FDA WARNING_LETTER - Essential Elements - November 17, 2022

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