FDA trumpets product listing requirement for dietary supplements—again

The Food and Drug Administration continues to support a legislative proposal requiring a listing of dietary supplement products and the ingredients in them.

Speaking during a recent conference hosted by the American Herbal Products Association (AHPA), an FDA official said the legislative proposal would have a significant impact on understanding a marketplace that has grown from an estimated $4 billion in annual sales in 1994 to a conservative estimate of $60 billion today.

The Dietary Supplement Health and Education Act was passed into law in October 1994.

Cara Welch, Ph.D., who oversees the Office of Dietary Supplement Programs, suggested a listing requirement would give FDA insight into such trends as new dosage forms. For instance, she contrasted the market in the 2000s, when gummies were starting to pop up in dietary supplement products, with today’s market, where gummies rank among the most popular forms of supplements.

Having the ability to use such information in the market “and apply it to our regulatory activities would allow us to … prioritize our activities to make the biggest impact,” Welch said during AHPA’s Botanical Congress on Nov. 14.

Mandatory product listing legislation was introduced last year in Congress but did not get to the finish line.

Related:FDA gives update on dietary supplement office status in new Human Foods Program

FDA behind idea; industry is divided

The proposal has the support of top FDA officials, including Commissioner Dr. Robert Califf, while industry trade groups have been divided over the idea for several years.

“FDA’s leadership has been very up front and supportive of the need for improving and modernizing FDA’s regulation of dietary supplements,” Welch said during the AHPA conference.

AHPA President Michael McGuffin pointed out a new law requires listing of cosmetic products but noted there’s an exemption for companies with annual sales of less than $1 million, and he asked Welch whether there’s “any tolerance for thinking that there’s a small business exemption for mandatory product listing.”

Welch noted the importance of small businesses in the dietary supplement industry and larger economy and said, “I’d love to … get further discussion on exactly that topic, i.e., bring it to the table, Michael.”

“We’re just one partner in this,” the FDA official added. “Changes to legislation for dietary supplements  … obviously it needs to work for the regulator. It also needs to work for industry and ultimately for the consumer.”