The regulator and the regulated appeared to reach a rare kumbaya moment last summer — an agreement on the outline of legislation to beef up the agency’s authority while giving the industry greater certainty. But the talks collapsed, and those once-promising private discussions have given way to public pronouncements of disillusionment, frustration and distrust.
In a letter Thursday, a top FDA official charged that the cosmetics industry’s latest proposals would undercut the government’s already weak authority, prevent states from undertaking enforcement actions and “put Americans at greater risk from cosmetics-related illness and injury than they are today.”
In his letter, FDA Deputy Commissioner Michael Taylor told two trade groups representing the $60 billion-a-year industry that there is no longer enough common ground to “justify devoting further taxpayer resources to this negotiation.”
The Personal Care Products Council, which represents an estimated 600 companies, quickly rejected the notion that it wants to weaken federal oversight of cosmetics, and it said suggestions that cosmetics products are dangerous are reckless, counterproductive and not supported by data.
“We are extremely disappointed that FDA has indicated they will not participate in further discussions,” Lezlee Westine, the group’s president, said in a statement. “We all share in the common goal of protecting consumers. In fact, product safety is the cornerstone of all that this industry represents. . . . We will work with Congress to pursue meaningful solutions.”
The stalemate has proved particularly galling to consumer advocacy groups, who have long pushed for more government oversight over the chemicals used to produce millions of products used by Americans every day, from lipstick and hair spray to toothpaste, deodorant and baby lotion.
Janet Nudelman, director of the California-based Campaign for Safe Cosmetics, said the industry’s proposals — which could put the onus on the FDA to prove that questionable chemicals are unsafe and could preempt some state regulations — are “a slap in the face” to Americans who expect transparency about the products they use.
“Industry simply should not be calling the shots anymore,” she said. “They’ve been calling the shots for over 75 years in what little federal regulation there is.”
She cited tests that have turned up lead in lipstick, formaldehyde in hair care products and mercury in face cream. The cosmetics industry has called some of those findings misleading and unnecessarily alarming, noting that the FDA found no level of lead in lipstick that would pose health concerns.
Compared to its authority to oversee pharmaceuticals and foods, the FDA remains virtually toothless when it comes to regulating cosmetics. It has no power to review products before they go on the market. Companies do not have to list all of the ingredients in their products, and they do not have to register their manufacturing facilities with the government. They also are not required to report “adverse events,” making it difficult for regulators to spot potential problems.
Other countries have put in place far more stringent regulatory systems. The European Union, for example, has banned the use of about 1,300 chemicals in consumer cosmetics products. By comparison, the FDA has banned fewer than a dozen, most of which were listed in the 1970s and 1980s, the agency said. FDA and industry officials began working on a regulatory framework at the urging of members of Congress, who have yet to act on proposed bills to update the regulation of cosmetics.
The two sides reached an agreement on a basic outline, according to the FDA: The FDA would gain the ability to review specific cosmetics ingredients before products were put on sale. Companies would be required to notify the agency of health problems that their products caused, and the FDA could order a mandatory recall of a dangerous product. The agency also would create a set of accepted manufacturing practices and would collect about $20 million a year from the industry in user fees.
That tentative bargain did not last. FDA Commissioner Margaret A. Hamburg told industry representatives that their “change of heart” amounted to “a missed opportunity to better serve the public and strengthen your industry.” An industry group replied that companies “have not had a change of heart in their commitment to work with FDA, and we continue to operate in good faith.”
Despite that rift, some
companies have made changes in the wake of consumer demands. Johnson & Johnson recently reformulated its iconic baby shampoo and other products after pledging to remove formaldehyde and another chemical that regulators have deemed potentially harmful, even as it has maintained that the products were safe.