FDA WARNING_LETTER - Herbal Healer Academy, Inc. - November 09, 2018

On September 12, 2019, the FDA issued a Warning Letter to Herbal Healer Academy Inc. following an inspection from November 5-9, 2018. The inspection, product label/catalog review, and website review (www.herbalhealer.com) revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

The FDA identified numerous products, including HHA CMO, HHA Colloidal Silver, and HHA 4-Herb Tea, as unapproved new drugs and misbranded drugs. These products are marketed with therapeutic claims for disease treatment, cure, mitigation, or prevention (e.g., arthritis, cancer, infections), making them "new drugs" under section 201(p) of the Act, requiring prior FDA approval. Additionally, many are misbranded under section 502(f)(1) for lacking adequate directions for layperson use, as they are intended for conditions requiring professional supervision. Specific homeopathic products like Herbal Healer Parasite Detox and Cataract Drops are also deemed misbranded prescription drugs under section 503(b)(4) for not bearing the "Rx only" symbol.

Furthermore, the company's dietary supplements, including HHA 4-Herb Tea Bulk and HHA Colloidal Silver, are adulterated under section 402(g)(1) due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR