Short answer: the US doesn't pre-approve supplements — but that freedom comes with a catch most brands underestimate. If your product contains an ingredient that wasn't on the US market before 1994, you may need to notify the FDA before you sell it, and getting that wrong is one of the most common ways supplement launches go sideways. Here's how the US system actually works.
The framework: DSHEA and "no pre-approval"
US dietary supplements are governed by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which sits inside the Federal Food, Drug & Cosmetic Act. The defining feature: unlike a drug, a supplement does not need FDA approval before going to market. The manufacturer — not the FDA — is responsible for ensuring the product is safe and that its claims are truthful and substantiated.
That sounds liberating, and it is. But "no pre-approval" doesn't mean "no rules." It means the rules are enforced after you're on the shelf, through FDA and FTC action — and a product that breaks them can be pulled, seized, or hit with warning letters, after you've already invested in the launch.
A dietary supplement, under DSHEA, must be a vitamin, mineral, herb or other botanical, amino acid, or a "dietary substance to supplement the diet" — or a concentrate, metabolite, constituent, or extract of these.
The NDI question: the trap that catches new ingredients
This is the part brands most often miss. A New Dietary Ingredient (NDI) is a dietary ingredient that was not marketed in the US before 15 October 1994. If your supplement contains an NDI that hasn't been present in the food supply as a food, you must submit a premarket safety notification to the FDA — at least 75 days before you market it — under section 413 of the FD&C Act.
The notification has to establish that the ingredient will reasonably be expected to be safe under the conditions of use on your label. Crucially, an NDI notification is a notification, not an approval — the FDA can object, and many notifications draw objections. Ingredients already in the food supply before October 1994 ("grandfathered" or pre-DSHEA ingredients) don't need an NDIN, but proving an ingredient's pre-1994 history isn't always straightforward, and the FDA has long signalled it reads that exemption narrowly.
This is exactly where trendy actives, novel botanicals, and newer compounds run into trouble: a brand assumes "supplements don't need approval", launches an ingredient with no NDI notification and no clear pre-1994 history, and finds itself marketing what the FDA considers an adulterated product.
Claims: structure/function vs. disease
US supplements may make structure/function claims — how an ingredient affects the normal structure or function of the body ("supports immune health", "helps maintain healthy joints") — provided they carry the required FDA disclaimer and the brand holds substantiation. What they may not do is claim to diagnose, treat, cure, or prevent a disease. The moment a claim crosses into disease territory, the FDA treats the product as an unapproved drug, and the FTC separately requires that all claims be truthful and substantiated.
The CBD footnote
It's worth knowing the most prominent exception: the FDA holds that CBD is excluded from the dietary-supplement definition (because it was first approved as a drug), so CBD can't currently be sold as a US dietary supplement regardless of hemp origin — a separate issue we cover in our CBD market breakdown.
The practical takeaway
Selling into the US comes down to three questions:
- Is every ingredient either pre-1994 / in the food supply, or covered by an NDI notification? This is the one that catches new ingredients.
- Are your claims structure/function, with the disclaimer and substantiation — and not disease claims in disguise?
- Is anything excluded outright (like CBD)?
The "no pre-approval" system rewards brands that do this homework and punishes the ones who assume it means "no rules". Regulave checks your ingredients and claims against US requirements — flagging the NDI question and the structure/function line — so you find these issues before a warning letter does.
Last reviewed: June 2026. This article is general information, not legal or regulatory advice; US supplement rules are detailed and enforcement evolves. Verify current requirements with the FDA or a qualified regulatory professional. Check your formulation and claims with Regulave →