FDA WARNING_LETTER - Delta 8 Hemp - May 04, 2022

On May 4, 2022, the FDA issued a Warning Letter to Delta 8 Hemp after reviewing their website, delta8thc.market, in April 2022. The FDA determined that the company was selling unapproved new drugs and misbranded drugs, and adulterated food products containing Delta-8 THC.

The products, including "Delta 8 THC Distillate Oil," "Delta 8 THC Vape Cartridge," "Delta 8 THC Disposable Vape Pen," "Delta 8 THC Tincture," "Delta 8 Infused Gummies," and "Delta 8 Infused Sour Gummies," were deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act because they were marketed with claims indicating intended use for disease treatment, prevention, or to affect body structure/function (e.g., boosting immune system, reducing anxiety). These products are not generally recognized as safe and effective (GRASE) and lack FDA approval.

Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act as their labeling lacks adequate directions for use by a layperson, and they are not exempt from this requirement.

The "Delta 8 Infused Gummies" and "Delta 8 Infused Sour Gummies" were also found to be adulterated foods under section 402(a)(2)(C