This is an episode of the Glossy Beauty Podcast, which features candid conversations about how today’s trends are shaping the future of the beauty and wellness industries. More from the series →
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In December, America’s first big move to regulate the beauty industry in more than 80 years went into effect with the Modernization of Cosmetics Regulatory Act of 2022, best known as MoCRA. But it isn’t until the end of this month that the industry will meet its first big deadline from the Food & Drug Administration.
By July 1, brands and manufacturers must provide a list of their products and where they were made to the FDA through its online portal called Cosmetics Direct. It’s the first of many deadlines and requirements, some of which are still in flux, that will slowly reshape how the industry is regulated over the next few years.
For example, MoCRA will give the FDA new visibility into what’s in beauty products and where they are manufactured. It also provides new authority to the FDA to issue mandatory product recalls and alert consumers to common allergens through mandatory warning labels. That’s thanks, in part, to new visibility into fragrance ingredient lists, which had long been classified as intellectual property but must now be shared with the FDA.
Previously, America’s regulation was made up of small federal and state laws, which created a growing movement for better regulation. For example, brands like BeautyCounter spent years lobbying for better regulation on social media and on the hill in Washington, while brands like Henry Rose by Michelle Pfeiffer was created to offer an alternative to the under-regulated fragrance industry.
So how did this piece of legislation finally get passed? While you may not know attorney Katlin McKelvie by name, she is a Washington D.C.-based lawyer who was integral in the creation of MoCRA.
McKelvie has more than two decades of experience working in food and drug law, including 11 years at the FDA and is currently a partner with law firm Gibson, Dunn and Crutcher in Washington, D.C. She also served as the Deputy General Counsel of the United States’ Department of Health and Human Services and as the Deputy Health Policy Director and Senior FDA Counsel to the Senate Committee on health, education, labor and pensions for chair Patty Murray. While working with Congress, she helped shape many pieces of legislation that have impacted us all, including MoCRA.
On today’s episode of The Glossy Beauty Podcast, McKelvie shares the origin story for MoCRA, including the challenges and compromises made during its early days in the Senate. She also shares the challenges she suspects brands may face while navigating compliance, the requirements the FDA will release next and the changes consumers can expect in the coming years. Excerpts from the discussion, below, have been lightly edited for clarity.
On the biggest issues brands should be thinking about now
“Brands should already be thinking about safety substantiation because those requirements are already in place. They should also be thinking about how they’re going to start complying with, or continue to comply with, good manufacturing practices. There’s also a rule on fragrance allergen labeling coming down the pike. Certain fragrance allergens will need to be on the label of the products. The FDA will have to issue a rule on that, [but] it is likely going to look much like the law in Europe that’s currently in place, so companies can look to Europe for how that might look.”
A timeline of the full MoCRA rollout
“There are a number of requirements already in effect, and now the FDA has to go through this rule-making process for others — and there may be some delay in those regulations. But I would think within two or three years is when they will all be in effect.”
On the uptick in reformulations post-MoCRA
“I do think that there will be, and have been, reformulations as a result of MoCRA. Companies have had an obligation to substantiate the information about the safety of the ingredients of their products, and some of them are taking a closer look at information that’s available about the safety of some of these ingredients and are acting in a more conservative manner. So [they’re] reformulating some of those products to make sure they have ingredients that have substantial evidence of their safety.”
Where brands and manufacturers could struggle next
“In the immediate term, [brands could struggle with] adverse event reporting — including how that works and what types of reports companies are expected to make to the FDA because it’s a new process. The [FDA is] working through that [now]. I know the FDA hasn’t spoken yet or issued guidance or regulations or anything on safety substantiation, so it’s a bit of a black box. Companies are trying to anticipate where the FDA might end up there, and there’s some uncertainty in that regard.”