Eagles Song Health and Wellness LLC – FDA Warning Letter, Oct 28, 2020

The FDA issued a Warning Letter to Mr. and Ms. Zellers, operating Eagles Song Thrive Cafe, after reviewing their website, www.eaglessongthrivecafe.com, in August and October 2020. The FDA determined that the products Greens Hornet Tonic Alchemy, Senior Sage, and Organic Cacao Paste are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims indicate they are intended for disease cure, mitigation, treatment, or prevention. Examples include claims for Greens Hornet Tonic Alchemy regarding "Reversal of Type II Diabetes," "Allergies," "Migraine Headaches," "Cholesterol Lowering," and "Blood Pressure Lowering," and that "Disease won't thrive in an alkaline body." Specific ingredients like Reishi Mushroom, Olive Leaf, and Spirulina are also associated with various disease treatments. Senior Sage is marketed for "Inflammation (Protection from Disease)," and Organic Cacao Paste for "Reduces the Risk of Stroke and Risk of Heart Attacks" and acting as an "Anti-Depressant."

These products are considered "new drugs" because they are not generally recognized as safe and effective for their intended uses, requiring prior FDA approval. Furthermore, Greens Hornet Tonic Alchemy and Organic Cacao Paste are misbranded as they lack adequate directions for use by a layperson, being intended for conditions requiring professional supervision.

The letter requires a written response within fifteen working