FDA Says Safety, Appetite Claims Unproven : U.S. Seizing Drug-Laden Diet Patches

The federal government is seizing millions of dollars of so-called diet patches, drug-laden patches stuck on the skin that manufacturers claim cut appetite, but that the FDA says are not proven safe or effective.

The Food and Drug Administration said Friday that U.S. attorneys’ offices in San Diego and Los Angeles had made the first seizures of patches and raw materials worth $22.5 million, branding them “the newest weight-loss gimmick.”

“The patches, sold as part of a kit with appetite-control claims, have not been shown to be safe and effective, nor do they have approval from the FDA,” the agency said. It was also concerned that the diet stickers mimic legitimate medicated patches that deliver drugs, such as anti-nausea medicine, through the skin.

Marshals seized cartons of Appetoff patches at Meditrend International, also called Bokkie International, in San Diego. In Los Angeles County, they confiscated patch ingredients worth $22 million from the Beco Chemical Co. in Lynwood, and labeling for the Appetoff patches from the Jerica Packaging Co. in Sylmar.

The FDA had told Meditrend and other companies that the patches were being sold illegally because they make medical claims but have not been approved by the agency, which requires drugs be proven safe and effective. In recent weeks, the agency learned that manufacturers were falsely claiming the FDA had approved them.

This month, the FDA is celebrating 50 years of operation under the Food, Drug and Cosmetic Act which sharply cut the nation’s trade in snake-oil and quack remedies.

“These seizures should be a warning to other companies that the law signed by President Franklin D. Roosevelt on June 25, 1938, continues to be vigorously enforced by the FDA,” the agency’s commissioner, Frank Young, said.