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Avoid An FDA Warning Letter: A Compliance Tool For Cosmetic Claims

This article was originally published in The Rose Sheet

Executive Summary

INFOGRAPHIC: The Rose Sheet’s compliance guide highlights the most challenging cosmetic products to market competitively without running afoul of FDA regulations and the riskiest types of claims a company can use at a time of intensive agency scrutiny.

The marketplace may be changing, but FDA’s stance on disease-treatment and body structure/function claims on cosmetic products is unwavering, with at least 18 warning letters issued to skin-care companies for claims violations over the past 13 months.

The below guide highlights claims, product types and even product names that can pose risks, potentially drawing unwanted FDA attention at a time of unprecedented enforcement activity.

A downloadable PDF version of the guide is available here with links to in-depth Rose Sheet coverage of recent warning letters and related enforcement trend analysis.


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