A major deadline on beauty and personal care regulations is fast approaching, with much more to come – although some experts believe this is still not enough.
Under the Modernization of Cosmetics Regulation Act, or MoCRA, passed by Congress in late 2022, cosmetics companies in the US are required to register their facilities with the Food and Drug Administration by Monday, which has been pushed back from the original deadline of December. They must also list each cosmetic product marketed, including the product ingredients, and provide any updates annually.
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“Normally, the proverbial camel’s nose goes under the tent,” said Marc J. Scheineson, a partner at Alston & Bird and a former FDA deputy commissioner, of the registration process. “As the FDA puts stricter regulations on companies, they want to know who’s out there and what they’re making and selling and that’s probably going to be thousands and thousands of different products and companies, so that should keep the FDA busy for a while. – I only study the registrations and listings that are expected to arrive shortly.’
MoCRA is the first major statutory change to the Food, Drug and Cosmetic Act related to the regulation of cosmetics since the enactment of the FDCA in 1938. While not as far-reaching as some had hoped, the headline is that the FDA has been authorized by Congress ordered to tighten the regulation of the cosmetics industry.
The registration process follows other MoCRA requirements already in effect as of 2023, including adverse event record keeping; reporting serious adverse events to the FDA within 15 days, and labeling cosmetics for professional use as “professional use only.” The FDA also now has sharper teeth on inspections, mandatory recalls and facility suspensions.
Yashi Shrestha, co-founder and head of science and research at Novi Connect, a clean beauty verification and ingredient sourcing platform, partnered with FDA compliance firm Registrar Corp. to help cosmetic and skin care brands across the country register their cosmetic facilities and product listings with the FDA. Now that that deadline is approaching, she turns her attention to the next agenda item: allergens.
It is expected that the FDA will soon make an announcement identifying fragrance allergens that must be listed on cosmetic labels, as well as the format for disclosure, in accordance with European Union and other international requirements.
“The focus so far has been on the registration of facilities and side effects. We know that the next thing to emerge is fragrances and allergens,” Shrestha said. “I see this being a big part of how we move forward, both on the side of the brands, who will continue to have full visibility into what they can potentially expose their consumers to, and on the side of the retailers, who will equally need will benefit from that transparency for their customers who purchase these products. We will help both retailers and brands translate these requirements into their standards for clean and safe products that can be brought to market.”
Scheineson added that unlike Europe, where trade secrets for cosmetics are not as well protected, labels in the US only have to list fragrances or flavors, but not what the formulas are. “Now the FDA will get guidance on how cosmetic products should be labeled,” he said.
For Debi Theis, president of Henry Rose, the genderless perfume brand founded by Michelle Pfeiffer, this move is “the right step forward.”
“Thirty percent of people have some kind of allergic reaction to fragrances. It’s really important that they have visibility into what’s in each of their products that contain fragrance… it’s just going to become more transparent from a consumer perspective,” she said. “We have always had our allergens on our packaging. In fact, we are 100 percent transparent about the ingredients, which goes one step further, because we think it is very important that the consumer knows what he is putting on his body.”
As for what else will happen, the industry is waiting for the FDA to issue guidance on good manufacturing practices, which will be published in 2025.
Kelly A. Bonner, associate at law firm Duane Morris, said: “They’re not reinventing the wheel. There are standards out there. It’s just going to be what the FDA says is the standard in the United States.”
The FDA has also published proposed rules regarding standardized testing methods for detecting and identifying asbestos in talc-containing products, which are pending.
In 2019, asbestos was found in some cosmetic products at Claire’s, but at the time the FDA could only advise consumers not to use them. The following year, Johnson & Johnson announced that this was the case stopping sales of his now controversial talc-based baby powder in the US and Canada after thousands lawsuits submitted by cancer patients. The lawsuits allege that the talc the company used in its baby powder product was contaminated with asbestos for years, potentially causing ovarian cancer in unwitting consumers. In 2023, it committed to using corn starch in all the baby powder it uses worldwide, and in June it reached a $700 million settlement in the talc case with US states.
Regarding the changing regulatory landscape, the Personal Care Products Council, the industry’s trade body, said: “PCPC member companies continue to work diligently to meet all MoCRA deadlines.”
Bonner, for example, believes the industry has taken the changes seriously and that the FDA’s goal is to get through the first few years of MoCRA and then take stock.
“Ultimately, the FDA will take a good look at it and think, ‘Okay, what are our enforcement priorities now that we have the data, now that we have everything in order? How do we adjust this? How can we refine this to better help the industry and consumers?’”
But many also believe that much more needs to be done.
Homer Swei, vice president of Healthy Living Science at the Environmental Working Group, said that while MoCRA is an important step forward in improving the safety and transparency of cosmetics, it falls short in one crucial area: mandating the safety assessment of individual chemicals used in personal care products. care products.
“People use multiple products every day, often in layers, without knowing the full extent of potential chemical exposure,” he continued. “With the exception of talc and PFAS, improvements to the definition and determination of safety were left out of MoCRA and are generally left to manufacturers. This is different from international regulations, where the government plays a more active role in determining safety and safe use. A stricter law would ensure that every ingredient is thoroughly tested and assessed for safety before being allowed into products that consumers use every day.”
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