FDA Finally Rejects Petition For Federal Exemption For Marijuana More Than A Decade After It Was Filed
MJ moment
More than a decade after it was filed, the Food and Drug Administration (FDA) has finally rejected a petition to exempt bulk marijuana and cannabis tinctures from regulated control under a long-standing federal statute. In September 2011, FDA received the request from a doctor and an attorney from California, seeking an exemption under the federal Food, Drug, and Cosmetic Act (FDAC) that would allow bulk marijuana and tinctures to be marketed without requiring an approved “new drug” application. The petitioners specifically asked for an administrative hearing to consider their assertion that a “grandfather clause” in FDAC that provides exemptions for drugs produced before 1938 would apply to cannabis, which they said was actively marketed and sold in the U.S. in the early 20th century. FDA responded to the petition last week by denying it—a decition that took more than 11 years. That’s a fairly significant time-lapse for a nine-page response that essentially provided a statutory explanation to justify the denial. The agency said in its response letter that the petitioners have “not demonstrated that you have a right to an opportunity for a hearing,” nor have they demonstrated “that a formal evidential hearing is in the public’s interest.” A main part of the agency’s statutory interpretation is that the exemption cited by petitioners requires a given substance to have been classified as “specific finished drug products.” They therefore would have needed to prove that there is a current cannabis product that was marketed between 1907-1938 in order to “serve as a companion” that would make it eligible for an exemption. Generic bulk marijuana and tinctures don’t fit the bill, FDA said. Asked by Marijuana Moment why the review and response took over a decade, an FDA spokesperson said that the agency “has many pressing priorities, and we do our best…
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