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Humane Cosmetics Act Lacks FDA Assurance Regarding Alternative Methods

This article was originally published in The Rose Sheet

Executive Summary

Available non-animal tests for substantiating cosmetic safety "by all appearances are valid," but questions remain as to whether FDA agrees, according to EAS Senior Advisor John Bailey. In the absence of agency guidance on alternative methods and a defined pathway for regulatory acceptance, some industry members are hesitant to get behind the proposed Humane Cosmetics Act in the U.S., the former FDAer suggested in an interview.

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Humane Society Gears Up For Renewed Push Behind U.S. Animal-Test Ban

The Humane Society Legislative Fund is hopeful that the Humane Cosmetics Act will be another "success story" for the group, while continuing to question why industry hasn't gotten behind the legislation in greater force. In an interview, HSLF Executive Director Sara Amundson rejected concerns raised by industry stakeholders, maintaining that the legislation gives firms the opportunity to demonstrate their compliance with broader bans on cosmetic animal testing in other parts of the world.

U.S. Or China? Humane Cosmetics Act Could Force Multinationals To Choose

The draft Humane Cosmetics Act differs in its wording from the European Cosmetics Regulation in a way that could address what animal-rights groups see as an unintended loophole in the EU's marketing ban – namely, its applicability to cosmetic animal testing under third-country regulations. The U.S. proposal ostensibly would bar products and ingredients from market if they've undergone cosmetic animal testing anywhere in the world, posing a potential dilemma for multinationals with business in China, for example.

Industry May Lean On Outside Animal Data If Humane Cosmetics Act Passes

A ban on cosmetic animal testing in the U.S. would challenge companies' ability to ensure product safety as required by the Federal Food, Drug and Cosmetic Act, particularly with respect to safety-assessment components that can't be readily or confidently addressed by alternative methods. Companies facing liability risks may choose to borrow safety data for their ingredients derived via animal testing in other sectors to meet non-cosmetic regulatory requirements, TSG Senior Regulatory Consultant Bob Stewart suggests.

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