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Sunday, October 12, 2008

US Congress tackles FDA device, cosmetic oversight

(Page 2)

"Requiring FDA to conduct pre-approval inspections ... would bring the approval process to a grinding halt," Steven Ubl, head of the Advanced Medical Technology Association, said in testimony to the panel.

Industry groups also questioned additional inspection fees for device companies, which already pay the FDA to review products for approval.

FDA officials told lawmakers they have taken steps to increase inspections and set up agency offices in other countries, among other efforts.

Stephen Sundlof, head of the FDA's Center for Food Safety and Applied Nutrition, which oversees cosmetics, urged lawmakers to focus their legislation on more risky products and make greater use of private inspections.

COSMETICS UNCHECKED

Democrats said the FDA has even less power to monitor lotion, make-up and other cosmetic products that have gone largely unregulated for decades.

Roughly $62 billion in personal products are sold in the United States each year, Sundlof said. The number of imported products has tripled since 2000 and is expected to grow, he added.

Yet the industry is largely overseen by rules established 70 years ago. Since then, the FDA has looked at 11 percent of related ingredients and banned or restricted 10 types that posed safety risks.

"I think improving oversight authority of cosmetics is long overdue," said Rep. Jan Schakowsky, an Illinois Democrat.

Sundlof acknowledged that just one-third of all U.S. cosmetic makers are currently registered with the agency, adding that companies are responsible for ensuring safety before marketing their products.

Unlike drugs or devices, cosmetics are not approved by the FDA before they are sold.

Pamela Bailey, head of the Personal Care Products Council industry group, said current law was strong enough, but urged lawmakers to give the FDA more money to carry out its duties.

FDA's Sundlof said regulating cosmetics has become a challenge as more products use sophisticated ingredients and "straddle the line between cosmetics and drugs


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