FDA WARNING_LETTER - Herbal Hope, Inc.

The FDA reviewed Herbal Hope, Inc.'s website, herbalhope.net, and determined that products Restoration, Real Relief, Invigorate, Breathless, and Immunity are promoted for conditions that classify them as drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). Therapeutic claims on the website, such as "A powerful diabetes drink" for Restoration and "potent anti cancer drink" for Invigorate, establish their drug intent for disease treatment or prevention.

These products are not generally recognized as safe and effective for their claimed conditions, making them "new drugs" under section 201(p) of the Act. They are illegally marketed without prior FDA approval, which requires scientific data demonstrating safety and effectiveness.

Furthermore, the website displays a Certificate of FDA Registration alongside products, misleadingly suggesting FDA approval or sanction. This misbranding violates section 502(a) of the Act for the drug products and section 403(a)(1) for dietary supplements E2, Weighin, Flush It, Sexual Energy Drink, and Wellness.

Herbal Hope, Inc. must take prompt action to correct these violations and prevent recurrence. Failure to comply may result in enforcement actions, including product seizure and injunctions. A written response detailing corrective steps is required within fifteen working days to Quyen Tien, Compliance Officer.