FDA Draft Guidance Seeks to Improve Safety Information on Dietary Supplements

Key Takeaways

  • A new draft guidance from the FDA indicates that the agency may gather more safety information on dietary supplements.
  • Manufacturers would be required to submit late notifications if their products contain new dietary ingredients.
  • This guidance is still far from an extensive reform of dietary supplement regulations.

Three out of four American consumers take dietary and nutritional supplements routinely, yet many of these products have slipped through regulatory loopholes.

Since the Food and Drug Administration (FDA) classifies dietary supplements as food, they aren’t required to undergo an extensive review process as prescription drugs do.

The FDA takes a “safe until proven unsafe” approach with dietary supplements, according to a journal article by George Kennett, JD. This means the agency would only remove supplements from the market if they were found to be unsafe or if the product claims were false or misleading.

But this lax policy may be due for a change. In a recent draft guidance, the FDA proposed to increase safety information on “new dietary ingredients” (NDI), such as vitamins, minerals, and probiotics. Dietary ingredients are considered “new” if they were not marketed before the enactment of the Dietary Supplement Health and Education Act (DSHEA) on October 15, 1994.

Manufacturers are responsible for submitting their products for safety review if they contain an NDI. But the FDA acknowledged that many companies have failed to comply with the requirement. If the proposed guidance is finalized, these manufacturers will have 180 days to submit any late NDI notifications. 

“The resulting notifications the agency receives through this period of enforcement discretion will help increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace,” Cara Welch, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, said in the press release.

Understanding FDA’s Role in Supplement Regulation

More than half of Americans taking supplements mistakenly believe that most dietary supplements on the market have been declared safe and effective by the FDA, according to a recent poll by the Reis Group.

An assessment showed that in the past decade, over 1,000 supplements were found to contain ingredients that are toxic or otherwise only available in prescription drugs. The most common ones were sexual enhancement and weight-loss dietary supplements.

“Many supplements in the market make health claims that are simply unproven,” Alice Figueroa, MPH, RDN, CDN, a registered dietitian, told Verywell in an email.

Collagen, for example, is widely accepted to support hair and nail growth. However, Figueroa said there isn’t enough scientific evidence to recommend these supplements to her clients.

“It’s more nutritious, satisfying, and cost-effective to eat a meal or snack that includes protein-rich foods like eggs, tofu, soy milk, yogurt, or fish, which provide complete proteins, instead of coffee with collagen,” Figueroa said.

Although the FDA maintains a list of NDIs that have been reviewed, average consumers may not be able to identify whether a product has been reviewed by the agency.

“By simply looking at the supplement’s box at the store or reading the ingredient list and nutrition facts, it is not possible to determine whether an ingredient is NDI,” she said.

While the FDA has no authority to regulate dietary supplements before they are available for purchase, it will also be nearly impossible for the agency to monitor more than 143,000 products that are being sold in the United States.

Consumers can use the Health Fraud Product Database to see which supplements have been found to contain dangerous ingredients. But even the FDA acknowledges that this list is just a “small fraction” of the potentially unsafe supplements on the market.

Does the FDA Draft Guidance Go Far Enough?

The new guidance is only a small step toward establishing a more comprehensive regulatory framework. Figueroa said she would like to see how this new guidance will be enforced, especially since the FDA has been relaxed about compliance in the past few decades.

Although the FDA said it “intends to exercise enforcement discretion, for a limited time and in limited circumstances,” it’s unclear whether penalties would involve fines, the removal of products, or civil lawsuits.

Even if manufacturers submit an NDI notice to the FDA, these producers can rely on in-house data to support their safety claims.

“Supplement manufacturers can submit industry-sponsored studies, which may be biased, present conflict of interest, or lack statistical significance,” Figueroa said.

Ultimately, this new guidance only extends to supplements containing new dietary ingredients. This is a step in the right direction but experts want the FDA to apply strict regulatory standards to all supplements.

“Consumers deserve to know whether a supplement has been shown to be beneficial to health based on unbiased research using similar standards to the ones we use to the determine the side effects, benefits, risks, and safety standards for over the counter medications, vaccines, and prescription medications,” Figueroa said.

What This Means For You

Consider speaking with your healthcare provider before taking a new supplement to determine if the supplement is right for you. Organizations, like United States Pharmacopeia (USP), also offer independent third-party verification of supplements. Look for the USP label on supplements to ensure that the ingredients are safe and accurate.