Dietary supplements regulatory obligations are increasingly questioned as dietary supplements gain market share in the fields of nutrition, wellbeing and prevention.
Despite their growing popularity, the regulatory framework applicable to dietary supplements remains widely misunderstood, particularly when it comes to clinical trials and human studies.
Unlike medicinal products or medical devices, dietary supplements are not subject to a prior demonstration of clinical efficacy before being placed on the market.
This absence of a clinical efficacy requirement does not mean, however, that dietary supplements operate outside a structured and demanding regulatory framework.
Dietary supplements regulatory obligations before placing products on the market
It is essential to recall a fundamental principle:
dietary supplements are not required to undergo clinical trials prior to market entry, unlike medicinal products (which require a marketing authorisation based on efficacy) or medical devices (which require a clinical evaluation).
However, the absence of mandatory clinical trials does not imply regulatory freedom or lack of oversight.
Dietary supplements are governed by a specific regulatory framework, distinct from health products but equally structured.
What is a dietary supplement from a regulatory perspective?
According to Article 2 of Directive 2002/46/EC, dietary supplements are defined as foodstuffs intended to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form.
They are therefore distinguished from medicinal products and medical devices by:
- the absence of a therapeutic purpose,
- a nutritional or physiological mode of action,
- their classification under food law.
This legal definition is central to understanding dietary supplements regulatory obligations and their boundaries.
The European regulatory framework applicable to dietary supplements
Dietary supplements are subject to a harmonised European regulatory framework, notably:
- Directive 2002/46/EC, which defines their legal status and authorised substances,
- Regulation (EC) No 1924/2006 on nutrition and health claims,
- Regulation (EU) No 1169/2011 on food information to consumers.
🔗 Official sources:
https://food.ec.europa.eu/safety/labelling-and-nutrition/food-supplements_en
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32002L0046
However, placing dietary supplements on the market remains a national competence, with specific procedures defined by each Member State.
Dietary supplements: market access requirements in FranceIn France, dietary supplements are not subject to a marketing authorisation based on clinical efficacy.
They are, however, subject to a mandatory prior national declaration, which constitutes an administrative authorisation to place the product on the market.
Before any commercialisation, dietary supplements must be declared to the authorities in accordance with Decree No. 2006-352.
This procedure aims to verify in particular:
- compliance of the composition,
- adherence to authorised substance lists,
- ingredient safety,
- labelling compliance.
🔗 Official source (public service):
https://compl-alim.beta.gouv.fr/blog/1/
Since 26 April 2016, declarations must be submitted online via a dedicated electronic procedure.
The role of French authorities
The regulatory oversight of dietary supplements in France is based on coordination between several authorities:
- DGCCRF (Directorate General for Competition, Consumer Affairs and Fraud Control), responsible for regulatory compliance, commercial practices and claims;
- ANSES (French Agency for Food, Environmental and Occupational Health & Safety), responsible for scientific risk assessment, ingredient expertise and nutrivigilance.
Controls may take place prior to or after market entry, particularly following reports, alerts or non-compliance findings.
Product safety: a central regulatory obligation
Even in the absence of clinical trials, the core obligation remains that of operator responsibility, derived from food law.
Manufacturers or distributors must be able to demonstrate that the dietary supplement is:
- safe for human health,
- used under normal or reasonably foreseeable conditions,
- appropriate for the intended target population.
This demonstration is generally based on:
- bibliographic data,
- toxicological assessments of ingredients,
- existing scientific references.
Product safety therefore lies at the heart of dietary supplements regulatory obligations.
Can human studies be conducted on dietary supplements?
Yes — but within strict limits.
Dietary supplements may be subject to:
- nutritional studies,
- interventional or observational studies,
- research classified as “non-health-product research”.
In France, such studies fall under the framework of research involving human participants (RIPH).
They do not constitute clinical trials as defined for medicinal products or medical devices.
Dietary supplements clinical studies: risk of reclassification
Poorly designed or improperly exploited studies may lead to:
- reclassification as a medicinal product,
- or reclassification as a medical device.
Key risk signals include:
- medical or therapeutic evaluation criteria,
- explicit pathological targets,
- communication resembling therapeutic claims.
In such cases, the ANSM may intervene.
Conclusion
In France, dietary supplements benefit from a specific regulatory framework, based not on clinical efficacy demonstration, but on regulatory compliance, product safety and fair consumer information.
Although dietary supplements are not subject to mandatory clinical trials prior to market entry, they remain fully subject to regulatory controls and to the responsibility of the operator placing them on the market.
Human studies may represent a valuable scientific tool, provided they are properly framed, justified and used.
More broadly, mastering dietary supplements regulatory obligations — covering composition, labelling, claims, safety and communication — remains the key challenge for securing the development and commercialisation of dietary supplements.
