Regulation of Dietary Supplements in the US
Jules Walters • Nov 8, 2022
Many people ask why the Food and Drug Administration (FDA) doesn’t regulate dietary supplements. At least, why not in the same strict way that the same body regulates prescription and over-the-counter drugs.
The simple answer is that supplements are classified as food products, not medicines, so they’re covered by a different set of rules.
The FDA and the FTC
The FDA and the Federal Trade Commission (FTC) share responsibility for overseeing dietary supplements and their promotion. The FDA’s responsible for safety, quality and labeling, and the FTC is for advertising.
The current rules do prohibit the makers and distributors of dietary supplements and ingredients in the US from marketing products that are adulterated or misbranded. The FDA, though, only has authority to take action against wrongdoers after the product is marketed.
As the FDA explains: the agency is “limited to post-market enforcement only because, unlike drugs that must be proven safe and effective for their intended use before marketing, there are no provisions in law for the FDA to approve dietary supplements for safety before they reach the consumers”.
Food supplement labeling
The rules do cover supplement labeling, though. So, as a minimum, the label should state that the product is a “dietary supplement”. Alternatively, it should display an equivalent term – such as “nutritional” or “calcium supplement”. The label must also detail the name and place of business of the manufacturer, packer or distributor.
And the label has to carry nutritional details in the form of a “Supplement Facts” panel, similar to the labels we see on food packaging. The panel must state serving size, number of servings in the container, dietary ingredients – and their weight. Alternatively, the panel may indicate the ingredient’s percentage of “Daily Value”.
Also, any supplement that makes a claim to a health benefit must print an accompanying disclaimer. The statement simply needs to inform consumers that the claim of benefit has not been evaluated by the FDA. And that needs to appear either in its labeling or advertising.
Another thing: the disclaimer must state the product isn’t intended to “diagnose, treat, cure, or prevent any disease”. That’s to distinguishes it for the consumer from an approved pharmaceutical drug. Only an FDA-approved drug can legally make such a claim.
Finally: any ingredients that aren’t listed on the supplement panel should appear in a list beneath it. Typically, these will include binders, fillers and taste and appearance enhancers. Here you might see water, sugar, food and color additives, as well as gelatin, starch, stabilizers, preservatives and flavoring
GMP certified and USP verified
There are two other signs you can look out for on product labeling and advertising for added quality assurance. It’s not a legal requirement, though, to display either.
One is the USP-verified mark. USP (short for United States Pharmacopeia) is a non-profit organization that works closely with the FDA. USP independently sets standards for dietary supplements and food ingredients. And supplements that go through USP’s optional testing and evaluation program, and meet all its strict criteria, can be flagged ‘USP Verified’.
The second is a sign that the manufacturer follows the rules of Good Manufacturing Practice (GMP). That’s a legal requirement. Better still is a statement or mark on the container to prove it’s had GMP compliance independently certified.