FDA to Strengthen Regulations of Dietary Supplements

The Food and Drug Administration is working to implement new requirements for the regulation and oversight of dietary supplements. In a statement, the FDA said it wants to protect Americans from the potential dangers of products that don’t meet the agency’s standards, specifically those “spiked with drug ingredients not declared on their labels, misleading claims, and other risks.”

Today, the dietary supplements industry has outpaced the original regulations signed by Congress in 1994; in the U.S. alone, three out of four people take a dietary supplement on a regular basis, according to the FDA, including one in three children. The Dietary Supplement Health and Education Act (DSHEA) no longer reflects the $4 billion supplements market from 25 years ago, which has soared to more than $40 billion today, according to the FDA—with as many as 80,000 products on the market. Globally, the dietary supplements market is expected to reach more than $278 billion in sales by 2024, according to a recent report by Grand View Research. 

“It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy,” said Scott Gottlieb, M.D., FDA Commissioner, in the FDA’s statement. “The DSHEA imposes a number of requirements around the manufacture and labeling of dietary supplements,” he said. “We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk.”

Gottlieb admitted that he has benefited from the use of dietary supplements and recognizes the benefits of certain products as part of a comprehensive care plan. The FDA’s concern is that as the popularity of supplements has grown, so has the amount of potentially dangerous or misleading products. “We want to ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else,” Gottlieb said, “and that those products are consistently manufactured according to quality standards.”

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As it works to develop new policy changes around dietary supplements, the FDA wants to enhance its dialogue with the public and is working on developing a new rapid-response tool to alert the public about any dietary supplement concerns on the market. It also wants to improve its product safety evaluations and is working to submit new dietary ingredient (NDI) notifications to help them better evaluate a new ingredient before it reaches consumers. The Botanical Safety Consortium, a newly formed group of government officials, academics and scientists, will help evaluate the safety of botanical ingredients and other mixtures in dietary supplements and look at innovative toxicology tools, alternatives to animal testing, and more improvements within the industry.

To call out some companies with questionable ingredients, the FDA recently sent out 12 warning letters and five online advisory letters to companies. These companies may have marketed supplements with unproven claims to prevent, treat, or cure Alzheimer’s disease, diabetes, cancer, and even opioid addiction. “One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products,” said Gottlieb.

To help manage the inner workings of the agency’s new policy advancements, the FDA also established the Dietary Supplement Working Group, a team of representatives across the agency, to help oversee its organizational structures, processes, procedures, and practices to help modernize its approach in regulating dietary supplements, according to Gottlieb.

“In the coming months, we’ll be providing additional details on the steps we are talking to continue moving our dietary supplement program forward to implement these priorities,” Gottlieb said. “Our new approach benefits consumers by balancing new policies to promote innovation and efficiency in the marketplace for dietary supplements with increased steps to protect the public from potential safety issues.”