FDA
Food and Drug Administration
FDA (Food and Drug Administration) is the U.S. federal agency that regulates food, drugs, and dietary supplements. For nutra, it matters which health claims are permitted.
What is FDA (Food and Drug Administration)?
FDA stands for Food and Drug Administration, a federal agency of the U.S. Department of Health and Human Services. It oversees the safety and labeling of food, medicines, cosmetics, medical devices, and dietary supplements. For nutra arbitrage, the FDA matters because the U.S. dietary supplement market is regulated separately from drugs, and mistakes in wording usually come from confusing the two.
## How the FDA regulates supplements
Under the DSHEA (Dietary Supplement Health and Education Act) of 1994, dietary supplements do not require FDA pre-approval before going on the market, unlike drugs. The manufacturer is responsible for product safety and truthful labeling. The FDA intervenes after the fact: it can declare a product 'adulterated' or 'misbranded', issue a warning letter, or initiate a recall. That is why describing a supplement as 'FDA approved' in advertising is almost always an error or a direct form of misleading the consumer.
## Health claims
Structure/function claims are allowed, for example 'supports joint health'. Claims about treating, preventing, or diagnosing diseases are not allowed, for example 'cures arthritis'. Such claims turn the product into an unregistered drug. The standard disclaimer stating that the FDA has not evaluated the claim is required when structure/function wording is used.
## Manufacturing and reporting
Supplement manufacturers must follow the GMP requirements for dietary supplements (21 CFR part 111) and keep records of serious adverse events. For a partner or arbitrageur, this means that when vetting a product, the landing page and creatives are not the only things that matter. Manufacturing documentation and the label composition matter as well.
## Common mistakes
Typical mistakes include using the FDA logo or the phrase 'FDA approved' in advertising; promising results in creatives with medical wording; transferring EU or Russian rules to the U.S. market without checking; and assuming that the absence of pre-approval means there are no restrictions. Ad networks and payment partners often block offers for the same reasons, even when the FDA has not formally intervened.
FAQ
Does the FDA approve supplements before they are sold?
No, most dietary supplements in the U.S. do not require FDA pre-approval. The agency reviews products after the fact, including based on complaints and adverse event reports.
Can I write 'FDA approved' in supplement advertising?
That wording is misleading for a supplement and often leads to creative rejection. You may only refer to compliance with requirements, and only when there is a real basis for it.
How is the FDA different from the FTC?
The FDA regulates product composition, manufacturing, and labeling, while the FTC is responsible for advertising honesty and marketing claims. In practice, both regulators can act against the same offer.