Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistBio Wellness 444 LLC was warned for selling unapproved new drugs—"Silver Bullet elite douche" and "Silver D elite douche"—in violation of the Federal Food, Drug, and Cosmetic Act sections 505(a) and 301(d). The products were marketed with disease claims and health benefit statements (including claims about colloidal silver relieving symptoms of viral and bacterial infections) on the company's website and Instagram, establishing them as drugs requiring FDA approval before commercial distribution. The FDA found no pre-market approval or authorization for these products, which were being sold directly to consumers without a prescription through interstate commerce channels.