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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USDA Publishes Long-Awaited Interim Regulations Governing the Production of Legalized Hemp

Yesterday, the United Stated Department of Agriculture (USDA) released its interim final rule setting forth the proposed rules and regulations regarding the production of hemp under the provisions of the Agricultural Improvement Act of 2018, or the “2018 Farm Bill.” As mandated by the 2018 Farm Bill, the proposed regulations outline provisions for both the approval by the USDA of State or Indian Tribe proposed plans as well as the development of its own federal plan for the production of hemp in the absence of an applicable approved State or Tribal program. While the draft rule is still subject to further comment, it provides the first official guidance from the USDA regarding the lawful production of hemp under the 2018 Farm Bill. In general, each of the approved State, Indian Tribe or Federal Plans include requirements for documenting and reporting, such as: Land descriptions, including geospatial location identifiers and total crop acreage Sampling and...

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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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DEA Schedules a FDA-Approved CBD Drug

As beverage manufacturers mull the creation and distribution of cannabidiol (CBD)-infused products, the US Drug Enforcement Administration’s (DEA) recent actions regarding an approved CBD drug merit exploration. CBD is one of many chemicals in the cannabis plant, and the US Food and Drug Administration (FDA) has stated that CBD does not produce the same euphoric effect as tetrahydrocannabinol (THC), marijuana’s psychoactive component. In June, FDA approved the first drug comprised of an active ingredient (CBD) derived from marijuana, Epidiolex. FDA approved the CBD oral solution for patients two years of age and older who have seizures associated with two forms of severe epilepsy. According to DEA and FDA, the CBD in Epidiolex is extracted from the cannabis plant and is a purified drug substance. Though it is derived from the cannabis plant, the FDA-approved drug has no more than 0.1 percent residual THC. Last week, DEA announced an order scheduling Epidiolex...

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Alcohol, Cannabis and State Driving Laws

As more states legalize the recreational use of marijuana, beer servers will undoubtedly face situations in which a patron is too impaired to drive due to the consumption of both cannabis and alcohol. State laws do not provide a crosswalk of breath alcohol concentration (BrAC) limits and nanograms per milliliter (ng/ml) of delta-9-tetrahydrocannabinol (THC) in a driver's body fluids. But a few states have established limits on the nanograms per milliliter (ng/ml) of THC that may be present in a driver's blood or urine. States will continue to create and modify statutory and regulatory schemes focused on marijuana impairment. In doing so, state legislatures will likely revisit the policy discussions on limits for alcohol consumption. Read the full article.  Originally published in The New Brewer, July/August 2018.

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The Intersection of Spirits and Marijuana

In the past three years, TTB has approved an increasing number of certificate of label approvals (“COLA”) for hemp-flavored vodka, from Mill Six’s hemp, white tea and ginger flavored vodka to Olde Imperial Mystic’s hemp infused vodka. Distillers have designed labels with green smoke-like images and psychedelic sixties-style lettering to hint at their cultural connection to marijuana. As more states have legalized recreational cannabis, distillers have been thinking more ambitiously about combining their distilling business with one or more aspects of the emerging marijuana business. Read the full article. Originally published in Artisan Spirit: Winter 2017.

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