It’s crunch time for natural health and supplement supporters to let Congress know where we stand on mandatory FDA product registration for supplements. Action Alert!
Senator Dick Durbin (D-IL) has introduced his mandatory listing bill, S.4090. Standalone bills like Durbin’s are tough to get through Congress, but unfortunately Senate HELP Committee Chair Patty Murray (D-WA) has made it clear that she would like to see mandatory listing attached to the Prescription Drug User Fee Act (PDUFA). PDUFA is legislation that must pass by the end of September in order for the FDA to continue collecting drug user fees.
We breathed a sigh of relief last week when the House Energy and Commerce Committee released their PDUFA draft legislation and didn’t include the supplement listing mandate. There is still the threat that the bill could be amended in the committee markup or on the House floor to add mandatory listing. However, we know the bigger threat is that mandatory supplement listing gets attached to PDUFA in the Senate, so now we hold our breath again as we expect the Senate HELP Committee to release its draft PDUFA legislation any day now.
Attaching mandatory supplement listing to PDUFA, a drug bill, is completely inappropriate. Fundamental to supplements is their intention to supplement the diet. Therefore, according the Federal Food, Drug and Cosmetic Act supplements are regulated as food. Supplements do not pay user fees to the FDA like drugs and they do not go through the new drug pre-approval process. This does not mean supplements are not regulated. Rather, supplements are regulated similar to foods in that manufacturers register their facilities with the FDA, follow current good manufacturing practices, and products must follow proper labeling requirements.
Many members of Congress don’t understand how the additional regulatory burden of extensive product listings with the FDA will negatively impact our access to dietary supplements, increasing costs and killing supplement innovation in the U.S. This is why we are so concerned about this seemingly innocuous proposal being attached to the must-pass PDUFA legislation.
The managers of PDUFA know they have to pass their legislation, so they don’t want to add anything too controversial. If we don’t let our elected officials know this is controversial, and we don’t want it, then Senate HELP Chair Murray and Senator Durbin will have an easy time slipping it into PDUFA.
Action Alert! Congress is currently considering if they should attach mandatory supplement product listing to PDUFA. Please write Congress TODAY to let them know you care about your access to safe, affordable, innovative supplements and you don’t want this additional unnecessary regulation to harm your access!
