How Dietary Supplements Are Regulated in the US

The regulatory framework for supplements differs fundamentally from that for medicines, and understanding how explains most of what you see on labels.

The framework

The Dietary Supplement Health and Education Act of 1994 established that dietary supplements are regulated as a category of food rather than as drugs. Manufacturers do not need FDA approval before marketing a product. The manufacturer is responsible for ensuring its products are safe and that claims are truthful and not misleading. The FDA's role is largely post-market: it can act against adulterated or misbranded products after they are on sale.

Claims and their limits

Structure-function claims - statements about how a nutrient affects the normal structure or function of the body - are permitted, provided they carry the standard disclaimer and are substantiated. Disease claims, asserting that a product diagnoses, treats, cures, mitigates or prevents a disease, are not permitted for supplements. The line between the two is where most enforcement activity sits, and warning letters over disease claims are issued regularly.

What this means practically

FDA registration of a manufacturing facility is a notification requirement, not approval or endorsement. GMP compliance is legally mandatory, so claiming it is a baseline rather than a credential. Neither means anyone independent has tested the finished product. New dietary ingredients require notification, but the compliance rate is imperfect. The practical upshot for a buyer is that voluntary third-party certification carries more information than any regulatory claim on the label.

A note on Cognizil

We publish this blog on the Cognizil official website, so treat anything we say about our own product as coming from an interested party. What we can do is be specific: Cognizil is a liquid dropper supplement taken once daily, and it makes no claim to treat, cure or prevent any disease. It also contains St. John’s Wort, so if you take any prescription medicine, read our interaction guide before the sales page. If you want the drawbacks first, start with Cognizil reviews and complaints.