US trade group the American Herbal Products Association (AHPA) has estimated the country’s dietary supplement industry will need to spend nearly 20 million dollars for initial compliance with the Dietary Supplement Listing Act, a bill introduced by Senators Richard Durbin (D-IL) and Mike Braun (R-IN) that would establish a requirement for mandatory product listing (MPL) for all dietary supplements marketed in the United States.
The US natural products industry remains split over the The Durbin-Braun bill, with some leading groups openly supporting mandatory product listing but others sharply critical.
Initial compliance costs would just be the start
AHPA , which opposes the controversial bill, says its early estimate reflects only the costs of product data entry for initial compliance, and it does not include associated training costs or other year-over-year costs for continuing compliance.
“We are conducting this study because the fundamental question of cost has been missing from the mandatory product listing conversation to date,” said Robert Marriott, Director of Regulatory Affairs. “This information is essential for all stakeholders to weigh the supposed benefits of MPL against its costs to industry.”
AHPA has taken a position of opposition to the Dietary Supplement Listing Act, holding the belief that the existing regulatory framework for dietary supplements provides FDA with all the authority needed to properly regulate the field. AHPA continues to support legislative amendments to the Federal Food, Drug, and Cosmetic Act that clearly benefit consumers and achieve their ends in a manner that minimizes burdens on the regulated trade.
Entire produce categories at risk
The Natural Products Association (NPA) has warned that the Durbin-Braun bill will “raise prices, cripple innovation and leave consumers and industry stakeholders vulnerable”. The NPA says that the new legislation could threaten entire product categories, and cites CBD and hemp-based products as example. Commenting, Dr. Daniel Fabricant, NPA president and NPA CEO of Natural Products Association, said: “Those who support this bill, including Senator Durbin, Senator Braun, and trade organizations, can’t answer basic questions about its merits and more importantly the harm it would do. Such as, ‘What if, a company submitted a listing for a product containing CBD, which FDA still does not consider a legal dietary ingredient, would that automatically be stopped? Would this, in one fell swoop, make all CBD-hemp supplements ‘misbranded?’”