Under the European Cosmetics Regulation, cosmetics by definition can “protect” parts of the body and “keep them in good condition,” which provides latitude for structure/function claims that firms do not have in the U.S. While there is interest, particularly among multinationals, for similar license in the states, the tradeoff could be more burdensome requirements for efficacy and safety substantiation that smaller companies could not support.
Hypothetically, harmonizing the U.S. definition of a cosmetic with that in the European Union could result in fewer FDA warning letters and potentially benefit consumers, but increased leeway for product claims likely would come at a cost to small businesses.
Recent warnings issued to cosmetics manufacturers in the states largely have centered on benefit claims that define recipients’ products as...