miércoles, 6 de enero de 2016

FDA Law Blog - Cannabidiol Research and Mailing Marijuana Ads: Several Recent Developments

Posted: 05 Jan 2016 11:31 PM PST
By Larry K. Houck –
Several recent developments relating to cannabidiol and marijuana occurred over the past several weeks. We summarize them below:
One Step Forward for Cannabidiol Research
The Drug Enforcement Administration (“DEA”) announced that it has eased some of the regulatory requirements for FDA-approved clinical trials with cannabidiol (“CBD”). DEA, Press Release, DEA Eases Requirements for FDA-Approved Clinical Trials on Cannabidiol (Dec. 23, 2015). CBD is an extract of the marijuana plant and, like marijuana, is currently classified as a Schedule I controlled substance. However, CBD contains less than one percent tetrahydrocannabinol (“THC”), the active ingredient in marijuana, and thus, appears to have a very low potential for abuse. DEA has been considering for a number of years whether CBD should be descheduled based on its lack of abuse potential. Under current regulations, researchers must obtain a DEA registration and submit a research protocol to conduct clinical trials with CBD under a Food and Drug Administration (“FDA”) Investigational New Drug Application. 21 C.F.R. § 1301.18. Researchers submit a protocol with their DEA application indicating the quantity of CBD that they will use in their research. DEA’s recent action will allow a DEA-registered researcher who is granted a waiver to “readily modify their protocol and continue their research seamlessly” and obtain additional needed CBD. Prior to DEA easing the regulatory requirements, researchers who required additional CBD than what was initially approved had to submit a written request to modify their registration. Both DEA and FDA had to approve the modification request. DEA opined that the change “will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies.” DEA announced the action in a news release and by letter to DEA-registered CBD researchers.
Neither Snow Nor Rain Nor Gloom of Night . . . But Marijuana Ads?
As previously reported (here and here) both DOJ and the Treasury Department have emphasized that the federal government will not interfere with activities authorized under state marijuana laws and regulations except pursuant to several enforcement priorities where the federal government may still seek to enforce federal prohibitions on marijuana. A recent letter from the United States Postal Service (“USPS”) to Congress has made it clear that such enforcement priorities extend to using the U.S. mail for advertising marijuana sales.
In a December 15, 2015 letter responding to an inquiry from Senator Ron Wyden (D. Oregon), the USPS stated “that advertisements for the sale of marijuana are non-mailable.” Letter to the Honorable Ron Wyden, U.S. Senate, from Thomas J. Marshall, General Counsel and Executive Vice President (Dec. 15, 2015). The USPS Portland (Oregon) District Office had initiated the correspondence that led to the USPS national policy letter when it warned a local newspaper that material containing advertisements for marijuana sales are non-mailable and noted that the authority for enforcing the CSA “rests primarily” with DEA under DOJ. Mailpieces Containing Advertisements About Marijuana, United States Postal Service (Nov. 27, 2015). The USPS letter to Senator Wyden stated that marijuana is a Schedule I controlled substance under the federal CSA and the CSA prohibits persons from placing “in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule I controlled substance” and using the mail to facilitate committing an act or acts that constitute a felony under the CSA. The letter further states that this CSA provision expresses Congress’ judgment that the mail should not be used to transmit advertisements for the sale of marijuana even if permitted by state law. The USPS determination impacts newspapers and other publications who use the mail for delivery.
The letter notes that it has issued national policy that instructs Postmasters and Managers of Business Mail Entry that they do not have the authority to decide whether matter is non-mailable because of content and they cannot deny or exclude it from the mail. Instead, they should advise those mailing the non-mailable material about their obligation to comply with the CSA, and accept the material if the person mailing the material insists on mailing it. Postmasters and Managers of Business Mail Entry must follow the Postal Operations Manual and report mail “that appears non-mailable” to the local Inspection Service responsible for their facility. The matter will “be turned over to the responsible law enforcement agencies for investigation if appropriate.”
The USPS letter attempts to distinguish this action from recent amendments to the federal spending bills that prohibit DOJ and DEA from using funds to interfere with a state’s law authorizing the use, distribution, possession or cultivation of medical marijuana.  See e.g.Consolidated and Further Continuing Appropriations Act, 2015, H.R. 83, 113th Cong. § 538 (2014). The USPS letter opines that Congress’ decision to add that restriction in the 2015 federal appropriations act does not affect the agency’s view that marijuana sales advertisements are non-mailable under the CSA and that treating such advertisements as non-mailable “in no way prevents states from implementing their medical marijuana programs, because it does not inhibit the ability of state-sanctioned medical marijuana distributors to conduct their activities in accordance with state law. . .[r]ather, it simply clarifies that those distributors cannot use a federal instrumentality-the U.S. Mail-to solicit sales in contravention of federal law.”
The USPS decision does seem inconsistent with the current position of the DOJ and Treasury Department in regard to not interfering with state marijuana laws. However, one way to view the USPS decision is that the federal government is stating that while it will not interfere with state laws and regulations, they will also not allow a federal agency to be used to facilitate a state activity that is a violation of federal law and regulations. This is akin to a prohibition on allowing a state marijuana retail establishment on federal land. It also must be assumed that these restrictions would extend to advertisements for any marijuana-related products which are also prohibited under 21 U.S.C. § 863 prohibiting the sale of drug paraphernalia. Finally, it begs the question: Which law enforcement authority will receive and investigate reports of mailing publications advertising marijuana sales from the local USPS Inspection Service?

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