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The FDA’s Role in Regulation


You may have heard things like ‘supplements are unregulated’ in the past, but that statement is only half true.

A more accurate description would be ‘regulations exist, but supplement manufacturers and marketers are expected to self-enforce, and the FDA lacks the resources to police everybody.’

When you look at almost anything in the category of supplements, you’ll probably see this text somewhere, verbatim:

‘These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.’

That text is required by the FDA to clarify that the product you’re looking at is not a drug (hence the second sentence), and that any claims made about it have not been confirmed to be truthful or, really, based in any evidence whatsoever (that’s the first sentence).

No wonder this industry has a bad reputation! You see why we put so much emphasis on clinical studies and third-party testing? You can say whatever you want!

That’s not really true. The fact of the matter is that, as with every industry, truth in advertising is the law of the land, and while shysters get away with it, bad actors get caught all the time too.

What is the FDA?

The Food and Drug Administration is the segment of the US government responsible for regulating both supplements, which fall under the ‘food’ umbrella, and drugs, as the name may have suggested to you. In addition to food and drugs, they work to ensure the safety of cosmetics and medical devices as well.

What’s the difference between a supplement and a drug?

The Food, Drug, and Cosmetic Act of 1938 is the law that stipulates that the FDA regulates food separately from drugs. Under this rule, drugs are defined as products used for medical purposes, whereas foods have nutritional purposes, and food is the category supplements fall under. Drugs are for treating, preventing, diagnosing, or curing diseases, and thus, by exclusion, supplements can’t be marketed with claims to do any of those things.

Another important distinction between supplements and drugs: drugs, in the eyes of the FDA, are unsafe until proven safe. That means in the drug approval process, drugmakers need to prove via ‘substantial evidence’ that the drug is both safe and effective through a series of clinical trials. This applies to both prescription and over-the-counter drugs.

To the converse, supplements, like food, are considered safe until proven unsafe. According to David Kessler, commissioner of the FDA when the Dietary Supplement Health and Education Act of 1994 (DSHEA) was approved:

“The 1994 Dietary Supplement Act does not require that dietary supplements … be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace. The agency is permitted to restrict a substance if it poses a ‘significant and unreasonable risk’ under the conditions of use on the label or as commonly consumed…Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger. Nor does the public understand how potentially dangerous these products can be.”

Woof. Scary stuff, right?

What regulations are there on supplements?

Supplement regulations distinct from those on foods do exist — lots of them, in fact, but, taken in aggregate, the upshot is that the regulation of supplements is significantly lighter than it is on drugs. That means that, as with your regular diet, the onus is on you, the consumer, to make informed decisions about supplements. Again, you see why we put so much emphasis on clinical studies and third-party testing?

That also means that supplement manufacturers, distributors, and marketers can sell things that have no effect, have poorly understood effects, have many side effects without carrying a warning, interact with other supplements or drugs, are known to be poorly tolerated, or are even stronger than advertised.

We don’t want to give the impression that it’s entirely the wild west out there — in the rule (21 CFR 111), supplement manufacturers are required to self-report to the FDA any complaints of Serious Adverse Events they receive from customers, and companies that routinely fail to comply with this (or are routinely filing SAE reports) are liable to eventually be fined or shut down by the FDA.

Nonetheless, the fact remains that almost every rule in the code relies on companies to self-report, self-police, self-inspect, and self-document, with only the threat of inspection to keep them honest. The FDA simply does not have the resources to properly police the industry. As a company with integrity as its guiding principle, we wish this were not the case.

It’s not a level playing field between our approach and that of companies selling whatever, and saying whatever, they want. We have to make a lot of chewy points about studies and lab tests to help consumers understand why our product is different from the ones promising to zap your brain.

The majority of regulatory scrutiny is directed at the manufacturers, who have to comply with cGMPs (current Good Manufacturing Practices), but for distributors and marketers, who are, in most cases, the authors of the formula and arbiters of the claims made to consumers, compliance is enforced only when the FDA takes notice via a direct complaint.



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