FDA WARNING_LETTER - ICA Health, LLC/Future Formulations, LLC - September 20, 2021

The FDA issued a Warning Letter to Dr. Wilson regarding products sold on www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org. The FDA reviewed these websites in July 2021 and determined that Dr. Wilson’s Good Sugar, Dr. Wilson’s Super Immune Space Sprinkles, Dr. Wilson’s Cortisol Stress Reset, Dr. Wilson’s BFF, and Dr. Wilson’s Nat-Stim are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims establish their intent for use in the cure, mitigation, treatment, or prevention of diseases, including metabolic syndrome, diabetes, cardiovascular disease, anxiety, mood disorders, cognitive impairment, sleep problems, inflammation, depression, high cholesterol, high blood pressure, heart attack, stroke, pain, decreased immune function, alcoholism, addiction, autoimmune inflammatory reactions, bronchitis, pneumonia, respiratory infections, dental problems, fibromyalgia, herpes, hypoglycemia, rheumatoid arthritis, and the common cold.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their stated uses and lack prior FDA approval. Introducing or delivering them into interstate commerce without approval violates sections 301(d) and