03.27.12
While the big news in Washington today centers on the Supreme Court and President Obama’s healthcare law, there’s a hearing going on that matters to makers of lipsticks and mascara as well.
The Health Subcommittee of the House Committee on Energy and Commerce has scheduled the “Examining the Current State of Cosmetics” hearing for today, March 27.
In his opening statement as released prior to the hearing’s start, Rep. Joseph R. Pitts, stated, “For the past several years, the industry and members of both parties have been reviewing FDA’s regulatory authority over these products. One issue under review is the need for a national uniform standard for cosmetic products and preemption of state legislation.”
Pitts said he hoped that the witness would share their “perspectives on several matters, including what deficiencies, if any, you currently see in FDA’s regulatory authority over cosmetics; what new authorities, if any, do you believe FDA needs in this area; and if new authorities are needed, what will be the impact on small businesses across the country?”
The witness list includes Michael M. Landa, director of the Center for Food Safety and Applied Nutrition (CFSAN); Halyna Breslawec, chief scientist and EVP for science, the Personal Care Products Council; Curran Dandurand, co-founder and CEO of Jack Black Skincare; Debbie May, president and CEO, Wholesale Supplies Plus, and Michael J. DiBartolomeis, chief occupational lead, Poisoning Prevention Program & California Safe Cosmetics Program, California Department of Public Health.
“While cosmetic products remain among the safest in commerce, the existing system for regulating our industry is overdue for a makeover,” said Lezlee Westine, president and CEO of the Personal Care Products Council, which for several years has been advocating for reform.“The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve.”
The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of all public and stakeholder groups and to review all safety determinations made by the independent Cosmetic Ingredient Review (CIR) Expert Panel.CIR was established in 1976 with the support of the FDA and the Consumer Federation of America.While companies do assess the safety of products and ingredients prior to marketing, creating these new processes will provide the added transparency that consumers are seeking.
The Council’s science and legal experts advocated for these and other changes at today’s hearing of the Health Subcommittee of the House Committee on Energy and Commerce.
“The basic statutory provisions that govern FDA regulatory authority over cosmetics today were put in place in 1938,” said Peter Barton Hutt, the former chief counsel for the FDA and longtime Harvard law lecturer on the current legal and regulatory system, who is also on the witness list today. “Since then, FDA and the cosmetic industry have worked together to keep pace with changing technology by the promulgation of creative regulations and the establishment of new regulatory programs.”
Despite the fact the FDA has repeatedly stated that cosmetics are the safest products they regulate, Hutt said that the increasing global nature of the industry, a desire for more transparency from consumers and other factors suggest “it is time to bring FDA’s statutory authority up to date.”
Dr. Breslawec, the Council’s chief scientist agreed with Hutt, recommending that FDA incorporate the CIR findings into its product regulatory process.
“FDA should formally recognize the findings of the CIR Expert Panel as part of the regulatory regime for cosmetics,” Breslawec said. “Science and safety are the foundation of the cosmetics industry and collectively we must remain steadfast in our commitment to safety.Acceptance and reliance on CIR findings will reaffirm that commitment.”
Through its experts, the Council offered the following specific provisions for Congress to consider which would bolster FDA’s oversight:
1.Enacting into law the existing FDA voluntary programs for registration of manufacturing establishments and listing of cosmetic products and their ingredients.
2. Requiring submission of reports on adverse reactions that are serious and unexpected.
3.Mandating FDA regulations establishing Good Manufacturing Practices (GMPs) for cosmetics.
4.Establishing programs to require FDA to review and determine the safety of cosmetic ingredients and constituents along with strong FDA enforcement.
5. Requiring FDA review of all CIR determinations on cosmetic ingredient safety and either accept or reject those determinations.
6. FDA establishment of a national cosmetic regulatory databank for use by other state authorities and the public.
7. An unambiguous Congressional determination that, as modernized, the revised statute will apply uniformly across the country.
“Our industry supports these important reforms and encourages Congress to act on them,” said Westine. “We are requesting comprehensive, mandatory regulation and our rationale for that is simple: it is in the best interest of regulators, manufacturers and consumers – all of whom will greatly benefit for years to come.”