FDA Looking Into Skin-Patch Diet Aids, Claims of Two Firms
In response to consumer inquiries about “skin-patch” diet aids marketed by two Southern California companies, the Food and Drug Administration said it is looking into the devices and the claims made about them.
In addition, the state Department of Health Services said it is investigating the two firms, New Source in Laguna Hills and Meditrend International in San Diego, because of inquiries from potential skin-patch distributors.
“No manufacturer or distributor has presented evidence that any non-prescription skin patch for any use is safe and effective for any indication,” the FDA said in a position paper released last week. “No such products for non-prescription use have been approved by the agency.”
FDA spokesman William Grigg said his agency has been deluged with consumer inquiries about patch remedies, particularly those marketed by New Source and Meditrend International.
“Consumers . . . have the impression that we have put these products through the usual procedures and have come to a judgment that they are safe and effective,” Grigg said.
The patch-making companies “have not submitted any proof to us, so we cannot assure people that (weight-loss patches) are either safe or effective,” Grigg said. “We’re investigating the products to see what action might be taken.”
According to federal regulations, if the products claim to cure disease or change body functions, then the companies would have to get FDA approval and remove the products from the market while the review process takes place.
Skin patches have several approved prescription uses, Grigg said, including the administration of nitroglycerin, synthetic estrogen and a motion-sickness drug.
Dr. William Jarvis, president of the National Council Against Health Fraud, has filed a complaint with the FDA against the appetite-control patches. He said the complaint claims that such remedies are “clearly an unapproved medical device” and have become the latest questionable health fad.
“The Band-Aid with the snake oil on it is the latest wrinkle to lose weight or stop smoking,” Jarvis said. “It might have the same effect of tying a string on your finger to remind you you’re on a diet. If you put it over your mouth, it might help.”
New Source officials could not be reached for comment. But a memo from New Source to its distributors, obtained by the Texas Department of Health, claims that the firm’s “appetite control patch is now cleared by the FDA.”
In addition, the memo touts patches in the works that will help consumers tan, quit smoking, lose their craving for alcohol, control the symptoms of premenstrual syndrome and combat AIDS.
“Our patch products are sophisticated, unitized devices designed to allow the active ingredients to be time released into the body, not just a band aid,” says the memo, which is dated March 19, 1988.
Lenwood Scholtz, assistant director of the Texas Health Department’s division of food and drugs, said that his agency is investigating non-prescription patch technology--particularly a manufacturer operating in Irving, Tex.--and is keeping New Source under observation.
“To the best of our knowledge, New Source has not sold any patches in Texas,” Scholtz said. “We’ve had calls from potential distributors, and we’ve gotten ahold of their flyers, which we strenuously object to.”
Scholtz said that he contacted New Source about the flyer and received a letter from New Source officials saying that they plan to “correct it” and that a new flyer will be distributed this week.
Investigative efforts by the California Department of Health Services have been slowed because New Source reportedly will not distribute its appetite-control patches until late June.
“We are investigating,” said Ozzie Schmidt, supervising investigator of the agency’s food and drug division in Orange County. “We’ve had inquiries from other enforcement agencies and also from prospective distributors. We are finding out what the product is and what the claims are. We haven’t been able to secure the product yet.”
Schmidt said the state food and drug division’s San Diego office is looking into Meditrend, also because of distributor inquiries.
Clifton Jolley, an outside spokesman for Meditrend, said the company’s Appetoff weight-loss system “relies upon a variety of homeopathic preparations, none of which are controlled substances and all of which fall under the general (FDA) guidelines for homeopathic substances.”
The system includes a 30-day supply of adhesive patches and appetite-suppressing tonic, instructions and a regimen of diet and exercise. The company makes no claims that the patch and solution, used alone, are weight-reducing agents, Jolley said.
“What they appear to do is to enable most people to stay on the sensible diet recommended by the company--or any diet they choose,” Jolley said. The Appetoff system has been on the market since last fall and had $6-million in sales in the first quarter of 1988.