If you’re planning to sell the same supplement in both Europe and the United States, you’re not running one regulatory project, you’re running two. Here’s the side-by-side that most consultants charge €5,000 to draw up.
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 you sell first and prove safety later if challenged. The EU mostly requires you to notify before you sell.
The 7 differences that matter
1. Pre-market notification
EU: most member states require you to notify the food authority before placing the product on their market. Some accept the notification as filed, some require an active review.
U.S.: no pre-market notification. You register the facility (FDA Reg. for the manufacturer, in our case Reg. No. 14287957814) and start selling. 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 if you can substantiate them, 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’s 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. PharmScale runs 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 BiH Ministry of Health permit and is recognised across the EU.
U.S.: the manufacturer must hold an FDA Food Facility Registration. Re-registration is required every two even-numbered years.
What “compliance” looks like as a project
For a single product launching in EU + U.S., expect roughly:
- 1 master formula, one recipe, two label panels
- 2 label files, EU and U.S. versions, sometimes also language variants for EU
- 2 dossiers, one EU notification (per market entered), one U.S. self-assessment
- 1 master CoA, same Certificate of Analysis acceptable for both
How PharmScale handles both sides
Our regulatory team holds active dossiers across all 27 EU member states, the U.K., and the U.S. We file once, then adapt the documentation per market. You get one project manager, one formulation, one production line, two compliant products.