Dietary Supplement and Non-Prescription Drug Consumer Protection Act

Dear Majority Leader Boehner,

 

     There is currently legislation pending in Congress (S. 3546/ H.R 6168) that would create a mandatory adverse event reporting (AER)system at the Food and Drug Administration (FDA) for dietary supplements (i.e., for Vitamin C, Vitamin E, calcium, etc.).  Although this legislation has been characterized by some as a "compromise bill" that has been agreed to by the industry, that characterization is absolutely not true.  The National Health Federation membership, other health-freedom organizations, and some 60 million consumers of dietary supplements have voiced significant concerns opposing this big-government, trial-lawyer-friendly legislation.  I wanted you to know that constituents throughout this nation strenuously oppose S. 3546 and H.R. 6168.

 

     Even at this late date, the AER bill has fortunately not passed the Senate.  We hear that it is to be passed out of the Senate without debate, then slipped through the House at the last minute, WITHOUT A COMMITTEE HEARING, and forced upon industry and millions of consumers.  We urge you to join us and oppose this last-minute, ill-thought-out legislation.  The AER bill’s true goal is to expand government, spend millions of taxpayer dollars, cost American industry millions of dollars to comply with no clear goal of what may or may not be accomplished, and finally, needlessly diminish consumer choice by forcing safe dietary supplements into a straight-jacket meant only for dangerous drugs. 

 

     The AER bill imposes a significant and unjustified layer of bureaucracy that neither the FDA, the public, nor the bulk of the supplement industry has requested or been demonstrated to be scientifically or factually needed or justified.  This effort is simply and plainly an attempt by the primarily Democratic Party segment of the House and Senate that want big-government regulation and control over the benign industry of dietary supplements.  Vitamins and herbal remedies do not present a medical, scientific, or regulatory threat to the health of the millions of Americans that take them on a daily basis.  We respectfully ask for your support to oppose this horrible legislation.

 

     Importantly, there is already an existing reporting system (FDA's MedWatch Program), which allows medical professionals an opportunity to direct complaints involving prescription drugs, non-prescription drugs, dietary supplements, and other food products to FDA through the MedWatch program.  The pending AER bill replaces this voluntary system, which is working, with a burdensome and punitive bureaucratic process that will be imposed upon thousands of manufacturers and tens of thousands of distributors to make medical decisions as to whether or not an "adverse event" has even occurred.  Sadly, this bill mandates no medical or scientific review by anyone, even the FDA.  Clearly, this effort is solely by those that favor big-government regulation first, trial lawyers second, and science and facts only a distant third - if even at all.

 

      These bills should be defeated - period.

 

     At the very least, these bills should be amended to include a medical-review process to determine causation before FDA releases these reports.  Time has nearly run out on the 109th Congress, though, and Chairman Barton has not held a hearing and mark-up of the House bill in the Energy and Commerce Committee as was expected.  Had a hearing been held, that committee would have heard loudly from the manufacturers, distributors, retailers, and consumers of dietary supplements who strongly oppose the bill, especially in its current form.

 

     As has been rumored, we are very concerned about this legislation being brought to the floor next week without the benefit of a hearing and mark-up in either chamber of Congress.  We are especially worried that the bill would be heard on the suspension calendar without the possibility of floor amendments being offered.  The far-reaching effects of this bill and its lack of consensus warrant full consideration of its issues in the 110th Congress.

 

     We respectfully request that you oppose consideration of  S. 3546 and H.R. 6168 in the House in these closing days of the 109th Congress.  Thank you for your consideration of this most important matter.  Thank you for your proven leadership and attention to important issues such as this one.

 

     Sincerely,