Supplement, NHP or Drug: Where the Line Sits

Classification follows the claim and the market, not the molecule. A compound lawful as a dietary ingredient in the United States may require a license in Canada, a novel food authorization in the European Union, and a marketing authorization anywhere if the label says it treats something.

United States

A dietary supplement is a product intended to supplement the diet containing a dietary ingredient, and it may carry structure and function claims with a disclaimer that the statement has not been evaluated by FDA. An ingredient not marketed in the US before October 1994 is a new dietary ingredient and generally requires a premarket notification at least 75 days before sale. Disease claims move the product into the drug category regardless of ingredient. Synthetic copies of peptide hormones are generally not eligible dietary ingredients, which is the crux of several ongoing disputes in the peptide trade.

Canada

Canada regulates natural health products as a distinct class under the Natural Health Products Regulations. A product needs a product license and an NPN or DIN-HM before sale, site licensing applies to manufacturers and importers, and permitted claims are tied to the evidence submitted or to a published monograph. The monograph system is useful for partners, because meeting a monograph specification shortens the review substantially. Ingredients outside the monographs require a full submission with the supporting evidence.

European Union and Switzerland

In the EU, food supplements are regulated as food, with health claims limited to the authorized list under Regulation 1924/2006. An ingredient without significant consumption history in the EU before May 1997 is a novel food and needs authorization before sale. Botanicals and cosmetic ingredients follow separate regimes, and Switzerland maintains its own food and therapeutic products law administered by the Federal Food Safety and Veterinary Office and Swissmedic. The practical consequence is that a single formulation often needs different claims and sometimes different compositions per market.

What this means for a formulation program

Decide the market and the claim first. The claim determines the evidence tier required, the evidence tier determines the studies, and only then does formulation design follow. Encapsulation can improve stability or release, but it does not create a regulatory pathway and cannot substitute for a notification, license or authorization. Excipient selection follows the same logic, since a material acceptable in a cosmetic may not appear on a food additive or pharmacopeial list in the target market. Confirming the accepted lists first avoids reformulating after stability work is already complete.

Key facts

• A new dietary ingredient in the US generally requires notification to FDA at least 75 days before marketing (21 U.S.C. 350b; 21 CFR 190.6)
• Structure and function claims on US supplements require the statutory disclaimer and substantiation (21 CFR 101.93)
• Natural health products in Canada require a product license and NPN or DIN-HM before sale (Natural Health Products Regulations, SOR/2003-196)
• EU health claims on foods are limited to those authorized under Regulation (EC) No 1924/2006, and significant consumption before 15 May 1997 determines novel food status (Regulation (EC) No 1924/2006; Regulation (EU) 2015/2283)
• FDA amended its position on nicotinamide mononucleotide in dietary supplements following citizen petitions, illustrating how ingredient status can shift (FDA citizen petition response, 2025)

Name your market and claim, and we will scope the pathway with you.

Related reading

• regulatory and stewardship overview
• peptide regulatory status
• sport and anti-doping
• what we will not make
• compound library
• licensing and white label
• feasibility studies
• how bioavailability is measured
• Vegalab platform technology