Dubbed the "Safe Cosmetics Act of 2010," a bill introduced last week would dramatically overhaul personal-care regulation, requiring companies that manufacture, package or distribute cosmetics for use in the U.S. to register with FDA and provide the agency with a wealth of information about their product formulations and business practices.

HR 5786 would amend the "Federal Food, Drug and Cosmetic Act" to require full ingredient labeling on products, and FDA would assume responsibility for determining ingredient safety.

The bill was introduced July 20 by Rep. Jan Schakowsky, D-Ill., and co-sponsored by Rep. Ed Markey, D-Mass., and Rep. Tammy Baldwin, D-Wisc. It has been referred to the Committee on Energy and Commerce and the Committee on Education and Labor.

Sen. Dianne Feinstein, D-Calif., reportedly plans to introduce a Senate version of the bill.

The activist group the Campaign for Safe Cosmetics is championing the legislation, claiming it would help to prevent consumer exposure to toxic chemicals. Meanwhile, industry trade association the Personal Care Products Council says the legislation would contribute nothing to product safety and put an "impossible" burden on FDA.

One of the "biggest issues" the Council has with the legislation is the provision for registration, as manufacturers, packagers and distributors would be required to submit information to FDA regarding the number of workers they employ, gross receipts of sales, and names and addresses of their suppliers.

"Collection of all this information is simply not feasible for FDA, it would be impossible to administer and it's simply not necessary to enhance consumer safety," John Hurson, the Council's executive vice president for government affairs, said in a July 21 media call. "It's not clear why the entire food chain of people who are involved in industry need to register to provide consumers with additional protection," he added.

He suggested that as the bill currently stands, registration requirements also would apply to direct marketers and salons.

The bill stipulates that registration information would not be made public, except for the identity and location of registering companies.

FDA would set registration fees for companies with annual sales exceeding $1 million, prorated based on their gross receipts or sales.

Required: Safety Data Submission To FDA

The Safe Cosmetics Act would require manufacturers and distributors of cosmetics and ingredients to submit to FDA "all reasonably available information" about the "physical, chemical and toxicological properties of single or multiple chemicals listed on cosmetic labels."

The agency would collect information on ingredient functions and uses, exposure and fate information, as well as tests of finished cosmetics and "any other information used to substantiate the safety of such cosmetics or ingredients."

No later than one year after enactment of the bill, FDA would establish minimum data and testing requirements for manufacturers.

John Bailey, the Council's chief scientist, noted that if passed, the bill "would require that basically a dossier be submitted to FDA that would include a massive amount of data."

"What this would mean in a practical sense is that FDA would be overwhelmed with huge amounts of data for ingredients and materials that have no obvious safety concern," he said.

Hurson quipped that FDA would need to build another building "to house the people that would be looking at it all."

FDA would publish the non-confidential information it receives and establish lists of ingredients that are prohibited or restricted no later than two years after the bill's enactment.

It would base its lists on information from the Environmental Protection Agency, the International Agency for Research on Cancer, the National Institutes of Health, the California EPA and other "authoritative" international, federal and state entities, as well as information from industry.

"Cosmetic ingredients would be presumably determined to be unsafe if they appeared on any of these other institutions' lists," Hurson said.

According to the Council, such skittishness could make it "impossible" to sell nearly all personal-care products currently on the market.

Ingredients FDA has deemed safe also would be compiled in a list no later than two years after enactment of the bill.

Furthermore, FDA would develop a "priority assessment list" of at least 300 ingredients that are not on safe, restricted or prohibited lists and determine if they meet safety standards. The agency would be expected to add at least 100 ingredients to the priority list each year.

Janet Nudelman, a coordinator for the Campaign for Safe Cosmetics, noted during a media call that, generally speaking, the bill would transfer ingredient oversight responsibility from the Cosmetic Ingredient Review to FDA.

Trade Secrets No More

As written, the Safe Cosmetics Act contains provisions that essentially would eliminate company trade secrets, in line with the Campaign for Safe Cosmetics' demand for transparency.

Companies would be required to list all ingredients on product labels, including those that make up fragrance and colorants. Such details would no longer be considered confidential business information.

Though the concentration of ingredients in a product would still be considered confidential, the requirements nevertheless could cause "significant trade disputes internationally," Hurson said.

"These requirements exceed all such labeling laws in Europe and Asia," he said. "It removes nearly all trade secret protection for any ingredient in personal-care products that are used in commerce today."

Companies could petition for information to remain confidential "if the entity shows that there would be serious commercial harm to such entity if such information were disclosed publically."

However, Schakowsky maintained during a July 21 media call that there would be "strict oversight to make sure that any provisions are not abused by the industry."

"If it's an inert [ingredient], and deemed by the scientific community not to have any impact, that's one thing, but if they're just going to send in a list of all the ingredients they haven't listed before and ask for forgiveness, that's simply not going to happen," she said.

The bill defines ingredients to include "contaminants present at levels above technically feasible detection limits" and those that make up "fragrance" - all of which would need to be cited on labels.

The Campaign has called for contaminants and fragrance to be listed on labels in light of its studies on lead in lipstick and synthetic musks in newborns (¹ Also see "Lead-In-Lipstick Row Creates Opportunity For Some, Puts Others On Defensive" - HBW Insight, 29 October, 2007. and ² Also see "Study Finding Musks In Newborns Warrants Updated Fragrance Labeling Law - CSC" - HBW Insight, 7 December, 2009.).

Industry holds that listing every component on product labels would cause consumer confusion. "The labels would become fundamentally incomprehensible," Bailey said, noting the bill could potentially add hundreds of ingredients to product labels.

He pointed out that FDA is already authorized to require special use conditions or warnings on product labels where it sees fit.

The legislation mandates that ingredients be disclosed on the websites of Internet vendors as well.

The Safe Cosmetics Act would authorize FDA to order cosmetic product recalls, instead of requesting them, and would make it mandatory for companies to report adverse events that occur with the use of cosmetic products.

The bill directs FDA to consider labeling requirements for products containing nanomaterials and requires the use of animal testing alternatives "where practicable."

Bill Far Surpasses Industry Proposal

The Council proposed its own ideas for legislation July 15 with a letter to the chairmen and ranking members of the Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce.

It laid out a five-point plan including recommendations for mandatory manufacturer registration with FDA, a process to set safety levels for trace constituents, FDA oversight of Cosmetic Ingredient Review findings and creation of standard Good Manufacturing Practices (³ Also see "Council Proposes "Modernized" FDA Oversight Of Personal-Care Industry" - HBW Insight, 19 July, 2010.).

Some of the plan's elements correspond with components of the "FDA Globalization Act of 2009" introduced by Rep. John Dingell, D-Mich. (⁴ Also see "2009 FDA Globalization Act Scratches Fees For Cosmetics, “Unanticipated” AEs" - HBW Insight, 30 March, 2009.).

Schakowsky said Dingell's bill "is absolutely a great first step," but suggested "there is still more work to be done to ensure that cosmetic products are safe."

The legislator implied that the Safe Cosmetics Act goes beyond the Dingell bill to ensure "much greater protection" for consumers by "banning cancer-causing chemicals, reproductive toxins and ingredients that cause birth defects," while giving FDA authority to determine ingredient safety.

"I'm glad that the industry has recognized a need for increased oversight, particularly given that at the moment they have virtual free reign to put dangerous chemicals into their products," Schakowsky said. "I would hate for their rhetoric to overshadow the Safe Cosmetics Act's real call to action."

The Council maintains that the bill's scope and the severity of its restrictions are inappropriate, and the proposed system would not be achievable even with hundreds of additional staff and millions in funding.

The standards are "significantly stricter than those currently applied by FDA for food, drugs and medical devices," Hurson said. "If they were actually applied to other categories at FDA, they would ban a glass of water, vegetables and most prescription and non-prescription drugs."

Kurt Karst, a lawyer with Hyman, Phelps & McNamara, was not ready to compare the proposed framework to that in place for drugs and devices, "but it's certainly bringing [cosmetics] more in line with that type of regulatory system there when you're making substantial submissions to the agency," he said in a July 22 conversation with "The Rose Sheet."

Sponsor Counting On Consumer Backing

Schakowsky was optimistic about the bill's prospects. "I'm hoping to get bipartisan support that will expedite its movement to the house floor," she said.

Additionally, she is counting on consumer support for the legislation.

"I think the magic bullet that we have is, as the word gets out about the potential dangers in cosmetics ... there's going to be a lot of consumer support and push to make sure that this information is available," she said.

Hurson suggested the bill has "political limitations" in the current Congressional session "in terms of their time remaining to actually produce a lot of legislative accomplishments."

The Campaign for Safe Cosmetics' Nudelman is confident that the legislation will not be blocked by industry. "Industry is no longer represented by one trade association speaking in one voice," she said. "Instead, we have a huge growing sector of the industry that is siding with the public in saying that even a little bit of a cancer-causing chemical does not belong in cosmetics."

More than 1,000 companies have signed the Campaign's Compact for Safe Cosmetics, pledging to meet or exceed cosmetics formulation standards set out by the European Union "to be free of chemicals that are known or strongly suspected of causing cancer, mutation or birth defects," and to replace hazardous materials with safer alternatives within three years.

- Lauren Nardella ( ⁵ l.nardella@elsevier.com )

House's "Safe Cosmetics Act" Seeks End To Industry "Free Reign"

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