Recently, the FDA posted on the Federal Register seeking comments regarding World Health Organization international drug scheduling. With the help our our FDA attorneys at Amin Talati Upadhye, the US Hemp Roundtable submitted the following comments:
March 14, 2019
Division of Dockets Management
Food and Drug Administration
630 Fishers Ln, Rm 1061
Rockville MD 20582
Re: FDA-2019-N-0767-0001, 84 Fed. Reg. 7064 (Mar. 1, 2019); International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis; Request for Comments
To Whom It May Concern:
The U.S. Hemp Roundtable appreciates the opportunity to provide comments to the Food and Drug Administration (“FDA”) on the World Health Organization (“WHO”) recommendations regarding international manufacturing and distributing restrictions on certain drug substances, and in particular, WHO’s recommendation specific to cannabidiol (“CBD”) preparations and cannabis extracts and tinctures. We understand FDA will consider these comments in preparing the United States’ position on these substances during the United Nations Commission on Narcotic Drugs meeting (“CND meeting”) in March 2019.
The U.S. Hemp Roundtable is the hemp industry’s national business association that represents over fifty firms from across the country – at each link of the hemp supply and sales chain – and includes the membership of all of the industry’s major national grassroots organizations. We strongly urge FDA to recommend that the United States support WHO’s recommendation not to schedule CBD as an internationally controlled substance during the upcoming CND meeting. As explained below, the safety of CBD and its ability to improve public health are well established, and therefore FDA should continue to take actions that encourage continued access to CBD, in particular hemp-derived CBD. We also request that FDA support WHO’s recommendation to delete extracts and tinctures of cannabis from Schedule I of the 1961 Single Convention on Narcotic Drugs.
Hemp-Derived CBD and Low/Zero THC Cannabis Extracts and Tinctures Do Not Meet the Criteria for Controlled Substances
As stated in our previous comments to FDA related to this matter,1 CBD, whether derived from hemp or marijuana, is safe, has several health benefits, and does not meet the criteria to be a controlled substance. In addition, there is emerging scientific evidence suggesting that cannabinoids other than CBD, found in cannabis tinctures and extracts with low or zero THC, also have health benefits and low abuse and dependence potential, similar to CBD. We also support FDA’s statements regarding potential regulatory pathways for hemp-derived CBD as a food and dietary supplement ingredient.2 We encourage the agency to continue working with stakeholders such as the U.S. Hemp Roundtable to develop an appropriate framework that ensures the safety of CBD food and supplements while maintaining consumer access to these products.
As FDA is aware, during the 40th meeting of WHO’s Expert Committee on Drug Dependence (“ECDD”), the committee considered a critical review of CBD and ultimately concluded that because CBD does not have psychoactive effects, is not addictive, and is safe overall, CBD should not be scheduled within the International Drug Control Conventions.3 To give effect to this recommendation, the ECDD further recommended that a footnote be added to Schedule I of the 1961 Single Convention on Narcotic Drugs to read: “Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control.” The Roundtable supports this recommendation and encourages FDA to do the same, as it reflects FDA’s own position that CBD should not be a controlled substance.
In the FDA’s scheduling recommendation to the Drug Enforcement Administration (“DEA”) regarding Epidiolex, after conducting a thorough scientific analysis the agency concluded that CBD and its salts are safe and “do not have a significant potential for abuse and could be removed from control under the CSA.”4 Notably, after being advised by the DEA that federally de-scheduling CBD altogether would violate international treaty obligations, FDA recommended that CBD be placed in the least restrictive category, Schedule V. However, FDA further stated that CBD could be de-scheduled in the future if its treaty obligations no longer require control of CBD. We also believe FDA’s conclusions regarding the safety and low abuse and dependence potential of CBD apply to other low THC cannabis extracts, and we encourage FDA to recommend against the scheduling of these substances as well.
Clarification Regarding the Status of Hemp-Derived CBD Under the CSA
The Roundtable also seeks to clarify certain statements in FDA’s Federal Register notice with regard to the status of CBD under the Controlled Substances Act (“CSA”). Section III of the notice states the following:
“[t]he principal cannabinoids in the cannabis plant include THC, CBD, and cannabinol. These substances are controlled in Schedule I under 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.”5
While it is true that cannabinoids derived from marijuana may be Schedule I controlled substances, as FDA is aware on December 20, 2018 the President signed into the law the Agriculture Improvement Act of 2018 (“the 2018 Farm Bill”). The law removes hemp and hemp derivatives, extracts, and cannabinoids – including CBD – from the definition of “marihuana” in Schedule I of the CSA, provided that the THC concentration is not more than 0.3%.6 Thus, the notice fails to recognize that CBD derived from hemp is not controlled substance so long as it meets the requirements of the 2018 Farm Bill. Rather, it is a lawful ingredient that may be used in a wide array of products not subject to DEA jurisdiction.
Hemp–Derived CBD is a Permissible Dietary Ingredient
Finally, we would like to take this opportunity to reiterate our position that hemp-derived CBD is a permissible ingredient in dietary supplements, as well as other food products. Although FDA has taken the position that dietary supplements and food are precluded from containing CBD due to the clinical investigations and subsequent approval of Epidiolex,7 the Roundtable disagrees with the agency’s position and contends that hemp-derived CBD is in fact a lawful dietary ingredient under the Federal Food, Drug, and Cosmetic Act.
As noted above, the Roundtable appreciates FDA’s willingness to work with stakeholders to develop an appropriate framework for hemp-derived CBD as a supplement and food ingredient. Multiple studies have demonstrated that hemp-derived CBD is safe with little or no side effects, even at high dosages,8 and FDA’s own research confirms these findings. In addition, a growing body of scientific research demonstrates CBD’s potential benefits for a wide range of health conditions, including mild, self-treating conditions in otherwise healthy people.9 Given the well-established health benefits and safety of CBD, additional regulatory pathways for hemp-derived CBD would both improve public health and encourage additional scientific research into the benefits for healthy and non-healthy populations.
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In closing, the U.S. Hemp Roundtable requests that FDA support WHO’s recommendation not to schedule CBD as an internationally controlled substance, as both FDA and WHO have recognized the safety, health benefits, and lack of abuse potential of CBD. We also urge FDA to continue its efforts to develop an appropriate regulatory pathway for hemp-derived CBD as a food and dietary supplement ingredient. In addition, FDA should recommend against the scheduling of other low and zero THC cannabis extracts and tinctures given their promising health benefits and low abuse and dependence potential.
Thank you for the opportunity to comment on this matter, and we would be happy to answer any questions or discuss our comments with the agency in more detail.
Directors of the U.S. Hemp Roundtable:
Josh Hendrix, President, CV Sciences, San Diego, CA
Steve Bevan, Chair, GenCanna Global, Winchester, KY
Brandon Beatty, Executive Vice President, Bluebird Botanicals, Broomfield, CO
Graham Carlson, Executive Vice President, CW Hemp, Boulder, CO
Gabriel Ettenson, Executive Vice President, Elixinol, Broomfield, CO
Steven Thompson, Executive Vice President, Zilis, Plano, TX
Chuck Schnieder, Ananda Hemp, Cynthiana, KY
John Puckett, Barlean’s, Ferndale, WA
Brent Brunner, Koi CBD, Norwalk, CA
Christian Cypher, Pyxus, Raleigh, NC
Jay Hartenback, Medterra CBD, Irvine, CA
Mike DeGiglio, Village Farms, Fort Davis, TX
Chase Terwilliger, CBDistillery, Sheridan, CO
Tracy Miedema, Presence Marketing, Seattle, WA
Josh Zwagil, HempWorx, Las Vegas, NV
Robert Rosenheck, Lord Jones, Los Angeles, CA
Deborah Gestnor, CBD USA Grown, Coraopolis, PA
Jason Mitchell, MetaCan, Roswell, GA
Vince Sanders, American Shaman, Mission, KS
Michael Welch, Rocky Mountain High Brands, Dallas, TX
Steve Smith, Pet Releaf, Littleton, CO
Dylan Summers, Lazarus Naturals, Portland, OR
Jeff Williams, Williams Ranch Company, Fort Stockton, TX
Counsel to the U.S. Hemp Roundtable:
Jonathan Miller, General Counsel, Frost Brown Todd, Lexington, KY
Rend Al-Mondhiry, Senior Counsel, Amin Talati Upadhye, Washington, DC
To view the official submission, click here.