FDA WARNING_LETTER - Dherbs.com

The FDA reviewed Dherbs.com's website and determined that seven products ("Astragulus-Goldenseal-Echinacea (extract)," "Full Body Detox Kit," "Prostate Formula," "Oxy-Drops," "Parasite and Worm Kit & Regimen," "Bio Insulin," and "Female Breast Oil") are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The therapeutic claims, including those in personal testimonials and metatags, establish their intent for use in the cure, mitigation, treatment, or prevention of disease, violating the Act.

These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their promoted uses. They lack prior FDA approval required by section 505(a). Additionally, the products are misbranded under section 502(f)(1) as their labeling fails to bear adequate directions for use.

The letter states that the listed violations are not exhaustive, as numerous other unlawful disease treatment and prevention claims were observed. Dherbs.com is responsible for ensuring compliance with the Act and its regulations. The FDA requires prompt corrective action to address these violations and prevent recurrence. Failure to comply may result in enforcement actions, including product seizure and injunctions. Dherbs.com must respond in writing within fifteen working