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From Health Law Daily, September 23, 2016

Senate HELP committee holds first hearing on cosmetic safety since 1974

By Harold Bishop, J.D.

When consumers use cosmetics and other personal care products, they generally assume that their contents are safe and effective. While this is true in most instances, most people are unaware that the FDA, which has broad authority to review and regulate chemicals found in drugs and other consumer products, has little actual authority to review or restrict chemicals in cosmetics. This fact, and recent concerns caused by products that have injured consumers, has led to the introduction of the Personal Care Products Safety Act (S. 1014) and a recent Senate hearing on the development and safety of cosmetics and personal care products.

Personal Care Products Safety Act. The bill, introduced on April 20, 2015, would amend the federal Food, Drug, and Cosmetic Act (FDC Act) to require cosmetics companies to (1) register their facilities with the FDA; (2) submit to the FDA cosmetic ingredient statements that include the amounts of a cosmetic's ingredients; and (3) pay a facility registration fee based on their annual gross sales of cosmetics, with the collected fees used for cosmetic safety activities.

Under the bill, if the FDA determines that a cosmetic has a reasonable probability of causing serious adverse health consequences, it may prohibit the cosmetic's distribution by suspending the cosmetic ingredient statement. If other cosmetics from the same facility may be affected, the FDA may prohibit distribution from the facility by suspending the facility's registration.

The bill would also require the FDA to review the safety of at least five cosmetic ingredients each year, and it would allow the FDA to establish conditions for safe use of an ingredient, including a limit on the amount of the ingredient or a requirement for a warning label. Cosmetics companies also would be required to report to the FDA any serious adverse health event associated with their cosmetics.

Under the bill, the FDA would: (1) develop and implement cosmetic manufacturing standards that are consistent with existing national and international standards; (2) be allowed to inspect a company's cosmetic safety records; (3) recall a cosmetic that is likely to cause serious adverse health consequences; and (4) encourage cosmetic safety testing practices that minimize the use of animals.

Senate hearing. In his introduction, Sen. Lamar Alexander (R-Tenn), Chairman of the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee) stated that he was glad to chair the hearing. Alexander noted that the FDA’s oversight of cosmetics was granted by the FDC Act (first passed in 1938) and the Fair Packaging and Labeling Act of 1966, and the last HELP committee hearing on cosmetics was back in 1974. The witnesses testifying at the hearing included:

  • Beth Jonas, Ph.D., Chief Scientist for the Personal Care Products Council, which represents approximately 600 large, medium and small sized manufacturers and distributors of personal care products.
  • Wilma Bergfeld, M.D., Chair of the Cosmetic Ingredient Review (CIR) Expert Paneland aconsultant and member of the FDA’s Dermatology and Ophthalmology Advisory Committee since 1973.
  • Scott Faber, Senior Vice President for Government Affairs at the Environmental Working Group (EWG), which has been evaluating the safety of personal care product chemicals for more than a decade.
  • Curran Dandurand, Chief Executive Officer of Jack Black LLC., a marketer of personal care products for men.

Jonas. Jonas testified that: (1) cosmetics and personal care products are among the safest product categories regulated by the FDA: (2) consumer and product safety are top priorities in the industry; (3) cosmetic safety assessments are thorough and address numerous health questions, including, the potential for cancer, reproductive harm, allergic reactions, and how an ingredient is cleared if it goes through the body; and (4) companies’ post market surveillance of the consumer experience acts to affirm product safety.

Jonas stated that the Personal Care Products Council supports independent programs to review product and ingredient safety, such as the Cosmetic Ingredient Review (CIR) Expert Panel, which was established in 1976 with involvement and support from the FDA and the Consumer Federation of America. The reviews by the CIR Expert Panel, according to Jonas, define safe ranges for ingredients used in products, and each ingredient report often involves the panel’s scrutiny of hundreds of studies.

Jonas, however, conceded, that despite the strong safety record in the industry, a comprehensive national program is needed to assure uniform regulation of cosmetics throughout the country and to prevent an unworkable patchwork of differing state requirements across the nation. As such, she offered the Council’s support for the goals contained in S. 1014.

Bergfeld. As chair of the CIR Expert Panel, Bergfeld testified that the CIR thoroughly reviews and assesses the safety of ingredients used in cosmetics in an open and expert manner, and publishes the results in peer-reviewed literature. And although funded by the cosmetics industry, Bergfeld assured the committee that the CIR and its review process are independent.

Bergfeld noted that the CIR solicits public comment at all stages of a multi-review process. If the open, scientific literature contains insufficient information or if the information submitted is insufficient to make a safety determination, Bergfeld indicated that the CIR calls on industry and other interested parties to undertake specific studies to address these insufficiencies, or to provide previously unpublished data.

Despite the good review work of the CIR, Bergfeld recognized the need for regular evaluation to ensure the effectiveness of its efforts and its ability to appropriately complement the FDA’s work. For this reason, she gave the CIR’s support to the congressional efforts to modernize the regulatory structure and to ensure the FDA has the appropriate funding, resources and administrative authority to continue to provide effective oversight of the cosmetics industry.

Faber. Faber testified that while most cosmetic chemicals likely pose little or no risk to human health, exposure to some chemicals used in cosmetics and other personal care products has been linked to serious health problems, including cancer and reproductive harm. Faber further noted that, in addition to risks to consumers, hair and nail salon workers are especially susceptible to cosmetic chemical exposures.

Faber readily conceded that the FDA has little authority to review or restrict chemicals in cosmetics. In fact, under current law, he admitted that the FDA can only restrict chemicals that render the product "adulterated," and the FDA has only banned or restricted nine ingredients under this authority.

Faber agreed that Congress must create a modern regulatory program for cosmetics and other personal care products, as proposed in S. 1014. As such, he testified that the EWG proposes the following reforms:

  • subject cosmetic chemicals of concern to review;
  • strengthen industry self-regulatory programs;
  • require facility registration and records access;
  • require good manufacturing practices;
  • require adverse event reporting and recall power;
  • expand disclosure requirements;
  • provide adequate resources; and
  • promote innovation

Dandurand. The testimony of the Jack Black CEO stressed that the science establishing ingredient safety varies from state to state, and that a consistent national standard would improve the existing regulatory framework. He expressed his support for: (1) mandatory registration of all U.S. and foreign manufacturing facilities that import products into the U.S. market; (2) requiring all manufacturers to file ingredient statements for all products they manufacture; and (3) requiring all manufacturers, both domestic and international, to follow good manufacturing practices, as established by the FDA.

Companies: Personal Care Products Council; Cosmetic Ingredient Review Expert Panel; Environmental Working Group; Jack Black LLC.

MainStory: TopStory CosmeticNews FDCActNews AdulterationNews EnforcementNews GMPNews RiskNews SafetyNews

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