The office of Sen. Dick Durbin (D-Ill.) is working on draft legislation to require mandatory listing of dietary supplement products with FDA, industry sources said.
The sources did not share specific details of the draft language, but they indicated the legislation would address such fundamental issues as who would need to list their dietary supplements with FDA and when.
A staff member for Durbin, Joe Lapaille, did not immediately respond to an emailed request for comment.
Durbin in previous years has worked on dietary supplement issues—including a successful effort in 2006 to enact legislation that requires manufacturers report to FDA series adverse events associated with their products.
And he’s long been in favor of requiring supplement companies to provide additional information to FDA. Introduced a decade ago by Durbin and Sen. Richard Blumenthal (D-Conn.), the “Dietary Supplement Labeling Act” would have required manufacturers to register their products with FDA, as well as provide a description of each supplement, a list of ingredients and a copy of the label.
The bill didn’t advance in the Senate, but in recent years, FDA has vigorously advocated for mandatory product listing. The agency cannot effectively police the vast dietary supplement marketplace if it doesn’t know about all the products being sold in the U.S., according to FDA and others who support its proposal.
The U.S. market contains as many as 80,000 dietary supplement products or more, based on FDA estimates. And annual sales have grown from an estimated $4 billion in 1994 to more than $55 billion in 2020, according to Nutrition Business Journal.
“FDA lacks the authority to require products marketed as ‘dietary supplements’ to be listed with the FDA, which would support agency action against non-compliant products and the manufacturers and/or distributors of such products,” an FDA spokesperson said via email. “Such authority would allow the FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, improve transparency and promote risk-based regulation.”
Some industry trade groups strongly support FDA’s proposal. Others are either opposed to it or neutral on the idea.
Critics have argued FDA already has access to ample information about dietary supplement products, including a “Dietary Supplement Label Database” maintained by the National Institutes of Health (NIH). According to NIH’s website, the database contains nearly 130,000 labels.
But “NIH is not a regulatory agency, and the issue here is adequate regulation of a product that’s underregulated at present,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest (CSPI), an advocacy group in the nation’s capital.
He made those comments during a recent episode of ‘short legal briefs,’ a program produced by Natural Products Insider that explores the intersection of business, law and regulations in the dietary supplement market.
“The fact that NIH can scratch and sniff until they find a bunch of labels and stick them on the web some place is not the same thing as having a database that’s systematically collected, properly archived, searchable … and complete,” Lurie added. “We have no idea what fraction of all supplements those ones that the NIH happens to have found actually represent.”
The Pew Charitable Trusts, a public policy organization with offices in Philadelphia, Washington, D.C. and London, also supports mandatory listing of dietary supplements.
“The FDA needs comprehensive information about the products being sold and what’s in them to effectively monitor the market for consumer safety risks and quickly remove products with illegal and dangerous ingredients,” said Kathy Talkington, who oversees Pew’s health policy programs, in an emailed statement. “We’ve been encouraged to hear interest in product listing legislation from members of Congress in both chambers and on both sides of the aisle, and we’re hopeful that a bill will be introduced and considered this year.”
One question raised by industry is whether FDA has adequate authorities to enforce a dietary supplement product listing if it becomes a legal requirement, noted Diane McEnroe, a partner in New York with the law firm Sidley Austin LLP.
Some industry stakeholders have supported adding a provision to the law that would make it a “prohibited act” to fail to list a dietary supplement with FDA. But the specifics of any product listing legislation—including whether Durbin incorporates broader reforms to the Dietary Supplement Health and Education Act of 1994 (DSHEA)—remain to be seen.