Industry eyes will be focused on the Senate tomorrow (Thursday) with the vote on Sen. Richard Durbin's controversial amendment to the pending Food and Drug Administration (FDA) User Fee Act scheduled for 2pm EST.
Sen. Durbin introduced the amendment to the pending Food and Drug Administration (FDA) User Fee Act to require supplement facility registration and product listing. The Illinois senator has sought such a change in the past, and the product registration and listing language in his amendment is identical to that contained in his Dietary Supplement Labeling Act of June 2011.
The chance of success for the FDA User Fee Act is high since the current FDA drug user-fee law will expire on September 30, and there is reportedly a “serious push by both the House and Senate to get a new user-fee reauthorization measure enacted by that date”, wrote Peter Evich, Vice President, Van Scoyoc Associates, and AHPA National Legislative Consultant in the May 2012 AHPA Report.
Industry trade associations responded rapidly to the announcement and are unanimously urging stakeholders to contact their two U.S. senators immediately and express their opposition to the Durbin amendment on dietary supplements to the FDA User Fee Act (S. 3187).
Loren Israelsen, executive director of the United Natural Products Alliance (UNPA) told NutraIngredients-USA.com: “Should this pass and become law it would impose significant costs.
“This would also provide FDA a wild card to declare a dietary supplement adulterated for a minor reporting failure.
“This is government overreach.”
According to background information provided by the American Herbal Products Association (AHPA), the Bioterrorism Act of 2001 established facility registration rules for food companies including dietary supplements firms would be amended to require that all supplement products be registered.
The requirement would encompass all dietary supplements, from daily multivitamin tablets and mineral products such as calcium tablets, to simple herbal capsules and tinctures.
The burden of this product registration requirement would be on product manufacturers, added AHPA. A contract manufacturer, however, has no present way of knowing when its customer’s product is discontinued and cannot reasonably be expected to provide required information regarding such discontinued supplements.
In addition, the amendment could also change facility registration renewals from every 2 years to every 30 days for supplement manufacturers that regularly add new products.