A US supplement brand with a successful product line — 47 SKUs, $12 million in annual revenue, strong Amazon rankings — came to us wanting to enter the EU market. Their first question was whether they could use their existing US labels and formulations. The answer was no to both. DSHEA and the EU framework are not compatible systems. They are built on fundamentally different regulatory philosophies, and understanding those differences is the starting point for any transatlantic supplement strategy.

What Is DSHEA?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the US federal law that defines dietary supplements and establishes the regulatory framework governing them. Under DSHEA, dietary supplements are defined as products intended to supplement the diet that contain one or more dietary ingredients — vitamins, minerals, herbs, amino acids, enzymes, or other substances.

The core principle of DSHEA is that dietary supplements are presumed safe unless FDA proves otherwise. Manufacturers do not need pre-market approval from FDA before selling a supplement. They must notify FDA within 30 days of marketing a new dietary ingredient (NDI) introduced after 15 October 1994, but this is a notification, not an approval process.

FDA’s role under DSHEA is primarily post-market: monitoring adverse event reports, conducting inspections, and taking enforcement action against unsafe or mislabelled products.

What Is the EU Food Supplement Directive?

EU Directive 2002/46/EC on food supplements establishes the EU framework for food supplements — defined as foodstuffs intended to supplement the normal diet that are concentrated sources of nutrients or other substances with a nutritional or physiological effect.

The directive establishes positive lists of permitted vitamins and minerals and their chemical forms. Only substances on these positive lists may be used in EU food supplements. Substances not on the list are prohibited unless a member state has a national authorisation or the substance is authorised under the Novel Food Regulation (EU) 2015/2283.

Unlike DSHEA, the EU framework is based on positive lists — what is explicitly permitted — rather than a general presumption of safety.

Key Differences: DSHEA vs EU Directive 2002/46/EC

Aspect	DSHEA (USA)	EU Directive 2002/46/EC
Regulatory philosophy	Presumed safe unless proven otherwise	Positive list — only permitted substances allowed
Pre-market approval	Not required (NDI notification for new ingredients)	Not required for listed vitamins/minerals; Novel Food authorisation for unlisted substances
Permitted ingredients	Broad — vitamins, minerals, herbs, amino acids, enzymes, and many other substances	Restricted to positive list for vitamins/minerals; herbs regulated separately
Maximum levels	No federal maximum levels (FTC regulates claims)	Member state discretion; EFSA provides guidance; harmonised EU maximums under development
Labelling	Supplement Facts panel; structure/function claims permitted with disclaimer	Nutrition labelling; health claims require EFSA authorisation under Regulation (EC) No 1924/2006
Health claims	Structure/function claims allowed with FDA notification and disclaimer	Only EFSA-authorised claims permitted
GMP	21 CFR Part 111	ISO 22716 (for manufacturing); food safety regulations
Enforcement	Post-market by FDA	Post-market by national authorities (DGCCRF in France, BVL in Germany, etc.)

The Positive List Problem

The most immediate practical challenge for US brands entering the EU is the positive list for vitamins and minerals.

EU Directive 2002/46/EC Annex I lists the permitted vitamin and mineral substances. The list is specific about chemical forms — for example, magnesium is permitted in 11 specific forms (magnesium carbonate, magnesium chloride, magnesium citrate, etc.). A magnesium supplement using a form not on this list — even if it’s a legitimate, safe magnesium compound — cannot legally be sold as a food supplement in the EU.

US supplement formulations frequently use ingredient forms that are not on the EU positive list. Common examples:

Magnesium threonate: Not on the EU positive list for magnesium (as of 2026). US brands using this form must either reformulate or seek Novel Food authorisation.
Nicotinamide riboside (NR): Authorised as a Novel Food in the EU, but with specific conditions and maximum levels that differ from typical US dosing.
Certain amino acid forms: Some amino acid derivatives used in US supplements are not on EU positive lists.

Before any EU market entry, a full ingredient-by-ingredient review against the EU positive lists is essential.

Health Claims: The EFSA Authorisation Requirement

Under DSHEA, supplement manufacturers can make structure/function claims — statements about how a nutrient affects the structure or function of the body — with a simple FDA notification and a mandatory disclaimer: “This statement has not been evaluated by the Food and Drug Administration.”

In the EU, health claims are governed by Regulation (EC) No 1924/2006. Only claims that have been scientifically evaluated by EFSA (European Food Safety Authority) and authorised by the European Commission may be used on food supplement labels and in marketing materials.

The EU Register of authorised health claims contains approximately 250 authorised claims, primarily for vitamins and minerals. The scientific bar for authorisation is high — EFSA requires robust clinical evidence demonstrating a cause-and-effect relationship between the nutrient and the claimed health benefit.

Many claims that are routine in US supplement marketing are not permitted in the EU:

“Supports immune health” — only permitted for specific vitamins/minerals at specific levels with specific wording
“Promotes cognitive function” — only permitted for specific nutrients with EFSA-authorised wording
“Boosts energy” — not a permitted health claim in the EU

US brands must audit every claim on their packaging and marketing materials against the EU authorised claims register before entering the EU market.

Novel Food: The Gateway for New Ingredients

For supplement ingredients that are not on the EU positive list for vitamins/minerals and are not traditional food ingredients with a history of consumption in the EU before 15 May 1997, the Novel Food Regulation (EU) 2015/2283 applies.

Novel Food authorisation requires a safety dossier submitted to EFSA, which conducts a scientific assessment. The process typically takes 18 to 36 months and costs €50,000 to €200,000+ in preparation and assessment fees.

Common supplement ingredients requiring Novel Food authorisation in the EU include:

Cannabidiol (CBD) — Novel Food status confirmed; authorisations being processed
Nicotinamide riboside (NR) — authorised with conditions
Certain botanical extracts not traditionally consumed in Europe
Synthetic versions of naturally occurring compounds

The Novel Food pathway is viable but slow and expensive. For brands with a single novel ingredient, it may be worth pursuing. For brands with multiple novel ingredients, reformulation for the EU market is often more practical.

Labelling Requirements: Supplement Facts vs EU Nutrition Labelling

US supplement labels use the FDA-mandated Supplement Facts panel, which lists serving size, servings per container, and the amount per serving of each dietary ingredient.

EU food supplement labels must comply with Regulation (EU) No 1169/2011 on food information to consumers, which requires:

Product name including the word “food supplement” (or national equivalent)
Names of the categories of nutrients or substances characterising the product
Portion of the product recommended for daily consumption
Warning not to exceed the recommended daily dose
Statement that food supplements should not be used as a substitute for a varied diet
Statement that the product should be kept out of reach of young children
Nutrient reference values (NRVs) expressed as a percentage of the recommended daily intake

The EU does not use the “Supplement Facts” format. US labels cannot be used in the EU without redesign.

The French Market Specifically

France has additional national requirements for food supplements beyond the EU baseline. The DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes) regulates food supplements in France and has published a list of authorised plants and plant parts for use in French food supplements (the “positive list of plants”).

France also requires notification of food supplements to DGCCRF before marketing — a process called “déclaration préalable de mise sur le marché.” This is a national requirement not present in all EU member states.

For brands entering the EU market through France first — a common strategy given France’s large supplement market (estimated at €2.2 billion in 2024) — these French-specific requirements add a layer of compliance on top of the EU baseline.

DSHEA and the EU food supplement framework are not compatible systems — they are built on different legal philosophies, different permitted ingredient lists, and different claims frameworks. US brands entering the EU market need a complete regulatory assessment covering ingredient compliance, claims review, labelling redesign, and potentially Novel Food authorisation or reformulation.

At Care Europe, we conduct EU market entry assessments for US and Canadian supplement brands, covering the full regulatory gap analysis from ingredient compliance to label review. Contact us at [email protected].

DSHEA vs EU Food Supplement Directive: Key Regulatory Differences