FDA in recent years has advocated for a change in the law, requiring that manufacturers of dietary supplements list their products with the agency. This legal framework could give FDA immediate access to a copy of each product label for the estimated 55,000 to 80,000 dietary supplements sold in the U.S.
Recently, an FDA official overseeing the Office of Dietary Supplement Programs (ODSP)—Cara Welch—said a mandatory product listing would give her agency visibility into the supplement market, facilitating its “ability to identify products, allocate resources and act more quickly to remove unsafe or otherwise illegal products.”
FDA’s proposal has drawn mixed reactions from industry trade groups and other professionals connected to the $55 billion-a-year dietary supplement industry. Some associations are clearly in support of the idea, while others are either opposed to it or have expressed reservations about the proposed requirement.
Host Josh Long sits down with two lawyers in support of a mandatory product listing to discuss the benefits of FDA’s proposal and often-cited criticisms of it:
- David Spangler, senior vice president of legal, government affairs and policy with the Consumer Healthcare Products Association (CHPA)
- Scott Bass, a partner with Sidley Austin LLP and outside counsel to CHPA