Protect Access to Dietary Supplements-(Revised)

[Guest guest]

Dear Health Activists,

Last July the Food & Drug Administration (FDA)issued a draft guidance that reinterprets the Dietary Supplement Health Education Act (DSHEA), the law that enabled Dietary Supplements to flourish and expand with new scientific and nutritional research.

The law had a provision that required dietary supplement manufacturers to notify FDA of any new dietary ingredient brought to the market after October 15,1994. FDA is now proposing that it will now require new studies of the safety and efficacy of all the supplements introduced or even changed since that date.

This would mean that most supplements on the market now, including resveratrol, coenzyme Q-10, probiotics and possibly even Vitamin D3 will have undergo new studies, and may be removed from the market until those studies are completed and FDA gives its approval.

FDA has even proposed that any changes in content or manufacturing processes, by supplement manufacturers will require new studies.

The exemplary safety record of dietary supplements during these last 17 years has been confirmed in the annual reports of the American Association of Poison Control Centers. While the number of serious adverse events and deaths associated with FDA approved prescription drugs number in the 10's of thousands, those associated with all dietary supplements are so small as to possibly be attributable to statistical error.

Dietary supplements have even been safer than food.

The FDA is accepting comments until December 2.2011. FDA does not have to take your comments seriously. And just in case the do, they may lose their job and be replaced by people who follow directions.

But your legislators write the laws that FDA has to follow and have the power to oversee agency's conduct.

Your legislators do have to take your opinions into account and if enough of you contact them, changes will be made.

Representative Dan Burton (R-IN) has introduced HR 3380 The Dietary Supplement Protection Act which would extend the date "grandfathering" new dietary ingredients to January 1,2007. So far this bill has no co-sponsors.Please write your congressmembers and ask that the original intent of DSHEA to protect access to dietary supplements should be affirmed again. Congress should hold hearing on the FDA guidance on dietary supplements and pass HR 3380.

I have prepared form letters to contact your Congressmembers. You each have one representative and 2 senators.

Letters would be more effective if you personalize them by telling which supplements you take and how they benefited your health if appropriate.

For your Representative go to www.house.gov

Enter your Zip code on the right and it will find your representative.

For your Senators go to www.senate.gov

A companion bill has not been introduced in the Senate yet so the form letter asks to introduce or cosponsor one.

Arnold