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

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.