Statement of CSPI president Dr. Peter G. Lurie

It’s very much an open secret that dietary supplements are largely under-regulated and that reforms are desperately needed so that consumers can have confidence that the products on the shelves are safe, contain the advertised ingredients, and bear no misleading claims of effectiveness. So it is very good to see interest in improving supplement regulation on the part of Senator Richard Durbin, Senator Mike Braun, Senator Patty Murray, and others in Congress.

The latter Senator’s effort, the Food and Drug Administration Safety and Landmark Advancements Act of 2022, is circulating in draft form, and may face action in the Senate HELP committee as soon as this week. Among other reforms, the bill requires companies to publicly list their supplements in an FDA database for the first time, improves oversight of high-risk supplements, and expressly prohibits products fraudulently marketed as dietary supplements.

Most Americans would be surprised to learn that a $40 billion industry that peddles some 50,000 pills, liquids, and powders is not required to list those products anywhere. While the HELP committee bill is an advance, to be sure, such product listings should also include summaries of the evidence for the products’ safety and effectiveness, and the pathway to market and specific amounts of each ingredient.

Beyond mere listing, though, true reform would close the loophole that lets supplement companies bypass FDA premarket review and determine for themselves that new dietary ingredients are “generally recognized as safe,” or GRAS.

U.S. regulators have the means of withdrawing dangerous toys from toy stores, grounding unsafe planes, recalling contaminated food, and so on. But it is a huge challenge for the FDA to remove dangerous supplements from the market, or even for it to punish those manufacturers who make unsubstantiated claims. Real reform must ensure that FDA has this authority, and it should include the ability to levy civil penalties against companies making dangerous or misleadingly labeled supplements. And the agency needs the funding to do this work. We urge members of the Senate HELP Committee to improve its draft by including these commonsense reforms.