It is the position of the United States of America to oppose the recommendation of the World Health Organization regarding the re-scheduling of Cannabis products at the United Nations before the Commission of Narcotics and Drugs on Monday March 18th, 2019 in Vienna Austria. This is contrary to the popular vote of American Citizens in 30 states and, the passage of the Farm Act law by congress in 2018.
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Your voice is needed to tell your representative at the United Nations about how you feel that the United States of America should vote YES on all recommendations by the World Health Organization to reschedule Cannabis including plants and extracts. This vote will direct the legislators in Washington DC to remove Cannabis from the Controlled Substances Act by making House Resolution 420 the law.
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Please make your comments and upload supporting files to the FDA before March 14th, 2019 11:59pm EDT by using this link. (Click Here to Enter your Comments) due by Thursday March 14th, 2019 @ 11:59p Eastern Standard Time
Tell your US/UN Representative to vote YES vote on Agenda Item 9(a) at 62nd Session 3/18/2019 from 3-6pm. Findings of the UN Social and Economic Council Committee
Agenda of the United Nation Office of Drugs and Crime Commission on Narcotics and Drugs 62nd Meeting in Vienna Austria
Thank you,
Cannabis Across Borders
The Official Position of the United States of America regarding Cannabis
At this time, it is uncertain whether the above notification from WHO of recommendations for proposed scheduling action on cannabis and cannabis related substances will be acted upon by 62nd session of the Commission on Narcotic Drugs (from 14 to 22 March 2019). The Bureau of the 62nd Commission is currently considering whether to postpone voting on the cannabis-related recommendations until the reconvened meeting in December, or the 63rd session of the Commission on Narcotic Drugs, March 2020. If voting is deferred to a later date the comment period will be reopened.
Although WHO has made specific scheduling recommendations for each of the drug substances, the CND is not obliged to follow the WHO recommendations. Options available to the CND for substances considered for control under the 1971 Psychotropic Convention include the following: (1) Accept the WHO recommendations; (2) accept the recommendations to control but control the drug substance in a schedule other than that recommended; or (3) reject the recommendations entirely.
Cannabis, also known as marijuana, is a plant known by biological names Cannabis sativa or Cannabis indica. It is a complex plant containing multiple cannabinoids and other compounds, including the psychoactive substance THC and other structurally similar compounds. Cannabinoids are defined as having activity at cannabinoid 1 and 2 (CB1 and CB2, respectively) receptors. Agonists of CB1 receptors are widely abused and are known to modulate motor coordination, memory processing, pain, and inflammation, and have anxiolytic effects. Marijuana is the most commonly used illicit drug in the United States.
The principal cannabinoids in the cannabis plant include THC, CBD, and cannabinol. These substances are controlled in Schedule I under the CSA. The synthetically derived single pure stereoisomer, delta-9-tetrahydrocannabinol (also known as dronabinol) is the active ingredient in two approved drug products in the United States, MARINOL (dronabinol) capsules, also available as a generic, and SYNDROS (dronabinol) oral solution. MARINOL is controlled in Schedule III, while SYNDROS is controlled in Schedule II under the CSA. Both MARINOL and SYNDROS are approved to treat anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional treatment.
CBD is another cannabinoid constituent of the cannabis plant. In the United States, one CBD-containing product, Epidiolex oral solution, has received marketing approval by the FDA for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older. On September 28, 2018, the Drug Enforcement Administration placed FDA-approved product Epidiolex to be marketed into Schedule V of the CSA. Currently, CBD that is not contained in an FDA-approved product with less than 0.1 percent THC is controlled as a Schedule I substance under the CSA. CBD is not specifically listed in the schedules of the 1961, 1971, or 1988 International Drug Control conventions.
FDA, on behalf of the Secretary of HHS, invites interested persons to submit comments on the notifications from the United Nations concerning these drug substances. FDA, in cooperation with the National Institute on Drug Abuse, will consider the comments on behalf of HHS in evaluating the WHO scheduling recommendations. Then, under section 201(d)(2)(B) of the CSA, HHS will recommend to the Secretary of State what position the United States should take when voting on the recommendations for control of substances under the 1971 Psychotropic Convention at the CND meeting in March 2019.
Comments regarding the WHO recommendations for control of Cannabis and Cannabis Resin; Dronabinol (delta-9-tetrahydrocannabinol); Tetrahydrocannabinol (Isomers of delta-9-tetrahydrocannabinol); Extracts and Tinctures of cannabis; Cannabidiol Preparations; Preparations Produced Either by Chemical Synthesis or as Preparation of Cannabis; under the 1961 Single Convention will also be forwarded to the relevant Agencies for consideration in developing the U.S. position regarding narcotic substances at the CND meeting.
Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03662 Filed 2-28-19; 8:45 am]
BILLING CODE 4164-01-P
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