FDA Guidance Could Impose Drug-Like Burden On Cosmetic Trials
This article was originally published in The Rose Sheet
An FDA guidance document intended to clarify if firms conducting certain drug studies involving human subjects are obligated to file Investigational New Drug Applications instead raises questions for the cosmetics industry.
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By misstating elements of the U.S. Food, Drug and Cosmetic Act, FDA’s guidance on Investigational New Drug applications is in violation of the law, the Personal Care Products Council’s legal head says. FDA surprised stakeholders by including IND requirements for cosmetics in a final guidance released in late 2013, subsequently opening the section up for comments, which were due April 7.
Comments may be submitted through April 7 regarding cosmetics-related sections in an FDA guidance that could impose the costs and burden of Investigational New Drug application on beauty companies conducting clinical trials. More news in brief.
A proliferation of “extreme” anti-aging cosmetic claims that crossed the line into drug territory led to FDA’s cluster of warning letters in 2012, according to Jennifer Thomas, director of the division of enforcement in the Center for Food Safety and Applied Nutrition’s office of compliance,