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FDA Rulemaking Could Be Imminent On Investigational New Drug Requirements For Cosmetics, Dietary Supplements

Executive Summary

Are investigational new drug applications required for clinical trials conducted by cosmetics companies to evaluate potential body structure/function effects, or clinical studies undertaken by dietary supplement companies to support a new or expanded health claim? FDA said they are in final guidance reissued in late 2015 and now has rulemaking planned on the subject that could commence this month.

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FDA's Final IND Guidance Has Industry On Edge: What Happens Next?

It remains to be seen how industry responds to FDA's newly reissued final guidance advising firms to file Investigational New Drug applications for studies exploring would-be cosmetics' structure/function benefits, and how rigorously the agency enforces its position. Attorney Paul Hyman speculates that FDA could rely on INDs to reinforce its authority in the context of warning letters issued to cosmetics firms for unapproved drug claims.

FDA Stands Firm: Clinical Trials Exploring Structure/Function Effects Need IND

Despite industry's assertion that FDA is unlawfully reinterpreting statutory definitions under the Federal Food, Drug and Cosmetic Act, the agency's republished final guidance maintains that cosmetics evaluated for structure/function effects in clinical trials require Investigational New Drug go-ahead before being transported from one state to another. Anti-aging skin- and hair-care research could be impacted most.


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