Who regulates you, and when

Supplements are regulated federally and comprehensively, and unlike most small-manufacturer categories there is no size at which the substantive rules begin.

Federal, from the first unit

FDA for manufacturing, labeling and claims. FTC for advertising. Your state for business licensing and zoning, and very little else.

There is no cottage exemption because cottage food laws cover food and a dietary supplement is its own category.

What FDA requires

Facility registration, which is administrative.

21 CFR 111 cGMP: specifications, identity testing of components, production records, a quality unit, reserve samples. All manufacturers, regardless of size, since June 2010.

21 CFR 101.36 labeling: the Supplement Facts panel, serving size, servings per container, Other ingredients.

And claims: structure/function permitted with substantiation and the disclaimer, disease claims not permitted at all.

FTC and the claims

Worth naming separately because brands forget it. FTC regulates advertising and requires that claims be truthful and substantiated by competent and reliable scientific evidence.

That obligation covers your website, your marketplace listing, your emails and what an influencer says on your behalf. FDA looks at the label; FTC looks at everything else.

What changes as you grow

Very little, legally, which is the point. The obligations that matter apply from the first unit.

What changes commercially is that wholesale buyers, marketplaces and insurers all begin asking for the evidence that you were already required to have. Growth does not add obligations here so much as it adds people checking.

References