FDA WARNING_LETTER - TEK Naturals - September 30, 2018

The FDA issued a Warning Letter to TEK Naturals, CEO Trevor Rose, on February 5, 2019, following a September 2018 review of their websites (www.burn4her.com, www.burnertek.com, www.mindignite.com, www.tekmale.com, www.testotek.com, www.teknaturals.com) and social media. The FDA determined that the products BURN4Her, BurnerTEK, Mind Ignite, TEK Male, and TestoTEK are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The violations stem from numerous therapeutic claims on their websites and social media, establishing the products' intent for use in the cure, mitigation, treatment, or prevention of diseases. Examples include claims for BURN4Her reducing heart disease risk and anxiety; BurnerTEK treating cancer, Parkinson's, and diabetes; Mind Ignite as an Adderall alternative for Alzheimer's, dementia, ADD/ADHD; TEK Male treating impotence and premature ejaculation; and TestoTEK fighting depression and regulating cholesterol. These claims render the products "new drugs" under section 201(p) of the Act, requiring prior FDA approval, which they lack.

Furthermore, the products are deemed misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson,