Hydroxycut: The Latest Gun in DSHEA’s Wild West

Don Greiwe
Attorney
(866) 735-1102 Ext 452
Posted by Don GreiweMay 11, 2009 9:32 AM

As you probably have heard, hydroxycut has been taken off the market. On April 30th the FDA warned consumers to immediately stop using all 14 Hydroxycut products. This comes after the FDA compiled a report detailing 23 complaints of serious liver problems ranging from jaundice to liver failure requiring transplant. In one case, a 19-year-old died as a result of the associated liver damage. The manufacturers of Hydroxycut (Iovate Health Sciences) has since recalled all Hydroxycut products from retailers nationwide.

The Dietary Supplement Health and Education Act, or DSHEA, was brought into law the in 1990s under the Clinton administration. Most dangerously, it allows dietary supplements to enter the over-the-counter market without any formal review by the FDA. It even limits the FDA’s power to ensure honest advertising; that duty is delegated the Federal Trade Commission. So despite that 8 pt font statement that “these claims have not been evaluated by the FDA” that’s onscreen when a dietary drug claims it’s a panacea, the FDA doesn’t even yield the power to sue the manufacturers who mislead a gullible consumer base via their the supplement's advertising. Many Americans would be shocked to know of how little regulatory power the FDA has over the dietary supplement market.

Without formal testing of these products, the dangerous propensity of certain dietary ingredients is usually not found until after enough deaths or injuries have occurred to make such a causal link. This could take years, as is the case with Hydroxycut and Ephedrine (now only legal for limited uses).

Some call it a cycle, and would expect another product in the near future to take Hydroxycut’s place in the market. Without change, this product will be untested and unproven. Now is the time for Congress to take action to amend the DSHEA. In the least, the FDA must be given the authority to more closely monitor and regulate the dietary supplement industry.

For more information, see this article. It gives more frightening details into how this latest recall is unfolding. As George Blackburn, M.D., Ph.D. states, "Every time we put a lid on it, as we did when we got rid of ephedra, now comes another round of adulterated products," he said. "Now with Hydroxycut, we have the same type of organ injury and illness, if not mortality, that comes from some unknown ingredient."

Patients should always tell their doctors of any supplements they are taking even if it is not known to be dangerous, because known injury may occur when combined with certain prescription medicines.

3 Comments

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Jon Benninger
Posted by Jon Benninger
May 15, 2009 5:33 PM

Please check your facts. The FDA does oversee dietary supplement labeling and always has, the FTC does not and never has. The FTC regulates advertising, and for all products, not just supplements. Your statement above is simply false. DSHEA is not the cause of most of the issues with dietary supplements. In fact, the cause is the unwillingness of the FDA to implement and enforce DSHEA. The agency has behaved like a scolded child ever since this law was passed. And it was not passed because of some powerful lobbying effort as the anti-supplement coalition claims. DSHEA was passed because the FDA was unfairly and arbitrarily declaring supplements to be unapproved food additives and unapproved drugs. In one case, FDA tried to stop the sale of black currant oil capsules by claiming that the capsule was the food, and therefore the oil inside was the food additive. Since the agency had not pre-approved black currant oil as a food additive, it was therefore adulterated. FDA lost the case, appealed, lost again with the judge calling their argument "alice in wonderland," and sought to appeal to the Supreme Court but the Solicitor General would not take the case. This demonstrates exactly how overzealous FDA was as it attempted to place every nutritional substance under the regulatory structure of either food additives or drugs. DSHEA was the result of this and other outrageous FDA acts and viewpoints. Following its passage, FDA took more than 12 years to institute the Good Manufacturing Practices (GMPs) specified by the law, the agency still has not addressed the New Dietary Ingredient pre-approval provision in any meaningful way, and rather than take enforcement action against companies selling misbranded or adulterated products, the agency has preferred to issue press releases and shrug its shoulders. To argue that DSHEA is the cause of today's issues with dietary supplements is, at best, uninformed. I've been covering this industry and this issue for many years, and I am happy to discuss it with you anytime. And if you would like to speak to the attorney who opposed FDA in the Traco Labs black currant oil case, please let me know. His firm is also the one that won the case in the 1960s when FDA tried to ban retail stores that sold vitamins from also selling books about vitamins. And in the 1970s when FDA sought to declare any vitamins that had more than tiny amounts of nutrients to be drugs (Congress was forced to act to put FDA back in check then too, passing the Proxmire Act). It has been a long story, and it is far from over. Thank you for your consideration,
Jon Benninger
Director of Business Development
Virgo Publishing
Phoenix, Arizona

Don GreiweInjuryBoard Attorney Member
Posted by Don Greiwe
May 20, 2009 10:37 AM

Jon, thanks for the additional information. There was a typo which I think was why you believed I was misinformed about DSHEA. That typo has been corrected. To your point, you raise an interesting perspective: It is not DSHEA in itself that has created an unregulated market, it's FDA's response to it. Is this fair to gather from your post? If so, it appears that FDA has been stepping up enforcement of what power it does has. In March, the FDA sent out 72 letters to manufacturers regarding undeclared ingredients - which from what I'm told is a far greater frequency than in the past.

It comes down to this: If the FDA is not exercising its power that it has been delegated, albeit much less than pre-DSHEA, it creates a very dangerous situation for consumers who think they are buying a product approved by the government, when in fact it was not. Perhaps DSHEA was passed in part to bring consistency to the FDA, but another intention was to protect consumers while streamlining manufacturing. As Hydroxycut and previous supplement disasters have shown, DSHEA is not living up to its purpose.

Jon Benninger
Posted by Jon Benninger
May 22, 2009 2:01 PM

Hello Don,
Thank you for the response. I still think it is incorrect to say that DSHEA limits FDA's power to ensure honest advertising. FDA has never been charged with regulating advertising, before or after DSHEA. That has always been the responsibility of the FTC, whether the ads for supplements, foods, tires, funeral services, shoes or anything else. On the other point, I would love to know how the situation with supplements would be different if FDA had actually implemented and enforced DSHEA. The responsible members of the supplement industry welcome FDA enforcement, and in fact, have lobbied for more funding for the agency, lobbied in favor of mandatory reporting of serious adverse events, and are hopeful that FDA will conduct inspections of many manufacturing facilities so that the bad actors are removed from the market. We had FDA's Brad Williams speak at one of our recent trades shows, and he encouraged industry to point out to the agency any companies that are not complying with the law. The real companies are happy to do this, as long as the agency responds. Anyway, I think we share a lot of common ground, other than the idea that FDA should be given more authority. I think the agency is broken (and not just in the supplement area), and that is where attention should be focused. After so many failures related to drug recalls, food contaminations, counterfeit drugs, etc., it is time to think about major changes to the agency, not to the laws.
Jon

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