Hydroxycut recall prompts calls for DSHEA review

By Lorraine Heller

- Last updated on GMT

Related tags Weight loss Dietary supplement Fda

The recent recall of top-selling Hydroxycut weight loss products has prompted the – not unexpected – call for a review of regulations governing dietary supplements in the United States.

According to the anti-obesity group Reality Coalition, this latest in a string of problematic weight loss supplements highlights the need for tighter regulatory standards.

"Now, is the ideal time for Congress to protect consumers by taking a closer look at the current Dietary Supplement Health and Education Act (DSHEA), raising the regulatory bar for weight loss supplement manufacturers to be accountable for the safety and efficacy of their products,” ​said Reality Coalition co-chair George Blackburn, MD, Ph.D.

Last Friday, 14 different products in the Hydroxycut line were recalled by their manufacturer Iovate Health Sciences after a number of adverse event reports found that they could be linked to serious liver damage. Hydroxycut is one of the most popular weight-loss supplement brands in the US. In 2008 alone, over nine million units of the product were sold.

To read the NutraIngredients-USA.com article on the recall, click here​.

Reality Coalition echoes concerns that are re-iterated without fail every time a problematic supplement product is discovered: Namely that the category is unregulated and poses a health risk to consumers.

According to Blackburn, the Hydroxycut recall "draws even further attention to the serious public health threat posed by unregulated dietary supplements. Consumers must be educated and continuously made aware that over-the-counter weight loss supplements are not FDA approved."


The Reality Coalistion was set up in 2006, supported by a grant from the drug firm GlaxoSmithKline (GSK). GSK, which currently sells the only approved over-the-counter weight loss drug sold in the US market, last year filed a petition with FDA requesting that weight loss claims be considered disease claims. The petition – which aims to wipe out the weight loss supplement category – is currently on hold, buried under a pile of other FDA priorities.

Industry support


Supplement trade groups have stood behind the Hydroxycut recall, terming it “appropriate action” ​to protect consumers.

However, trade organizations have repeatedly refuted claims that the supplement industry is unregulated, standing behind the hard fought-for DSHEA. The Council for Responsible Nutrition (CRN) last week re-iterated this belief: “The dietary supplement industry is regulated by the FDA and the Federal Trade Commission,”​ it said in a statement.



The Hydroxycut case is a major blow to a category already suffering from skepticism, and is expected to further erode consumer confidence.

However, weight loss remains a top priority for consumers, which has prompted a slightly more optimistic outlook that the market will rebound from this latest hit.

Mitch Skop, from ingredient group Pharmachem, which counts some weight loss ingredients in its portfolio, tells NutraIngredients-USA.com why the category is not doomed. To listen to the podcast, click here​.

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