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.
Tag Archives hemp
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.
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 issued a consumer update on cannabidiol (CBD) products and other products containing ingredients derived from cannabis. The update clarified that FDA "is concerned that people may mistakenly believe that trying CBD 'can't hurt'" because the agency has "seen only limited data about CBD's safety and these data point to real risks that need to be considered." FDA warned that CBD may have potential to injure the liver, cause negative drug interactions and affect male reproductive health, safety risks the agency identified during its review for the drug form of CBD. FDA's update coincided with the release of several warning letters to CBD companies from the agency's Center for Drug Evaluation and Research. The letters warned companies that the language used to describe the benefits of CBD amounted to adulterated foods and misbranded drugs. Following the November 25, 2019, update, consumers filed several…
In a letter to the U.S. Department of Agriculture (USDA), Sens. Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) have requested changes to the interim final rule on hemp production. Wyden and Merkley, who co-wrote the legislation that legalized hemp farming, passed along feedback from Oregon farmers, researchers and regulators, according to a press release. The letter cites five key complaints: Testing within 15 days of harvest may be "an impossible obstacle for growers to overcome" because it is insufficient time, "particularly if there are a limited number of registered laboratories with sufficient expertise to perform the necessary tests"; The requirement to submit hemp to laboratories registered with the Drug Enforcement Administration (DEA) could "cause tremendous bottlenecks and unnecessary delays," and the 2018 Farm Bill only granted USDA and the Food and Drug Administration "sole regulatory authority over hemp production"; "The interim final rule introduced a new requirement, contrary to the…
Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture (USDA) has received more than 600 comments. The rule set limits for the amount of tetrahydrocannabinol (THC) that can legally be produced by the crop, and farmers have reportedly told the agency that the limit is unmanageable. One issue is that the regulations do not acknowledge a difference between Delta-9 THC and THC-A, according to a former hemp farmer interviewed by Law360 who also reportedly said he had never seen a test result as low as the limit set by USDA. Another possible issue is that the crop must be tested by a laboratory registered with the Drug Enforcement Administration, which may reduce the number of qualified firms to a single laboratory. Comments on the interim final rule will be accepted until December 31.
The U.S. Department of Agriculture (USDA) has issued an interim final rule "specifying the rules and regulations to produce hemp." The rule outlines provisions for USDA "to approve plans submitted by States and Indian Tribes for the domestic production of hemp" and "establishes a Federal plan for producers in States or territories of Indian Tribes that do not have their own USDA-approved plan." Under the rule, hemp producers must obtain licenses, maintain "information on the land on which hemp is produced," comply with procedures for testing tetrahydrocannabinol concentration levels and dispose of non-compliant plants. The rule took effect October 31, 2019, and the agency will accept comments until December 30, 2019.
12
