Abuse of FDA Citizen Petitions

Did you know that:
A drug company petitioned the FDA to ban a B vitamin in order to protect its own drug product?
Or that the second largest drug company in the world is using the FDA’s citizen petition process in order to try to prevent any dietary supplement product from making weight loss claims.  The company wants weight loss claims to be re-classified as disease claims!
If you’ve been reading our efforts to stop Wyeth from working with the FDA to ban bio-identical estriol, then you’re probably not surprised that the FDA is being used to try to ban natural products.
But did you also know that you can help keep natural, safe products on the market by simply writing Congress and the FDA and telling them you’re supportive of Vitamin B6 and that you don’t want the FDA restricting free speech?
THE DETAILS
Medicure Pharma’s attempt to ban the natural, bioactive form of vitamin B6
On November 30, 2007, Medicure Pharma submitted a citizen’s petition to the FDA asserting that that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) should be banned.  Despite the fact that P5P most important, bioactive, natural form of vitamin B6, Medicure wants to see the product banned from sale by the US dietary supplement industry because its marketing of P5P-containing supplements undermines the company’s incentive to continue developing its drug product (MC-1).
Dr Robert Verkerk, Executive Director of our affiliate, the Alliance for Natural Health says, “This is an astonishing development that shows just how easily pharma companies are willing to show their hand. Well I’m sorry, natural got there first! You can’t just decide to have a natural form of a product banned because it interferes with your drug patents. We’ve found two patents secured by Medicure for P5P to be used in cases of heart disease. It seems they’ve come to the same realization as millions around the world—vitamins and other natural products can be used to help protect you from chronic diseases, including heart disease.”
A recent, large scale Japanese study, for instance, published in the Journal of the American College of Nutrition (2008 Feb;27(1): 127-36), concluded “Dietary intake of vitamin B6 was associated with a reduced risk of coronary heart disease among middle-aged non-multivitamin supplement users.  Dietary folate and vitamin B12 were also suggested to be protective factors for coronary heart disease.”
Glaxosmithkline’s attempt to shut down competition from the natural products industry in the weight loss field

On April 17, 2008, the world’s second largest drug company, GSK, along with the American Dietetic Association and the Obesity Society—both regarded by many as fronts for some drug companies — petitioned the FDA to try to prevent any dietary supplement product from making weight loss claims. The company wants weight loss claims to be re-classified as disease claims, therefore making them the sole domain of treatments with licensed pharmaceuticals. GSK’s Alli product directly competes with the wide range of dietary supplements that help support weight loss—and Alli has become the third top-selling obesity drug less than a year after its launch, despite serious side effects.
Commenting on the GSK petition, Verkerk added, “Obesity control is a growth area for Big Food which contributes so greatly to the problem. GSK —which works in cahoots with Big Food—now wants a slice of the action and it wants to eliminate the main source of competition—the natural products industry. Consumers must engage with these petitions and have their say. The time for sitting on the sidelines is over.”
These Latest FDA Petitions Follow the Recent Ban on Bio-Identical Estriol

Wyeth pharmaceuticals petitioned the FDA to ban bio-identical estriol, even though bio-identical estriol is a critical ingredient in bio-identical hormone therapies, and no adverse event had ever been associated with its use. AAHF, along with our congressional allies, are currently attempting to reverse this ban. Please do not let these new petitions to the FDA succeed.