FDA WARNING_LETTER - Enlifta, LLC - February 19, 2021

The FDA reviewed www.enlifta.com in December 2020 and February 2021, observing that it directs customers to Amazon pages for "Enlifta Mood Elevator" and "Enlifta Anxiety" products. The FDA determined that claims on the websites and Amazon pages, including testimonials, establish these products as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] due to their intended use in the cure, mitigation, treatment, or prevention of disease.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].

Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] as they lack adequate directions for use by a layperson. Since they