Healthy Skepticism Library item: 15583

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Edwards J.
Why Hydroxycut Had to Kill Someone Before the FDA Could Act
BNet 2009 May 4
http://industry.bnet.com/pharma/10001915/why-hydroxycut-had-to-kill-someone-before-the-fda-could-act/

Full text:

The FDA has moved to ban diet aid Hydroxycut after it received 23 reports of serious health problems and one death due to liver failure.

The recall points out the ridiculous position of federal law as it relates to diet supplements: Even though the FDA has sweeping powers to ensure the safety of drugs and food through its approval and inspection process, it has almost no power over the “diet supplement” industry.

The Dietary Supplement Health and Education Act of 1994 specifically removes FDA authority over the pills sold by GNC, Vitamin Shoppe, Herbalife, et al. It says:

… the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers … [unless a product] presents a significant or unreasonable risk of illness or injury …

Thus – unlike with meat, eggs, spinach, tomatoes or Lipitor – the FDA is limited to waiting until people actually die before the law permits it to inspect and ban a product. Which is exactly what has happened in the Hydroxycut case. The FDA said:

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Note that Hydroxycut was not on the list of banned/dangerous diet drugs that the FDA wanted pulled from shelves back in January, thus proving how little power the FDA has over diet supplements.

The diet supplement industry’s lobby group, the Council for Responsible Nutrition, wants the law to become even more relaxed. It is currently lobbying the FTC to give it the right to make false statements in ads so long as nobody could be expected to believe those statements. Its official position is:

An advertising claim that you don’t believe can’t hurt you.

Meanwhile, with the diet supplement industry an official wild west of dubious claims and big profits, big drug companies such as Bayer and Wyeth.