WASHINGTON — Rep. Frank Pallone Jr. (D., N.J.) is pressing a key committee in the House of Representatives to hold a hearing on cosmetics regulatory reform when Congress returns from a recess in September.
The Food & Drug Administration’s authority over regulating cosmetics, part of the Federal Food, Drug and Cosmetic Act, has not been updated since 1938 and stakeholders in the industry, health and safety groups, and the FDA have been working for years to overhaul the FDA’s oversight.
“The need to reform our country’s cosmetics regulatory system is long overdue,” Pallone said in a letter to Rep. Fred Upton (R., Mich.), chairman of the House Energy and Commerce Committee. “This committee, as the committee with jurisdiction over cosmetic regulation, should examine the existing framework and determine what improvements are necessary. We owe it to American consumers to do all we can to ensure we have a robust cosmetic regulatory system that ensures the safety of the cosmetic products that Americans purchase and use each day.”
Pallone said he plans to introduce legislation in the House this fall that would provide the FDA with additional authority and resources to regulate cosmetic products. He said the proposal will build off of legislation he authored in previous Congresses.
Pallone launched a probe of the manufacturer of Wen hair-care products in March over what he said are persistent safety issues that at the time had prompted more than 17,000 consumers to file complaints about a 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 infomercial giant Guthy-Renker LLC.
In July, the FDA issued a public safety announcement and started an investigation into Wen by Chaz Dean Cleansing Conditioners, noting it had received 127 reports from consumers about hair loss, breaking, balding, itching and rash.
The agency said it inspected the manufacturing and distribution facilities for the products and learned that consumers had reported reactions in more than 21,000 complaints submitted to Chaz Dean Inc. and Guthy Renker, the companies that market and manufacture the products.
The current statute does not require companies to share their safety information with the FDA, nor does the law require mandatory reporting of “adverse events.”
An aide for Pallone said there are not updates to report yet on the lawmaker’s probe. Pallone is urging the House committee to hold a hearing to examine the current regulatory framework for cosmetics.
He said a “limitation” of the current cosmetic regulatory framework is that “cosmetic manufacturers have no obligation to notify the FDA, if they receive adverse event reports from consumers. And even if [the] FDA becomes aware of adverse events associated with a cosmetic product, the agency lacks the authority to require that a manufacturer recall a product.”
The FDA can only ask a company to initiate a voluntary recall or work with the Department of Justice to initiate a product seizure, Pallone said.