Can Nicotine-Free Snus (Oral Pouches) Be Classified as Food Supplements? What About Creatine-Containing Straws? New Challenges for EU Food Law

Can a pouch placed under the lip, containing caffeine, vitamins, minerals or botanical extracts, be classified as a food supplement? If not, why are food supplements in spray form, applied directly into the oral cavity, already available on the market? Does the regulatory classification depend on how substances are delivered into the body, or also on the fact that the product itself is not swallowed? These are just some of the regulatory questions arising from the development of innovative product formats.

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Various innovative solutions are already available on the market:

• Oral pouches – products containing neither tobacco nor nicotine, but incorporating ingredients such as caffeine, vitamins, minerals or botanical extracts.
• Straws containing creatine or other ingredients – substances are released into the beverage during drinking, although the straw itself is not consumed.
• Food supplements in spray form – administered directly into the oral cavity, including sublingually.

Where is the boundary between food and products falling under other regulatory categories?

1. Is regulatory classification determined primarily by a product’s composition, intended purpose or method of use?
2. Must a substance be swallowed in order to be considered ingested?
3. Does absorption through the oral mucosa exclude the simultaneous ingestion of part of a substance with saliva?
4. Does the fact that a carrier is not swallowed affect the regulatory classification of the product as a whole?
5. Finally, should the same legal criteria apply to different innovative product formats?

The answers are of fundamental importance to businesses. Regulatory classification determines the applicable requirements concerning product composition, safety, labelling, placing on the market and the relevant regulatory oversight framework.

The issue is under discussion at EU level

The regulatory status of oral pouches was discussed at the meeting of the Standing Committee on Plants, Animals, Food and Feed (PAFF), General Food Law Section, on 16 October 2025. The issue is once again on the agenda of the Committee’s forthcoming meeting, scheduled for 16 October 2026.

Ahead of the forthcoming discussion, IGI FOOD LAW has submitted an expert position paper to the European Commission, highlighting the need for a broader approach to the regulatory classification of innovative products. The issue extends beyond oral pouches. It concerns the interpretation of fundamental concepts of EU food law in the context of new technologies and methods of delivering substances into the human body. Does the definition of food laid down in Article 2 of Regulation (EC) No 178/2002 also cover innovative products in which substances intended for consumption are released from a carrier that does not enter the gastrointestinal tract? Which legal criteria and product characteristics should determine their regulatory classification?

Resolving these questions is essential for establishing the scope of application of EU food law, the obligations of businesses and the competence of authorities responsible for the regulatory oversight of such products.

Implications for businesses

Responsibility for the correct regulatory classification of a product rests with the business operator placing it on the market. The classification adopted should be based on the product’s objective characteristics, composition, intended purpose and method of use, and must be justified under the applicable legislation. Regulatory classification also determines the requirements concerning product composition, safety, labelling, procedures for placing the product on the market and the competence of supervisory authorities. For innovative products, a properly documented legal assessment is particularly important, taking into account the current interpretative practice of national competent authorities and EU institutions.

IGI FOOD LAW has extensive experience in regulatory advisory services concerning innovative food products, including food supplements and novel foods. We are actively engaged in projects involving the regulatory classification and placing on the market of products incorporating new ingredients, technologies and delivery formats.

Our advisory services include assessing the legal status of products, identifying applicable regulatory requirements, evaluating the permissibility of ingredient use and developing regulatory strategies for placing products on the Polish and EU markets.

In our work, we consider not only the applicable legislation but also the current positions of the European Commission and national competent authorities, as well as the practical implications of the interpretations adopted.

For projects requiring regulatory classification or the development of a market-entry strategy for an innovative product, please contact the food law experts at IGI FOOD LAW: igifoodlaw@igifoodlaw.com.

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