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Strengthen FDA’s authority over medical devices

May 14, 2008

Consumers Union Applauds Effort To Strengthen FDA’s Authority Over Medical Devices and Cosmetics

Washington, DC– In testimony before the U.S. House Subcommittee on Health, Energy, and Commerce, Consumers Union praised Chairman John Dingell’s FDA Globalization Act’s provisions to inspect foreign and domestic medical device facilities and strengthen the Food and Drug Administration’s authority, including the mandatory reporting of adverse events for cosmetics.
CU also supports the provisions to allow the FDA to require recalls of unsafe food and drugs, and would prefer to see medical device facilities be inspected every year, rather than every two years as the bill currently sets forth.
Currently, ingredients used in cosmetic products are not known to the FDA and sometimes even unknown to the Poison Control Center, leaving both agencies unprepared to act effectively when faced with reports of counterfeiting or contamination. The FDA does maintain a voluntary registration for cosmetic establishments and formulations, and maintains a similar, but mandatory reporting for drug products. The legislation would make reporting adverse events of cosmetics mandatory, but as drafted, does not make the registration of ingredients mandatory, as CU would recommend.
“Cosmetics and other personal care products are just that, personal,” said Ami Gadhia, policy counsel for Consumers Union, nonprofit publisher of Consumer Reports magazine. “Like most drugs, they are often used on a daily basis, designed for frequent direct contact, in the mouth and on skin. Yet consumers are almost always disturbed to learn that unlike for drugs, the safety of cosmetic ingredients and their production is not subject to FDA scrutiny before they enter the marketplace,” according to Gadhia.
The Committee is considering a draft of the FDA Globalization Act, broad legislation that would reform the FDA. Consumers Union supports provisions in the draft that would give the FDA more funding to protect the nation’s food, drug, and cosmetic supply and give the agency the authority to recall food and drugs, country-of-origin labeling for produce, active pharmaceutical ingredients, biologics, and manufactured devices. The legislation also creates a fee requirement for importers of cosmetics, registration fees for food facilities, and Congressional review if the FDA plans to close any of the 13 labs, all supported by CU.
“We wholeheartedly support providing FDA with new authorities and resources,” said Gadhia in written testimony. “We are pleased that this Discussion Draft gives FDA a number of new – and very necessary – powers to better ensure the safety of our medical devices and cosmetics.”
For a complete copy of the testimony, click here.
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Jennifer Fuson
(202) 462-6262