FDA WARNING_LETTER - Lifted Naturals - February 19, 2021

The FDA issued a Warning Letter to Sylvia & Tim Hall of Lifted Naturals, following a December 2020 review of their website, www.liftednaturals.com. The FDA determined that the company's "Mood Boosting Probiotic" product is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The 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 website indicating its intended use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims include statements on the product page, About Us page, and a blog post titled “How do Probiotics Support a Healthy Mood?”

As a "new drug" under section 201(p) [21 U.S.C. § 321(p)], the product lacks FDA approval for safety and effectiveness, violating sections 301(d) and 505(a) [21 U.S.C. §§ 331(d), 355(a)]. Furthermore, the product is misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] because it lacks adequate directions for