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At trailblazing hearing on cosmetics, congressmen bounce ideas off FDA

by Gabriel NelsonE&E News
March 28th, 2012

It's rare for businesses to ask Washington to hit them with new regulations, but that's exactly what the members of the Personal Care Products Council did yesterday.

Cosmetics companies want Congress to update the laws that govern the safety of their products' ingredients, and members of the House Energy and Commerce Committee had plenty of ideas yesterday during the first hearing on the topic in at least three decades.

"Even though [the Food and Drug Administration] has repeatedly stated that cosmetics are the safest products they regulate, it is time to bring FDA's statutory authority up to date," said Peter Barton Hutt, an attorney at Covington & Burling LLP who testified on behalf of the trade group.

Cosmetics makers say that state policies, including a set of California rules dating back to 2006 that require manufacturers to disclose the use of chemicals that are suspected to cause cancer or developmental defects, would make it harder to do business across the country.

That argument seemed to get a warm reception from Rep. Leonard Lance (R-N.J.), who is said to be drafting legislation to include in a broader bill reauthorizing FDA's ability to collect fees from companies for inspections.

Legislation could push the states aside by giving more authority to FDA, which cannot currently treat cosmetics companies to the same inspections and disclosures as the food and drug companies that the agency also regulates.

"We need pre-emption in this area," Lance said yesterday.

To have the federal government override the states, as manufacturers would like, Lance would need to win support for the first major revision to FDA's oversight of cosmetics since 1938. To do that, he would likely need support from the Obama administration and from the Democrats who hold control of the Senate.

They have lined up behind health advocates, who say the public needs more reassurance that it won't be harmed by exposure to the 96 unique chemicals and 24,664 distinct hazardous ingredients that California has found in cosmetics through its program.

Democratic Reps. Edward Markey of Massachusetts, Jan Schakowsky of Illinois and Tammy Baldwin of Wisconsin have proposed a bill (H.R. 2359 <http://www.eenews.net/bills/112/House/260911161757.pdf> ) that would set a single nationwide safety standard for cosmetics and require labels to disclose all ingredients.

And yesterday, Democratic Reps. Frank Pallone of New Jersey and John Dingell of Michigan proposed a separate bill (H.R. 4262 <http://www.eenews.net/bills/112/House/270312163520.pdf> ) that Pallone described as a "starting point" for the negotiations with Lance and other Republicans on the committee.

Their bill would require cosmetics companies to register annually with FDA, disclose all products' ingredients and show that they are safe. FDA would also have the authority to recall unsafe products, which it cannot currently do.

"I know that there are other approaches to regulating cosmetics," Pallone said. "But what is clear from all perspectives is that FDA doesn't have the authority it needs to properly monitor an industry that touches nearly every American consumer. Well, I believe it's time that Congress fixed that problem."
Digging into the details
Michael Landa, the director of the agency's Center for Food Safety and Applied Nutrition, told the bills' sponsors that the agency can already prosecute cosmetics companies that use unsafe chemicals and run voluntary disclosure programs to inform the public, but it has little power to stop potentially harmful products from getting to the marketplace.

FDA estimates that one-third of manufacturers disclose their ingredients, he said.

In his budget request for fiscal 2013, President Obama has called for $19 million in new fees from manufacturers to run FDA's cosmetics programs. Some lawmakers raised concerns yesterday that the fees could hit small businesses hardest.

Landa responded by saying the design of the fee program would need to be negotiated. The amount paid could vary based on the size of a company, he said, and there could be exclusions for companies under a certain size.

"It would be important to be flexible in that regard," he said.

Health Subcommittee Chairman Joe Pitts (R-Pa.) kept his powder dry during the hearing, neither supporting nor opposing the plans put forward by his Democratic and Republican colleagues.

But other comments suggested the push could face pushback from lawmakers who do not want to give more responsibilities to the federal government. Rep. Joe Barton, a Texas Republican and a former Energy and Commerce Committee chairman, said he is wary of the effort, but he is a "possible" supporter "if we can find a solution that doesn't give too much authority to the FDA."

"Make no mistake," Barton said, "if we give the FDA new authority, they're going to use it. And if we give the FDA user fee authority, they're going to expand upon it."

"I mean, it's almost a law of nature," he added. "If you give a federal agency more authority, they use it, expand it. And if you give them more revenue, they consume it and then come back for more. At this stage, it seems to be somewhat benign, but the further we go down the trail, the more cumbersome it can be."

Rep. Henry Waxman of California, who leads the Democrats on the Energy and Commerce Committee, said the committee should keep working on a piece of stand-alone legislation if it cannot come to agreement on an addition to the broader reauthorization bill that is moving through Congress.

Waxman also said he thinks states should be able to supplement any new federal regulations where they deem it necessary.