FDA WARNING_LETTER - Bio Wellness 444 LLC - June 10, 2025

On March 10, 2025, the FDA reviewed the product labeling and social media (Instagram) for "Silver Bullet elite douche" and "Silver D elite douche" drug products, available for purchase on biowellness444.com. The FDA determined that these products are unapproved new drugs, marketed and introduced into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). The products are considered "drugs" under section 201(g)(1)(B) and/or 201(g)(1)(C) due to claims indicating intended use for disease treatment (e.g., bacterial vaginosis, yeast infections) and affecting body function, as evidenced by website content, product labels, and Instagram videos. As OTC colloidal silver-containing products promoted for disease treatment, they are deemed new drugs requiring an approved application under section 505 of the FD&C Act and 21 CFR 310.548(b). No such FDA approvals are in effect. The firm is required to notify the FDA in writing within 15 working days of receipt of the letter, detailing specific corrective actions taken to address these violations and prevent recurrence, along with supporting documentation. Failure to adequately address these concerns may result in legal action, including seizure and injunction.