoices had a significantly higher value). The Supreme Administrative Court dismissed the importer’s complaint regarding alleged violations of customs and administrative law by the customs authorities, and in its justification, cited the obligation to determine the amount due in a clear and precise manner, using objective and measurable data. The judgment is a reprimand for the company’s arbitrariness.

Separating costs is also important in so-called simplified procedures. As mentioned earlier, the simplified H7 declaration applies to products whose actual value, i.e., the price of the goods themselves, does not exceed €150. If the seller fails to separate the costs on the invoice, shipping costs will be included in the actual value – if this amount exceeds €150, the seller will have to go through the full customs procedure. Failure to clearly present the cost breakdown could also impact the efficiency of the entire import procedure. Because the simplified H7 declaration is processed automatically by the National Tax Administration, the algorithm may detect irregularities in the declared data, which may result in document revisions or a physical inspection of the package. This, in turn, can generate potential delays and other problems.

There are also minor and often overlooked issues, such as different CN codes for goods in the same package. A separate flat-rate customs duty must be paid for each item from a different line item. Let’s not forget the mundane, yet utterly human, issue: if the item we ordered doesn’t meet our expectations and we want to return it, the customs and VAT costs will not be refunded. With this in mind, it’s important to weigh the pros and cons before making a final decision.

Summary

The purchase of Tuwim’s “Locomotive,” besides its aesthetic appeal, undoubtedly provided Jan K. with insight into the EU customs system for goods imported from outside the European Union, specifically the USA. The most important lessons learned from this lesson include an awareness of the consumer’s role when importing goods from outside the EU and their customs and tax obligations, as well as the operating principles and powers of the Polish Post, along with its requirements for importers. The potential costs incurred by both consumers and sellers in transactions made via the online marketplace were also analyzed. A study of regulations and specific examples demonstrated the importance of a properly conducted procedure for both parties, so as to avoid unnecessary financial burdens on either side.

In the current era of globalization and the development of global export giants, purchasing products and services online is inevitable. American platforms such as Amazon, eBay , Wayfair, Target, and Walmart, having established a stable and strong position in the global market, conduct sales primarily focused on protecting their structures and generating profits. Therefore, as Polish consumers of American products, we should, above all, protect our own interests and financial security, be aware of the dangers and risks associated with ignorance of appropriate customs procedures and our obligations as a party to the transaction. In other words, let’s follow the example of Jan K., who fulfilled his desire for a unique book by studying his consumer rights and responsibilities on the American platform AbeBooks.

Bibliography:

Legal acts:

Act of 11 March 2004 on tax on goods and services (consolidated text: Journal of Laws of 2025, item 775, as amended). https://sip.lex.pl/#/act/17086198/444640770/podatek-od-towarow-i-uslug?keyword=podatek%20od%20towar%C3%B3w%20i%20us%C5%82ug%20&searchPit=2026-07-15

Act of 19 March 2004 – Customs Law (consolidated text: Journal of Laws of 2024, item 1373). https://sip.lex.pl/#/act/17088507/441956979/prawo-celne?keyword=ustawa%20prawo%20celne%20&searchPit=2026-07-15

Council Regulation (EC) No 1186/2009 of 16 November 2009 setting up a Community system of reliefs from customs duty (codified version) (OJ L 324, 2009, p. 23, as amended). https://sip.lex.pl/#/act/67914249/3571055/rozporzadzenie-1186-2009-ustanawiajace-wspolnotowy-system-zwolnien-celnych-wersja-ujednolicona?keyword=Rozporzadzenie%C4%85dzenie%201186%2F2009%20ustanawiaj%C4%85ce%20ws%C3%B3lnotowy%20system%20zwolnie%C5%84%20celnych%20(wersja%20ujednolicona)&searchPit=2026-07-15

Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 2013, p. 1, as amended). https://sip.lex.pl/#/act/68359246/176766672/rozporzadzenie-952-2013-ustanawiajace-unijny-kodeks-celny?keyword=Rozporz%C4%85dzenie%20952%2F2013%20ustanawiaj%C4%85ce%20unijny%20kodeks%20celny%20z%201%20maja%202016%20&searchPit=2026-07-15

Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 2015, p. 558, as amended). https://sip.lex.pl/#/act/68591768/181445989/rozporzadzenie-wykonawcze-2015-2447-ustanawiajace-szczegolowe-zasady-wykonania-niektorych…?keyword=Rozporzadzenie%20wykonawcze%202015%2F2447%20z%201%20maja%202016%20&searchPit=2026-07-15

Ministry of Finance. (2021, September 1). Tax clarifications regarding the so-called VAT e-commerce package introduced by the Act of May 20, 2021, amending the Act on Value Added Tax and certain other acts (Journal of Laws, item 1163) . https://www.podatki.gov.pl

Judgment of the Supreme Administrative Court in Szczecin of 17 March 1999, SA/ Sz 1731/98, M.Podat. 2000, no. 5, item 29.

https://sip.lex.pl/#/jurisprudence/520132316/1?directHit=true&directHitQuery=SA%2FSZ%201731%2F98

Artykuł A well-aimed shot at American e-commerce. A practical guide to customs clearance of US shipments through the Polish Post. pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

1. Reports only via e-Sanepid

Every dietary supplement introduced to the market for the first time must be reported to the Chief Sanitary Inspector (GIS). Until now, various forms were acceptable – paper or electronic, with a handwritten or electronic signature. After the amendment comes into effect, the only acceptable method will be the e-Sanepid platform.

What does this mean in practice?

• It is necessary for each person submitting notifications to have a qualified electronic signature or a trusted profile.
• All communication with sanitary inspection bodies – letters, decisions, and confirmations – will be handled through the platform account. The moment of notification submission will be clearly confirmed with an official receipt, eliminating disputes over the deadline.
• Companies that have previously used paper forms or traditional correspondence must immediately switch to the new channel and ensure appropriate employee training.

The change also concerns the timing of the notification obligation: the previous option to notify the Chief Sanitary Inspectorate (GIS) at the stage of intended product introduction is no longer available. The obligation now arises at the time of actual introduction to the market.

2. Strict deadlines and automatic presumption of irregularities

The amendment introduces a completely new mechanism for conducting investigations. This change has the greatest potential to surprise companies without effective internal compliance procedures.

How does the new mechanism work?

If the Chief Sanitary Inspectorate initiates an investigation and requests the entity to submit a scientific opinion, the company has exactly 14 days to submit an application to an accredited scientific unit – at the same time forwarding a copy of it to the Chief Sanitary Inspectorate.

The mechanism for presuming irregularities is a significant innovation. Previously, a company’s inaction during the proceedings did not automatically result in any legal consequences – the proceedings could drag on for years. Following the amendment, any failure to meet the 14-day deadline will lead to direct negative consequences, regardless of whether the product is safe.

3. Advertising without reporting? A fine of nearly one million zlotys

This change directly impacts brands engaging in active digital marketing. Previously, advertising or presenting a dietary supplement without prior notification to the Chief Sanitary Inspectorate (GIS) was punishable by a fine (a misdemeanor). Following the amendment, this becomes grounds for imposing an administrative fine – with new, significantly higher penalties.

What exactly is prohibited?

The amendment penalizes not only the sale of a supplement without reporting it to the Chief Sanitary Inspectorate (GIS), but also the mere advertising or presentation of it if the notification has not been effectively submitted. In other words:

• Sponsored post on Instagram or Facebook promoting a new supplement before notification = grounds for an administrative penalty.
• Product page in the online store visible to the public before successful reporting to GIS = risk of infringement.
• Promotional materials sent to wholesalers or distributors before GIS is notified = potential infringement.
• Influencer marketing initiated before the date of effective notification = liability on the part of the entity commissioning the campaign.

Prohibition on suggesting medicinal properties – wider scope

The amendment expands liability for violations of advertising requirements from labeling to the entire marketing message. Previously, sanctions primarily covered incorrect packaging labeling. Following the amendment, a company is responsible for every communication channel – online advertising, point-of-sale materials, newsletters, or YouTube videos – if the message suggests that a varied diet does not provide sufficient nutrients, or if a supplement is presented as a medicinal product.

4. Public register – the company’s reputation under public scrutiny

The Chief Sanitary Inspectorate (GIS) has maintained a register of dietary supplements before, but the amendment will significantly expand its scope and availability. The data will be published on the e-Sanepid platform and will include:

• the name of the product and its qualitative composition (without quantitative data – the recipe remains protected),
• product qualification proposed by the entity,
• information about the initiation or ongoing investigation,
• data on the detection of a prohibited ingredient.

5. Fines – increase by over 330%

The maximum administrative fine for violating food safety regulations is increasing from 30 to 100 times the average monthly salary. At the current salary level, this means:

The new penalties are imposed administratively (not as fiscal or misdemeanor offenses), which means faster proceedings and no need to prove intentional guilt. A mere finding of a violation is sufficient. The increased level of sanctions has a real deterrent effect, especially for companies with turnover in the tens of millions of zlotys.

The biggest risks – a practical overview

Artykuł CLIENT ALERT Dietary supplements market in Poland Amendments to food safety regulations | May 2026 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.