Controlled Substances Act

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

Marijuana, a Schedule 1 drug under the federal Controlled Substances Act (CSA), is the most commonly detected illicit drug in employment drug testing. According to Quest Diagnostics, in 2018, approximately 3% of urine-based workplace drug screenings tested positive for marijuana. Notwithstanding marijuana’s illegality under federal law, 33 states and the District of Columbia have legalized marijuana for recreational or medicinal use. And it is big business. The Colorado Department of Revenue recently revealed that its tax, license and fee revenue from marijuana has reached $1.02 billion. Legal marijuana appears here to stay in the United States.
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“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.
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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:

  1. the removal of hemp as a controlled substance and schedule I drug became effective upon enactment of the 2018 Farm Bill;
  2. 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;
  3. pending certain exceptions, individuals with certain controlled substance felony convictions will be barred from producing hemp; and
  4. 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 hemp in that state or territory.


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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:

  1. TTB will require a formula for any product containing a

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,

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 Farm Bill), removed hemp and its derivatives from the Controlled Substances Act, so they are no longer classified as controlled substances under federal law. This has prompted an avalanche of businesses marketing products containing hemp-derived compounds – most notably CBD – in ways that the FDA views as violations of the federal Food, Drug, and Cosmetic Act. According to the FDA, many questions remain concerning the safety implications of the widespread use of these products. Therefore, the FDA seeks relevant information to inform its position in regulating the development and marketing of cannabis products.
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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 under the least restrictive schedule of the Controlled Substances Act (CSA), schedule V. Notably, DEA still considers marijuana (which includes industrial hemp) and marijuana compounds other than Epidiolex to be schedule I controlled substances under the CSA. As a result, beverage manufacturers should carefully consider all legal implications prior to developing products that contain CBD.
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Today, Attorney General Jefferson B. Sessions announced, in a memorandum to all US Attorneys, the immediate revocation of five Obama Administration policies on federal marijuana enforcement, including Guidance Regarding the Ogden Memo in Jurisdictions Seeking to Authorize Marijuana for Medical Use, Guidance Regarding Marijuana Enforcement and Guidance Regarding Marijuana Related Financial Crimes. These three Obama-era guidance documents were drafted by then Deputy Attorney General James M. Cole in response to state legalization initiatives.
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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