FDA Warns Pharmagel, Updates Webpage On Drug-Claim Violations
This article was originally published in The Rose Sheet
Pharmagel's name and billing as "pharmaceutical grade anti-aging skin care" may have drawn FDA's attention, but benefits cited in the agency's warning letter – including collagen- and elastic-building claims – are consistent with FDA's enforcement action against other companies so far in 2015.
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A key component of FDA’s enforcement strategy in the cosmetics space is monitoring companies’ websites for overreaching product claims and issuing warning letters accordingly. Examination of past offenders’ current sites and updated claims offers potential visibility into language the agency will and will not tolerate when it comes to promoting skin-care benefits.
A bill introduced in the House Nov. 18 would preempt state regulations governing safe cosmetic ingredient use and health-related labeling requirements, such as those under California's Prop 65 law, and revise the "cosmetic" definition under federal law to allow for limited use of structure/function claims.
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.