International Irony: China Investigates U.S. Diet Patch

Is the hoodia diet patch a food or a drug, and why is the FDA so confused?


July 11, 2007 — -- When Axel Olsen was reading the New York Times online, a nubile girl sporting a diet patch on her trim waist jumped right out at him.

"It was so inappropriate," said Olsen, president of the new Pharmaceutical Safety Institute in Philadelphia. "The drug companies are regulated, but the FDA had not approved this ad."

The ad promotes the popular herbal appetite suppressant hoodia gordonii, which it claims has been used for "thousands of years" by South African bush men to keep hunger at bay when on long treks.

Touted as benign and natural, herbal products can be sold to children as young as 12 with virtually no regulation. Americans spent $22 billion on dietary supplements in 2006, according to the Nutrition Business Journal.

"These substances do have some biological activity, and therefore they are not completely innocuous," said Olsen, whose nonprofit organization was founded only seven months ago to respond to consumer concern about drug safety.

Even the Chinese — no scions of product safety — have launched an investigation into the use of these diet patches, alleging that Chelsea Clinton had lost 26 pounds using the device. [The Clinton camp flatly denied it.] Just this week, according to the official Xinhua News Agency, China executed its former drug watchdog chief for taking cash to approve untested medicine.

But in the voodoo world of U.S. government regulations, the trans-dermal diet patch falls into uncharted territory.

Is it a dietary supplement — which, as a food, escapes prior approval by the FDA? Or, because it is delivered via the skin and not ingested, is the patch classified as a drug, which faces tougher scrutiny?

FDA spokesman Kim Rawlings seemed confounded.

"Hoodia patches are not a device and probably should be regulated as a drug," Rawlings told ABC News. "But no one here is aware of any approval application. If it is making any medical claim, it is viewed as an unapproved drug."

What is problematic for psychologists is that advertizing for diet supplements is aimed explicitly at young, body-conscious girls who are vulnerable to misinformation.

"The reality is that more than 90 percent of females express dissatisfaction with their bodies," said California psychologist Edward Abramson."Girls are dieting in kindergarten."

In Abramson's book, "Body Intelligence: Lose Weight, Keep it Off and Feel Great About Your Body Without Dieting," he says girls needs to know they have "genetically determined limits."

"Not too many of us look like Vogue models," he said.

Many young girls turn to herbal diet aides because they are a quick fix and easy to buy.

Only two diet supplements have ever been outlawed in the U.S., according to Consumer Reports. In 2003, the FDA banned the herbal diet aid ephedra after several deaths, and, in 2004, the body building supplement androstenedione.

Consumer Reports warned readers about its "dirty dozen" toxic herbal supplements in a 2006 article. Americans spend about $76 million a year on just three of them.

Aristolochia, a known carcinogen used to heal wounds, also has been linked to kidney failure; the sexual stimulant yohimbe can cause heart and respiratory problems; bitter orange, whose ingredients are similar to ephedra, can cause liver failure.

At least five of these herbs are banned in Asia, Europe, or Canada.

Hoodia — be it drug or food — seems to have escaped the scrutiny of the FDA. The Federal Trade Commission, on the other hand, sued several manufacturers for false advertising of a similar diet patch in 2004 and 2006 and won.

"Given the very scanty evidence that hoodia works, and the even scantier evidence that it's safe, particularly for long-term use, we do not recommend [its] use," said Consumer Reports.

Under the 1994 Dietary Health and Education Act, only prescription and over-the-counter drugs are regulated and require approval. The FDA can, however, take enforcement action against dietary supplements if they are a risk to public health or falsely claim to "treat, prevent, cure or mitigate a disease," said Rawlings.

New regulations will go into effect in December will require the packaging to accurately reflect the contents. Manufacturers will also be expected to record quality controls and report "adverse events."

At The Health Nuts, a New York City franchise, a 10-day supply of 30 capsules of hoodia sells for $24.60. The hoodia diet patch lists for $32.95 for a month's supply and claims to be the "number one weight loss supplement in the world."

"We sell a lot of them," said sales clerk David Endo "We haven't had any complaints about side effects, though a person could be allergic to it. But you are never really sure if they are legitimate."

Hoodia patch studies have never been sponsored by the Office of Dietary Supplements at the National Institutes of Health, according to director Paul Coates. "They may have some health benefits, but we have no interest in them scientifically," he said.

"Overall, dietary supplements are safe, although there are exceptions, and they are important to know," said Coates. "People need to be armed with the right factual information to make the right choices, and they need to consult with their doctors."

Products can be contaminated or adulterated or mislabeled, and consumers should also consult their doctors for interactions with prescription drugs, said Coates.

The diet patch is another passive way to approach dieting, but historically -- at least with ephedra -- the results can be fatal.

"Any ingredient that is absorbed transdermally is biologically active," said Carla Wolper of the Obesity Research Center at St. Luke's Hospital in New York City.

"We don't know if they are safe without clinical trials to show that these work, or that there are dangers," she said. "There is little or no regulation and won't be until someone dies."

For more information on dietary supplements visit the National Institutes of Health's Office of Dietary Supplements.

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