Where Do MoCRA and HCA Fall in the Landscape of Animal Cosmetics Testing?

By Breanne Kincaid | August 31, 2023

From drug stores to department store cosmetic aisles, flashy labels highlighting that products are “cruelty free” or “not tested on animals” abound. It’s clear that consumer sentiment is driving substantial change in animal testing practices, and state and federal governments appear to be getting on board. Last month, Health Canada announced a ban on the production and trade of cosmetics that have been tested on live animals. This is consistent with Europe’s earlier prohibition. Within the United States, New York recently followed nine other states in adopting similar provisions barring the sale of new cosmetic products tested on animals. But what about US federal law?

The December 2022 Modernization of Cosmetics Regulation Act, or MoCRA, represents the first major update to the U.S. Food and Drug Administration (FDA) authority to regulate cosmetic and personal care product safety since 1938. The law takes a tepid step in the same direction by explicitly affirming that animal testing is not required to demonstrate a product’s safety, but it does not ban the use of cosmetic animal testing in the US. In addition to updates on animal welfare, the new law requires cosmetic manufacturers to provide evidence that a product is safe, to track adverse health events, to promptly report serious health effects to the FDA, and to include fragrance allergen information on product labels. It also gives FDA the authority to suspend a manufacturing facility’s operations if the location is producing cosmetics that are causing serious adverse health effects.

This raises an important question: How can a manufacturer ensure that a cosmetic or personal care product and its constituent ingredients are safe without the use of animal testing? With relative ease, as it turns out. Part of the recent impetus for humane cosmetics legislation stems from the successful development, validation, and adoption of test methods that use cells or discarded tissues to establish safety. The FDA and other international regulatory bodies already accept numerous alternative test methods that effectively determine whether a cosmetic or ingredient is corrosive to the skin, dangerous to the eye, carcinogenic, disruptive to hormones, or acutely toxic – all without testing on live animals. For example, the EpiDerm Phototoxicity Test uses a cellular model of human skin in order to test whether products like sunscreen and lotion become toxic after exposure to UV light. EpiDerm is an organotypic model, which means it captures the structure and functionality of an organ (the skin), allowing researchers to observe how a chemical might affect the different parts of the skin’s outermost layer.

While MoCRA addressed a laundry list of weaknesses in FDA’s authority to ensure that cosmetics and personal care products are safe, another bill which has not yet been signed into law takes a more pointed approach. The Humane Cosmetics Act, last introduced in December 2021, would bring the US in line with Canada and the European Union by banning the production and sale of cosmetics that have been tested on animals. The proposed legislation also aims to promote the development and use of more alternative test methods, like EpiDerm, to increase domestic and global confidence in alternative methods for cosmetics testing.

Although MoCRA may not have been as aggressive as animal advocacy groups would have preferred due to the lack of a total ban on animal cosmetics testing, the acknowledgment that sound science can be achieved in the absence of animal testing is a positive step that paves the way for more pointed bills like the Humane Cosmetics Act. In the interim, FDA can and should continue developing best practice guidelines for alternative test methods in cosmetic and other safety submissions, such as by publishing its five-year delayed Predictive Toxicology Roadmap.

The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.