United States: DEA approves synthetic THC while natural THC remains illegal

The legalization of cannabis in the United States still holds a few surprises. On the eve of Thanksgiving, the DEA announced classify a synthetic THC, dronabinol, as a Schedule II controlled substance, which recognizes the medical potential of synthetic THC and allows it to become a federally prescribed medication.

Natural THC, on the other hand, remains classified as a Schedule I substance, implying that it is potentially dangerous and has no medical value.

Only the form of dronabinol approved by the Food and Drug Administration (FDA), namely Syndros by Insys, the manufacturer of fentanyl, is classified under Schedule II. All other forms remain under Schedule I.

«It should be noted at the outset that any form of dronabinol other than the product approved by the FDA remains a Schedule I controlled substance, and those who handle such material remain subject to regulatory controls, as well as to criminal, civil, and administrative penalties applicable to Schedule I controlled substances as set forth in the CSA and DEA regulations.»

The usage restrictions also give Insys the right to set the price of the product for its THC brand, which can range from 1,000 to 20,001 TP4T per month.

The DEA has received numerous comments, which are available online, criticizing the hypocrisy of authorizing synthetic THC while keeping natural THC in the most restrictive category, or suggesting that pharmaceutical companies are more interested in their profits than in patients’ well-being.

Insys has recently been in the spotlight due to the opioid epidemic plaguing the United States. Its flagship drug, Fentanyl—a synthetic opioid painkiller—is accused of causing patients to become addicted and leading to numerous overdoses, including those of Prince and, more recently, Lil Peep. In 2016, more than 20,000 people are believed to have died in the United States from an overdose of fentanyl or one of its analogs.

Insys has also spent 500000$ to support the campaign against cannabis legalization in Arizona.

Insys is currently preparing a synthetic form of cannabidiol for use in treating children. This oral spray is currently undergoing clinical trials with the FDA.