Buy a full case and the price per unit drops automaticallyRequest a sample
AccountCart0
All ContainersBottlesJarsCaps & ClosuresPumps & SprayersTubs & PailsJugsDroppersTinsTubesAccessories
Industries
Learn
Selling it

Who is watching

Updated

On this page8
More parties take an interest in this category than in any other here, and the ones that act first are often not regulators.

FDA, on claims and on manufacturing

Claims that cross into disease territory, and compliance with cGMP. Enforcement in this space frequently begins with a warning letter that quotes a website rather than a label, which tells you where attention actually falls.

The FTC, on advertising

Advertising has to be truthful and substantiated, and that is a separate authority from the labeling rules. A claim can satisfy the structure/function framing and still be an advertising problem if the evidence behind it does not hold up.

Your state, on top of both

States have their own consumer protection authorities and some are notably active in this category. Being correct federally is not the end of the question.

And the platforms, who act fastest

Marketplaces, payment processors and advertising platforms all have their own supplement policies, frequently stricter than the law, and they act in days rather than months. For most small makers the first consequence of a bad claim is a suspended listing or a declined ad, not a letter.

Which is why the claim register is the control

One document, reviewed before anything is published, covering the label, the site, the ads and the replies. It is the only mechanism that addresses all four audiences at once.

Record who told you what

Particularly for any state-level conversation, where the answer is local. Name, date, what you described and what they said.

Retailers do their own review

A shop or a distributor taking on a supplement often asks for the notification, the specification and sometimes evidence of cGMP, because they carry exposure too. Having those ready is a commercial advantage rather than only a compliance one.

The common thread is that all four read the same words. One register, reviewed once, answers every one of them.

References

21 CFR 101.93, Certain types of statements for dietary supplements, which carries the disclaimer word for word and the requirement to notify FDA within 30 days of first marketing a product bearing a structure/function statement. law.cornell.edu
21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. law.cornell.edu
Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.