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Daniel Donauer
Pranvera Rasaj
The conceptual distinction between foodstuffs and cosmetic products is extremely important from a legal perspective (e.g. with regard to the legality of a product) and, as a result, is regularly addressed in practice, for example recently in the Federal Supreme Court decision 2C_576/2023 of January 18, 2024. In this decision, the Federal Supreme Court had to evaluate – in the sense of an obiter dictum – the relevance factors for distinguishing between foodstuffs and cosmetic products for a CBD oil. The most important points in this context are summarized below.
1. Background and Reasoning of the Federal Supreme Court
In decision 2C_576/2023 of January 18, 2024, the Federal Supreme Court specifically dealt with the matter of a company that sells CBD oils and has been objected to (several times) in the past for violations of food law. After the Office for Consumer Protection of the Canton of Zug had taken measures and confiscated products, recalls were ordered based on a risk assessment of the products. The company’s appeal was subsequently rejected. The company filed an administrative court appeal to restore the suspensive effect, which was again rejected. The company then appealed to the Federal Supreme Court, which dismissed the appeal.
In the course of the proceedings and the decision, the complainant’s statement that the lower court had applied Art. 4 FSA arbitrarily and had wrongly classified the complainant’s CBD oil as a foodstuff and not as a cosmetic product was addressed, among other things.
As a result, the Federal Supreme Court, in line with the lower court, classified the disputed CBD oils in this case as foodstuffs, as the website did not provide any clear information on their use as cosmetic products. According to the Federal Supreme Court, the many healing claims and warnings also indicated that the products were likely to be taken orally. Furthermore, the intended purpose of the oils was unclear for consumers. In its decision, the lower court referred to the relevant legal basis for the safety of foodstuffs (Art. 7 FSA) and the regulations for maximum permissible levels of contaminants in foodstuffs. The interim decision also referred to the fact that the Federal Food Safety and Veterinary Office (FSVO) specifies a maximum daily dose of CBD that should not be exceeded in order to prevent liver-toxic effects. The lower court saw a potential health risk in the product in question, as an examination of the products revealed that the maximum THC levels were exceeded. The appellant was then unable to convincingly demonstrate that the cited values were not relevant for the assessment of the product, which is why the appeal was dismissed.
2. Definition of Foodstuffs
Art. 4 FSA defines foodstuffs as substances or products that are intended or can reasonably be expected to be ingested by humans in a processed, partially processed or unprocessed state. Thus, according to the legal definition, the qualification of a substance or product as food requires the existence of a general intake function and an explicit or implicit intake function.1
According to Art. 4 para. 1 FSA, a substance or product can be qualified as a foodstuff if a general intake purpose can be attributed to the product.2 Absorption in this context means that the product must penetrate or be “absorbed” into the human organism.3 It is a prerequisite that the substance intake – in the sense of Art. 4 para. 1 FSA – takes place orally via the gastrointestinal tract.4 A purely superficial application of the substance (on humans, e.g. on the skin) therefore does not fulfill the uptake criterion laid down in Art. 4 para. 1 FSA.5 By applying the ingestion criterion according to Art. 4 para. 1 FSA, products that can be applied externally to humans, such as cosmetic products, can be distinguished from foodstuffs. Furthermore, the ingestion criterion under food law pursuant to Art. 4 para. 1 FSA is (also) not fulfilled if a substance or material in question is used orally, but the application takes place exclusively within the oral cavity (so that, as a result, the main object is not absorbed into the gastrointestinal tract).
In addition to the above-mentioned basic requirement of a general intended purpose, it is also necessary that the product is either explicitly intended for (oral) ingestion by humans (i.e. explicit intended purpose) or, alternatively, that the product can be reasonably expected to be ingested by humans (i.e. implicit intended purpose). If the classification of the product lacks both an explicit and an implicit ingestion purpose, classification as a food is excluded from a legal point of view. The product in question would therefore have to be classified under a different product category in accordance with Swiss product law.
A product that is in principle ingestible is not to be qualified as a food and subject to the food regulations simply because it can be physically swallowed or ingested by consumers.6 Rather, the question is whether the manufacturer or distributor has explicitly and reasonably intended the product for an ingestion purpose typical of food (i.e. explicit ingestion purpose). Consequently, from a product regulatory perspective, the question of the intended purpose or use of the product offered by a manufacturer or supplier is always relevant for the classification of a product.
If a clear intended purpose or use cannot be inferred from the corresponding declarations, a reasonably foreseeable intended use (i.e. implicit intended use) must be used as an alternative in accordance with Art. 4 para. 1 FSA. If there is corresponding information in connection with the use of the product that declares the intended use of a substance or a product and it is clear from this that a food law intended use within the meaning of Art. 4 para. 1 FSA is not intended for the product, then from a legal point of view it is not possible to classify the product as a food and therefore it is not subject to the provisions of food law.7
3. Definition of Cosmetic Products
The classification of a product as a food is therefore inadmissible if – despite the physical possibility – a substance or product could certainly be ingested, but such ingestion cannot reasonably be assumed, i.e. by a person of normal understanding. It is precisely in order to avoid the risk of possible misuse that Swiss product law regularly provides for the determination of an intended use or purpo Definition of Cosmetic Products
The term cosmetic product, in turn, is based on the wording of Art. 5 lit. b FSA. Accordingly, utility articles are articles that fall under one of the following product categories: […] cosmetic products and other articles, substances, and preparations which, according to their intended purpose, come into external contact with the body, teeth or mucous membranes.
The term “cosmetic product” is then specified as follows in Art. 53 para. 1 of the Foodstuffs and Utility Articles Ordinance (FSO) of December 16, 2016: Cosmetic products are substances or preparations intended to come into external contact with certain parts of the human body such as the skin, the hair system, the nails, the lips or external intimate regions or with the teeth and the mucous membranes of the oral cavity for the sole or predominant purpose of cleansing, perfuming, altering the appearance, protecting, maintaining in good condition or influencing body odor. This definition has been adopted from European Union law.8
In summary, this results in the following requirements for a substance or preparation to qualify as a cosmetic product. The requirements are external application, use on certain parts of the human body, including the teeth and the mucous membranes of the oral cavity, the predominant purpose of cleaning, perfuming, changing appearance, protecting, maintaining in good condition, or influencing body odor and no main intended use for ingestion, inhalation, injection or implantation.
4. CBD in Food and Cosmetic Products
In principle, according to Swiss food law, foodstuffs can be freely placed on the market (self-regulation principle). By way of exception, however, certain food categories must be approved by the FSVO before being placed on the market. The individual cannabinoid substances and hemp extracts containing cannabinoids are to be qualified as novel foods within the meaning of Art. 15 para. 1 FSO and are therefore generally subject to authorization within the meaning of Art. 16 f. FSO.9
However, products containing CBD can also be placed on the market as cosmetics under different conditions. For the relevant requirements, reference should be made to Art. 53-60 FSO and the associated VKos. Cosmetics must then be safe in accordance with Art. 15 FSA. The safety of cosmetics must be guaranteed by a product information file (PIF). The use of cannabis, i.e. non-resinized flowers and fruit stems, and products made from them (i.e. hemp extracts, CBD) in cosmetics is generally prohibited. Exceptions to this ban are seeds and leaves not mixed with flowers or inflorescences.10
However, the interpretation of the permissibility of cannabis in cosmetics is criticized in the doctrine. It is unclear, for example, whether the THC content of less than 1% must be taken into account in the manufacture of cosmetics and whether this circumstance has an impact on the classification as a narcotic. It is argued that a restrictive interpretation based on purely formal legal considerations is inappropriate.11
5. Analysis of the Statements of the Federal Supreme Court
With regard to the distinction between CBD oils as foodstuffs and CBD oils as cosmetics, the most recent decision of the Federal Supreme Court now provides various indicators by means of which a distinction can or (currently) should be made in practice. The Federal Supreme Court focused on the following characteristics of the product (and qualified the product as a food):
- The CBD oils were offered in different flavors;
- there was a lack of an explicit area of application (e.g. skin, hair) and concrete information on the effect or function of CBD oils as a cosmetic product;
- The purpose of the oils was unclear to consumers;
- the website referred to “revenue” in various places; and
- there were many warnings and corresponding prompts on the company’s website, which in turn indicated a systemic effect that could not be achieved with drop-dosed absorption via the skin.
As already mentioned, in order to qualify as a foodstuff, the substance must be ingested orally via the gastrointestinal tract within the meaning of Art. 4 para. 1 FSA. Pure oral intake or use exclusively within the oral cavity is not sufficient. Furthermore, the explicit or alternatively implicit purpose of ingestion must be taken into account. For example, it must be analyzed whether the manufacturer has explicitly and reasonably intended the product for a typical food intake purpose or if – despite the physical possibility – a substance or product could certainly be ingested, but such an intake cannot reasonably be assumed, i.e. by a person of normal understanding.
The distinction between purely oral intake and intake via the gastrointestinal tract was not addressed in this decision. The explicit or implicit purpose of ingestion was only dealt with superficially and reference was made to the overall consideration of the product. However, according to the Federal Supreme Court, the explicit purpose of intake was not stated by the appellant. Thus, there was no explicit scope of application and the intended purpose was unclear for consumers. Whether only the different flavors of the CBD oils can be understood as an implicit intended use remains questionable. According to the lower court, this factor, together with the fact that the website referred to “ingestion” in various places, was sufficient to qualify the product as a foodstuff. According to the Federal Supreme Court, this statement at least does not appear to be incorrect or arbitrary.
The Federal Supreme Court then (regrettably) hardly addressed the requirements as a cosmetic product, although a CBD oil, as mentioned above, can certainly be qualified as a cosmetic product and is regularly so.
1 Cf. Donauer, in: PraxPro-MLL Legal (ed.), N 63.
2 See, for example, decision BGer 2A.565/2000 of May 8, 2011.
3 Cf. Gattiker, Lebensmittel und Gebrauchsgegenstände, in: Biaggini/Häner/Saxer/Schott, Fachhandbuch Verwaltungsrecht, Zurich/Basel/Geneva 2015, N 16.28 et seq.
4 Cf. Donauer, Grundlagen des Lebensmittelrechts, in: Donauer/Reeves/Weber (eds.), Lebensmittel- und Gebrauchsgegenständerecht, Zurich/Basel/Geneva 2020, p. 24 f. with further references.
5 On the definition of food, see ‘Botschaft’ on the Federal Act on Foodstuffs and Utility Articles of May 25, 2011, p. 5598.
6 For the intended definition of food, see ‘Botschaft’ on the Federal Act on Foodstuffs and Utility Articles of May 25, 2011, p. 5598.
7 Cf. Donauer, in: PraxPro-MLL Legal (ed.), N 73.
8 Cf. Art. 2 para. 1 let. a of Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009 on cosmetic products.
9 Cf. Donauer, in: PraxPro-MLL Legal (ed.), N 1144 f.
10 Cf. Donauer, in: PraxPro-MLL Legal (ed.), N 1178-1182.
11 Cf. Donauer, in: PraxPro-MLL Legal (ed.), N 1183.
