From Food Supplement to Dietary Supplement: How to Cross the Border From the EU to the USA While Remaining Compliant

Are Food and Dietary Supplements the Same?

The world of food supplements is huge, and the business opportunities are unlimited. With a growing need to streamline production, marketing activities and to introduce efficiency, some companies are looking for opportunities where the same product covers multiple markets.

If you're planning to introduce your EU food supplement to the US market as a dietary supplement, understanding the regulatory framework of both markets is essential to avoid challenges from authorities, namely FDA (Federal Drug Administration) and FTC (Federal Trade Commission). The approach in the two regions varies significantly, although they both have as primary scope to protect consumers. This blog post will guide you through the key regulatory aspects to consider when looking to launch an EU food supplement into the USA market.

Key Regulatory Differences: EU vs. USA

The main difference lies in how these products are regulated. Food supplements marketed in the EU fall under the general food law, while in the USA, they are regulated by the Food and Drug Administration (FDA) under 21 CFR Part 111 in accordance with the Dietary Supplement Health and Education Act of 1994 (DSHEA). From here, several divergence points arise:

Legal Name

The EU implemented the term Legal Name where certain product categories are defined by law and that specific name must be used. In the EU, the legal name is “food supplement”, while in the USA we have the concept of Statement of Identity where the products are prescribed to be called “dietary supplement” or the word dietary to be replaced by the name of a nutrient or group of nutrients defining the product.

Allowed Ingredients

The use of vitamins and minerals is common in both territories. The EU implemented a positive list of permitted vitamins and minerals and their sources for use in food supplements defined in the EU Food Supplements Directive 2002/46/EC, while the US system operates on a "generally recognized as safe" (GRAS) basis, or notifications as New Dietary Ingredients. This means certain ingredients allowed in EU supplements might not be permitted in US supplements. For instance, some nutrients widely used in the EU might require premarket approval as New Dietary Ingredients before use in US products, or the establishment of GRAS status and immediate placement in the food supply before use in supplements.

Labelling

Regulatory requirements also vary significantly between the two markets. The EU regulations require the presentation of nutritional information, while US regulations focus on the structure and content of the Supplement Facts panel, including specific disclaimers and warning statements. For example, the EU requires the labelling of allergens in a distinctive manner from the normal text used in the list of ingredients (e.g. bold text) while the US mandates the declaration of major food allergens in a "Contains" statement. 21 CFR Part 111 is also very specific where the Supplement Facts panel must be placed and what the size of text and thickness of separator lines should be.

Claims

The types of claims permitted on product labels differ as well. The EU has a more rigorous system for health claims, requiring pre-approval and scientific substantiation. In contrast, the US has a limited list of approved health claims, but the concept is different. The equivalent of an EU health claim in the USA is called structure/function claim, which describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans. These are allowed without pre-approval but with a notification system to the FDA after the marketing of the product begins. However, the FDA and FTC do have the expectation that marketeers hold robust scientific evidence to support the structure/function claims.

Registrations

While the EU does not have a centralised notification system for food supplements, many EU member states do, where a series of technical documents must be submitted by the food business operator for pre-approval.

Good Manufacturing Practices (GMPs)

While both the EU and the USA require adherence to GMPs, The EU focuses on HACCP principles and the FDA has specific CGMP regulations for dietary supplements defined in 21 CFR Part 111.

What Nutra Compliance Can Offer

  1. Formulation Review: Review your product's ingredients to ensure they comply with US regulations. Support with New Dietary Ingredient submissions, GRAS Self Affirmation or finding alternatives that are hassle free.
  2. Label Adaptation: Revise your product label to meet FDA requirements, including the Supplement Facts panel, ingredient listing, allergen declarations, and possible claims.
  3. Claims Substantiation: Review of proposed structure/function claims to ensure the wording is aligned with FDA principles and gather scientific evidence to support them.
  4. Structure Function Claim Notifications: Claim notification after marketing of products.

Partner with Nutra Compliance to streamline your food supplement transition from the EU to the USA. Contact us to learn how we can help you achieve compliance and minimise the risk of challenges.