FDA WARNING_LETTER - Nefeteri Wellness

On May 30, 2025, the FDA issued a Warning Letter to Nefeteri Wellness, specifically to owner Nerissa Irving, regarding the unapproved new drug products "LOTUS FRESH™ intimate/flora gel" and "LOTUS FRESH™ v-gel moisturize & balance." The FDA reviewed product labeling, including the company's website, thelotusfreshline.com, where these products are sold without a prescription.

The products are deemed "drugs" under sections 201(g)(1)(B) and 201(g)(1)(C) of the FD&C Act due to their intended uses, as evidenced by claims such as "fighting yeast and chronic bacteria vaginosis," "antimicrobial properties," "natural antibiotic that treats yeast infections, bacterial vaginosis, and vaginal itching," and "combat infections." Both products contain colloidal silver and are marketed for treating vaginal infections.

According to 21 CFR 310.548(b), any OTC drug product with colloidal silver promoted for disease treatment/prevention is considered a new drug requiring an approved application under section 505 of the FD&C Act. Nefeteri Wellness has no such FDA-approved applications for these products. Therefore, "Intimate/flora gel" and "V-gel" are unapproved new drugs, violating sections 505(a) and 301(d) of