FDA Responds to Marijuana-Related Petition After More Than a Decade

FDA Responds to Marijuana-Related Petition After More Than a Decade

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The Food and Drug Administration (FDA) has finally responded to a marijuana-related petition after eleven years. After much deliberation, the agency finally decided to do it Reject a petition to exempt bulk marijuana and cannabis tinctures from regulated scrutiny under a long-standing federal law reported marijuana moment.

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

Mikuriya and McPike were hoping to be considered by an FDAC grandfather clause which provided exceptions for drugs manufactured before 1938. The petitioners asked for an administrative hearing to consider whether cannabis qualifies for the exemption, as they say the substance was promoted and sold in the US in the early 1900s.

Last week, the FDA finally got around to denying the petition, saying the petitioners “not demonstrated that you have a right to a fair hearing‘ and that they have not shown ‘that a formal hearing of evidence is in the public interest’. The Agency stressed that the cited exemption requires that a specific substance be classified as “certain finished medicinal products.” This means that Mikuriya and McPike would need to have a current marijuana product advertised between 1907 and 1938 to be taken “as a companion” and qualify for an exemption. Generic bulk cannabis and tinctures just don’t fit the definition.

Marijuana Moment asked the agency what it was like. An FDA spokesman responded that the agency “ “has many urgent priorities and we are doing our best to solve them in time.

“The referenced petition has raised significant issues that require full review and analysis by agency officials,” the spokesman said. “We…

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