Are Supplements Regulated by the FDA?

There’s a lot of talk about supplement regulations (or the lack thereof) in the United States. And unfortunately, a lot of the criticism is true: companies can (and do) launch products without research or oversight and often make health claims that are unsubstantiated. Supplement safety falls under the FDA, but because supplements are not considered prescription drugs, they’re monitored similarly to food, which means oversight happens after the product has already hit the shelves. Here’s what you need to know about supplement regulation by the FDA.

Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA), but they’re regulated as food (instead of prescription drugs). This means that safety is on the manufacturer (not the government). While many brands do some due diligence (including third-party testing), there is no central authority overseeing the sale of supplements before they’re sold to the public in the U.S.

Ingredients that were not on the market prior to 1995 are considered new dietary ingredients (NDI) and do require an NDI application to show the ingredient safety and efficacy. But, it’s up to the brand to do this. (If they don’t, they can be forced to stop selling.)

No. You can sell supplements without any approval or oversight and the dosage and ingredients are not monitored or approved by the FDA or any other regulatory body, before they’re sold to you. Since there’s no approval process, consumers (that’s you!) need to trust brands and companies to do the work of verifying ingredient safety, proper dosages, and third-party testing before selling. Some brands do this due diligence, but many don’t.

Yes, the FDA can force a company to recall supplements. Many manufacturers will participate in voluntary recalls, where they initiate the recall themselves. But, the FDA can force a recall if a manufacturer doesn’t take it upon themselves and there is evidence (usually from customer complaints) that there’s a safety issue with the product.

Though the FDA doesn’t approve supplements before they’re sold, there are some standards that brands are expected to follow (which are in the Federal Food, Drug, and Cosmetic Act). The FDA can send a warning letter, which is an official and public letter letting a manufacturer or company know that there are documented violations of the Act. These are often related to health claims on packaging or in marketing materials, including claiming to cure an ailment or disease. 

The hope is that a company will voluntarily fix the issues, and the letter gives the company an opportunity to respond before anything is escalated.

The differences between Health Canada and the FDA when it comes to supplement regulation come down to pre-market approval. Health Canada takes a proactive approach to health and safety: products must meet strict standards and have a license before they are sold. The FDA has a more reactive approach: if concerns are raised by the public once a product is available for sale, then the FDA can step in and enforce consequences.