San Diego Firm’s Weight-Loss Patch Off the Market
A local company selling a skin-patch weight-loss system has removed its product from the market in response to a Food and Drug Administration statement that the new-wave diet aids qualify as drug-delivery systems and require FDA approval.
Meditrend International of San Diego, which has marketed its Appetoff reducing system since January, said Wednesday that it will halt sales of the Band-Aid-like product as soon as possible, according to Clifton Jolley, an outside spokesman for Meditrend.
A second company, New Source Ltd. of Laguna Hills, had planned to introduce a weight-loss patch of its own, called Le Patch, in mid-June. New Source is the subject of investigations by the FDA and health officials in two states. Company officials could not be reached for comment.
In answer to a flood of inquiries from consumers and the media, the FDA’s Center for Drug Evaluation and Research said this week that products such as Appetoff and Le Patch “are being viewed as a drug-delivery system that requires FDA approval,” according to FDA spokesman William Grigg.
Previously, the FDA’s official position was that it was investigating the diet patches and was not sure whether it had jurisdiction. No diet-patch company has submitted its product for evaluation and approval by the FDA, Grigg said.
There are several approved prescription uses for skin patches, however, including the administration of nitroglycerin, synthetic estrogen and a motion-sickness drug.
Le Patch is an adhesive device that contains a proprietary formula called “Cehpatrex.” It is designed to be placed anywhere on the body and is one element of a diet program that includes exercise, vitamins and a low-calorie diet.
The Appetoff system, which costs $30 for a 30-day supply, includes adhesive patches, an appetite-suppressing tonic, and a regimen of diet and exercise. At least a half-dozen similar products are being marketed throughout the country, law enforcement agents said.
Health experts have called skin-patch diet programs the latest questionable health fad. “If you put (them) over your mouth, it might help you lose weight,” said Dr. William Jarvis, president of the National Council Against Health Fraud.
Although Grigg said that the FDA announcement this week did not indicate any change in agency policy, he did say that any new use of the skin patch, including weight loss, has to go through the FDA.
“As a result of that position by the FDA, Meditrend has elected to withdraw its patches from the market,” Jolley said. The withdrawal date “is being negotiated with the FDA right now. This is a new interpretation by the FDA. The FDA has been aware of this product since January.”
Meditrend also will change its name to Bokkie Ltd., Jolley said, and will come out with a revised Appetoff system that does not incorporate a skin patch. The new product will be available as soon as sales of the original cease.
New Source officials said in an earlier interview that they make no claims that their Le Patch actually assists in weight reduction.
“We are not making any drug claims,” Robert W. Singerman, New Source president, said in an earlier interview.
While New Sources said its strategy for selling Le Patch takes it out of the FDA’s jurisdiction, Grigg said that remains “a lawyer’s decision.” But, he said, “it’s hard to understand why someone would sell something in a health atmosphere and make no claims for it.”
