The same supplement sold in Europe and in the United States is not one regulated product. It is two products built from one formula. We run both sides for our own brands, so here is the side-by-side, without the parts people usually leave out.
Different worlds, different starting assumptions
The U.S. treats food supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994 and FDA’s 21 CFR Part 111 cGMP. The EU treats them under Directive 2002/46/EC, with each member state setting its own notification process. The U.S. lets a product sell first and prove safety later if challenged. The EU mostly requires notification before sale.
The 7 differences that matter
1. Pre-market notification
EU: most member states require the food authority to be notified before the product is placed on their market. Some accept the notification as filed, some run an active review.
U.S.: no pre-market notification. The manufacturing facility is registered (ours is FDA Reg. No. 14287957814) and the product can go on sale. Only “new dietary ingredients” require an NDIN 75 days before market.
2. Label structure
EU (Reg. 1169/2011): “Nutrition declaration” with energy in kJ + kcal, mandatory allergen highlighting, “Food Supplements” prominently displayed, recommended daily portion, warning not to exceed.
U.S.: “Supplement Facts” panel (different from Nutrition Facts), “Statement of Identity” (e.g., “Multivitamin Dietary Supplement”), structure/function claims with the FDA disclaimer.
3. Permitted health claims
EU: only claims listed in the EU Register of nutrition and health claims (Reg. 1924/2006). No claim outside this list, even if true.
U.S.: structure/function claims allowed where they can be substantiated, with the standard disclaimer (“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”)
4. Active ingredient limits
EU: several member states cap upper levels (e.g., Belgium caps Vitamin D at 50µg/day). What is legal in Italy may not be legal in Germany.
U.S.: few statutory caps for vitamins/minerals. The market self-regulates with industry-driven Upper Limits.
5. Heavy metals
EU: Reg. 2023/915 sets contaminant limits. We run every batch at 5× stricter than these caps for lead, cadmium, mercury and arsenic.
U.S.: California Prop 65 is the practical limit (lead: 0.5µg/day). Many products fail Prop 65 before they fail FDA.
6. Excipients and additives
EU: only additives on the approved list (Reg. 1333/2008) at specified levels.
U.S.: GRAS framework. Generally Recognized As Safe ingredients can be self-affirmed by the manufacturer.
7. Manufacturing facility registration
EU: the manufacturer must be registered with the food authority of the production country. Our facility holds the permit of the Ministry of Health of Bosnia and Herzegovina for the production of food supplements.
U.S.: the manufacturer must hold an FDA Food Facility Registration. Re-registration is required in every even-numbered year.
What both sides cost in paperwork
For a single product sold in the EU and the U.S., the file looks like this:
- 1 master formula, one recipe, two label panels
- 2 label files, EU and U.S. versions, plus language variants for individual EU markets
- 2 dossiers, one EU notification per market entered, one U.S. self-assessment
- 1 master CoA, the same Certificate of Analysis is accepted on both sides
One formula, one production line, two compliant products, and roughly double the documentation. The documentation is the part nobody photographs.
How we handle both sides
Our regulatory lead builds the master dossier once, then adapts it per market instead of starting over. The formulation, the specification and the notification are handled by the same people who run the production line, so a regulatory constraint gets designed into the formula rather than discovered after the batch exists.
Today that work carries one product on the market, PureNADH in the United States, with more in development. It is built to cover 27 EU member states, the U.K. and the U.S., because a formula that can only clear one of those regimes is a formula we would eventually have to make twice.