The regulatory landscape of the beauty industry is changing. Here’s the latest

A major deadline is approaching in beauty and personal care regulations, and there are still many changes ahead — although some experts believe it’s still not enough.

Under the Modernization of Cosmetics Regulation Act (MoCRA), passed by Congress in late 2022, cosmetics companies across the U.S. are required to register their facilities with the Food and Drug Administration by Monday, up from an original December deadline. They must also list every cosmetic product they market, including the product’s ingredients, and provide any updates annually.

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“This is usually where the proverbial camel’s nose ends up under the tent,” said Marc J. Scheineson, a partner at Alston & Bird and former deputy commissioner of the FDA, about the registration process. “For the FDA to bring companies into more stringent regulation, it wants to know who’s out there and what they’re making and selling, and it’s probably going to be thousands and thousands of different products and companies, so that should keep the FDA busy for a while — just examining the registrations and listings, that are soon to come.”

MoCRA is the first major statutory change to the Food, Drug, and Cosmetic Act regarding cosmetic regulations since the FDCA was passed in 1938. While it is not as far-reaching as some expected, the headline is that Congress has directed the FDA to tighten regulation of the cosmetics industry .

The registration process is consistent with other MoCRA requirements effective from 2023, including record keeping regarding adverse events; 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 in terms of inspections, mandatory recalls and plant suspensions.

Yashi Shrestha, co-founder and head of chemistry and sustainability at Novi Connect, a clean cosmetics and ingredient verification platform, has partnered with FDA compliance firm Registrar Corp. to help beauty and skincare brands nationwide register their cosmetics facilities and product listings with the FDA. As the deadline approaches, she’s turning her attention to another agenda item: allergens.

The FDA is expected to soon issue a statement specifying the fragrance allergens that must be included on cosmetics labels, as well as the format for such disclosure, in line with European Union and other international requirements.

“Up until now, we’ve been focused on object logging and adverse events. We know that the next thing that’s going to come up is fragrances and allergens,” Shrestha said. “I see that being a huge part of what we’re doing going forward, both on the brand side, who will continue to have full visibility into what they’re potentially exposing their consumers to, and on the retail side, who will need to have the same level of transparency for the customers who are buying these products. We’re going to help both retailers and brands turn these requirements into their standards for clean and safe products that they’re bringing to market.”

Scheineson added that unlike in Europe, where cosmetics trade secrets are not as well protected, in the U.S. labels must only list fragrances or flavors, but not the formula. “Now the FDA will have guidelines for labeling cosmetic products,” he said.

For Debi Theis, CEO of Henry Rose, the premium genderless perfume brand founded by Michelle Pfeiffer, the move is “the right step forward.”

“Thirty percent of people have some kind of allergic reaction to fragrance. It’s really important that they have visibility into what’s in each of their fragrance products… From a consumer perspective, it’s becoming more and more transparent,” she said. “We’ve always had allergens on the packaging. We actually have 100 percent transparency, which goes a step further because we think it’s really important for the consumer to know what they’re putting on their body.”

The industry is waiting for the FDA to issue guidelines on good manufacturing practices, which are due to be published in 2025.

Kelly A. Bonner, an associate at the law firm Duane Morris, said of this: “They’re not reinventing the wheel. There are standards. It’s just going to be whatever the FDA decides is the standard in the United States.”

The FDA also published proposed regulations on standard testing methods for detecting and identifying asbestos in talc products, which are pending review.

In 2019, asbestos was found in some Claire’s cosmetics products, but at the time the FDA could only advise consumers against using it. The following year, Johnson & Johnson announced that it had cessation of sales currently controversial talc-based baby powder in the USA and Canada, thousands each court cases submitted by cancer patients. The lawsuit alleged that the talc the company used in its baby powder had been contaminated with asbestos for years, which could cause ovarian cancer in unknowing consumers. In 2023, it pledged to start using cornstarch in all the baby powders it uses around the world, and in June it reached a $700 million settlement over talcum powder with U.S. states.

On the changing regulatory environment, the Personal Care Products Council, an industry trade organization, said, “PCPC member companies continue to work diligently to meet all MoCRA deadlines.”

Bonner, for example, believes that the industry is serious about change 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 hard look at this and say, ‘OK, what are our enforcement priorities now that we have the data and everything is in place? How do we improve this? How can we improve this to better help the industry and better help consumers?’

However, many believe that there is still much work to be done.

Homer Swei, vice president of Healthy Living Science at the Environmental Working Group, said that while MoCRA is a big step forward toward improving the safety and transparency of cosmetics, it falls short of one key goal: requiring safety inspections of individual chemicals used in beauty products. personal care.

“People use many products every day, often putting them on themselves without knowing the full extent of their potential chemical exposure,” he continued. “With the exception of talc and PFAS, improvements in definitions and safety determinations were omitted from 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 stronger law would ensure that every ingredient is thoroughly tested and verified for safety before it is approved for use in products that consumers use every day.”

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