An FDA proposal that would require manufacturers of dietary supplements list their products with the agency has gained support among several consumer advocacy groups and industry associations.
FDA has floated the idea through two consecutive budget requests by the Trump administration and reiterated its support for a mandatory product listing during public events.
A mandatory listing would allow 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,” an FDA spokesperson said by email. “We look forward to working with Congress and other stakeholders to advance this goal, as it would significantly enhance the agency’s ability to efficiently and effectively protect the public health.”
Three of five major trade groups in the supplement industry support the proposal: Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and United Natural Products Alliance (UNPA). Two trade associations are not in favor of it: the American Herbal Products Association (AHPA) and the Natural Products Association (NPA).
Congressional action likely required
For the proposal to take effect, FDA would likely need Congress to amend the law since the agency does not believe it has clear authority to require listing of dietary supplement products. The Nov. 3 election could help or hurt the chances of a bill being introduced in 2021 and ultimately landing on the desk of the next president.
“Under the current administration, [I] don’t believe Congress has an appetite for this,” UNPA President Loren Israelsen said in an interview.
He predicts FDA would “ramp up” its efforts on Capitol Hill if Joe Biden is elected the next president and Democrats take control of both chambers of Congress.
In the GOP-controlled Senate, it remains to be seen who will chair the Committee on Health, Education, Labor and Pensions (HELP), which has jurisdiction over FDA. Sen. Lamar Alexander, Republican from Tennessee, is retiring.
If the Republicans remain the majority in the Senate, possible chairs of the HELP Committee include Sens. Richard Burr of North Carolina, Rand Paul of Kentucky or Bill Cassidy of Louisiana, said David Spangler, senior vice president of legal, government affairs and policy with CHPA.
Sen. Patty Murray (D-Washington), ranking member of the HELP Committee, would be in line as its chair if the Democrats wrest control of the Senate from the GOP.
In the House, where Democrats are expected to retain a majority, Rep. Frank Pallone (D-New Jersey) chairs the Energy and Commerce Committee, which has jurisdiction over FDA.
Representatives for Murray and Pallone did not respond to requests for comment on a mandatory product listing.
Pallone is considered friendly to industry, but he is also sympathetic to the concerns of FDA, said a…