Natural Hope Herbals, LLC – FDA Warning Letter, Jun 10, 2021

The FDA issued a Warning Letter to Natural Hope Herbals following a March 2021 review of their website, naturalhopeherbals.com. The FDA determined that the company sells supplement products, including Super Tonic, Respiratory Aid, Wild Cherry Honey Syrup, Ivy Oaky, Jewelweed Spray Combo Pack, Jewelweed Spray, Prostate Health, Kidney/Bladder, and Bone & Tissue Connect, with claims establishing them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The claims, found on product webpages and in newsletters, suggest the products are intended for the cure, mitigation, treatment, or prevention of disease. Examples include Super Tonic for "fighting possible infection," Wild Cherry Honey Syrup for "dry coughs," Ivy Oaky/Jewelweed Spray for "soothing summertime rashes" and "poison ivy and oak," Prostate Health for "decreased prostate function," Kidney/Bladder for "kidney stones" and "kidney infections," and Bone & Tissue Connect for "pain relief" and "healing" of bone and connective tissue. A testimonial for Respiratory Aid also indicated its use for "getting a bug."

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Furthermore, Prostate Health and Kidney/Bladder products