Thursday, June 26, 2008

Government Regulations ALERT for US Citizens

GlaxoSmithKline, a major pharmaceutical company, has written a "citizen petition" to the US FDA in order to request that the FDA consider changing its rules about dietary supplement claims. In this writer's opinion, this is one of the first steps to giving unlimited power to the pharmaceutical industry.

The claims in question are those by dietary supplement companies regarding "weight loss." As it stands currently, supplement manufacturers of any product that aids in weight loss are allowed to make that claim. What GSK would like to do is to have the FDA make this supplement claim illegal, by declaring that being overweight is a disease. (For example, supplements can not claim to "cure cancer," or anything similar). This could be the first step in broadening of government powers to stop us from buying products that are natural or herbal in nature.

You can see why GSK is doing this . . . This is the manufacture of "Alli" which is an over the counter (OTC) non-prescription version of the drug orlistat, (Xenical®, Roche), the only FDA approved OTC drug for weight loss. Alli is one of the largest-selling weight loss products in the world, with cumulative sales at approximately $315 million (USD) since its launch in June 2007. I am sure that some natural products dampen GSK's sales levels each year, and the company is out to target dietary supplement makers.

Paul Dijkstra, CEO of InterHealth, a producer and marketer of clinically-researched, patented dietary supplement ingredients, submitted comments on behalf of his company earlier in June. He wrote (e-mail June 17, 2008):

"There are many reasons for people who are overweight to want to lose weight. Weight loss supplements are purchased and used by many people whose concern is not disease prevention, but appearance driven. Many people want to simply look better, feel better and have more energy. It is common for people to want to lose 10 to 20 pounds to help boost their self esteem or look good for an upcoming event such as a wedding, class reunion or bathing suit season. Ruling that weight loss claims are disease claims would be unjust and would give an immense power to the pharmaceutical industry, which would not be in the best interest of consumers trying to achieve improved body composition and weight loss goals with proven supplements. In addition, many people take these supplements to help maintain their healthy lifestyle, not to lose weight. For instance, some weight loss ingredients exert their effect by controlling appetite. These ingredients can help people sustain satiety, reduce daily caloric intake and have more energy and time to concentrate on their busy lives."

I agree 100% with this executive. But my biggest concern is that I do not want anyone in government to regulate my ability to buy natural products and herbs, which are a gift from the creator; they should be available freely to all who want them.


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