Issue Date: April 16, 2012
Reforming Cosmetics Law
For the first time in three decades, Congress is considering updating the law that governs the safety of cosmetics. The push for new legislation is coming primarily from the cosmetics industry, which is concerned about the increasing globalization and complexity of the cosmetics supply chain and the lack of a national standard for ingredients in cosmetics and personal care products.
“The cosmetics industry continues to be affected by rapid globalization of supply chains, expansion in foreign markets, new technology, and increased consumer interest in product information,” Peter B. Hutt, senior counsel at the law firm Covington & Burling, testified late last month at a House of Representatives hearing held by the Health Subcommittee of the Energy & Commerce Committee. “In much the same way that market changes require companies to adjust business plans, these global challenges justify the modernization of regulatory structures,” he said on behalf of the Personal Care Products Council, an industry trade group.
Unlike drugs, biologics, and medical devices, cosmetics are not subject to premarket approval by the Food & Drug Administration. Under the Federal Food, Drug & Cosmetic Act, “cosmetics manufacturers are largely responsible for substantiating the safety of their products and ingredients before they go to market,” said Rep. Joseph R. Pitts (R-Pa.), chair of the subcommittee.
Even so, “cosmetics are the safest products that FDA regulates,” Hutt stressed. “Current FDA regulation of cosmetics, in partnership with strong industry investment in product safety, ensures that cosmetics products in the marketplace today do not present a risk of significant illness or injury,” he said.
Democrats also support reform but for reasons different from industry’s. They argue that industry efforts are not enough to keep dangerous products off the market. They cite recent examples of safety problems including carcinogens in baby shampoo, formaldehyde in Brazilian Blowout hair straightener, lead in lipstick, and mercury in skin-lightening cream.
FDA has little authority over the safety of everyday cosmetics and personal care products, said Rep. Frank Pallone Jr. (D-N.J.). “From moisturizers, lipsticks, and fragrances, to sunscreens, soaps, and toothpastes, these products have become an ordinary and, in most cases, habitual part of our lifestyles,” he said. Such products “are not high-risk, but they are by no means risk-free,” he added.
Pallone and other lawmakers pointed out that FDA has little knowledge about domestic and foreign facilities that are manufacturing cosmetics for the U.S. market. Cosmetics facilities can voluntarily register with FDA, but FDA does not have the authority to require facilities to do so. In addition, cosmetics manufacturers are encouraged to disclose the ingredients of their products to FDA, but FDA estimates that only about one-third of them do.
Legislation introduced by Pallone the day before the hearing addresses that lack of authority. Called the Cosmetics Safety Enhancement Act of 2012 (H.R. 4262), the bill would “require an annual registration for all companies, along with a fee to help maintain that activity,” Pallone explained.
The legislation would also require cosmetics companies supplying the U.S. market to provide FDA with an annual listing of their products, demonstrate the safety of their products, report serious adverse events to FDA, and follow Good Manufacturing Practices. In addition, it would allow FDA to recall unsafe cosmetics.
A similar bill, the Safe Cosmetics Act of 2011 (H.R. 2359), was introduced last year by fellow subcommittee member Rep. Jan D. Schakowsky (D-Ill.). That bill would establish strong national safety standards for cosmetics ingredients; ban carcinogens, mutagens, and chemicals that cause reproductive harm; require full ingredient disclosure and labeling; and provide FDA with recall authority.
“Cosmetics contain ingredients that can cause cancer, mutate cellular structure, and cause reproductive and developmental harm,” Schakowsky asserted at last month’s hearing. “Industry claims that these ingredients are present at such low doses that they aren’t a problem, but men, women, and children are exposed every day to dozens or hundreds of ingredients” in cosmetics, she added. “We have to consider the cumulative effect of exposure.”
Some Republicans at the hearing were supportive of giving FDA more authority over the cosmetics industry, in large part because of industry pressure for a national standard for cosmetics ingredients. Such a standard would enhance public health and ensure that the interstate flow of cosmetics is not disrupted by a patchwork of state standards, Rep. Leonard Lance (R-N.J.) said. “We need preemption in this area,” he stressed.
Others were not as receptive. “I haven’t heard of health issues from the application of cosmetics,” said Rep. Joseph L. Barton (R-Texas). “What seems to be driving this train,” he said, is that some states are adopting regulatory standards that make it difficult for companies to operate in multiple states. “The way to address that would be to work with each of the state legislatures rather than have a national standard,” Barton suggested.
Lawmakers are likely to add cosmetics legislation to a larger bill that reauthorizes FDA to collect fees from the drug and medical device industries. But to do so, they will have to come to an agreement quickly. The user fee reauthorization bill must pass Congress by Sept. 30, the end of the fiscal year.
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