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Pot Mouth Spray Seeks FDA Approval

By Stephanie Rabiner, Esq. on January 24, 2012 | Last updated on March 21, 2019

GW Pharmaceuticals, a British company, has asked the Food and Drug Administration to approve a pot mouth spray -- the world's first marijuana-based prescription drug.

The spray, called Sativex, contains THC and cannabinoids. These chemicals are said to have anti-inflammatory, anticonvulsant and anti-tremor properties. They also stimulate appetite.

Sativex is currently available in Canada, New Zealand and 8 European countries. But marijuana is illegal in the United States.

Can the pot mouth spray be approved?

Marijuana is classified as a Schedule I drug under the Controlled Substances Act. Schedule I drugs have a high potential for abuse and no currently accepted medical use.

The Food and Drug Administration, along with the Drug Enforcement Administration, is tasked with deciding how to classify drugs. Reclassification must be backed by scientific and medical evidence.

The FDA's scientific and medical findings are binding on the DEA. Arguably, this means marijuana must be reclassified if the FDA decides the drug has medical benefits. This would need to happen before the agency approves the pot mouth spray.

Unfortunately for GW Pharmaceuticals, this chain of events is unlikely to materialize anytime soon.

Despite contrary studies, the FDA has continually held that marijuana has no medical benefit. In July 2011, the DEA refused to reclassify marijuana, reports ABC News. It, too, claimed the drug currently has no medical use.

It is this line of thinking that makes approval of the pot mouth spray improbable. The FDA and DEA have the power to reclassify marijuana, but they won't.

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