The FDA and sports supplements.
Brian May 6th, 2009
Many of you have probably heard about the Hydroxycut recall being bandied about the internet and media outlets. If you haven’t heard this story check out http://www.medscape.com/viewarticle/702283, or http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html. Take a look at the time frame over which the incidents occurred.
In 2003 ephedra was in the hot seat after a pitcher died while taking the supplement. You can view the article here http://www.nytimes.com/2003/03/17/business/media-business-advertising-after-pitcher-s-death-marketers-dietary-supplements.html?sec=&spon=&pagewanted=1. Ephedra (the crushed up root and stem of the plant) and pure chemical ephedrine were subsequently banned in 2004 after much pressure from critics. Keep in mind that Ma Huang (a Chinese herb which contains ephedrine) has been in use for centuries and over 10,000 people/year die from taking OTC aspirin, tylenol, ibuprofen and naproxen sodium.
The FDA is responsible for ensuring that the foods we consume are safe, and the drugs brought to market are safe, effective and live up to their claims. Supplements fall out of the jurisdiction of the FDA because they are neither a food or a drug (this is why you always see “these statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease” on the side of the bottle). As such, supplement companies can put any substance they want into a product with little chance of being caught. However, if there are adverse effects or deaths from a product the FDA can investigate, and ask that the product be removed from the shelves.
The popularity of a supplement, and ultimately its life cycle, is much like our economy in that it is self regulating. If a product does not live up to its claims, or causes harm, it will only be a matter of time before it doesn’t sell and is off the shelves (due to consumer feedback and purchasing habits). There was a popular bodybuilding supplement in the 1990′s called Hot Stuff that was removed from the shelves because athletes were testing positive for performance enhancing drugs. Ultimate Orange suffered the same fate, but eventually came back reformulated.
Many critics of the supplement industry, and some members of Congress, have called for sweeping reforms to the supplement industry including FDA regulation. What does this mean to you, the consumer? Higher prices, less selection and less availability. You may think you are not affected because you only take vitamin C or a multi, but these will all fall under the jurisdiction of the FDA. The reason these products are affordable is because they don’t have to go through the rigors of FDA approval.Â
Take Away Points
- Always heed the warnings on the side of the bottle; they are there for a reason
- Research the product you want to purchase and make sure it is right for you (there are plenty of forums out there with customer feedback)
- Keep current on proposed legislation involving the supplement industry
- Even if you are healthy, consult your Dr. about the product you wish to take if you have any lingering questions or concerns
- Be leery of any research that tries to use animal studies to show human results