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.
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.
Steven Tave, who leads FDA’s Office of Dietary Supplement Programs, suggested a mandatory product listing would not undermine the Dietary Supplement Health and Education Act of 1994.
Thomas Gremillion, director of food policy at the Consumer Federation of America, an association of non-profit consumer organizations, said a mandatory listing could subject “Bottom-feeders” in the dietary supplement industry to enforcement action for failure to list their products.
McGuffin raised concerns that, short of a premarket approval process unanimously opposed by industry, there is no mechanism to verify the accuracy of the information provided to FDA. Marketers of drug-spiked products that falsely claim to sell dietary supplements will either ignore the listing requirement or fail to disclose their products contain such drugs as sildenafil, he predicted.
Dan Fabricant, president and CEO of NPA, questioned how a mandatory listing would benefit consumers or FDA. In a series of articles reported by Natural Products Insider, he criticized the agency for failing to take enforcement action against so-called copycats of NDIs, whose identity and safety has not been reviewed by FDA. In the series, Tave acknowledged receiving “Mountains and mountains of information” from people close to a supplement maker, Natural Alternatives International Inc., which requested FDA enforce against forms of beta-alanine manufactured in China.
In an April 2001 report on adverse event reporting for dietary supplements, OIG recommended requiring manufacturers of supplements to register their products with FDA. “A complete product registry would allow FDA to instantly access a list of all the ingredients in a particular product and determine the product manufacturer’s name as soon as it receives an adverse event report,” OIG stated.