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?

ByABC News
July 10, 2007, 4:19 PM

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.