On May 6, 2025, the Supreme Administrative Court, reviewing a cassation complaint filed by an entrepreneur operating in the dietary supplements sector, issued a judgment under case number II GSK 1813/24, which constitutes an important point of reference for the interpretation of food law regulations, particularly in the field of dietary supplement labeling. The case concerned the sanitary inspection authorities’ objection to the use of the terms “dosage” and “composition” on a dietary supplement label, which, in their view, could mislead consumers as to the nature of the product. The Court adopted a functional and purposive interpretation, emphasizing that the labeling of dietary supplements should be assessed not only from the perspective of the literal wording of the provisions but also taking into account the technical, linguistic, and consumer context. This ruling sets new standards for administrative practice and industry communication, and its consequences may have systemic implications for the entire dietary supplements market in Poland.
Factual background of the case
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The case concerned a dietary supplement placed on the market by an entrepreneur who included, among other things, the terms “dosage” and “composition” on the product label. Following an inspection, the sanitary authority concluded that the use of the term “dosage” could imply medicinal properties of the product, which is not permissible for foodstuffs, and that the use of the word “composition” instead of “ingredients” violated the provisions of Regulation (EU) No 1169/2011 of the European Parliament and of the Council. As a result, the authority issued an administrative decision ordering a change in the labeling and imposed a financial penalty.
The case, which was ultimately resolved by the Supreme Administrative Court in its judgment of May 6, 2025 (case no. II GSK 1813/24), originated from a decision issued on December 16, 2020, by the Lower Silesian Provincial Sanitary Inspector. In that decision, the authority imposed seventeen separate financial penalties on the entrepreneur for irregularities in the presentation and advertising of seventeen different food products, including dietary supplements.
After the entrepreneur filed an appeal, the Chief Sanitary Inspector annulled the decision of the Lower Silesian Provincial Sanitary Inspector in its entirety and ruled on the merits of the case, imposing two financial penalties: the first in the amount of PLN 15,000 for violations of the provisions on health and nutrition claims (Article 103(1)(1) of the Food and Nutrition Safety Act), and the second in the amount of PLN 10,000 for violations of the provisions on dietary supplement labeling (Article 103(1)(1b)(c) of the same Act). The violations concerned, among other things, the use on the website and in promotional materials of terms such as “dosage” and “composition” instead of “ingredients,” which, in the opinion of the Chief Sanitary Inspector, was inconsistent with Regulation (EU) No 1169/2011 and the Regulation of the Minister of Health of October 9, 2007.
The entrepreneur challenged the decision of the Chief Sanitary Inspector before the Provincial Administrative Court in Warsaw, which, in its judgment of February 8, 2024 (case no. V SA/Wa 944/23), annulled the decision of the Chief Sanitary Inspector. According to the Court, the Inspector had violated both substantive and procedural law, including by incorrectly classifying the use of the terms “dosage” and “composition” as violations of Regulation (EU) No 1169/2011. The Court emphasized that removing these alleged infringements from the description of the violation could have affected the amount of the financial penalty imposed.
Moreover, the Provincial Administrative Court held that in the contested decision the Chief Sanitary Inspector failed to present the violations concerning the presentation and advertising of one of the products – “S[…]” – even though the decision also applied to that food product. The lack of a description of violations with respect to this product constituted a breach of administrative procedure provisions, in particular Articles 7, 77 § 1, 80, and 107 § 3 of the Code of Administrative Procedure, since the appellate authority’s decision annulled the first-instance authority’s decision in its entirety and ruled on the merits of the case. This required a full presentation of all established violations with respect to each product covered by the proceedings.
In all other respects, the Provincial Administrative Court accepted the authority’s findings and their legal assessment; however, the identified procedural deficiencies and the misinterpretation of substantive provisions resulted in the annulment of the Chief Sanitary Inspector’s decision.
The Chief Sanitary Inspector disagreed with the Provincial Administrative Court’s judgment and filed a cassation complaint with the Supreme Administrative Court, challenging the ruling in its entirety. In the cassation complaint, the Inspector alleged, among other things, an incorrect interpretation of Article 103(1)(1b)(c) of the Food and Nutrition Safety Act in connection with Article 7(1)(a) and (b) and Article 18(1) of Regulation (EU) No 1169/2011, as well as §5(2)(3) of the Regulation of the Minister of Health. The Inspector argued that the use of the terms “dosage” and “composition” instead of “ingredients” constituted a violation of food law provisions, and that the Provincial Administrative Court’s challenge of this was unjustified. Furthermore, procedural violations were alleged, which could have had a significant impact on the outcome of the case, emphasizing that the authority had taken all necessary actions to clarify the factual circumstances.
Legal framework – regulations on dietary supplements
According to the Act of August 25, 2006, on Food Safety and Nutrition, a dietary supplement is a food product intended to supplement the normal diet, being a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect, and placed on the market in a form that allows for dosage. Dietary supplements may not have medicinal properties within the meaning of pharmaceutical law, and their labeling, presentation, and advertising must not suggest that a balanced diet fails to provide sufficient amounts of nutrients.
The Regulation of the Minister of Health of October 9, 2007, and Regulation (EU) No 1169/2011 of the European Parliament and of the Council set out detailed requirements regarding the composition and labeling of dietary supplements. These regulations require, among other things, the indication “dietary supplement,” the name of the category of nutrients, the recommended daily portion, a warning not to exceed this portion, and information that the supplement should not be used as a substitute for a varied diet. This information must be provided in Polish, in a clear and durable manner.
Regulations on dietary supplements in Poland result from the implementation of European Union provisions, in particular Directive 2002/46/EC and Regulation 1169/2011. The aim of these regulations was to ensure a high level of consumer protection, transparency of information, and harmonization of the internal market. In Poland, these provisions were implemented through the Act on Food Safety and Nutrition and the implementing regulations of the Minister of Health. Over the years, these regulations have been amended multiple times, including with regard to maximum doses of active ingredients, mandatory warnings, and notification procedures.
Supreme Administrative Court’s assessment
The Supreme Administrative Court, examining the cassation complaint filed by the Chief Sanitary Inspector, conducted a comprehensive assessment of both substantive and procedural allegations, addressing the interpretation of the Food Safety and Nutrition Act, the Regulation of the Minister of Health, and Regulation No. 1169/2011. Although the reasoning of the Provincial Administrative Court’s judgment contained certain interpretative errors, the Supreme Administrative Court found that its operative part was in accordance with the law, which justified the dismissal of the cassation complaint under Article 184 of the Code of Administrative Court Procedure.
Allegation concerning the term “dosage”
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The key issue in dispute was whether the use of the term “dosage” on a dietary supplement label could be considered a violation of Article 7(1)(b) of Regulation No. 1169/2011, which prohibits attributing to food products effects or properties they do not possess. The Chief Sanitary Inspector argued that the use of this term could suggest that the product has medicinal properties, thereby misleading the consumer.
The Supreme Administrative Court did not share this argument, pointing out that dietary supplements are food products intended to be consumed in small, measured single quantities, as defined by law (Article 3(3)(39) of the Food Safety and Nutrition Act) and Directive 2002/46/EC. According to Article 27(2) of the Act, the labeling of a dietary supplement must include information on how to use it, which corresponds to the concept of the “recommended daily portion” (§5(2)(3) and (4) of the Regulation of the Minister of Health). The Court held that there is no reason not to treat this portion as a dose, and that the term “dosage” is consistent with the function of a dietary supplement and does not imply medicinal effects, provided it is not accompanied by therapeutic claims.
The Court emphasized that the Regulation of the Minister of Health was issued pursuant to statutory delegation and cannot be interpreted in a manner inconsistent with the law, as provided by Article 92(1) of the Constitution of the Republic of Poland. Furthermore, according to Article 6(3)(b) and (c) of Directive 2002/46/EC, the EU legislator treats the terms “recommended portion” and “recommended dose” as equivalent, which further confirms the permissibility of using the term “dosage” in the context of dietary supplements.
Allegation concerning the term “composition” instead of “ingredients”
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The Supreme Administrative Court upheld the allegation concerning the incorrect interpretation of Article 18(1) of Regulation No. 1169/2011 by the Provincial Administrative Court. The first-instance court had considered the Chief Sanitary Inspector’s classification of the use of the heading “composition” as a violation to be excessive formalism. However, the Supreme Administrative Court pointed out that, pursuant to Article 9(1)(b) and Article 18(1) of the Regulation, the list of ingredients must be preceded by a heading containing the word “ingredients.” The exception to this rule, set out in Article 16(2), applies only to very small packages, which was not relevant in this case. Consequently, the Court agreed with the Chief Sanitary Inspector on the legitimacy of challenging the entrepreneur’s product labeling in this respect.
The Supreme Administrative Court also addressed the procedural allegation concerning the lack of a description of violations related to the presentation and advertising of the products. The first-instance court correctly noted that the Chief Sanitary Inspector’s decision, which annulled the DPWIS decision in its entirety and ruled on the merits, should have included a full description of violations for each product covered by the proceedings. The authority did not dispute that a procedural lapse had occurred and attempted to rectify it only at the cassation stage, which constituted a belated analysis of the evidentiary material.
The Supreme Administrative Court reminded that administrative courts do not conduct evidentiary proceedings but supervise the activities of public administration for compliance with the law (Articles 3 §1 of the Code of Administrative Court Procedure and Articles 1 §1 and §2 of the Act on the System of Administrative Courts). Accordingly, the obligation to collect and evaluate evidence rests with the administrative authority, and any failure to fulfill this duty cannot be remedied during judicial proceedings.
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In summary, taking the above into account, the Supreme Administrative Court held that, despite certain errors in the reasoning of the Provincial Administrative Court’s judgment, its operative part was in accordance with the law. The Court emphasized that the violation of Article 18(1) of Regulation No. 1169/2011 could have affected the amount of the imposed penalty, but not the justification for annulling the Chief Sanitary Inspector’s decision. Accordingly, pursuant to Article 184 in fine of the Code of Administrative Court Procedure, the Supreme Administrative Court dismissed the cassation complaint and upheld the Provincial Administrative Court’s judgment.
Regarding the use of the heading “composition,” the Supreme Administrative Court held that although Regulation 1169/2011 requires the use of the term “ingredients,” an extended form, e.g., “supplement composition,” does not violate the provisions, provided that the term is not entirely omitted. The Court emphasized that the administrative authority should precisely describe each violation, and the absence of such a description in the decision may lead to its annulment due to a breach of administrative procedure.
The Supreme Administrative Court’s judgment highlights the necessity of applying a purposive and functional interpretation when assessing the compliance of dietary supplement labeling with legal provisions, marking a significant shift in the previous practice of sanitary inspection authorities and administrative courts.
In reviewing the cassation complaint, the Supreme Administrative Court held that in the case of dietary supplements, the term “dosage” may be used provided it does not imply medicinal properties but refers solely to the recommended portion for consumption. The Court emphasized that a dietary supplement is intended to be consumed in small, measured single quantities, which justifies the use of the term “dosage” in an informational context.
Regarding the use of the heading “composition,” the Supreme Administrative Court held that an extended form, e.g., “supplement composition,” does not violate the regulations, provided that the term “ingredients” is not entirely omitted.
Analysis of the terms “dosage,” “serving,” and “ingredients” – implications for the industry
The term “dosage,” although associated with medicinal products, in the context of dietary supplements refers to the recommended portion for consumption, as confirmed by the definition in the Food Safety and Nutrition Act. “Serving” refers to the technical aspect of dividing the product into single consumption units, which is relevant when formulating usage instructions. “Ingredients” is the term required by Regulation 1169/2011 as the heading for the list of substances present in the product, whereas “composition” is a colloquial term that may only be used as part of an extended heading, e.g., “supplement composition.”
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The Supreme Administrative Court held that the use of the term “dosage” in the context of dietary supplements is permissible, provided it does not suggest medicinal properties of the product. This means that manufacturers may use this term in consumption instructions, as long as it does not blur the line between a food product and a medicinal product.
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This provides greater flexibility in consumer communication, particularly regarding usage instructions.
The Supreme Administrative Court indicated that although Regulation 1169/2011 requires the use of the term “ingredients,” an extended form, e.g., “supplement composition,” does not violate the regulations, provided that the term is not entirely omitted.
This gives manufacturers the possibility to use more understandable and aesthetically pleasing graphic forms on labels, without the risk of them being automatically deemed non-compliant with the law.
Related case law – other judgments in dietary supplement cases
To fully understand the significance of the Supreme Administrative Court’s judgment II GSK 1244/22, it is also necessary to refer to other rulings of administrative courts that in recent years have shaped the interpretative practice regarding the labeling of dietary supplements, as well as the boundaries of permissible marketing and informational communication concerning these products. Although issued in separate proceedings, these rulings constitute an important complement to the interpretation of food and pharmaceutical law, and their analysis allows for the identification of judicial trends and the assessment of risk areas for manufacturers.
Of particular note is the Supreme Administrative Court’s judgment II GSK 1813/24 of May 6, 2025, in which the Court unequivocally confirmed the permissibility of using the term “dosage” on dietary supplement labeling, provided it is not accompanied by any suggestion of medicinal effects. The Court pointed out that although this term is traditionally associated with medicinal products, in the context of dietary supplements it refers to the technical aspect of consuming the product in a specified amount, which aligns with its definition as a food product intended to be consumed in small, measured portions. This ruling represents an important affirmation of the position expressed in judgment II GSK 1244/22 and strengthens the argumentation of entrepreneurs in disputes with sanitary inspection authorities.
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A review of the above rulings allows the conclusion that the case law concerning dietary supplements is moving toward greater precision and formalization of labeling requirements, while simultaneously recognizing the need for a rational interpretation of the regulations in the context of the product’s function and its perception by consumers. Manufacturers are advised to monitor current case law and adapt their informational practices to the prevailing standards of legal interpretation.
Recommendations for entrepreneurs
Entrepreneurs should conduct an audit of their product labeling, taking into account the guidelines arising from the Supreme Administrative Court’s judgment. It is important to ensure that information on labels is formulated precisely, to avoid wording that suggests medicinal effects, and to document all administrative decisions in a manner that allows for their effective challenge. It is also advisable to implement compliance procedures in line with the resolutions of the Dietary Supplements Team, which, although not legally binding, may influence the inspection practices of the Chief Sanitary Inspectorate.
The judgment emphasizes that administrative authorities must precisely indicate violations in their decisions. For manufacturers, this means that during inspections they should request a clear and detailed justification of any decision, and in its absence, they have a stronger position in appeal or court proceedings.
In light of the judgment, manufacturers should conduct an audit of their product labeling, taking into account the new interpretations. This concerns not only terminology but also the presentation of information, graphic proportions, and the placement of warnings.
The judgment may influence the way advertising and informational campaigns are conducted. Manufacturers can communicate more freely about the method of consuming a supplement; however, they must avoid any suggestions related to treatment, disease prevention, or effects on specific medical conditions. The line between information and therapeutic suggestion remains thin and requires particular caution.
Future outlook
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The Supreme Administrative Court’s judgment may serve as an impetus for the amendment of national regulations, particularly regarding the clarification of terminology used in dietary supplement labeling. An increase in legal disputes concerning the interpretation of these provisions can be expected, as well as a likely intensification of educational activities by regulatory authorities and industry organizations. The dietary supplement industry, facing regulatory challenges, should strive for greater transparency, legal compliance, and dialogue with administrative authorities.
Companies that were previously penalized for using terms such as “dosage” or “composition” may consider various legal measures, relying on current Supreme Administrative Court case law. The judgment opens the way for new arguments in challenging decisions that were based on an overly literal interpretation of the regulations.
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