Immune & Genetics Protocols, LLC

Warning LetterOpen

William Denizard-Flores Manager Immune & Genetics Protocols, LLC 1655 SW 63rd ST RD Ocala , FL 34476 United StatesFEI 3017144189Issued Mar 30, 2021Office of Human and Animal Food Operations, East Division IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017144189.

Violations2

Issue DateMar 30, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Immune & Genetics Protocols, LLC
Location: William Denizard-Flores Manager Immune & Genetics Protocols, LLC 1655 SW 63rd ST RD Ocala , FL 34476 United States
FEI Number: 3017144189
Country: United States
Issue Date: March 30, 2021
Issuing Office: Office of Human and Animal Food Operations, East Division IV
Product Type: Drugs
Status: Open

Summary

Immune & Genetics Protocols, LLC was warned for marketing Immune Bio Green Cell as an unapproved new drug in violation of the Food, Drug, and Cosmetic Act. The company made disease claims on its website and social media stating the product could treat, mitigate, or prevent conditions including autism, asperger syndrome, diabetes type 2, and cancer-related side effects, thereby establishing the product as a drug requiring FDA approval before marketing. These claims—including assertions that the product could "attack malignant cells" and "activate the regeneration of pancreatic cells"—were made without the required new drug application or evidence of safety and effectiveness. The company was selling the unapproved product directly to consumers through its website at biogreencell.com.

Immune & Genetics Protocols, LLC FDA Warning Letter, March 30, 2021