Major Change Is Coming To Beauty Regulation: Is the Industry Ready For It?

Well, 80-some years later, change is coming in the form of the Modernization of Cosmetics Regulations Act (MoCRA). Sweeping updates will mean that the beauty industry better aligns itself with supplement manufacturers—and even closer to the EU, which is often held up as the standard for cosmetic regulation.

For the most part, MoCRA hasn't received much broad media attention. However, for trade websites, regulatory publications, and legal blogs, it's become something of a trending topic as folks discuss what the act means in practice. And according to my sources, there's still a lot we don't know about what changes the act will bring about. In the meantime, beauty brands are quietly preparing for these new regulations to be enacted over the course of the next several months and years. 

From what we do know: There are important areas where it grants the FDA much-needed jurisdiction, and it's a step in the right direction. 

Over the last few years, there have been several notable recalls in the beauty industry. For example, there were two big recalls of dry shampoos in recent memory: In 2022, Unilever recalled 19 dry shampoos1 because of a possible benzene (a known group A human carcinogen, according to the Environmental Protection Agency) contamination. In 2021, Procter & Gamble recalled 32 dry hair products2 because of a similar contamination issue. Sprayable sunscreen is another hot topic: Several major beauty conglomerates have issued recalls due to contamination, from Banana Boat, Unilever, P&G, and Johnson & Johnson. 

Contract manufacturers (factories that make cosmetic formulas for the brands to then package, market, and sell) have to now register with the FDA and adhere to Good Manufacturing Practices3, which is something the drug and supplement market already does. 

Brands also have to register their formulas with the FDA, providing safety substantiation for the ingredients and formulas. This moves the FDA closer to the EU, where formulas aren't assumed safe—they have to be shown to be so, with the burden of proof on the brand itself. 

Mandatory adverse event reporting is something the supplement industry already has in place, and now cosmetic companies will have to follow suit. Essentially, this means that companies have to report adverse reactions within 15 days of being notified by a consumer. Prior to this, reporting anything to the FDA was entirely voluntary—even keeping record of it was.

Now, how the FDA defines adverse events is a fairly high threshold: "A 'serious adverse event' is defined as an adverse health-related event associated with the use of a cosmetic product that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement." 

Meaning: Finding a face cream irritating for your particular skin type doesn't qualify for reporting to the FDA. 

But what's promising about this is that it will hopefully spur brands into more diligent and thoughtful record-keeping of customer feedback—yes, even the negative comments. Of course, some brands may already have a system in place to keep track of reactions or issues (at least the high-quality, thoughtful ones do). But considering how saturated the market is with new companies, there are likely many who haven't been encouraged to do this until now. 

Listen, lots of folks will tell you to avoid anything with "fragrance" on the ingredient list, as it could contain a host of iffy and irritating ingredients. While I understand where the concern is coming from, I don't believe fragrance is a dirty word. Many brands nowadays create thoughtful, safe fragrances that follow IFRA guidelines. 

That doesn't mean potential allergens aren't hiding under the umbrella term. Under MoCRA allergens—both natural and synthetic—must be disclosed on the ingredient list when they are present in the formula at relevant concentrations. 

Going forward, brands will need to provide proof of safety for their products and ingredients (as part of the registration process). But the FDA could—and should—go further on what they qualify as safe. 

"This is such a huge step in the right direction that most of us are just immensely glad that something is changing. Can more be done? Absolutely! But this is a great start," says Koestline. "In the future, it would be good to see maybe clearer testing requirements for each manufactured lot of cosmetics, raw materials as well as formula itself; better definitions of what an 'infection' means, clearer regulations on what can and cannot be said on the label in terms of claims."

Davis also notes she'd like to see more clarity around how they define safety. "The act asks for 'safety substantiation,' but the definition of 'safety' is quite vague," she says, adding, "I would love to see greater accountability in the supply chain; ingredient suppliers should show that they've evaluated a material, its hazard and risk before they sell it to beauty brands to use in products that we use daily over our lifetimes.

As most beauty folks know, the EU bans far more ingredients than the US. The EU follows the "precautionary principle" with ingredients, which means they more eagerly ban ingredients that could potentially be harmful to human or environmental health. 

While no ingredient bans were made under MoCRA, they are taking steps to investigate some of the more questionable ones. For example, there is now stricter testing on talc (a great step!) and a directive for the FDA to investigate PFAS in cosmetic products and provide a report on their safety—but that won't be coming for another three years. 

Long-awaited changes are coming to the beauty industry, both big and small. While much of it will be happening behind the scenes, it will hopefully mean beauty brands are more thoughtful and diligent in their formulations and creations. Now, we wait and see how urgent these changes are—and how thorough the FDA will be in regulating them. 

"The biggest takeaway for the consumer is that the FDA is finally paying attention to cosmetics," says Koestline. "Almost everyone I have spoken to is glad. These are all welcome changes in the industry although there is some skepticism with regard to how well the FDA will follow through on these new regulations."