The global food supplement market has been experiencing steady growth for the last few years. Key factors such as wellness trends, greater consumer awareness and the development of e-commerce are constantly driving this phenomenon, which is bound to scale up even more in the future.
Placing a food supplement on the market can be challenging, especially if it is headed to EU and US markets. This would imply the formulation of a food supplement that would be able to meet the requirements of the different regulations across the two continents.
Below is a list of the critical points of both EU and US frameworks addressing the food supplement marketing procedure to give a brief overview.
EUROPEAN UNION
Definition and Classification
Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form […] to supplement the regular diet. Nutrients are intended as minerals, vitamins and other substances. Food supplements are regulated under Directive 2002/46/EC.
Ingredient Approval
Directive 2002/46/EC provides information on vitamins and minerals allowed in food supplements. However, each member state has implemented the directive in their national law, which might have resulted in different maximum vitamin and mineral amounts permitted in food supplements. As a guide, tolerable upper intake levels of vitamins, minerals and other nutrients are provided by the European Food Safety Authority (EFSA)[1]. If the food supplement is or contains a new ingredient (not significantly consumed before May 15 1997, in Europe), it should get authorisation from the European Union before its market -as stated in Regulation (EU) No 2015/2283. There may be cases where a food (e.g., botanical extracts) is traditionally consumed in a country and not in another, creating misalignment between member states and marketing procedures. Competent national authorities should be consulted in the latter cases.
Health Claims
Claims about health benefits must first be authorised by the European Commission and based on scientific evidence. The European Food Safety Authority (EFSA) is in charge of assessing the relationship cause-effect of a food supplement. Health claims are regulated under Regulation (EC) No 1924/2006; the allowed ones can be found on the EU website.
Labelling Requirements
Food supplement labelling must comply with Regulation (EU) No 1169/2011. List of ingredients, allergen presence, daily consumption, warning not to exceed the recommended daily dose, a statement that food supplements should not be used as a substitute for a balanced diet and that the product should be stored out of the reach of young children are some of the mandatory information.
Market Notification
In many member states, manufacturers or importers must notify the competent authority when placing a product on the market. This procedure can vary according to the country.
UNITED STATES
Definition and Classification
The term dietary supplement is defined by the Dietary Supplement Health and Education Act (DSHEA) as a product (other than tobacco) that is intended to supplement the diet which bears or contains one or more of the following dietary ingredients: a) a vitamin, b) a mineral, c) an herb or other botanical, d) an amino acid, e) a dietary substance for use by man to supplement the diet by increasing the total daily intake, or f) a concentrate, metabolite, constituent, extract, or combination of any ingredient above-mentioned.
Ingredient Approval
A new dietary ingredient (not marketed in the United States in a dietary supplement before October 15, 1994) intended to be used in a food supplement must be notified to the Food and Drug Administration (FDA) through the NDI notification procedure. If a substance is recognised as GRAS, it can be marketed without pre-market approval. There are cases where a food supplement can be concluded GRAS by an independent panel and be voluntarily notified by the FDA.
Health Claims
Claims are categorised as health, nutrient content, or structure/function claims and require FDA authorisation based on significant scientific agreement. The claim must comply with the requirements of section 403(r)(6) of the FD&C Act (21 USC 343(r)(6)), and it should be notified to FDA within 30 days after first marketing the dietary supplement with the claim.
Labelling Requirements
Labels must include the following five statements: 1) identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labelling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
Post-Market Surveillance
The FDA monitors adverse event reports and can act against unsafe or misbranded products. On the other hand, the Federal Trade Commission (FTC) regulates advertising, ensuring that marketing claims are truthful and not misleading.
In the EU and the US, the regulatory framework aims to ensure consumer safety, product quality, and truthful marketing, thereby protecting public health and maintaining fair trade practices.
For any doubt/clarification, ask Chemsafe!
[1] Overview on Tolerable Upper Intake Levels as derived by the Scientific Committee on Food (SCF) and the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). 9 December 2023.
