Regulation of Dietary Supplements: Analysis of AMCU Cases, Current Legislative Requirements, and the New Law on Dietary Supplements

In March 2025, Cratia, in collaboration with the “Apteka” Weekly, held an analytical webinar focused on the regulation of dietary supplements. The event aimed to highlight key trends in law enforcement, raise awareness among market operators, and promote compliance with legislative requirements. Cratia donated all proceeds from the event to UNITED24 as a charitable contribution toward the reconstruction of hospitals and the procurement of medical equipment to save Ukrainian lives.

During the webinar, Cratia delivered three presentations, including:

• Analysis of AMCU Cases: Information in Advertising and Labelling
• Current Requirements for the Regulation of Dietary Supplements in Ukraine
• The New Law on Dietary Supplements

The first presentation, delivered by Maksym Bagrieiev, Managing Partner of Cratia, was devoted to the recent practice of the Antimonopoly Committee of Ukraine (AMCU) concerning the dissemination of misleading information in the labeling and advertising of dietary supplements. The webinar featured an in-depth analysis of over 10 recent cases, including those related to products such as “Bazooka,” “Doppelherz,” “Feminozid,” “Diabetex Balance,” and others. Particular attention was paid to the nature of the violations, which were classified under Article 151 of the Law of Ukraine “On Protection Against Unfair Competition” as dissemination of misleading information by attributing medicinal properties to dietary supplements.

Special emphasis was placed on the wording used on packaging and in advertisements that triggered AMCU claims. In most analyzed cases, dietary supplements were presented as having properties typical of medicinal products, for example:

• “For cough relief”
• “Expectorant effect”
• “Helps lower blood cholesterol levels”
• “Reduces the risk of thrombosis”
• “Normalizes blood glucose levels”
• “Supports vascular elasticity,” and similar claims.

The AMCU interprets such statements as health claims, which, under Order No. 1145 of the Ministry of Health, are only permitted if listed in Annexes 2 or 3 to the Requirements. Cratia’s experts analyzed the positions of the AMCU, the Ministry of Health, the State Service of Ukraine on Food Safety and Consumer Protection (SSUFSCP), and the State Expert Center (SEC) of the Ministry of Health, which were involved in the case reviews.

The AMCU applies a very strict approach to evidentiary support. The Committee does not accept references to:

• Sanitary and epidemiological expert reports
• Toxicological or nutritional institute reports
• Scientific literature publications
• Even certificates from EU countries, if they do not confirm the clinically proven efficacy of the specific dietary supplement in the declared context.

As noted during the webinar, the evaluation of individual ingredient properties (even from authoritative sources such as EMA or PubMed) is not a sufficient basis for making claims at the level of the finished dietary supplement. The AMCU insists that all information about the product’s properties must be substantiated under the current Ukrainian food legislation, not by analogy with pharmaceutical products.

The methodology used by the AMCU to establish violations was also discussed in detail. It includes monitoring of advertising and packaging, consumer and competitor surveys, and analysis of the relationships between manufacturers, distributors, and economic operators responsible for the product information.

The presentation by Oksana Oliinychuk, Head of the FMCG Department at Cratia, focused on three critically important areas: the legal definition and classification of dietary supplements, composition requirements, and labeling and permissible claims.

The speaker emphasized that a dietary supplement is a food product that must be safe, dosed, and intended solely as a complement to the regular diet, without any treatment or preventive properties. It must not have pharmacological, immunological, or metabolic action, and any resemblance to medicinal products in form or packaging does not alter its legal nature.

The presentation thoroughly covered regulatory acts that define permissible ingredients—such as vitamins, minerals, amino acids, plant extracts, microorganisms, etc.—and the maximum intake levels, which must not exceed three times the physiological norm or approach a therapeutic dose.

Attention was also drawn to prohibited ingredients (e.g., aloe-emodin, ephedra, monacolins from red yeast rice) and novel food products that require special registration.

One of the central sections of the presentation was devoted to labeling. According to the expert, the most common violations include:

• Absence of the official designation “dietary supplement”
• Use of terms typical for medicinal products (e.g., “active ingredient,” “excipient”)
• Incorrect indication of ingredient quantities or use of unauthorized claims

The presentation emphasized the distinction between mandatory and voluntary information on packaging, allergen labeling rules, font and language requirements, as well as specific regulations concerning GMO-related information.

Separate attention was paid to claims about nutritional value, health benefits, and disease risk reduction. The speaker stressed that:

• Such claims may only be used if registered (in Ukraine or the EU)
• They must meet quantitative and scientific criteria for application
• They must not imply therapeutic properties

Use of statements such as “improves liver function,” “reduces joint pain,” or “protects against viruses” is prohibited unless properly registered and supported by evidence.

In the closing presentation, Maksym Bagrieiev presented an analysis of the new Law of Ukraine, which significantly changes the regulatory approach to dietary supplements. The law, adopted by the Verkhovna Rada in 2024, establishes a modern regulatory framework for the manufacture, import, and distribution of dietary supplements, harmonized with European legislation.

First and foremost, the updated definition of the term “dietary supplement” was introduced, clearly distinguishing these products from medicinal products. According to the law, dietary supplements are to be consumed in measured amounts as an additional source of nutrients and must not exert therapeutic effects. Thus, the law lays the foundation for the legal separation of dietary supplements from pharmaceuticals — a long-standing issue in market practice.

One of the key innovations is the introduction of a state-approved list of permitted ingredients and the establishment of maximum intake levels. This mechanism is intended to prevent the use of hazardous substances or those with pharmacological action in the composition of dietary supplements. The Ministry of Health of Ukraine is authorized to approve the relevant ingredient lists and threshold doses.

Under the new law, before placing a product on the market, the operator is required to submit a notification to the designated authority. This must include information on the composition, dosage form, country of origin, labeling text, as well as details about the manufacturing site and distributor. Without completing this notification procedure, the product may not be legally marketed.

The law explicitly prohibits any references to therapeutic, preventive, or analgesic properties. Even general phrases like “supports normal blood pressure” or “boosts immunity” may be considered violations unless supported by proper scientific substantiation and officially registered either in Ukraine or the EU. As the speaker emphasized, the new approach eliminates the possibility of manipulating product claims—regardless of the information’s source or its availability in open publications.

The new law provides a six-month period for implementation following its official publication and an additional year for the continued sale of dietary supplements already on the market, provided that the appropriate notification is submitted. Administrative liability is established for violations of the new requirements.

During the discussion, several practical cases and business-related questions were addressed, such as: how to correctly formulate information on product packaging, whether scientific sources may be used for substantiation, and how the regulator treats products containing ingredients such as melatonin or CBD. Particular attention was given to “umbrella brands” that combine dietary supplements and medicinal products under one product line — these are of particular concern to regulators and pose a heightened risk of legal violations.

Our Services

Cratia provides professional support in the legalization, safety management, and quality assurance of dietary supplements in Ukraine. Our team has the necessary knowledge, experience, and expertise. Our specialists are fluent in English and well-versed in European legislation.

We offer:

• Consultations on legal requirements for dietary supplements
• Review of composition and labeling, including health claims
• Development of compliant labeling in accordance with legal requirements
• Preparation of voluntary documentation (declarations, reports)
  

We provide preliminary consultations free of charge. Call us at +38 (044) 223-61-67, email us at info@cratia.ua, or visit our office for a meeting.