Modernization of Cosmetics Regulation Act grants FDA new authorities

05 Apr 2023 --- The Modernization of Cosmetics Regulation Act (MoCRA) was passed last December and is now providing the US Food and Drug Administration (FDA) with new authorities. This law is expected to ensure the safety of cosmetic products on the market.

The rules also apply to manufacturers of ingestible products for the nutricosmetic industry that are meant for “for internal use.” Beauty-from-within innovations are shifting to holistic health with a focus on the gut-skin axis and immunocosmetics.

MoCRA is touted to be the “most significant expansion” of the FDA’s authority for regulating cosmetics since the Federal Food, Drug and Cosmetic Act was passed in 1938.

People use approximately six to 12 cosmetics products daily, shares the FDA. As consumers use cosmetics every day, there is a need to ensure a further high-level safety that meets the most recent scientific knowledge.

“Examples of some of these products include makeup, nail polishes, shaving cream and other grooming products, perfumes, face and body cleansers, hair care products, moisturizers and other skincare products,” the FDA shares.MoCRA requires the industry to comply with regulations that the FDA will establish.

FDA’s new authorities
There are two central powers granted to the FDA, enabled by MoCRA.

Firstly, the MoCRA will allow the FDA to access and copy certain cosmetic product records, including safety records, if certain conditions are met.

In addition, the FDA now has the power to issue a mandatory recall if it deems that there is a “reasonable probability” for a cosmetic product to be adulterated or misbranded or if the exposure to the cosmetic will cause serious adverse health effects or death.

If the responsible person refuses to recall the batch voluntarily, the agency can issue a mandatory recall.

As MoCRA affords the FDA resources and authority to monitor brands in the personal care space and enforce recalls, it however does not provide legal definitions for “clean,” “natural,” or “green” beauty products, Amyris underscored.

New requirements for manufacturers and processors
Responsible persons are now required to report “serious adverse events” caused by the use of cosmetic products to the FDA within 15 business days of receiving the report. Additional information – medical information, for instance – must be sent to the agency within one year of the initial report.

For manufacturers and processors of cosmetics, MoCRA requires the registration of their facilities with the FDA, with a renewal of registration every two years.FDA now has the power to issue mandatory recalls.

Moreover, the FDA has been granted the authority to suspend a facility’s registration if the agency finds a cosmetic product manufactured or processed by the registered facility has a “reasonable probability” of causing serious adverse health consequences.

The FDA can also suspend a facility’s registration if it believes that other products manufactured or processed may be similarly affected – as the failure of one cannot be isolated from other products or if the case raises concerns about other products manufactured in the facility.

The consequence of a suspended registration is a prohibition from distributing or selling cosmetics in the US market from the facility.

New rules for the industry
Responsible persons must list all marketed cosmetic products with the FDA. They must also share product ingredients and annual updates.

For safety, responsible persons are now required to maintain records to support the safety claims of their products.

MoCRA also requires the industry to comply with regulations that the FDA will establish for good manufacturing practices (GMP), fragrance allergen labeling requirements and standardized testing methods for detecting and identifying talc-containing cosmetic products.

However, certain small businesses are exempt from GMP, registration and product listing requirements. This exemption does not apply to manufacturers or facilities producing or processing products that regularly come into contact with the mucus membrane of the eye, injectables, products for internal use or those that alter appearances for more than 24 hours (and is not removable by the consumer).

Additional exemptions exist for certain products and facilities subject to drug and device requirements.

In related news, after the Biden administration released the US budget for the 2024 fiscal year, the FDA requested a funding allocation of US$5 million from the total budget to modernize oversight of cosmetics.

By Venya Patel

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