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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Outside the industry, the viewpoints were more pragmatic. Scot Long, an exercise physiologist and professor from Mississippi, weighed in, writing: “Bottom line, do I think that Hydroxycut is an evil product? No. I think many people abused this product (taking too much) and some may have even had pre-existing medical conditions. Do I recommend it to my students, clients and friends? Of course not. I do think, however, that Iovate Health Sciences could have made a safer product. But it shouldn’t shoulder all the blame.”

Marion Nestle, author of “Food Politics,”  wrote in her San Francisco Chronicle column, “I freely concede that most supplement companies make reliable products, but without federal oversight how is anyone – even a store clerk – supposed to know which ones they are. Some clerks may know their business, but in my experience few think critically about the products they are selling and most appear to take the manufacturers’ words at face value.”

After a Hydroxycut recall article was posted on FitSugar.com, a commenter who goes by the name Mondaymoos offered this first-person experience : “I never took diet pills for the purpose of losing weight. Me, and a lot of other people in the military, used them as a tool to work 12 hour shifts and still go out and have a life afterwards without racking up massive calories in energy drinks and soda. Was it a healthy decision, probably not. Did it work? Definitely yes.”

Consumers seem to know that there are no magic diet pills and that abusing a product is probably harmful. Thus, rhetoric that casts the FDA — or a manufacturer — as hero or villain does not sway consumers. They would rather know the benefits and risks of a product, and make an informed choice based on that.

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The recent recalls of peanuts and pistachios brings to mind public concerns about the safety of all foods, including nutritional supplements. There’s good reason to be worried, if a recent report on Chinese slimming capsules is accurate. A study by German scientists found that the product contained sibutramine, which is banned for use as a dietary supplement in the United States.

The danger is only partly the ingredient; the FDA does approve the use of sibutramine as an appetite suppressant for weight loss. The greater worry is that the substance was not listed on the product label.  And sibutramine is the culprit du jour; there may be other undeclared — and possibly more harmful — ingredients that unwitting distributors and retailers are today offering to their American customers as being natural and supporting good health.

The research scientists warned in their report: “Products available without a prescription whose contents are claimed to be purely herbal may nonetheless contain synthetic substances in concentrations far above the therapeutic range and may be a cause of poisoning.”

The researchers found anecdotal evidence of people becoming ill in Germany and Poland. On Jan. 27, the FDA warned consumers not to take a dietary supplement called Venom Hyperdrive 3.0 because it contained sibutramine. The agency said in a statement that “the pills can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke.”

Such is the stuff that lawsuits and stronger regulations are made of. The food poisoning incidents involving nuts are leading to civil and criminal action, multi-million dollar fines, and congressional calls for tighter regulation. The peanut recall could cost its industry as much as $1 billion, according to one estimate. The damage is bleeding into health food industry. An Oregon company that emphasizes healthful products, Paley’s, recalled some products because they might be tainted.

High-profile incidents with untested dietary supplements might lead to court and legislative action. At least dietary supplement one company recalled some of its stock of Venom because of safety concerns.

The German scientists formulated their solution in their report: “It would be desirable to implement the obligation to declare ingredients and dose. The marketability of the product must be checked, particularly in countries in which the ingredients are classified as prescription drugs and in which a pharmaceutically defined medicine is available.”

The U.S. system does not work that way. At present, self-reporting is more the norm.  That could change given consumer suspicions about food safety and the pressure on government to respond quickly and severely to the next food scare.

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We originally reported on the FTC action in a post in September of 2007.  At that time we noted that if successful, this will be the second contempt order entered against Trudeau.

Well, it’s official.  Contempt order two has been entered and Trudeau has been ordered to repay the victims of his scams to the tune of $37 million.

Trudeau has had several run-ins with the FTC, as detailed in the case filings archived at the FTC website.  To access the entire FTC v. Trudeau case file, click here.

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One is rimonabant, which the agency is not approved for marketing in the United States. In October 2008, Sanofi-aventis, which legally sells rimonaban in Europe under the brand name Acomplia agreed to stop marketing the product. The FDA has identified another unlisted diet pill ingredient, phenolphthalein, a suspected cancer-causing agent. The health risks of some ingredients include seizures, strokes and heart attacks, the FDA says.

The makers and sellers of the 69 products are at risk, first with regulators for not disclosing the ingredients and second with consumers who may fall ill. There is also a threat to makers of wholesome diet products. The FDA says that some of the targeted products are advertised with words such as “natural” and “herbal.”

Agency action places a cloud over all dietary supplement companies by casting suspicion on labels, products and manufacturers. Firms that produce and sell untainted products may become targets of fast-spreading, erroneous rumors. The best responses: Put a message all over your Web site; tell your customers, retailers and distributors that your products are safe; and prepare for the calls and e-mails.

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According to the FTC’s complaint, the defendants, operating through their umbrella company Ultralife Fitness, Inc., lured customers by promising to send, for a specified trial period, free samples of the dietary supplement Hoodia, which they claimed caused weight loss. The supplement was purportedly derived from the cactus-like Hoodia gordonii plant, which is found in southern Africa.

To read the press release, click here

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If successful, this will be the second contempt order entered against Trudeau. Trudeau has had several run-ins with the FTC, as detailed in the case filings archived at the FTC website.

This latest Trudeau incident provides some insight into the intersection of supplement marketing practices and the first amendment. The FTC could not, consistent with the First Amendment, prevent Trudeau from writing about whatever he chose in his books. However, the FTC can, and has, enjoined Trudeau from making unfair and deceptive claims about what he writes in those books, including, as in this instance, claims that a weight loss plan is “easy” when it actually involves eating a 500 calorie starvation diet combined with daily injections of a prescription drug banned in the U.S.

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