New York Nutrition Company / American Metabolix

Warning LetterOpen

Jason Duran/Markus Trillsch Owners New York Nutrition Company / American Metabolix 1083 FM 812 Unit B Cedar Creek , TX 78612-3689 United StatesIssued Aug 31, 2021Division of Human and Animal Food Operations West III

View Letter

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

Violations1

Issue DateAug 31, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: New York Nutrition Company / American Metabolix
Location: Jason Duran/Markus Trillsch Owners New York Nutrition Company / American Metabolix 1083 FM 812 Unit B Cedar Creek , TX 78612-3689 United States
FEI Number: N/A
Country: United States
Issue Date: August 31, 2021
Issuing Office: Division of Human and Animal Food Operations West III
Product Type: Drugs
Status: Open

Summary

New York Nutrition Company / American Metabolix was cited for distributing unapproved new drugs and misbranded products, including Muscle Test, Banish, Ketogenic Diet Aid, and Keto Friendly Collagen, which made disease treatment and prevention claims (such as anti-cancer, sexual dysfunction, and breast cancer prevention) that classified them as drugs under federal law. The company also violated regulations by marketing Exile Euphoric Weight Loss, Exile Super Shock, Havok Hardcore, and Keto Pump products as adulterated drugs without FDA approval. The FDA's June 2021 website review identified these violations, and the warning letter was delivered via overnight mail in August 2021, requiring the company to cease introducing these products into interstate commerce for their claimed therapeutic uses.

New York Nutrition Company / American Metabolix FDA Warning Letter, August 31, 2021