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FDA’s draft guidelines aim to improve dietary supplement safety information


Key points to remember

  • New draft guidelines from the FDA say the agency can gather more information about the safety of dietary supplements.
  • Manufacturers would be required to submit late notifications if their products contain new food ingredients.
  • This orientation is still far from an in-depth reform of the regulation of food supplements.

Three out of four American consumers regularly take food and nutritional supplements, yet many of these products have escaped regulatory loopholes.

Since the Food and Drug Administration (FDA) classifies dietary supplements as foods, they are not required to undergo an extensive review process like prescription drugs do.

The FDA is taking a “safe until proven unsafe” approach with dietary supplements, according to a journal article by George Kennett, JD. This means that 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 to a change. In a recent draft guidance, the FDA proposed to increase safety information on “novel food ingredients” (NDIs), such as vitamins, minerals and probiotics. Dietary ingredients are considered “novel” if they were not marketed before the enactment of the Dietary Supplements, 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 has acknowledged that many companies have failed to comply with the requirement. If the proposed guidelines are finalized, these manufacturers will have 180 days to submit any late NDI notifications.

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

Understand the role of the FDA 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 survey by the Reis Group.

An evaluation showed that over the past decade, more than 1,000 supplements contained ingredients that were toxic or only available in prescription drugs. The most common were dietary supplements for sexual enhancement and weight loss.

“Many supplements on the market make health claims that are simply unproven,” Alice Figueroa, MPH, RDN, CDN, 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 customers.

“It is 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 protein, 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 determine if a product has been reviewed by the agency.

“By simply looking at the supplement box at the store or by reading the ingredient list and nutritional information, it is not possible to determine if an ingredient is NDI,” she said.

Although the FDA does not have the authority to regulate dietary supplements before they are available for purchase, it will also be nearly impossible for the agency to monitor the more than 143,000 products sold in the United States.

Consumers can use the Fraudulent Health Products Database to see which supplements contain dangerous ingredients. But even the FDA acknowledges that this list is only a “small fraction” of potentially dangerous supplements on the market.

Do the FDA’s draft guidelines go far enough?

The new guidelines are just a small step towards establishing a more comprehensive regulatory framework. Figueroa said she would like to see how these new guidelines will be enforced, especially since the FDA has been lax on compliance over the past few decades.

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

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

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

Ultimately, these new guidelines only extend to supplements containing new dietary ingredients. It’s a step in the right direction, but experts want the FDA to apply strict regulatory standards to all supplements.

“Consumers deserve to know if a supplement has been shown to provide health benefits based on unbiased research using standards similar to those we use to determine side effects, benefits, risks and drug safety standards. over-the-counter, vaccines, and prescription drugs,” 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 the ingredients are safe and accurate.