FDA plans to do more work on list of unlawful ingredients in supplements

FDA in 2019 announced a tool to alert consumers of ingredients the agency deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.

This week, the acting director of FDA’s Office of Dietary Supplement Programs (ODSP)—Cara Welch—acknowledged the agency has not “utilized the ingredient advisory list quite as much as I’d like to see, but it’s something we’ll be working on this year.”

The Dietary Supplement Ingredient Advisory List identifies ingredients that do not appear to be lawful ones in dietary supplements. While the list is not exhaustive, it presently includes the following ingredients: 1,4-DMAA, 5-alpha-hydroxy-laxogenin, andarine, bismuth nitrate, higenamine, hordenine, n-methyltyramine, octopamine, sodium tetrachloroaurate and sulbutiamine.

FDA makes its preliminary determinations for various reasons, including:

- the ingredient appears to be excluded from use in a dietary supplement;

- the ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use;

- and/or the ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied.

Welch said her agency needs a process to move ingredients off the advisory list as FDA makes final determinations about their legal status.

“The goal is to provide some actual concluding remarks on that ingredient,” she said Tuesday during the Dietary Supplements Regulatory Summit, a collaboration of five trade groups and hosted this year by the Natural Products Association (NPA).

Once FDA has made a final determination, she added, the idea would be to place the ingredient on a separate list that the agency has not yet developed.

“The FDA continues to work on streamlining its processes and improving transparency to ensure that stakeholders and consumers are notified when the FDA identifies ingredients that do not appear to be lawfully included in products marketed as dietary supplements, including with the Dietary Supplement Ingredient Advisory List and our Dietary Supplement Products & Ingredients webpage,” an FDA spokesperson said in an email.

Benefits of dietary supplement ingredient advisory list

The advisory list is beneficial to FDA and industry, according to Welch. “Sometimes, an ingredient shows up on there and everyone says, ‘Oh well, shoot, I’ve been using that ingredient for a while.’ Ideally, they can then undergo their own review internally and say, ‘Are we confident in the use of this ingredient? Are we confident that it’s pre-DSHEA or a new dietary ingredient but in the food supply so a notification isn’t required?’”

Welch also said investigators with FDA’s Office of Regulatory Affairs can review the advisory list, and when they identify an ingredient on the list, query a manufacturer to determine the manufacturer’s basis for producing the ingredient. That information can then be shared with FDA.

“We don’t always know what’s been marketed in the food supply,” Welch shared.

FDA unveiled the advisory list in 2019 as part of the agency’s efforts announced earlier that same year to modernize its regulatory framework over supplements to meet the demands of a fast-growing industry.

“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a 2019 statement announcing the tool. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This list is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination."