Loading…
SkinPro distributed SKINPRO ULTRA BRIGHTENER HYDROQUINONE, an unapproved new drug intended for skin bleaching and lightening, in violation of section 505(a) of the Federal Food, Drug & Cosmetic Act. The product was also misbranded under section 502(ee) of the FD&C Act, as evidenced by marketing claims on the product label and company website describing it as a "maximum strength" skin lightener for eradicating dark spots and hyperpigmentation. The company introduced and delivered the product into interstate commerce without FDA approval, which is prohibited under sections 301(a) and (d) of the FD&C Act.