FDA WARNING_LETTER - Apex Hemp Oil LLC - November 25, 2019

On November 25, 2019, the FDA issued a Warning Letter to JT Taylor of Apex Hemp Oil following an October 2019 review of their website, apexhempoil.com. The FDA identified several violations related to the marketing and sale of products containing cannabidiol (CBD).

The "Apex CBD Livestock Pellets," "Apex Organic K9 Oil," and "Apex CBD Dog Treats" were deemed unapproved new animal drugs, unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Claims like "help fight infection and inflammation" and "PAIN RELIEF" established their drug intent. These products lack FDA approval, conditional approval, or index listing, making their interstate commerce prohibited.

The "CBD Lip Therapy," "CBD Hemp Lotion," and "CBD Hemp Oil" were classified as unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. Claims such as "helps cells regenerate" and "answer for sore muscle aches" indicated their drug intent. These products are not generally recognized as safe and effective and lack FDA approval.

Furthermore, "CBD Chocolate Bar" and "CBD Hemp Protein Powder" were found to be adulterated under section 402(a)(2)(C)(i) and prohibited from interstate commerce under section 301