FDA Isn’t Listening—Time to Turn Up the Heat!February 14, 2012
A champion of supplements in the House sends a warning to FDA. Persuade others in Congress to join him with our Action Alert!
As we reported last week, FDA has flatly refused to listen to the Senate, rejecting the call of Sens. Tom Harkin (D-IA) and Orrin Hatch (R-UT) to withdraw its disastrous New Dietary Ingredient draft guidance and start over. You may recall that Harkin and Hatch are the original drafters of DSHEA, the law that requires supplement manufacturers to submit notifications whenever an NDI is introduced into the marketplace. FDA’s job was to articulate how those notifications are to be submitted, but they ignored the original intent of Congress and created a de facto approval system for any supplement or ingredient created or changed over the past eighteen years.
Now Rep. Jason Chaffetz (R-UT) has composed a letter to FDA expressing regret over FDA’s dismissal of Senators Hatch and Harkin’s request and reiterating that Congress did not intend to give FDA pre-market review of new dietary ingredients, nor did it intend to permit the agency to treat dietary ingredients in the same manner as food additives.
The letter goes on to articulate the legal problems with FDA’s proposal, and strongly urges FDA to withdraw its guidance and instead design a fair and workable NDI notification system. It also requests that FDA refrain from taking any enforcement action that is based solely on positions articulated in the draft guidance that are not unequivocally grounded in the law.
Rep. Chaffetz’s letter to FDA ends with a warning that, in the unfortunate event that FDA does not withdraw this guidance as requested, legislation to clarify current statute will be considered. Let’s show FDA that the House means business—that there is support from Democrats and Republicans alike to withdraw the draft guidance altogether, so that consumers won’t lose access to thousands of supplements.
Please write to your congressional representative and ask that he or she sign onto Rep. Chaffetz’s letter to FDA. Reiterate the serious concerns with NDI guidance—how it severely threatens access to thousands of supplements, even though supplements have a proven safety record (unlike FDA-approved drugs!)
And if you haven’t yet asked your representative to make a one-minute floor speech on this subject, please do that as well.
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