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Dr. Thomas Balshi/Intilight distributed an unapproved new drug product called "INTILIGHT INTIMATE LIGHTENING TREATMENT" containing 2% hydroquinone intended to bleach and lighten skin, violating section 505(a) of the FD&C Act. The product was also misbranded under section 502(ee) of the FD&C Act, as evidenced by labeling and website claims describing it as a "safe and effective" skin lightening treatment. The company marketed the product for purchase on its websites (intilight.com and southflderm.com) without FDA approval, introducing an unapproved drug into interstate commerce in violation of sections 301(d) and (a) of the FD&C Act.