TAKE ACTION: GSK Threatens Access to Weight Loss Supplements

Washington, DC - On April 17th, 2008, pharmaceutical giant GlaxoSmithKline (GSK) submitted a Citizen Petition (yes, we know, GSK is not a citizen) calling for the U.S. Food and Drug Administration (FDA) to reclassify all weight loss support claims for dietary supplements as disease claims. Read the full petition here.
 
GSK was joined in this petition by three organizations that it generously supports: the American Dietetic Association, The Obesity Society and Shaping America’s Health. The organizations’ signatories included a lobbyist, a person who helped get obesity classified as a disease and a fundraising guru.
 
If the FDA were to—in a hypothetical act of audacious ignorance—agree with this petition, American consumers would be unarguably cheated out of hundreds of legally and responsibly marketed dietary supplement products.

CLICK HERE to Tell the FDA to Reject GSK's Petition (A sample letter is attached at the end of this article for your convenience). Please note: This link takes you to the FDA's "comments" page; make sure that you choose "Individual Consumer" as your submitter category, and type "n/a" for organization name since it is your own submission.

The stage would be set for challenges to other types of claims and to what would constitute irreparable damage to the dietary supplement industry and irrevocable losses to consumer choice.
 
What a shameful state of affairs this is for the FDA.
 
Citizen petitions, when originally instituted, were supposed to be just that: a formal means for a citizen, or more broadly the public, to contact the FDA and “seek its action or response on a particular matter.”
 
The original intent of citizen petitions has been perverted to now facilitate “citizen” petitions from corporate behemoths that are so removed from anything remotely resembling a citizen, or the public at large, that to continue calling them “citizen petitions” is an insult to all Americans.
 
Perhaps they should be called “Big Pharma Petitions” since the ones submitted by actual citizens, citizens groups and the public are the ones which tend to fall into the eternal and stygian FDA backlog.
 
CLICK HERE and Tell the FDA to Keep Their Hands Off of Your Supplements (A sample letter is attached at the end of this article for your convenience). Please note: This link takes you to the FDA's "comments" page; make sure that you choose "Individual Consumer" as your submitter category, and type "n/a" for organization name since it is your own submission.

In the GSK petition’s summary, GSK and its co-petitioners state: “Moreover, the actions requested in this petition would help address concerns about the safety of weight loss supplements” and “By requiring weight-loss supplements to undergo pre-market review, FDA would shift the burden to manufacturers to show that their products are safe.”
  
Given the solid safety record of dietary supplements sold in health-food stores—and the incredibly poor safety record of drugs foisted on the American public—how could any pharmaceutical company have the unmitigated gall to ask this country (and its servant, the FDA) to ignore the 100,000 deaths and over 1 million adverse events every year from properly prescribed FDA pre-approved drugs?
 
Could it be because effectively removing dietary supplements that assist people in achieving body composition and weight loss goals would provide Big Pharma (including GSK) an El Dorado, like the legendary lost city of gold?
  
So the questions are these:
 
1. Are we willing to see irreparable harm come to health food supplements?
2. Do we want Big Pharma to manipulate the tools of public redress to do this?
3. Do we want to offer the drug makers with an incalculable revenue boon while delivering a mortal wound to the natural products industry?
4. Do we want Big Pharma and the FDA to decide what sorts of products we can have access to?
5. Or do we want to keep our dearly won health freedoms?

If your answer is “No!” to the first four questions and “Yes!” to the very last question, then you need to CLICK HERE and tell the FDA exactly what you think about this so-called Citizen Petition. (A sample letter is attached here for your convenience). Please note: This link takes you to the FDA's "comments" page; make sure that you choose "Individual Consumer" as your submitter category, and type "n/a" for organization name since it is your own submission.

You may also send your comments on this petition to (Use the sample letter attached at the end of this article, or, if you write your own, make sure you refer to Docket # 2008-P-0248-0001):

Lyle D. Jaffe
Division of Dockets Management 
Office of Management Programs
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857

Or, call them at: 1-888-INFO-FDA (1-888-463-6332)