MoCRA: Updates to FDA Safety Substantiation Requirements

Husch Blackwell LLP

MoCRA makes safety substantiation mandatory for cosmetics companies. Pursuant to MoCRA’s Section 608, the responsible person is required to “adequately substantiate” that a cosmetic product is safe and maintain associated records to support such representations. Safety substantiation documentation must be available by December 29, 2023 when MoCRA’s new requirements go into effect.

Safety substantiation is not a new concept for the cosmetic industry. In the past, under 21 C.F.R. § 740.10(a), all cosmetic product ingredients and finished cosmetic products had to be adequately substantiated for safety prior to marketing. Products that did not meet this requirement were deemed misbranded. However, 21 C.F.R. § 740.10(a) did not explicitly require cosmetics companies to conduct safety substantiation. Rather, in lieu of safety substantiation, it allowed cosmetic manufacturers to label cosmetic products with the disclaimer “Warning – the safety of this product has not been determined.” MoCRA removes this option and directly requires companies to substantiate the safety of each of their cosmetic products.

MoCRA’s requirements regarding documentation of safety substantiation are also new. Under Section 608, the responsible person must maintain safety substantiation records. In practice, MoCRA makes product safety information more accessible to the FDA regulators, and it makes the review and testing of cosmetic safety a common requirement in the industry.

What is “safe”?

Pursuant to MoCRA, a product is “safe” if it is “not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.” 21 U.S.C. § 364d(c)(2). However, a cosmetic ingredient or cosmetic product is not injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. The responsible person must make the final determination of safety, despite the fact that the ultimate decision of whether a cosmetic product or ingredient is safe is left with the FDA. To determine safety, the impact of cumulative or other relevant exposure to a given cosmetic product or any of its ingredients may be considered.

What is “adequate substantiation of safety” and how to comply?

Neither MoCRA nor the existing regulations state exactly how a cosmetic company can substantiate that a product or ingredient is safe. However, MoCRA encourages the responsible persons to put products through the requisite tests, studies, research, and/or analyses to “support a reasonable certainty” of safety.

While a “reasonable certainty” of safety may seem like a daunting standard, we anticipate that the safety substantiation methods that the FDA had recognized prior to MoCRA will remain valid under the new system. Note that the FDA continues to support “the development and use of alternatives to whole-animal testing as well as adherence to the most humane methods available within the limits of scientific capability when animals are used for testing the safety of cosmetic products.” While the FDA accepts toxicological test data on cosmetic products and ingredients as a viable means of safety substantiation, the FDA also recommends that manufacturers use available safety data on individual ingredients or products with similar formulations. Often, ingredient suppliers can provide cosmetic companies with safety information for individual cosmetic components. Manufacturers can also consider information from scientific sources such as PubMed.

Cosmetics companies should brace themselves for increased scrutiny surrounding safety substantiation in the post-MoCRA world. The regulatory ambiguity around the concepts of “safety” and “adequate safety substantiation,” coupled with the new recordkeeping requirements, may bring forth new allegations that products are not safe. Companies can prepare for this by reviewing their safety substantiation practices and working with ingredient suppliers now to ensure they are compliant with available guidance.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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