by James J. Gormley 

On April 17th, 2008, pharmaceutical giant GlaxoSmithKline (GSK) submitted a Citizen Petition (FDA-2008-P-0248-0001) calling for the U.S. Food and Drug Administration (FDA) to reclassify all weight loss support claims for dietary supplements as disease claims.

GSK was joined in this petition by three organizations that it 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.

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 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—unless, of course, the petition challenges the sacred cow of FDA decision making.

Such a sacred cow was challenged by the non-profit group, Public Citizen (a true consumer group), on April 10th, 2006, when it called on the Agency to not allow a GSK drug (orlistat)—which is said by the group to have a history of side effects and gastrointestinal problems—to be re-classified as an over-the-counter (OTC) weight loss drug, now called alli™.

Public Citizen’s objections cited such embarrassing product usage problems as anal leakage and such serious problems as pre-cancerous lesions.

On February 7th, 2007, the FDA dismissed the group’s well argued petition, saying that the product label already warns people about the messy bowel problems.

As to those pesky pre-cancerous cellular changes allegedly caused by the drug (called “aberrant crypt foci”), the FDA said they aren’t of clinical significance.

Interesting, because according to the NIH National Cancer Institute, aberrant crypt foci represent “one of the earliest changes that can be seen in the colon that may lead to cancer.”

But, then again, FDA’s approvals were being called into question—institutional arrogance can’t allow that—and a powerful drug maker’s products were also being questioned.

Now, let’s turn back to the GSK Citizen Petition.

In the 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.”

What about the potential safety problems related to GSK’s alli™? This product went through both a prescription drug and an albeit cursory OTC safety review process and it still has a number of reported concerns associated with it.

Or what about GSK’s prescription diabetes drug, Avandia? The FDA issued a safety alert related to this drug, indicating that “there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”

Shortly thereafter the FDA required a “black box warning” with this drug, one which says: “Warning: Congestive Heart Failure and Myocardial Ischemia.” It appears the much-touted FDA drug prescription safety review process didn’t work here either.

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 an El Dorado, like the legendary lost city of gold?

So I guess 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 please comment below with exactly what you think about this so-called Citizen Petition.

If you want them, as I do, to summarily deny this outrageous petition, then please indicate that in your comment below.

An award-winning journalist, published author, and member of the prestigious American Society of Journalists and Authors (ASJA), Gormley has 20 years of experience in health-related media communications. He is a senior policy advisor for Citizens for Health (www.citizens.org), an advisory board member of the National Health Research Institute (NHRI)and a member of the Institute of Food Technologists (IFT). From 2006 to 2008, Gormley directed three leading health-food trade magazines for VRM Inc. He is perhaps best known for having served as the longtime editor-in-chief of Better Nutrition magazine (1995 to 2002) and for having founded Remedies magazine in 2006. A consumer health advocate and industry champion, Gormley has also been a frequent guest on television and national radio where he has spoken out on a variety of health and regulatory issues.