Is the Food & Drug Administration protecting consumers from dangerous and fraudulent claims by supplement makers, or are they simply reacting after the fact when it’s too late? That’s what the advocacy group called the Reality Coalition thinks. And there’s some merit to that claim. The group argues that the Dietary Supplement Health and Education Act (DSHEA), does little to protect consumers from unsafe supplements like Hydroxycut until it’s too late.

Earlier this month, the FDA ordered a recall on the popular weight loss supplement Hydroxycut, after it received 23 reports of serious liver problems, ranging from jaundice and elevated liver enzymes. In 2007, a 19-year-old died of liver damage related to the use of Hydroxycut. Amazingly, that wasn’t reported to the FDA until this past March.

To make matters worse, there have been other problems associated with Hydroxycut, including seizures, heart problems, and rhabdomyolysis, a muscle ailment that can lead to other issues.

The controversy over the dangers of certain supplements really came to the forefront when major league baseball pitcher Steven Belcher died while using ephedra. Since then, there seems to have been more sensitivity to the dangers that some supplements may pose.

As a result, the FDA has gotten more aggressive in monitoring dietary supplements. In March, the agency sent letters to 72 companies regarding unlisted ingredients, and many of the companies subsequently recalled their products.

The problem that seems to be the most pressing, and obvious, is that under the current incarnation of the DSHEA, supplement companies don’t need FDA approval before they are put on the market. How insane is that? That’s akin to testing cars for safety after they are made.

How many more people need to become sick or die before a common sense revision to the law is brought about?

“Now is the ideal time for Congress… to raise the regulatory bar for weight loss supplement manufacturers to be accountable for the safety and efficacy of their products,” says Louis J. Aronne, M.D., co-chair of Reality Coalition. “We firmly believe that there needs to be an FDA review process for all over-the-counter weight loss products.”

(via: News Inferno)

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It’s Time for Better Supplement Regulation

From the FDA press release — 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.

The teen’s death happened in 2007, and was only reported to the FDA in March 2009. Dr. Linda Katz of the FDA’s food and nutrition division said it has taken so long to bring this to the public’s attention because the cases were rare and the FDA has no authority over supplements (a government report in March 2009 called for higher supervision of supplements by the FDA). “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” she said.

The FDA does not regulate supplements with the same authority it does pharmaceuticals. Producers do not have to have an FDA approval nor inspection of the products for safety or efficacy before being sold to consumers. “You really have to be careful about dietary supplements, especially weight-loss pills,” said Ano Lobb, who has studied Hydroxycut for Consumer Reports. “People believe that the FDA has verified that these products are at least safe and effective, and that’s really not the case. When you see fantastic claims — that’s generally what they are.”

The FDA does monitor aftermarket reports for health problems related to these supplements. A similar warning in 2004 regarding ephedra forced the government to enact a ban on the supplement ingredient following reports of heart attack and stroke.

This list of Hydroxycut products being recalled include:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Hydroxycut Cleanse and Hoodia products are not affected by the recall.

“The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts,” per the FDA press release.

via FDA and Associated Press

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