ALCOHOL LAW ADVISOR
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
ALCOHOL LAW ADVISOR
Regulatory and Distribution Law Updates for the Alcohol Industry
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If the DEA Does Not Quickly Reexamine Marijuana’s Classification Under the Controlled Substance Act, the Second Circuit Might

“Plaintiffs claim that marijuana has extended their lives, cured seizures and made pain manageable. If true, these are no small things.” So wrote Judge Calabresi on behalf of the United States Court of Appeals for the Second Circuit (Second Circuit) in Washington, et al. v. Barr, et al. In Washington, a coalition of plaintiffs launched a broad attack on marijuana’s status as a Schedule I drug under the Controlled Substances Act (CSA). The plaintiffs include the parents of infants Alexis Bortell and Jagger Cotte. According to the plaintiffs’ allegations, Alexis Bortell suffers from chronic, intractable seizures, and Jagger Cotte suffers from Leigh’s disease, a progressive neurometabolic disorder characterized by necrotizing (dead or dying tissue) lesions on the brain. After exhausting traditional treatment options, the children found relief with medical marijuana. The plaintiffs also include Jose Belen, an Iraq war veteran who suffers from post-traumatic...

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Learnings from the FDA Hearing on Cannabis and Cannabis-Derived Compounds

On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health benefits associated with cannabis products. More than 110 speakers, including academic researchers, trade associations and cannabis product manufacturers, presented to the FDA panel during the all-day hearing. Below we outline the notable points from the hearing, including statements by FDA officials and interesting speaker comments. This hearing must be viewed as part of the FDA’s information-gathering process. The agency made no pronouncements regarding its regulatory approach toward cannabis and cannabis-derived compounds. In announcing this hearing in early April, former Commissioner Scott Gottlieb cautioned that the questions surrounding possible legal pathways for cannabidiol (CBD) and other cannabis-derived compounds will take...

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USDA Issues Opinion on Several Hemp-Related Provisions of the 2018 Farm Bill

On May 28, 2019, the United States Department of Agriculture (USDA) issued a legal opinion to address questions raised by several hemp-related provisions of the Agricultural Act of 2018, better known as the 2018 Farm Bill. The USDA opinion clarifies four areas of the 2018 Farm Bill: the removal of hemp as a controlled substance and schedule I drug became effective upon enactment of the 2018 Farm Bill; following the publication of implementing regulations, states and Indian tribes cannot prohibit interstate transportation and shipment of hemp and hemp-based products, and the USDA confirmed that this preemption also covers hemp produced under the 2014 Farm Bill; pending certain exceptions, individuals with certain controlled substance felony convictions will be barred from producing hemp; and following the enactment of the 2018 Farm Bill, states and Indian tribes still retain the ability to regulate hemp production, including the ability to grow or cultivate...

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CDC and SAMHSA to Hold Summer Meetings for Public Health and Marijuana

The Centers for Disease Control (CDC) and Substance Abuse and Mental Health Services Administration (SAMHSA) announced meetings to be held this summer related to public health and marijuana. The CDC’s Board of Scientific Counselors will convene for a two-day meeting, July 16–17, 2019, to discuss a wide variety of topics, including the role of the CDC’s National Center for Injury Prevention and Control in “addressing public health concerns related to marijuana.” This portion of the meeting will be held on July 17, will be open to the public and will allot 15 minutes for public comments at the end of the session from 3:40–3:55 pm on July 17, 2019. As described in the Federal Register notice of the meetings, the Board of Scientific Counselors conducts and assists other appropriate public health authorities, scientific institutions and scientists in the conduct of research, investigations, demonstrations and studies relating to the causes, diagnosis, treatment,...

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TTB’s Take on Alcohol Beverages Infused with Cannabidiol

On April 25, 2019, TTB published Industry Circular 2019-1. It addresses the hot topic of alcohol beverages (especially beer) infused with hemp-derived ingredients–with cannabidiol (CBD) as the clear focus of industry interest. While hardly surprising, the Industry Circular takes or reiterates the following positions: TTB will require a formula for any product containing a hemp-derived ingredient TTB will not approve a formula for any product containing a Schedule I controlled substance under the Controlled Substances Act TTB will not approve a formula for any product containing CBD until FDA changes its current position towards CBD as a food ingredient. FDA currently views interstate commerce in any food containing CBD as a violation of the federal Food, Drug & Cosmetic Act TTB will continue to approve formulas for alcohol beverages containing ingredients derived from hemp seeds and hemp oil TTB will not approve a formula for any product containing a hemp...

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Congress Can Open Financial Institutions to Legal Cannabis Industry with SAFE Banking Act

Federal statutes create risk for banks that want to operate in the cannabis space. Banks face the threat of civil actions, asset forfeiture, reputational risk, and even criminal penalties if they do business with customers in the cannabis industry. Further, because most banks will not touch cannabis money, the growers, processors, and retailers in the industry must often operate on a cash-only basis. The Internal Revenue Service has even had to build “cash rooms” to accommodate taxes paid by legal cannabis companies. Access the full article.

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Interstate Hemp Transportation: A Cautionary Tale

Unlike hemp, marijuana still is subject to state statutes and the federal Controlled Substances Act. The legal distinction between hemp and marijuana is too subtle for the human eye, or a trained K-9’s impressive nose, and it has created a quandary for interstate hemp shippers. Until federal law clarifies interstate commerce laws pertaining to hemp, producers should reconsider transporting hemp through less-receptive states. Access the full article.

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FDA Releases Warning Letters to CBD and Hemp Oil Companies

Last week the Food & Drug Administration (FDA) made public three new warning letters to Cannabidiol (CBD) and hemp oil product companies sent by FDA and the Federal Trade Commission (FTC). FDA has previously targeted cannabis product companies. The new warning letters are consistent with FDA Commissioner Scott Gottlieb’s recent statements that the FDA will go after manufacturers of CBD products that make health and wellness claims that FDA views as egregious. For example, the CBD companies in question allegedly marketed their products for Alzheimer’s disease, fibromyalgia, inflammation, skin conditions, autoimmune disorders, anxiety, cancer pain, PTSD and depression, to name a few symptoms. These companies are making food, dietary supplements, and cosmetic products, as well as products for pets (CBD for dogs). Some highlights: One letter specifically calls out a CBD isolate product (blue CBD crystals isolate 1500 mg). Some have advanced arguments that a...

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FDA Announces Public Hearing on Products Containing Cannabis or Cannabis-Derived Compounds

On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional information regarding health and safety risks, manufacturing and product quality, marketing, labeling and the sale of such products. The FDA’s notice announcing the hearing recognizes that the regulatory landscape surrounding cannabis continues to evolve at both the federal and state levels. At the state level, 33 states and Washington, DC, allow for the medical use of marijuana and 14 additional states have medical programs limited to cannabidiol (a/k/a CBD) products. Moreover, 10 states and Washington, DC have legalized marijuana for recreational use, while 13 additional states have decriminalized recreational marijuana possession in some form. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (often called the 2018...

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USDA Gathers Stakeholder Input on Hemp Production

The Agricultural Act of 2018, better known as the 2018 Farm Bill, authorizes the US Department of Agriculture (USDA) to approve plans submitted by states, territories and Native American tribes for the commercial production of hemp. Under the 2018 Farm Bill, “hemp” is the cannabis plant and any part of that plant, including the seeds and all derivatives, extracts, and cannabinoids, with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis. The USDA is currently drafting regulations on hemp production, which could address topics such as sampling processes, testing requirements, disposal of violative plants and products derived from those plants, inspections, licensing, compliance and other procedures. To solicit stakeholder input on these procedures and their implementation, the USDA Agricultural Marketing Service hosted the 2018 Farm Bill Webinar on the Domestic Hemp Production Program on March 13, 2019. The...

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