# FDA WARNING_LETTER - Essential Elements - November 17, 2022

Source: https://www.keypedia.com/records/warning_letter/essential-elements/ce9bf33d-e22f-4cbc-8d45-d8a2936255bb

> FDA WARNING_LETTER for Essential Elements on November 17, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Essential Elements
- Inspection Date: 2022-11-17
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Essential Elements Nutrition on November 14, 2022, following a review of their website (www.essentialelementsnutrition.com) in August 2022 and product listings on their Amazon storefront. The FDA determined that the company's CholestAid product is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The CholestAid product is deemed a "drug" under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] due to claims on the company's websites indicating its intended use in the cure, mitigation, treatment, or prevention of disease. As a "new drug" under section 201(p) [21 U.S.C. 321(p)], it lacks FDA approval, violating sections 301(d) and 505(a) [21 U.S.C. 331(d), 355(a)].

Furthermore, CholestAid is misbranded under section 502(f)(1) [21 U.S.C. 352(f)(1)] because it lacks adequate directions for use by a layperson, as it is intended for diseases requiring supervision by a licensed practitioner. Introducing

## Related Officers

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

Company: https://www.keypedia.com/companies/essential-elements/17e7cac1-dc88-4f2c-a41c-ea487549d131

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