FDA WARNING_LETTER - Earth Turns, LLC - October 31, 2018

The FDA issued a Warning Letter to Earth Turns, LLC on February 5, 2019, following a review of their website (www.earthturns.com) in September and October 2018. The FDA determined that the products Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, and Fundamental Omega-3 are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and and Cosmetic Act.

The products are deemed drugs under section 201(g)(1)(B) of the Act because website claims, including those on specific webpages and metatags, and on their Facebook page, indicate they are intended for use in the cure, mitigation, treatment, or prevention of diseases such as Alzheimer's, memory improvement, stroke, and diabetes control.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use. As they are intended for diseases not amenable to self-diagnosis or treatment, they require supervision by a licensed practitioner, making