The Food and Drug Administration Safety and Innovation Act (S.3187) is a bill that is considered "must-pass" legislation and without notice, Senators Dick Durbin and Richard Blumenthal offered their anti-supplement amendment (No. 2127) to the bill. Their amendment creates duplicative, unnecessary, and unexpected new regulations while upending current law and the regulatory process.
As you know, Sen. Durbin has engaged in this sort of dirty-trick legislative process before in an attempt to regulate away your supplements. The amendment will:
Circumvent the FDA's New Dietary Ingredient Industry Guidance. FDA and the dietary supplement industry are currently engaged in conversations regarding implementing a new dietary ingredient notification process. The Durbin amendment creates an entirely new law that would require new FDA regulations, likely erasing nearly two decades of DSHEA's positive influence in favor of Durbin's knee-jerk approach to governing.
Require that a "facility engaged in the manufacturing processing, packing, or holding" of dietary supplements to register with the FDA. Title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 already requires supplement facility registration! Extra regulation drives up costs of supplements.
Hurt businesses and the economy with burdensome and unexpected new regulations. Supplement manufacturers have thirty days to register their products after marketing or face charges of misbranding. Given that there are thousands of products currently in the market, these regulations will force significant numbers of products off the market as industry adjusts to the new regulations, costing the industry significant revenue, and causing the loss of American jobs. Most importantly, this amendment would drastically limit you access to supplements as companies would likely remove their products from store shelves in order to meet Durbin's thirty-day deadline.
Contact your senators IMMEDIATELY and tell them to OPPOSE the Durbin and Blumenthal amendment no. 2127 to the FDA Safety and Innovation Act (S.3187).
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