ICA Health, LLC/Future Formulations, LLC

Warning LetterClosed

Dr. James L. Wilson Owner/Manager ICA Health, LLC/Future Formulations, LLC 1340 E. 20th Street Tucson , AZ 85719-6710 United StatesIssued Sep 20, 2021Office of Human and Animal Foods Operations – Division West 4

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateSep 20, 2021

Product TypeDrugs

StatusClosed

Closeout LetterOct 24, 2023

Letter Details

Firm: ICA Health, LLC/Future Formulations, LLC
Location: Dr. James L. Wilson Owner/Manager ICA Health, LLC/Future Formulations, LLC 1340 E. 20th Street Tucson , AZ 85719-6710 United States
FEI Number: N/A
Country: United States
Issue Date: September 20, 2021
Issuing Office: Office of Human and Animal Foods Operations – Division West 4
Product Type: Drugs
Status: Closed
Closeout Letter: October 24, 2023

Summary

ICA Health, LLC/Future Formulations, LLC was warned for marketing five products (Dr. Wilson's Good Sugar, Super Immune Space Sprinkles, Cortisol Stress Reset, BFF, and Nat-Stim) as unapproved new drugs through their websites. The company violated the Federal Food, Drug, and Cosmetic Act by making disease claims that established these products as drugs—including claims that Good Sugar helps diabetics and metabolic syndrome patients, and listing hypoglycemic properties for ingredients like cinnamon, gymnema, and chromium. The FDA's review of www.icahealth.com, www.drwilsons.com, and www.adrenalfatigue.org conducted in July 2021 determined the products were intended for cure, mitigation, treatment, or prevention of disease, requiring FDA approval before marketing.

ICA Health, LLC/Future Formulations, LLC FDA Warning Letter, September 20, 2021