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 draft Act of April 13, 2026, amending the Act on Food and Nutrition Safety will enter into force six months after its publication. The new regulations primarily impact producers, importers, distributors, and sellers of dietary supplements – both in traditional and online channels. Below, we present the real changes to your business.
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.
Modern medical devices used in plastic surgery and aesthetic medicine now operate within an exceptionally complex regulatory environment. The issue no longer concerns only product safety itself, but above all the boundary between permissible information, advertising, and the legal architecture of digital communication platforms used by manufacturers in the life sciences sector.
Poland has for years represented one of the most restrictive approaches in Europe. That is precisely why the recent judgment of the Court of Justice of the European Union in Commission v Poland, delivered on 19 June 2025 in Case C-200/24, is so important. It does not only affect one domestic provisions. It forces us to revisit a broader question: where is the proper legal balance between public health protection, professional ethics, consumer information, and economic freedom in the pharmacy sector?
