Tag Archives cannabis

The U.S. Food and Drug Administration (FDA) has announced the availability of draft guidance that "outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and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.

The U.S. Food and Drug Administration has urged several sellers of products with cannabidiol (CBD) to stop marketing their products as able to treat or prevent COVID-19. The letters, sent by the Center for Drug Evaluation and Research (CDER), emphasize that “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” The targeted CBD Sellers—including Indigo Naturals, Native Roots Hemp, CBD Online Store and Nova Botanix LTD—market their products with claims ranging from “boosting the immune system” to providing stress relief “when everyone else is panicking.” The letters urge the companies to respond within 48 hours to a CDER COVID-19 Task Force email address.

Following the passage of the 2018 Farm Bill, which legalized the cultivation of hemp, cannabidiol (CBD) became the star ingredient of 2019, featured on its own as an oil or in food and beverages. The U.S. Food and Drug Administration (FDA) struggled to keep up with the hype; while CBD stayed in legal limbo, U.S. lawmakers and other public officials urged the agency to take action and create a legal framework for a burgeoning industry capitalizing on the popularity of CBD and its purported calming and healing effects. Several companies went too far in their marketing, however, according to the U.S. Food and Drug Administration's and Federal Trade Commission's warning letters focused on the claimed benefits of the product. The U.S. Department of Agriculture issued its interim final rule on hemp production in October, but the announcement drew hundreds of comments urging the agency to make pragmatic adjustments. Sens. Ron…

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.

The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have announced a joint warning letter sent to Rooted Apothecary LLC focused on the potential benefits that the company claimed its cannabidiol (CBD) products could provide. "The Agency continues to be concerned about the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA as is required by law and to protect the public health," the letter states. "There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD. Without this information, we are unable to ensure that these products will not cause harm to people who use them." The agencies warn that Rooted Apothecary is marketing unapproved drugs because it advertises its CBD-infused products as helping to diagnose, cure, mitigate, treat or prevent a number…

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