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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Cannabis and Hemp Update

Cannabis legalization receives widespread popular support. According to opinion polls, more than two-thirds of Americans support full legalization—a steep rise in support considering that as recently as 2005, almost two-thirds of Americans opposed legalization. The country appears on the path to full cannabis legalization, but until that time, citizens and companies should be aware of the legal risks involved in entering the cannabis space. Access the full article. Originally published in The New Brewer, July/August 2019.

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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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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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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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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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