DEA to Remove Import/Export Provisions of Hemp, FDA-Approved Products Containing CBD
The Drug Enforcement Administration will remove from its regulations the import and export provisions for FDA-approved products that contain cannabidiol (CBD), the agency said in a notice issued Aug. 20. The import and export provisions applied to “drug products in finished dosage formulations that have been approved by FDA and that contain CBD derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.” The DEA in 2018 classified the products in Schedule V of the CSA (see 1809270033), but because the products are no longer controlled, that listing is being removed, it said.
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The DEA looked at the cost savings involved from the change. “DEA analyzed its internal import and export data to identify the average number of permits issued for FDA-approved CBD products over a three year period beginning January 1, 2016 and ending December 31, 2018,” it said. During that time “there was an average of 52 import permits and one export permit issued per year, the elimination of which will result in an average annual cost savings of $1,814,” it said. The interim final rule only “conforms DEA’s regulations to the statutory amendments” to the Controlled Substances Act that were a result of the Agriculture Improvement Act of 2018. The CSA changes were already in effect and the interim final rule doesn't “add additional requirements to the regulations,” the agency said.
The DEA also did a similar analysis of the de-scheduling of hemp seeds that similarly removes import and export provisions (see 1904250029). During the three-year period, “there was an average of 88 import permits issued for hemp seed per year, and no exports,” the agency said. Based on that, “DEA estimates the average annual cost savings attributable to the elimination of import permits for hemp seed, and the elimination of annual registration renewals for hemp seed importers to be $3,225.”
Comments on the interim final rule are due Oct. 20.