US supplements: no pre-approval, but cGMP and NDI apply

The US classifies these products as dietary supplements: unlike Korea, there is no pre-market approval or registration — but post-market obligations are heavy.

Three requirements matter most: ① Supplement Facts labeling with permitted claims only (structure/function statements — no disease treatment or prevention claims), ② manufacturing under cGMP (21 CFR Part 111), and ③ a New Dietary Ingredient (NDI) notification 75 days before marketing for ingredients not sold in the US before 1994.

Flagship Korean ingredients like red ginseng and probiotics vary in NDI status by ingredient, so review the formulation early. US importers will also request documentation from the Korean manufacturer under FSVP.