cannabidiol – Cannabis Industry

July 2, 2019 by Duane Morris

Florida’s Budding Cannabis Industry Expands With New Hemp Law

According to a research report published by Cowen & Co. earlier this year, the investment bank believes that the U.S. market for cannabidiol (CBD) consumer goods could reach $16 billion—a “conservative” forecast—by 2025, up from between $600 million and $2 billion in 2018 retail sales. As the third-most populous state in the country, this is a very big deal for Florida.

Florida’s state hemp program law, Section 581.217, Fla. Stat., created by the enactment of Senate Bill 1020, has the potential to transform Florida’s agricultural landscape while also capitalizing on a fertile market of enthusiastic cultivators and eager consumers.

With a population of more than 21 million, Florida has long been viewed as ripe for potential commercialization by the cannabis industry. Gov. Ron DeSantis made headlines in March when he signed legislation that effectively repealed the ban on smoking and “vaping” medical cannabis. Yet outside of Florida’s medical marijuana program (and the hemp pilot project discussed below), cannabis—which includes hemp and hemp-derived products—has remained a controlled substance, making the manufacture, processing, sale and possession of hemp or hemp-derived products (including cannabidiol, i.e., CBD-infused items) a criminal endeavor. Even within the state’s medical use program, the cultivation of cannabis, even for medicinal purposes, remains tightly regulated.

To read the full text of this article by Justin M. L. Stern, Robert A. Zinn, Jay Steinman and Jennifer A. Migliori, please visit the Duane Morris website.

June 24, 2019October 17, 2019 by Duane Morris

FDA Comments on the Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds and Extends Comment Period

At the U.S. Food and Drug Administration’s (FDA) public hearing on May 31, 2019 (read more about the hearing), over 100 people presented to a panel of FDA stakeholders and to over 500 attendees. Last week, FDA stated in a post that it recognizes the “significant public interest in these products, for therapeutic purposes and otherwise” but reiterated that “there are many unanswered questions about the science, safety, and quality of many of these products.”

The good news for the industry is that FDA “recognize[s] the need to be clear and open about where things stand, and about the efficient and science-based way in which we are moving forward,” including “being transparent and up-front” as they continue to collect data and information on CBD. FDA is taking an “Agency-wide, integrated, and collaborative approach” to regulating products made from CBD and is exploring potential pathways to market for CBD products. However, FDA still grapples with how to balance the desire for widespread availability of CBD products with the desire to preserve incentives for research and drug development of CBD products.

View the full Alert on the Duane Morris LLP website.

May 7, 2019 by Duane Morris

Green Light for the Sunshine State: Florida Legislature Approves Sweeping Changes to Hemp, CBD Regulation

On May 3, 2019, the Florida legislature passed SB 1020, creating the state hemp program and authorizing the Florida Department of Agriculture and Consumer Services (FDACS) to enact regulations to govern the program. The bill, first filed in the Florida Senate on February 13, 2019, passed with overwhelming support; the final version passed by a margin of 39-0 in the Senate after passing 112-1 in the House. Governor Ron DeSantis has until May 18, 2019, to veto the bill or it will automatically become law.

“The historic vote,” according to FDACS Commissioner Nicole Fried, is in response to the federal 2018 Farm Bill, which “removed the prohibitions on industrial hemp in place since 1937 and authorized states to create hemp programs.” Id. If SB 1020 becomes law, it will fundamentally alter the treatment of hemp and hemp extracts, including cannabidiol (CBD) products, under Florida law.

View the full Alert on the Duane Morris LLP website.

May 6, 2019 by Duane Morris

Patent and Trademark Office Issues New Guidelines for Hemp Following 2018 Farm Bill Legalization

On May 2, 2019, the United States Patent and Trademark Office (USPTO) made available a new examination guide aimed at clarifying the examination procedure for trademarks used in connection with cannabis and cannabis-derived goods and services.

These guidelines are a direct response to the signing of the Agricultural Improvement Act of 2018 (2018 Farm Bill) into law on December 20, 2018. The 2018 Farm Bill changes certain federal authorities relating to the production and marketing of “hemp,” defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the Controlled Substance Act’s (CSA) definition of marijuana, which means that cannabis plants and derivatives such as cannabidiol (CBD) that contain no more than 0.3 percent THC are no longer controlled substances under the CSA.

View the full Alert on the Duane Morris LLP website.

November 17, 2017 by Duane Morris

FDA Warns Cannabidiol-Infused Products Manufacturers Over Health Claims

The U.S. Food and Drug Administration (FDA) has recently issued warning letters to four companies concerning the marketing of products containing cannabidiol (CBD). FDA alleged that claims made on websites and social media webpages concerning the health benefits of CBD violated the Federal Food, Drug and Cosmetic Act. The products at issue included CBD-infused oils, edibles, tinctures and creams, and the manufacturers included statements claiming various health benefits from CBD.

To read the full text of this Alert, please visit the Duane Morris website.