Lawmakers Want FDA to Regulate Cosmetics

Posted March 28, 2012 at 6:36pm

There’s formaldehyde in your Brazilian Blowout, lead in your Grecian Formula hair dye and who knows what in your perfume. Certainly not the government.

For the first time in more than 30 years, lawmakers are preparing to extend the Food and Drug Administration’s authority to regulate cosmetics, setting off a battle between large makeup manufacturers and consumer safety advocates over how far the government should go.

For months, the cosmetics industry has been fighting a bill introduced by Rep. Jan Schakowsky (D-Ill.) that would ban the use of ingredients linked to cancer and reproductive disorders and require companies to include complete ingredient labels on fragrances and salon products.

The FDA is all but powerless when it comes to policing hair care products, makeup and facial treatments — an industry that brings in about $60 billion every year. The agency has no authority to regulate ingredients or recall products, and while it can ban substances deemed dangerous, it rarely does. The European Union, by contrast, has a list of about 1,200 ingredients that cannot be used in cosmetics.

If a company wanted to put arsenic in body lotion, for example, it would not be required to report that to the government, nor would the government have the authority to pull the product from shelves, said Rep. Ed Markey (D-Mass.), one of the bill’s co-sponsors, in a House Energy and Commerce Committee hearing on the issue Tuesday.

The industry acknowledges that the cosmetics regulatory regime needs a makeover. Recent news stories about illnesses related to mercury found in skin creams have further tarnished its image.

“There is no statutory path for the people expressing safety concerns to get those concerns resolved,” said John Hurson, the executive vice president for government affairs at the Personal Care Products Council, the industry’s trade association. “FDA doesn’t have to do it. We want to make them. … We need maximum public credibility.”

The industry would benefit from putting its seal of approval on tougher standards, but in the council’s eyes, not all approaches are created equal.

The council is fighting to make sure new government requirements don’t hamstring innovation, compromise trade secrets or unnecessarily restrict key chemicals.

This spring, the group wrote a bill of its own and began circulating it on Capitol Hill.

The proposal was the result of a three-year, $3.5 million lobbying effort by the council’s in-house lobbyists and those at Policy Directions Inc. and the Duberstein Group.

Despite all of its work, the council is still not satisfied with an alternative, more industry-friendly bill that was introduced Monday by Democratic Reps. John Dingell (Mich.) and Frank Pallone, whose district includes New Brunswick, N.J., home to Johnson & Johnson, one of the industry’s biggest players.

So the council has turned to Rep. Leonard Lance, an obscure New Jersey Republican who represents the neighboring district, to introduce yet another alternative modeled after the council’s proposal.

Lobbyists expect Lance to drop his version in the coming weeks, but an office spokesman declined to discuss timing or the degree of industry input in his bill.

The industry-backed bill would require the FDA to investigate safety concerns only when petitioned by outside parties. It would, however, require companies to report facilities, product ingredients and adverse events, according to a summary the council provided to Roll Call.

Unlike the Pallone and Schakowsky proposals, it would not levy a fee on cosmetics companies to help fund the FDA’s expanded activities. Council lobbyists argue that they have backed increased funding for the agency’s Office of Cosmetics and Colors since 2006 and that is enough.

One of the three proposals will likely be added to the reauthorization of the Prescription Drug User Fee Act program, a must-pass bill that helps fund the FDA and expires in September.

Safety advocates dismiss the council’s approach, arguing that it would leave the FDA’s cosmetics office underfunded and at the mercy of the industry. Today, the only other body monitoring the ingredients used in cosmetics, the industry-funded Cosmetic Ingredient Review, is housed in the same 17th Street Northwest building as the trade association. The FDA has no authority to enforce CIR recommendations.

“I think there has been undue influence on the Office of Cosmetics and Colors from the cosmetics industry since they started regulating cosmetics 70 years ago,” said Janet Nudelman, the policy director of the Breast Cancer Fund, which sponsors the Campaign for Safe Cosmetics, a coalition of 150 organizations representing consumers, salon workers and environmentalists. “It’s such an incestuous relationship.”

Nudelman’s group paid the Raben Group $120,000 in 2011 to handle its legislative agenda, including efforts to promote the Schakowsky measure.

In 2006, the FDA concluded that hydroquinone, a chemical found in skin-lightening products, might act as a carcinogen and recommended it be removed from a list of safe ingredients, but it still has not acted on the recommendation, Nudelman noted. In December, the agency reported that the amount of lead found in hundreds of lipsticks was safe — a finding the Campaign for Safe Cosmetics refutes.

The industry is pushing especially hard for a provision that would bar states from pre-empting national regulations. Safety advocates argue that would jeopardize more aggressive state laws such as the one California passed in 2005 that allowed the state’s attorney general to sue Brazilian Blowout, a North Hollywood-based company whose hair-straightening product emits formaldehyde gas.

A spokesman for the cosmetics council noted that formaldehyde is safely used as a preservative in many products such as shampoo.

“Their approach is basically not based on a scientific review of those ingredients. It is based on the conclusion that if there are questions raised about an ingredient, it should be taken out,” Hurson said. “We just fundamentally disagree with that.”