This is a tale of two types of weight-loss products and how the Food and Drug Administration had different responses to similar problems with them. The separate, but not equivalent treatment raises questions about how the FDA operates.

On Aug. 24, the FDA issued a statement about an ongoing safety review of orlistat based on reports of liver injury in people taking the weight-loss drug. It is marketed as the prescription drug Xenical and the over-the-counter medication Alli.

The FDA said it had received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008.  Of those cases, 27 required hospitalization and six resulted in liver failure.

Sound familiar? It should. On May 1, the FDA issued a warning about the danger of Hydroxycut based on 23 reported liver problems over seven years, including 16 hospitalizations. One person died in February 2007 after taking that weight-loss product.

That is where the stories diverge. For orlistat, the FDA is conducting a review because, “no definite association between liver injury and orlistat has been established at this time,” according to the release. “Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.”

In contrast, the FDA told consumers to stop immediately using Hydroxycut even though the agency acknowledged in a health hazard evaluation board report that “The Board does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

Despite a lack of direct evidence, the board concluded “that the ingestion of the dietary supplement, Hydroxycut, presents a severe potentially life-threatening hazard to some users.” The makers of Hydroxycut immediately ordered a recall.

What might the same health board members think about orlistat? It has caused liver injuries for a longer time period and has put more people in the hospital with similar ailments — jaundice and liver failure.

Does the FDA give greater weight to the patient death? If so, it seems to us that the product would have been recalled in 2007.

Is the difference the way the products are regulated? The FDA approved Xenical in 1999 and Alli in 2007. None of the ingredients in Hydroxycut were identified in the report as needing FDA review.

If the distinctions are not clear from a review of the facts, then what are we to expect the next time a weight-loss product is associated with health problems?

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Hamburg

The FDA has put supplement companies on notice that violators can expect earlier detection and prosecution. Remarks by commissioner Margaret Hamburg on Aug. 6 strongly suggest that the agency has shifted to a policy of less talk and more action. In a speech to the Food and Drug Law Institute, Hamburg said the FDA will be more vigilant, strategic, quick and visible.

To that end, Hamburg said the FDA has instituted six policy changes:

• Fewer, if any warnings. “If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter,” Hamburg said.
• Greater emphasis on swift enforcement. “When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses,” she said.
• Fewer warning letters. The letters are now limited to significant legal issues. “Most enforcement letters will be able to move forward through a more streamlined process.,” Hamburg said.
• Shorter post-inspection deadlines. “When the FDA finds that a firm is significantly out of compliance, we expect a prompt response,” she said. “The firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.”
• More follow-up on enforcement actions. “After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices,” Hamburg said.
• Public notice of completed corrections. “We will provide to the firm a ‘close-out’ letter, indicating that the issues in the warning letter have been successfully addressed.”

In sum, a supplement maker can expect a knock on the door before getting a letter in the mail. If the FDA perceives a significant risk to public health, it will ask enforcement agencies to take immediate steps. In some circumstances, there will be no warning and no negotiation before a plant is shut down or a product is recalled.

Why is the change in policy needed? Hamburg, who has been on the job just 90 days,  pointed to slow action on serious violations regarding product quality; adulteration and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising. Agencies took to long to respond because of procedures and policies, she said.

The industry response must be to get better or get out. Get better at controlling ingredient quality; get better at manufacturing; get better at documentation; get better at advertising and marketing; get better at legal representation. Otherwise, get out of the business.

While the actions may seem harsh, they increase the public’s confidence in the dietary supplement industry, Hamburg said.  “The solution is a commitment to compliance backed by a strong compliance program. Now is a good time to reassess whether you have such an effort in place.”

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The FDA has just announced a massive recall of the popular weight loss supplement, Hydroxycut.

According to the FDA press release dated today, 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.

Hydroxycut is manufactured and distributed by Iovate Health Sciences.  As of this writing, both the hydroxycut.com and iovate.com websites are effectively “down” with all information having been stripped from their home pages.  Expect recall notices to be posted there shortly.

A long list of products are included in the recall.  They are:

• 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

According to FDA, one death due to liver failure has been reported.   If there is real causation behind this announcement then this could be one of the largest supplement liability issues ever.

Stay tuned for more news as we receive it.

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The recall is detailed on the FDA website here.   As you may have heard, all of the recent salmonella-tainted products have contained peanut paste or peanut butter made at a Peanut Corp. of America plant in Blakely, Georgia.

GNC’s chews were sold in 60-count containers with the UPC 48107036942, with lot numbers ending 8275 and 8255.  Refunds are available by calling GNC’s customer service at 1-888-462-2548.

Anyone searching for a safe peanut based protein bar might want to try VPX Zero Impact MRB bars in peanut butter and jelly flavor.  I have it on good authority that VPX has confirmed its supply of peanuts is safe.  Tasty too!

Other protein or energy bar recalls include:

• Nature’s Path Peanut Butter Optimum Energy Bars
• TWISTED and TITAN Branded Nutrition Bars
• ZonePerfect Chocolate Peanut Butter Bars, ZonePerfect Peanut Toffee Bars and NutriPals Peanut Butter Chocolate Bars
• Clif and Luna bars containing peanut butter
• Creative Energy Foods, Inc. bars marketed under brands Can Do Kid, Isagenix IsaLean, Nestle, Zone, Think Thin, Promax 70, Promax, and Shaklee
• Supreme Protein brand Peanut Butter Crunch Bars and Caramel Nut Bars

Updates:

• The Center for Science in the Public Interest criticizes FDA’s response to the salmonella outbreak as inadequate and ineffective.
• The New York Times reports that the plant in Georgia that produced peanut butter tainted by salmonella has a history of sanitation lapses.
• CDC website on the salmonella outbreak.
• FDA searchable database of peanut products recalls.
• The Washington Post reports that Peanut Corporation of America knowingly shipped contaminated peanut butter twelve times in the past two years!

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