House Report Charges FDA Failure on Products for Fighting Wrinkles : Health: The agency is accused of not warning consumers about risks involved in unapproved uses of Retin-A, collagen and silicone.

A House subcommittee is accusing the Food and Drug Administration of failing to warn consumers about risks from products claiming to erase wrinkles and improve appearances.

In a report to be released today, the panel urges that the FDA be given greater authority to investigate the cosmetic drugs’ safety as well as possible financial conflicts of interest involving researchers who tout the popular products.

The report, based on a three-year investigation by a subcommittee of the House Government Operations Committee, focuses on the potential dangers and marketing irregularities associated with three commonly used products.

The panel found that Retin-A, which has been approved for treating acne, also is being marketed for unapproved uses: eliminating wrinkles and as a salve for precancerous skin.

The report charges that FDA officials “stood by passively for more than three years” as Ortho Pharmaceuticals promoted the unauthorized use of Retin-A with speeches and interviews of scientists who were paid consultants to the company.

Critics have complained that long-term use of Retin-A may cause skin cancer and may contribute to birth defects if used by pregnant women.

The subcommittee also noted that for more than 20 years, silicone injections have not been approved by FDA researchers but patients unknowingly have been “put at risk of permanent disfigurement while the FDA did virtually nothing to curb” silicone use.

In its report, the human resources and intergovernmental relations subcommittee says that FDA investigators were aware of doctors who brazenly defied laws restricting cosmetic use of silicone injections for more than a decade, only to drop their inquiries in 1985 after being warned that one of the doctors was treating former First Lady Nancy Reagan.

“Since then, thousands of men and women have received injections for the cosmetic treatment of wrinkles and scars and for fuller lips, while the FDA did almost nothing to warn consumers or physicians about the risks,” the panel says. “To this day, the FDA has never released the results of a Dow Corning study showing that at least 2% of the silicone-injection patients had suffered from necrosis of the skin on their face.”

The report also says that collagen injections are approved for treating wrinkles and acne scars but not for lip enlargements, which “are the current fad.”

The subcommittee documents how FDA officials “acquiesced to demands” by Collagen Corp. that it not report scarring and abscesses caused by its collagen injections. The panel says that those blemishes lasted longer than the touted benefits of the product. Company officials have not conducted extensive research into its products but deny that collagen injections can be dangerous, the report says.

Under federal law, cosmetic manufacturers are required to prove that a product is safe and effective for a particular use and may only market the product for its approved benefits. Consumers, however, often use a cosmetic for an “off-label” use that the FDA has not authorized because the product failed to meet government standards or the manufacturer failed to submit an application.