‘Le Patch’ Merely a Diet Aid, Company Says in Face of Inquiries

In the wake of government investigations of its “Le Patch” diet aid, a Laguna Hills company said Friday that it makes no claims that its skin-patch product actually assists in weight reduction.

Robert W. Singerman, president of New Source Ltd., said that the patch is part of a system that includes diet and exercise. Although the Le Patch system will not be available until the middle of June, between 8,000 and 10,000 distributors across the country have already signed up to sell it. Some have paid in advance for their supplies.

It was potential distributors who alerted government agencies--including the federal Food and Drug Administration--to the patch with inquiries about its efficacy. In addition, a sales representative distributed a memo making claims that the company acknowledged that it cannot back up.

The memo used the New Source Ltd. logo and claimed that Le Patch is an “appetite control patch now cleared by the FDA.” It was obtained recently by the Texas Department of Health as part of an ongoing investigation into non-prescription patch technology.

Singerman said that the memo was the product of “overzealous sales representatives” acting on their own and that his company “has never published any claims that it is or is not approved by the FDA.”

Le Patch is an adhesive device that contains a proprietary formula called “Cephatrex,” Singerman said. Designed to be placed anywhere on the body, the patch is one element of a diet program that includes exercise, vitamins and a 1,000- to 1,200-calorie-per-day diet.

“Because of the difference of opinion with the FDA, we’re not saying that it does anything,” Singerman said. “We are not making any drug claims. Now it’s classified merely as a diet aid” and does not need FDA approval. “At worst case, we’re saying it (the patch) is a health reminder,” he said.

When asked why a consumer would pay $49.95 for a month’s supply of Le Patch if he cannot claim that the patch controls appetite, Singerman responded:

“Our system is guaranteed for results. If you’re dissatisfied, you can send it back for a prompt refund.”

FDA spokesman William Grigg said that his agency has been deluged with consumer inquiries about patch remedies, particularly those marketed by New Source and a San Diego company called Meditrend International. As a result, the agency released a position paper last week condemning all non-prescription uses of patch technology. Grigg said the FDA is currently investigating the recent rash of Band-Aid-like patches that claim to control the appetite.

“No manufacturer or distributor has presented evidence that any non-prescription skin patch for any use is safe and effective for any indication,” the paper said. “No such products for non-prescription use have been approved by the agency.”

The California Department of Health Services said that its food and drug division is currently investigating Le Patch and the claims made about it. Singerman said that he has not been notified of the state investigation.