Just the right amount of time has passed since Iovate Health Sciences removed Hydroxycut products from stores shelves to dispassionately examine the decision, how it came about, and what it could mean for the weight-loss category. Supplement recalls trigger a certain amount of melodrama as typified by this MSNBC headline: "FDA Warns Dieters: Stop Hydroxycut Use Now." Time tends to put these messages in perspective.
The facts are that in March, FDA told Iovate that liver toxicity involving Hydroxycut presented a "severe, potentially life-threatening hazard" to some users. On April 29, FDA attorney Eric Blumberg called Iovate to discuss the actions expected of the company. In a subsequent call, Iovate informed Blumberg about its intention to recall all Hydroxycut products, including drink mixes and caplets, which were beyond the scope of FDA's initial request.
FDA based its decision to recall Hydroxycut on "three lines of evidence": adverse-event reports (AERs), peer-reviewed literature, and hepatologist reports. Each area deserves a closer look.
A total of 23 adverse-event reports were received from 2002 to March 2009. Of the reports' subjects, 15 were women, and 16 individuals were hospitalized. Most of them had no prior history of liver disease.
The Hydroxycut case also had an interesting connection with ephedra. Seven AERs occurred between 2002 and 2004, before Hydroxycut was reformulated without the now-banned ingredient. FDA noted that most of the AERs—16 to be exact—were received after the beginning of 2004, when ephedra was no longer in the product or the market.
QUOTE OF THE MONTH
"It's always difficult when popular weight management and sports nutrition ingredients come under public scrutiny. It's a black mark against our entire industry. But it underscores the vital importance of using well-researched, tried-and-true ingredients." — Bob Green, president, Nutratech Inc., exclusive worldwide distributor of Advantra Z
There was one death, a 20-year-old male who went to an emergency room on January 19, 2007, in liver failure and hepatic encephalopathy. Later, during an operation in a liver transplant center, he was found to have necrosis of both the large and small intestines. He died on February 12, 2007.
FDA's Center for Food Safety and Applied Nutrition (CFSAN) received news that the death was related to Hydroxycut on March 24, 2009. Wasting no time, the agency searched its database and found four published reports of liver disease that occurred in six persons following the consumption of Hydroxycut capsules/caplets. FDA then consulted hepatologists Tse-Ling Fong, MD, of the University of Southern California, and William Lee, MD, of the University of Texas Southwestern Medical Center. The physicians told FDA of patients with severe liver disease associated with the use of Hydroxycut, including two cases requiring transplants following acute liver failure.
One week later, FDA contacted Iovate about its decision to recall Hydroxycut.
This chronology shows important facts behind the recall. First and foremost, FDA did not act in haste or without adequate evidence. One could argue that 23 AERs over nine years does not constitute a recall scenario. The calculus changed when a fatality was involved.
No single ingredient was responsible for the recall. The agency admits that it does not know enough about the ingredients, nor does it know what the effects would be over time. This fact is crucial. Ingredient suppliers should be very careful about their response to an FDA recall. Breathing a hint that one ingredient was more responsible than another would be a mistake.
Iovate could return, but the road will not be easy. FDA would allow a reformulated Hydroxycut back on shelves provided each ingredient was a dietary ingredient before October 15, 1994. The alternative is submitting a premarketing notification under the 21 U.S.C. sect. 350b(a)(2) and 21 CFR 190.6.
Lastly, while FDA initiated the recall, Iovate willingly pulled Hydroxycut from distribution and included products not required by FDA to be recalled. Skeptics might argue that the company operated in its own best interests and did not respond until FDA stepped in. That is true to an extent, but give credit where credit is due. Iovate did the right thing, which is good for everyone.
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Jim Wagner, Publisher