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Talk to a SpecialistTalk to a SpecialistLeRoche Benicoeur, operating as ConceiveEasy, was cited for marketing an unapproved drug product containing homeopathic and herbal ingredients without proper FDA authorization. The company made disease claims on its website and social media stating the product treats infertility conditions including PCOS, luteal phase defect, and recurrent miscarriages, thereby establishing it as a drug under the Federal Food, Drug, and Cosmetic Act. These marketing claims for uses in the cure, mitigation, treatment, or prevention of disease violated FDA regulations, as the product had not been approved as a new drug before introduction into interstate commerce. The Federal Trade Commission jointly reviewed the company's website in coordination with FDA's March 2021 inspection.