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

03 Nov 2015

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.

Personal-care firms examining products' potential structure/function benefits via clinical trials need an Investigational New Drug exemption to ship product across state lines to study sites, according to reissued final guidance from FDA that reinterprets the definitional divide between cosmetics and drugs.

The agency's position, while not legally binding, stands to have a significant impact on the cosmetics sector, and likely the anti-aging skin- and hair-care segments most of all.

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