How will FDA’s new cosmetics regulations affect the natural products industry?

Nutritional OutlookNutritional Outlook Vol. 26 No. 6
Volume 26
Issue 6

Here’s what brands need to know about the FDA’s Modernization of Cosmetics Regulation Act.

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The 2022 Modernization of Cosmetics Regulation Act (MoCRA) is a 36-page law that overhauls FDA’s powers and mandate in the cosmetics arena. This new law has a variety of requirements that are coming into effect in a staged manner, with the earliest requirements taking hold on December 29, 2023.

The law impacts not only finished-product brands but also suppliers, manufacturers, and processors involved in the production of cosmetic products. As the law rolls out, brands in the nutricosmetics space will want to take note of the new legal requirements they must meet. Here are some of the new obligations MoCRA imposes on natural products companies.

VCRP Has Expired; Companies Must Wait to Register

In 1972, FDA created the Voluntary Cosmetic Registration Program (VCRP) for domestic and foreign cosmetics manufacturers. While not an approval system, the VCRP enabled FDA to better regulate the cosmetics market; the system provided FDA with information regarding the ingredients in various cosmetics products as well as their frequency of use.

Now, though, VCRP has expired. With MoCRA taking hold, FDA stopped accepting VCRP submissions effective March 27, 2023. An FDA press release dated March 27, 2023, explained that FDA is currently creating a new registration system for suppliers and brands to list their facilities and products. FDA has asked that cosmetics companies wait to register until the new system is available.

All Manufacturing Facilities Must Be Registered

In addition to requirements for brands and suppliers, MoCRA introduces a new registration mandate for manufacturing and processing facilities. Under MoCRA, all manufacturers and processors involved in cosmetics production must register with FDA and renew their registration once every two years. FDA may suspend a facility’s registration if that facility is found to have manufactured a product that has a reasonable probability of harming consumers. Suspension of registration results in a prohibition on manufacturing or processing cosmetics products.

Cosmetics Products Must Be Listed with FDA

In addition to ensuring that all manufacturing facilities are registered, each individual product must also be registered with FDA. The registration must include a full list of the product’s ingredients, and any changes to this list must be updated with FDA on an annual basis. Each product's listing must be submitted within 120 days of its market launch, and the product registration must be renewed once per year.

Safety, GMP, Adverse Events Must Be Documented

MoCRA creates new safety requirements for ingredient suppliers and brands. First and foremost, companies in the cosmetics space are now responsible for ensuring they have documentation proving that their products are safe for consumer use. Companies are required to meet current Good Manufacturing Practice (cGMP) requirements in their facilities and must label products if they contain fragrance allergens. Furthermore, companies must use standardized testing methods to monitor for asbestos in any cosmetics products that contain talc. MoCRA requires that companies report adverse events within 15 days of discovering the adverse event; these reports are required to be kept for six years.

One of the most significant new changes brought in by this new regulation is that FDA now has the authority to issue cosmetics recalls. If FDA is able to ascertain that a certain cosmetics product is misbranded, adulterated, or otherwise harmful to consumers, FDA can issue a mandatory recall of that product. FDA also has the authority to inspect cosmetics manufacturing and processing facilities and records.

Who Is Exempt from MoCRA?

While MoCRA represents the most significant overhaul of FDA’s oversight of cosmetics since the Federal Food, Drug, and Cosmetic Act (FD&C Act) was passed in 1938, not all companies will be subject to these new regulations. Under Sections 612 and 613 of MoCRA, certain companies are exempt.

The new law includes an exemption clause for small businesses. A small business is defined as one that averaged less than $1 million per year in sales in the most recent three-year period. To be eligible for an exemption, these small businesses must not be involved in manufacturing cosmetics that are injected, intended for internal use, intended to alter appearance for more than 24 hours, or that come into contact with the mucus membrane of the eye.

Brands Must Act Now to Comply

MoCRA is being implemented in a staged manner, with the first requirements coming into effect on December 29, 2023. While brands have until 2025 to update their labels, production facilities must be registered by the end of 2023; meanwhile, adverse events reporting must start immediately. With FDA having new powers to regulate cosmetics, natural products companies in this space have a vested interest in coming into compliance with the new law as soon as possible.

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