“It represents a sea change,” said Kelly A. Bonner, an associate at law firm Duane Morris about the Modernization of Cosmetics Regulation Act.
Passed by Congress at the end of last year, the ruling, known in the industry as MoCRA, is the first major statutory change to the Food, Drug and Cosmetics Act regarding the regulation of cosmetics since the FDCA’s enactment in 1938.
While not as far-ranging as some had hoped, the headline is that the Food and Drug Administration has been ordered by Congress to engage in more regulatory activity of the cosmetics industry.
“It creates substantial new compliance obligations for cosmetics companies, specifically manufacturers, packers and distributors,” said Bonner. “Consumers are really the beneficiaries of this….it’s going to mean that consumers will receive more information about the products that they use.”
Among the changes, the Environmental Working Group, a nonprofit organization, stated that companies will be required to prove the safety of their products and allow the FDA to review related records when the health of consumers may be at risk.
As part of this, cosmetics companies will have to register with the FDA, report products and ingredients as well as fragrance allergens, adopt good manufacturing practices and report serious adverse events caused by using products within 15 days.
Companies will also be required to test personal care products made with talc for asbestos, while the FDA will receive other oversight powers for cosmetics, including order recalls, and will have the authority to suspend a company’s registration.
Asbestos was found in some cosmetics products at Claire’s in 2019, but at the time the FDA could only advise consumers not to use them. The following year Johnson & Johnson announced it was discontinuing the sale of its now controversial talc-based baby powder in the U.S. and Canada after thousands of lawsuits filed by cancer patients, alleging that talc used by the company in its baby powder product was contaminated by asbestos for years, potentially causing ovarian cancer in unwitting consumers. This year, it pledged to begin using cornstarch in all baby powder it uses globally.
“Although more is needed to ensure the safety of chemicals used in cosmetics, this update is a welcome step in the right direction,” said Scott Faber, senior vice president for government affairs at EWG. “Consumers, not just the FDA, will have more information when purchasing cosmetics, since fragrance allergens will now be on product labels.”
While some of this, including mandatory recall authority, needs to be in place in the next year, other regulations won’t come into force for three years.
At the top of their to-do lists, companies will have to prepare to register facilities with the FDA and submit to the FDA lists of products and ingredient information including the location of manufacturer and the ingredients of any fragrances or flavors, according to Bonner.
“One thing to note about that is that companies will be required to submit this information to the FDA. That said, it does not necessarily follow that this information will remain confidential because in the United States, you can obtain information from the FDA pursuant to Freedom of Information Act requests,” she said. “So it is possible that this ingredients list of products can become public information… unless it is covered by an exemption and, I would say, particularly the trade secret exemption.”
Of MoCRA, the Personal Care Products Council, the industry’s trade organization, said: “[Its] passage was a truly bipartisan effort that brought together members of Congress…. to advance science-based federal regulatory reforms. PCPC is meeting this historic moment by providing the FDA with industry’s perspective as the Agency develops implementing regulations. PCPC remains firmly committed to supporting the FDA in its public health mission as the Agency works to implement this new law.”
But many believe there is still much more to be done.
While Jen Lee, chief impact officer at Beautycounter, welcomed the regulation as a “big move” that will pivot the industry in the right direction, she stated that there’s always work to be done.
“The personal care product provisions will allow the FDA to review safety records for chemicals of concern, but it is not required to do so. Congress failed to provide the FDA in the end-of-year spending bill with the resources needed for that work,” she told Beauty Inc. “The onus of using safer products shouldn’t be on the consumer. It should be with the manufacturer or the brand.”
Ken Cook, EWG president and cofounder, said that the work of banning or restricting chemicals will now fall to the states. “The cosmetics provisions in the end-of-year spending bill preserve the ability of states to ban toxic chemicals from cosmetics, as California, Colorado and Maryland have recently done. Some of the most extreme voices in the cosmetics industry and their fellow travelers wanted to eviscerate state powers, but EWG insisted on preserving the ability of states to ban or restrict chemicals of concern.”
There are also still no industrywide rules for what a product labeled “clean” should entail, which is the subject of an ongoing lawsuit against Sephora.
Source: WWD