ICA Health, LLC/Future Formulations, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your websites, www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org establish these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.§ 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Dr. Wilson’s Good Sugar, Dr. Wilson’s Cortisol Stress Reset, Dr. Wilson’s BFF, and Dr. Wilson’s Nat-Stim products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Dr. Wilson’s Good Sugar, Dr. Wilson’s Cortisol Stress Reset, Dr. Wilson’s BFF, and Dr. Wilson’s Nat-Stim fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].