Tag Archives cannabis

The U.S. Department of Agriculture has released its final rule governing the cultivation of hemp, which will take effect March 22, 2021. The draft rule would have required hemp to be shown to contain less than 0.3% tetrahydrocannibanol (THC) on testing conducted within 15 days of harvest, a proposal that drew criticism from several parties. The final rule reduces some of the requirements, such as allowing 30 days to test and raising the negligence threshold to 1% rather than 0.5%. The rule also allows some flexibility for states to develop testing methods that take into account variables such as regional environmental factors.

The Court of Justice of the European Union (CJEU) has prevented France from banning the marketing of cannabidiol (CBD) "lawfully produced in another Member State when it is extracted from the Cannabis sativa plant in its entirety and not solely from its fibre and seeds." In its ruling, CJEU found that "CBD cannot be classified as a 'narcotic drug,'" and although France is "not required to demonstrate that the dangerous property of CBD is identical to that of certain narcotic drugs," the country "must assess available scientific data in order to make sure that the real risk to public health alleged does not appear to be based on purely hypothetical considerations. A decision to prohibit the marketing of CBD, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other Member States, can be adopted only if that risk appears sufficiently established."

The New York State Department of Health released proposed regulations that would govern cannabinoid hemp products. The regulations would establish licensing for cannabinoid hemp extractors, manufacturers and retailers and set limits on products permitted to be sold at retail. Food products would be limited at 25 mg of cannabinoids, and all cannabinoid hemp products would be required to bear labels listing the amount of cannabinoids in the product. "These regulations are the next step toward regulating the growing hemp industry in New York in a way that protects consumers and helps ensure the industry's long-term viability," said Governor Andrew Cuomo in a press release.

The Hemp Industries Association and RE Botanicals Inc. have filed a lawsuit challenging the Drug Enforcement Administration's (DEA's) interim final rule implementing changes to the scope of the agency's control over cannabis and tetrahydrocannabinol (THC). Hemp Industry Ass'n v. DEA, No. __ (D.C. Cir., filed September 18, 2020). "The DEA’s interim final rule clarifies that all hemp derivatives or extracts exceeding 0.3% THC shall remain Schedule I controlled substances," the industry group's press release states. "This could be interpreted to include intermediate hemp derivatives that temporarily exceed 0.3% during processing, but contain less than 0.3% in final products. As such, it improperly establishes the DEA’s authority over legal hemp activities, which is contrary to the plain language and intent of the 2018 [F]arm [B]ill." The plaintiffs argue that the DEA interim final rule was arbitrary and capricious and beyond the agency's jurisdiction, and they urge the court to hold the…

The U.S. Department of Agriculture has announced that it will provide an additional 30 days for public comments on the interim final rule (IFR) that established the Domestic Hemp Production Program. According to the announcement, "Comments are solicited from all stakeholders, notably those who were subject to the regulatory requirements of the IFR during the 2020 production cycle." The deadline for comments on the rule is October 8, 2020.

The U.S. Drug Enforcement Administration (DEA) has proposed a rule that would codify the legalization of hemp cultivation and related definitions passed in the 2018 Farm Bill into the Controlled Substances Act. The amendments include (i) modifying federal rules to state that "the definition of 'Tetrahydrocannabinols' does not include 'any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o'"; (ii) removing from Schedule V a "drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol [] derived from cannabis and no more than 0.1% (w/w) residual tetrahydrocannabinols"; (iii) removing import and export controls on these substances; and (iv) modifying federal rules by "stating that the definition of 'Marihuana Extract' is limited to extracts 'containing greater than 0.3 percent delta-9-tetrahydrocannabinol on a dry weight basis.'"

U.S. Sen. Chuck Schumer (D-N.Y.) has called on the U.S. Department of Agriculture (USDA) to "delay the issuance of a U.S. Domestic Hemp Production Program final rule until 2022 and allow hemp growers and producers across the country and in Upstate New York to continue to operate under the 2014 Farm Bill pilot program regulations until that time." Schumer's press release includes the letter he sent to Secretary Perdue. "[A]s industrial hemp farmers and businesses explore the full benefits of the 2018 Farm Bill, they have experienced serious difficulty integrating the Interim Final Rules into their operations. Particularly in the current COVID climate, I see many farmers and processors in New York struggle with incorporating these changes into the existing state Pilot Programs. In a time when farmers and producers struggle with economic uncertainty, the implementation of the Interim Final Rules will create costs without the support of offsetting revenues."…

The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance that "outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products." The agency will accept comments on the guidance until September 21, 2020.

The Texas Department of State Health Services has published a proposed rule that would regulate “the manufacture, distribution, and retail sale of consumable hemp and consumable hemp products in the State of Texas.” The rule details licensure for consumable hemp manufacturers or distributors; required testing to determine the presence or concentration of cannabinoids, THC, pathogens, pesticides and heavy metals; packaging and labeling requirements; and enforcement measures. The earliest possible date of adoption for the rule is June 7, 2020.

Several dispensaries of recreational marijuana in Massachusetts have filed a lawsuit alleging that Governor Charlie Baker exceeded his authority by classifying recreational-use marijuana retail establishments as non-essential while declaring medical-marijuana dispensaries and liquor stores as essential during a statewide shutdown to combat the spread of COVID-19. CommCan Inc. v. Baker, No. 2084CV00808 (Mass. Super. Ct., filed April 8, 2020). The complaint asserts that Massachusetts “seems to be the only state that has deemed medical marijuana essential but adult-use/recreational marijuana non-essential” and argues that California, Colorado, Illinois, Nevada and Washington classified both types of establishment as essential. The plaintiffs also include a Nantucket recreational-use dispensary and a war veteran who obtains marijuana from the dispensary for medical purposes because the nearest medical dispensary is more than an hour away. The court has reportedly denied an initial request for a preliminary injunction on the executive order.