FDA plans more work on listing illegal ingredients in supplements

The FDA announced in 2019 a tool to alert consumers to ingredients the agency deems banned for use in dietary supplements based on its “initial assessment” of an ingredient.

This week, the acting director of the FDA’s Office of Dietary Supplement Programs (ODSP), Cara Welch, admitted that the agency had not “used the advisory list of ingredients as much as I would like, but it is something that we will be working on this year.

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

The FDA makes its preliminary decisions for a variety of reasons, including:

– the ingredient seems to be excluded from use in a food supplement;

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

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

Welch said his agency needed a process to remove ingredients from the advisory list as the FDA makes final decisions on their legal status.

“The goal is to provide some real closing remarks on this ingredient,” she told the Dietary Supplements Regulatory Summit on Tuesday, a collaboration of five trade groups and organized this year by the Natural Products Association (NPA).

Once the FDA makes a final decision, she added, the idea would be to put the ingredient on a separate list that the agency has yet to develop.

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

Benefits of the Dietary Supplement Ingredient Advisory List

The advisory list is beneficial to the FDA and the industry, according to Welch. “Sometimes an ingredient pops up there and everyone says, ‘Well, shoot, I’ve been using this ingredient for a while. Ideally, they can then undergo their own internal review and say, “Are we confident in using this ingredient?” Are we convinced that this is a pre-DSHEA or a new dietary ingredient, but in the food supply, therefore, notification is not required? “

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

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

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

“As the dietary supplement market has grown, the introduction of new ingredients often raises complex questions involving science, policy and law,” said Frank Yiannas, FDA deputy commissioner for policy and law. food response, in a 2019 statement announcing the tool. “In the time it takes for the FDA to make a final decision, consumers and industry may incorrectly conclude that a lack of action by the FDA indicates that these ingredients are legal. This list aims to inform consumers and industry more quickly. It also allows stakeholders to share information with us that they believe may be relevant to our determination. “