What are food supplements?
Food supplements are defined as "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination [...]" (Directive 2002/46/EC of the European Parliament, transposed into French law by Decree no. 2006-352 of 20 March 2006).
Food supplements can be composed of :
- Nutrients : Vitamins & Minerals
- Plants or plant preparations
- Authorized Novel Foods: "any foodstuff which has not been used to a significant extent for human consumption in the Union before 15 May 1997", regardless of the dates of accession of the Member States to the Union.
- Other ingredients (taurine, caffeine etc.)
Navigating the evolving landscape of food supplement regulations
The food supplement industry has been growing rapidly in recent years, with consumers increasingly turning to these products to support their health and wellness goals. However, this growth has also attracted scrutiny from regulatory bodies, who are concerned about the safety and efficacy of these products.
In response, we are seeing a new wave of stricter regulations on food supplement labeling and health claims. These regulations aim to ensure that consumers have access to accurate and reliable information about the products they are purchasing, and that the products themselves are safe and effective.
The industry has historically been under-regulated, with many products making unproven claims about their health benefits. This has led to confusion among consumers, as well as concerns about the safety of certain ingredients. The rise of e-commerce has made it easier for unscrupulous manufacturers to sell substandard or even dangerous products to consumers. This has created a need for more stringent regulations to protect consumers from harm.
So what do these new regulations entail? They vary from country to country, but generally require manufacturers to provide more detailed information about their products, including a list of ingredients, recommended dosages, and warnings for specific audiences, (e.g. pregnant/lactating women, children, people with high blood pressure...). Health claims must be backed up by scientific evidence, and products must meet certain safety standards.
Overall, the call for stricter regulations on labeling and health claims for food supplements is an important step towards ensuring the safety and efficacy of these products. By implementing more comprehensive labeling requirements and more stringent regulations on health claims, consumers can make more informed decisions about the supplements they are considering, and have greater confidence in the safety and efficacy of these products.
The regulatory obligations for food supplements vary depending on the country in which they are being sold. In the European Union, food supplements are regulated under the Food Supplements Directive 2002/46/EC and Regulation 1169/2011. This directive requires that food supplements are safe, of good quality, and properly labeled.
In France, food supplements are regulated under the French Public Health Code (Code de la Santé Publique), which requires that food supplements must be authorized by the French authorities before they can be marketed, as specified in Article L. 112-1 of the Code de la Santé Publique. The authorization process involves submitting a dossier with information on the composition, safety, and efficacy of the food supplement.
The dossier needs to be submitted to Téléicare, which is managed by the DGAL. The DGAL refers to the Directorate General for Food (Direction Générale de l'Alimentation), which is a department of the French Ministry of Agriculture and Food. Additionally, after submitting the dossier, an engagement of compliance must also be sent to the DGAL.
In the United States, food supplements are regulated by the Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Under DSHEA, the FDA regulates dietary supplements as a category of food, rather than as drugs. The FDA requires that dietary supplements are safe, properly labeled, and do not make false or misleading claims.
In Australia, food supplements are regulated under the Therapeutic Goods Act 1989, which requires that food supplements meet certain safety and quality standards, and are labeled and advertised in accordance with the law. The Australian Therapeutic Goods Administration (TGA) is responsible for regulating food supplements in Australia.
In summary, regulatory obligations for food supplements will depend on the country of commercialisation, and may involve compliance with laws such as the Food Supplements Directive in Europe, the French Public Health Code in France, the Dietary Supplement Health and Education Act in the United States, or the Therapeutic Goods Act in Australia. Compliance with these regulations is important to ensure that food supplements are safe, effective, and accurately labeled.
Who is EcoMundo ?
Providing regulatory compliance services to the food supplement industry we offer a range of services related to regulatory compliance for food supplements, including risk assessment, labeling and packaging compliance, and product registration.
We help food supplement manufacturers and distributors ensure that their products meet regulatory requirements and are safe for consumption. We also provide guidance on the use of ingredients, claims, and labeling requirements in various countries around the world. Overall, helping companies navigate the complex regulatory landscape for food supplements and ensure that their products are compliant with applicable regulations is at the heart of our expertise.
For more information, please contact us!