Lawmakers seek to strengthen FDA's oversight of all cosmetics in the U.S.

WASHINGTON — House lawmakers unveiled a bipartisan draft proposal Wednesday aimed at strengthening the Food & Drug Administration’s regulatory oversight of cosmetics.

Reps. Frank Pallone Jr. (D., N.J.) and Leonard Lance (R., N.J.) are the two cosponsors of the proposal.

Under current law, the FDA cannot require cosmetics manufacturers to register with the agency, provide information about their products and ingredients or be required to test products for safety before bringing them to market, the lawmakers said.

The FDA’s regulatory authority over cosmetics is contained in a two-page section of the Federal Food, Drug and Cosmetic Act of 1938, and all stakeholders involved, including the personal-care products industry, argue it needs to be expanded and updated.

“Millions of Americans assume the cosmetics they use each day are safe, but the reality is that cosmetics are one of the least regulated consumer products on the market today,” Pallone said.

Pallone said the agency’s “lack of authority” puts consumers at risk.

“The bipartisan proposal Congressman Lance and I are putting forward today outlines a modern cosmetics regulatory framework that gives FDA the tools, information and resources necessary to protect Americans from potentially dangerous cosmetics products,” he added.

Pallone launched a probe of the FDA and the manufacturer of Wen hair-care products in March over what he said are persistent safety issues that have led more than 17,000 consumers to file complaints about a Wen cleansing conditioner that has allegedly caused significant hair loss, visible bald spots and other adverse side effects.

The Wen products are part of celebrity stylist Chaz Dean’s line of sulfate-free hair-care products that is marketed and distributed by Guthy-Renker LLC.

Lance said: “Consumers need to know that the products they are using are safe and business needs a 21st century FDA that responds as quickly as the new great idea is being developed. This bill modernizes statute that has been virtually unchanged for over 70 years by creating a more up-to-date regulatory structure for FDA oversight of the personal-care products industry and by extending important safety practices many companies are already following on a voluntary basis to the broader industry.”

The proposal would give FDA mandatory recall authority for potentially dangerous cosmetic products, as well as access to cosmetic records during inspections; provide the agency with the authority to collect data information on ingredients, and require FDA to review ingredients to determine if they are safe. It would also require cosmetic manufacturers, processors, packers and holders to register their facilities with the FDA and mandate that manufacturers report all adverse events to the agency.

The measure would also impose user fees on the industry, amounting to an estimated total of $20.6 million annually to pay for the expansion of the FDA’s authority.

The “discussion” draft measure will be circulated to collect feedback from all stakeholders involved with a goal of formally introducing a bill in the lame-duck session of Congress after the November elections or early next year, a spokesman said.

In the Senate, a bill introduced by Sens. Dianne Feinstein (D., Calif.) and Susan Collins (R., Maine) is considered to have support from many companies in the industry, as well as consumer and health groups. A separate bill in the House, introduced by Rep. Pete Sessions (R., Tex.) has the support from another segment of the industry.

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