# FDA WARNING_LETTER - Advanced Nutritional Supplements LLC - May 09, 2022

Source: https://www.keypedia.com/records/warning_letter/advanced-nutritional-supplements-llc/d88e88e0-c858-4c0b-9867-8f2008169c28

> FDA WARNING_LETTER for Advanced Nutritional Supplements LLC on May 09, 2022. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Advanced Nutritional Supplements LLC
- Inspection Date: 2022-05-09
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: This FDA Warning Letter addresses products labeled as dietary supplements: New God of Rage, God of War, New God of Fire, Legion: Extreme Fat Burner, Laxovar: Natural Recomposition, and Uprising: Natural Testosterone Support. The letter states that introducing or delivering these products into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are adulterated dietary supplements.

The core violation is that the products contain ingredients declared as dietary ingredients (higenamine HCl, hordenine HCl, and 5-alpha-hydroxy-laxogenin) that do not qualify as such under section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)]. Since these are not dietary ingredients, they are considered non-dietary ingredients. Non-dietary ingredients are subject to food additive regulations and must be generally recognized as safe (GRAS) or approved as a food additive. The FDA states that higenamine HCl, hordenine HCl, and 5-alpha-hydroxy-laxogenin are not GRAS for their intended use in these products.

Therefore, the products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)] because they contain

## Related Officers

- [Director](https://www.keypedia.com/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)

Company: https://www.keypedia.com/companies/advanced-nutritional-supplements-llc/5b6c4817-8c8e-4c57-9c2c-6372134f9f51

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2