Attorney Questions Supplement Mandatory Listing

Attorney Marc Ullman (Rivkin Radler) questions a push for mandatory dietary supplement listing with FDA in light of what he sees as the agency’s failure to enforce existing dietary supplement laws and regulations. In an online post for Natural Products Insider, Ullman writes that for at least eight years he has been expressing concern about the agency’s failure to enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA), especially in connection with the requirement that new dietary ingredients provide evidence of a reasonable expectation of safety. He also discusses the agency’s failure to respect intellectual property and the threat to safety posed by its inaction and the resulting entry of knockoff ingredients of unknown provenance into the U.S. marketplace.

Ullman writes that rather than call the agency to task for its failures, some want to grant FDA even more authority over supplements and, at least in theory, illegal products masquerading as supplements by creating a mandatory product listing.

He says proponents of the idea say it would require companies to list each of their product labels with FDA and a product would be considered adulterated automatically if its label was not listed with the agency.

“There is a very real threat that FDA could use a mandatory product listing as a device to create a premarket approval scheme for dietary supplements,” Ullman cautions. He adds that FDA has all the enforcement authority it needs under DSHEA. “A well-written import alert and a few Google searches would provide the agency with a real start on enforcement,” he says. “FDA is ‘pretending’ it needs mandatory product listing to target enforcement. Unfortunately, the marketplace and consumers will continue to be at risk until the supplement industry can find a way to come together and persuade lawmakers that a reevaluation of the entire structure and enforcement decision-making process at a broken FDA needs a radical overhaul.”