U.S. Hemp Roundtable Calls for FDA to Deschedule CBD
By ElixinolNovember 2, 2018
This week, the U.S. Hemp Roundtable submitted a statement to the U.S. Food and Drug Administration (FDA), requesting they deschedule hemp-derived cannabidiol (CBD) extract on a national level.
“In our opinion, hemp-derived CBD is already exempted from the Controlled Substances Act in the 2014 Farm Bill’s pilot program regime, and would be permanently and explicitly exempted from the CSA by the Hemp Farming Act, which we are very optimistic will be passed as part of the 2018 Farm Bill,” the U.S. Hemp Roundtable said.
The statements come in response to the FDA’s request for input from the public on how they should respond to the World Health Organization’s (WHO) stance on CBD. In Sept. 2018, the WHO recommended that CBD and products like it be descheduled on an international level.
“Yesterday, the US Hemp Roundtable issued its formal comments,” the U.S. Hemp Roundtable went on to say. “We urged the FDA to strongly recommend that hemp-derived cannabidiol (CBD), as well as other low-THC hemp extracts, should NOT be treated as controlled substances under international law.”
In its Oct. 30, 2018 statement to the FDA, the U.S. Hemp Roundtable said “hemp-derived CBD is a permissible dietary ingredient under the Federal Food, Drug, and Cosmetic Act (“FD&CA”) because it falls under subsection (E) as a dietary substance for use by man to supplement the diet by increasing the total dietary intake, and/or subsection (F) as an extract of the botanical plant Cannabis sativa L.”
You can read the U.S. Hemp Roundtable’s full statement here.
This week, the U.S. Hemp Roundtable submitted a statement to the U.S. Food and Drug Administration (FDA), requesting they deschedule hemp-derived cannabidiol (CBD) extract on a national level.
“In our opinion, hemp-derived CBD is already exempted from the Controlled Substances Act in the 2014 Farm Bill’s pilot program regime, and would be permanently and explicitly exempted from the CSA by the Hemp Farming Act, which we are very optimistic will be passed as part of the 2018 Farm Bill,” the U.S. Hemp Roundtable said.
The statements come in response to the FDA’s request for input from the public on how they should respond to the World Health Organization’s (WHO) stance on CBD. In Sept. 2018, the WHO recommended that CBD and products like it be descheduled on an international level.
“Yesterday, the US Hemp Roundtable issued its formal comments,” the U.S. Hemp Roundtable went on to say. “We urged the FDA to strongly recommend that hemp-derived cannabidiol (CBD), as well as other low-THC hemp extracts, should NOT be treated as controlled substances under international law.”
In its Oct. 30, 2018 statement to the FDA, the U.S. Hemp Roundtable said “hemp-derived CBD is a permissible dietary ingredient under the Federal Food, Drug, and Cosmetic Act (“FD&CA”) because it falls under subsection (E) as a dietary substance for use by man to supplement the diet by increasing the total dietary intake, and/or subsection (F) as an extract of the botanical plant Cannabis sativa L.”
You can read the U.S. Hemp Roundtable’s full statement here.
WHO, FDA appear to agree on CBD
In Aug. 2018, the WHO’s Expert Committee on Drug Dependence said, “[CBD is] generally well-tolerated, with a good safety profile,” and that it “does not produce the effects that are typically seen with cannabinoids such as THC. It also failed to produce significant effects in a human study of abuse potential…”
Based on its findings, the committee recommended that CBD be descheduled worldwide.
Additionally, a letter released by the FDA in May 2018 suggested that the agency may be on the same page as the WHO.
“CBD is a cannabinoid with no significant affinity for cannabinoid receptors (CB1 or CB2),” the letter said.
In the letter, the FDA also said that if CBD were to be descheduled internationally, then the United States may follow.
The scheduling discussion pertains to CBD extracts containing 0.3% THC or more–not hemp CBD extract like that contained in Elixinol’s products.
The U.S. Hemp Roundtable says “any movement in de-scheduling CBD is good for the hemp industry at large.” As a proud supporter of their initiative, we agree.
In Aug. 2018, the WHO’s Expert Committee on Drug Dependence said, “[CBD is] generally well-tolerated, with a good safety profile,” and that it “does not produce the effects that are typically seen with cannabinoids such as THC. It also failed to produce significant effects in a human study of abuse potential…”
Based on its findings, the committee recommended that CBD be descheduled worldwide.
Additionally, a letter released by the FDA in May 2018 suggested that the agency may be on the same page as the WHO.
“CBD is a cannabinoid with no significant affinity for cannabinoid receptors (CB1 or CB2),” the letter said.
In the letter, the FDA also said that if CBD were to be descheduled internationally, then the United States may follow.
The scheduling discussion pertains to CBD extracts containing 0.3% THC or more–not hemp CBD extract like that contained in Elixinol’s products.
The U.S. Hemp Roundtable says “any movement in de-scheduling CBD is good for the hemp industry at large.” As a proud supporter of their initiative, we agree.
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