FDA Responds To Marijuana-Related Petition After More Than A Decade, Procrastinate Much?

The Food and Drug Administration (FDA) finally responded to a marijuana-related petition after fully eleven years. After a good long think, the agency finally decided to reject a petition to exempt bulk marijuana and cannabis tinctures from regulated control under a long-standing federal statute, reported Marijuana Moment.

Back in September 2011, Dr. Beverly Mikuriya along with California attorney, William McPike submitted the request for an exemption under the federal Food, Drug and Cosmetic Act (FDAC) that would allow the marketing of bulk cannabis and tinctures without an approved “new drug” application.

Mikuriya and McPike were hoping to be considered under an FDAC grandfather clause that provided exemptions for drugs manufactured before 1938. The petitioners asked for an administrative hearing to consider if cannabis is suitable for the exemption in that the substance, according to them, was advertised and sold in the U.S. in the early 20th century.

Last week, the FDA finally got around to denying the petition, saying that the petitioners have “not demonstrated that you have a right to an opportunity for a hearing,” and that they had not shown “that a formal evidential hearing is in the public’s interest.” The agency highlighted that the exemption quoted demands that a given substance has been classified as “specific finished drug products.” This means that Mikuriya and McPike would have to show a current marijuana product that was advertised between 1907 and 1938 to be taken “as a companion” and be suitable for exemption. Generic bulk cannabis and tinctures just don't fit the definition.

Marijuana Moment asked the agency what took so. An FDA spokesperson replied that the agency “ “has many pressing priorities, and we do our best to resolve them in a timely manner.

“The referenced petition raised significant issues requiring extensive review and analysis by Agency officials,” the spokesperson said. “We responded publicly to the petition when we reached a decision on petitioners’ requests.”

The plaintiffs don’t plan to appeal the denial, because McPike believes that federal marijuana reform will come soon. 

Photo: Courtesy of Esteban Lopez on Unsplash