It's not often that industry representatives go before Congress to ask for more federal regulation, but that's what cosmetics makers want from the Food and Drug Administration.
"Even though FDA has repeatedly stated that cosmetics are the safest products they regulate, it is time to bring FDA’s statutory authority up to date,” said Covington & Burling senior counsel Peter Barton Hutt, testifying today before a House subcommittee on behalf of the major cosmetics industry trade association.
For cosmetics makers — a $60 billion category that includes not just lipstick and eyeshadow, but products like shampoo, deodorant, toothpaste and sunscreen — the newfound enthusiasm for federal oversight comes down to this: it’s better than 50 different state standards.
Faced with a growing number of new and inconsistent regulations at the state level, the cosmetics industry has concluded that a uniform national standard enforced by the FDA is preferable — so long as agency rules pre-empt state laws.
“Myriad diverse state regulations would substantially increase the cost of producing and distributing personal care products,” Curran Dandurand, chief executive officer of men’s personal care products company Jack Black, told the Energy and Commerce subcommittee on health. “The consequences for small business owners would be disastrous.”
Since 1938, cosmetics have been regulated by the FDA under the Federal Food, Drug, and Cosmetic Act. But the agency’s authority is weak — there’s no pre-market approval of products or requirement to substantiate product safety, no mandatory registration of facilities, no FDA recall authority and no requirement to report serious adverse effects.
Most people assume cosmetics are regulated by the government, said Rep. Ed Markey (D-Mass.), co-author of H.R. 2359, the Safe Cosmetics Act of 2011 (pending before a subcommittee). “But looks can be deceiving,” he said. “Most products are never assessed for safety, and the only federal agency with jurisdiction is operating with its hands tied.”
To drive the point home, he questioned Michael Landa, director of the FDA’s Center for Food Safety and Applied Nutrition.
“If the FDA believed the level of formaldehyde in baby bubble bath was harmful, could the FDA recall it?” he asked.
“No,” Landa said.
“If a company decided to include arsenic as an ingredient in face cream, would they even have to notify the FDA?”
“No, there’s no pre-market notification,” he said.
Still, Rep. Joe Barton (R-Texas) was skeptical that more regulation was the answer. “What’s the huge problem here that all of a sudden we need to enact some federal authority?” he said.
Landa responded that the FDA receives several hundred reports a year of problems caused by cosmetics but that reporting is voluntary and “surely doesn’t reflect the total number of complaints.”
Barton was unimpressed, noting there are 300 million consumers in America. “Why increase the regulatory burden?” If the problem is with inconsistent state laws, he said “the way to address it is to work with the state legislatures.”
The cosmetics industry, though, is pushing for one federal standard. Covington’s Hutt, testifying on behalf of the Personal Care Products Council, laid out key legislative changes that the industry supports, including making cosmetics companies register with the FDA, requiring companies to submit reports when there is a serious adverse reaction to one of their products and establishing good manufacturing practices.
The industry also backs “establishing programs to require FDA to review and determine whether controversial cosmetic ingredients and constituents are or are not safe, followed by strong FDA enforcement,” he said, and “an unambiguous Congressional determination that, as modernized, the revised statute will apply uniformly through the country.”
That may be a sticking point with some members of Congress. Rep. Henry Waxman (D-Calif.) argued that states “should be allowed to supplement” federal laws, if state standards are more stringent.
In 2006, California established the first state cosmetics-regulatory program in the nation. Michael DiBartolomeis, who heads the program, testified that more than 17,000 products have been reported to the program as containing one or more ingredients known or suspected to be carcinogens or reproductive or developmental toxicants.
Another potential disagreement is funding. The FDA’s fiscal year 2013 budget request includes new legislative authority for the FDA to require domestic and foreign cosmetics manufacturers to register with the FDA and pay an annual registration fee. The fee would generate $19 million to be applied toward developing guidance and safety standards. The FDA currently has just 14 people who work full-time on cosmetics issues.
“These products are not high risk, but they’re by no means risk-free,” said Rep. Frank Pallone Jr. (D-N.J.), who this week introduced HR 4262, the Cosmetics Safety Enhancement Act. “The FDA doesn’t have the authority it needs to monitor an industry that touches nearly every American consumer.”