05.23.12
As the Senate works to wrap up its consideration of S. 3187, the Food and Drug Administration Safety and Innovation Act, which extends the drug and device user fees for five years and authorizes new fees for generic drugs and generic versions of biotech drugs (biosimilars), a supplement amendment was filed that the American Herbal Products Association (AHPA) said should be of concern to the dietary supplement industry.
Sen. Richard Durbin, D-Ill., will seek an amendment to the pending, must-pass Food and Drug Administration (FDA) User Fee Act, which would, among other things, set new requirements for dietary supplement facility registration and listing of all products and their ingredients with FDA.
The product registration and listing language in his amendment is identical to that contained in last year’s S. 1310, also sponsored by Durbin, which industry associations including AHPA strongly opposes (click here to review AHPA’s analysis of the Durbin dietary supplement amendment). In short, the Sen. Durbin’s proposed amendment would impose an additional registration requirement to the existing biennial one for supplement manufacturers, processers, packers or holders. Facilities would have to submit to the FDA with their biennial registration a description of each product manufactured, a list of ingredients in each product, and a copy of the label and labeling. In addition, the same information would have to be provided to the FDA for every new product, reformulated product, and discontinued product within 30 days of marketing/removing the product. Any product made in a facility found not in compliance with this new requirement would be deemed adulterated.
AHPA urged those who oppose this attempt by Sen. Durbin to amend the Dietary Supplement Health and Education Act to contact their two U.S. senators immediately to express their opposition to the Durbin amendment on dietary supplements to the FDA User Fee Act (S. 3187).
Sen. Richard Durbin, D-Ill., will seek an amendment to the pending, must-pass Food and Drug Administration (FDA) User Fee Act, which would, among other things, set new requirements for dietary supplement facility registration and listing of all products and their ingredients with FDA.
The product registration and listing language in his amendment is identical to that contained in last year’s S. 1310, also sponsored by Durbin, which industry associations including AHPA strongly opposes (click here to review AHPA’s analysis of the Durbin dietary supplement amendment). In short, the Sen. Durbin’s proposed amendment would impose an additional registration requirement to the existing biennial one for supplement manufacturers, processers, packers or holders. Facilities would have to submit to the FDA with their biennial registration a description of each product manufactured, a list of ingredients in each product, and a copy of the label and labeling. In addition, the same information would have to be provided to the FDA for every new product, reformulated product, and discontinued product within 30 days of marketing/removing the product. Any product made in a facility found not in compliance with this new requirement would be deemed adulterated.
AHPA urged those who oppose this attempt by Sen. Durbin to amend the Dietary Supplement Health and Education Act to contact their two U.S. senators immediately to express their opposition to the Durbin amendment on dietary supplements to the FDA User Fee Act (S. 3187).