Tag Archives: Hemp

Florida’s Budding Cannabis Industry Expands With New Hemp Law

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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 Ron DeSantis made headlines in March when he signed legislation that effectively repealed the ban on smoking and “vaping” medical cannabis.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.

FDA Holds Public Hearing on Cannabis

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On Friday, May 31, 2019, the U.S. Food and Drug Administration (FDA) held a public hearing to discuss scientific data and information about products containing cannabis or cannabis-derived compounds. Acting Commissioner Sharpless made no new announcements about FDA’s current thinking about how it will regulate products containing cannabis or cannabis-derived compounds. However, it was clear from the FDA panel’s questions to the various academic, industry, and other stakeholders that FDA is looking for as much data from as many sources as possible. In particular, FDA’s questions focused on age and youth restrictions, dose and route of administration and how they affect the safety of the products, adverse event reporting, and interactions between cannabis/cannabis-derived products and other drugs. In addition, FDA continued to inquire about whether deregulating cannabis and cannabis-derived products would affect the incentive for research on these products.

Industry stakeholders asked for a prompt, expedited, clear, and transparent regulatory framework for products containing cannabis and cannabis-derived products. Specifically, industry sought clear definitions for terms like “full spectrum,” “broad spectrum,” “isolate,” and “THC-free.” Further, industry requested regulations on labeling, testing, good manufacturing practices, and track and trace for products. Many industry stakeholders asked FDA to look to the dietary supplement and food regulations already in place as a guideline for regulations on cannabis.

Continue reading FDA Holds Public Hearing on Cannabis →

USDA Memo Clarifies Key Provisions Regarding Hemp in the 2018 Farm Bill

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The Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), signed into law on December 20, 2018, altered the federal government’s treatment of hemp in a number of ways. The 2018 Farm Bill expanded the definition of “hemp” to include, explicitly, derivatives, extracts and cannabinoids, and removed hemp from the definition of federally unlawful marijuana under the Controlled Substances Act (CSA). See 2018 Farm Bill, Pub. L. No. 115-334 §§ 10113, 12619, 132 Stat. 4490. Notably, the 2018 Farm Bill also explicitly permitted the interstate transportation of hemp: “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (as added by section 10113).” Id. at § 10114.

Subtitle G, for its part, provides that “[n]othing in this section prohibits the production of hemp in a State or the territory of an Indian tribe—(1) for which a State or Tribal plan is not approved under this section, if the production of hemp is in accordance with section 297C or other Federal laws (including regulations).” Id. at § 10113 (emphasis added). This final clause, “or other Federal laws,” is significant because the Agriculture Act of 2014 (the “2014 Farm Bill”) is also a “federal law,” and to date approximately 40 states have instituted industrial hemp programs pursuant to the 2014 Farm Bill. Under the language of the 2018 Farm Bill, then, states may not interfere with the interstate transportation of hemp produced in accordance with either the 2014 Farm Bill or—once regulations are implemented and state hemp programs are approved—the 2018 Farm Bill.

Notwithstanding the language of the 2018 Farm Bill, the absence of federal regulations implementing the new law and sanctioning state hemp programs revised pursuant to the 2018 Farm Bill has caused significant confusion regarding the true impact of the act.

View the full Alert on the Duane Morris LLP website.

Big News for the Organic Certification of Hemp

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The public’s desire for organic products continues to grow. This is equally true for cannabis and hemp-derived products, especially where they are being used for medicinal purposes. The U.S. Department of Agriculture (USDA) has issued regulations setting out standards setting out specific requirements that must be met for an agricultural product to be labeled “organic”. In order to be able to include the USDA’s organic certified seal on a product’s packaging, a USDA-accredited certifying agency must verify that the product meets USDA’s regulations. This USDA certification provides many benefits, including, for example, premium prices for products. So why haven’t we seen many certifications for hemp products?

Back in 2016, the USDA, in conjunction with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, issued a Statement of Principles on Industrial Hemp concerning the applicability of Federal law to industrial hemp programs after the 2014 Farm Bill, but the ability to gain organic certification for hemp products was unclear. The USDA also issued Instruction: Organic Certification of Industrial Hemp Production (updated in September 2018), which stated that industrial hemp produced in accordance with the 2014 Farm Bill could be certified if it met all of the requirements of USDA’s organic regulations. The problem was that under the 2014 Farm Bill only certain parts of the hemp plant (e.g., the stalk and non-viable seeds) were permitted to seek organic certification. And, actually, some hemp seed products have received USDA organic certification.

Continue reading Big News for the Organic Certification of Hemp →

Case Sets Stage for Cannabis Patent Infringements Actions

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Getting a patent for a cannabis product is no more difficult than getting a patent for any other kind of product. However, with a high number of cannabis patent applications being approved, it is likely that many will be challenged for invalidation in the coming years.

Already one of these patents has gone to court in the U.S. District Court for the District of Colorado. In United Cannabis v. Pure Hemp Collective, United Cannabis Corp. claims that Pure Hemp Collective Inc. used a cannabis extract that United Cannabis had a patent on. Pure Hemp filed a motion for partial summary judgment, arguing United Cannabis should not have had a patent on the extract because it was something that occurred naturally. In April, U.S. District Judge William Martinez found the strain was altered and would not have occurred naturally and denied the motion for partial summary judgment. The case is still pending..

To read the full text of this article including Duane Morris Attorney Vince Capuano,  please visit the Duane Morris website.

Reprinted with permission from law.com, © ALM Media Properties LLC. All rights reserved.

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

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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.

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

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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.

California Industrial Hemp Registration is Now Open

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On April 30, 2019, the California Department of Food and Agriculture (CDFA) made available registration applications to cultivate industrial hemp. The CDFA’s approved regulations require, among other things, a prospective cultivator to register with the county agricultural commissioner where the cultivator is located and pay a $900 registration fee.

However, even though applications are now live, several counties throughout California still restrict or prohibit the cultivation of hemp. The CDFA has identified the following counties as restricting hemp cultivation: Amador, Calaveras, Glenn, Humboldt, Lassen, Marin, Mariposa, Mendocino, Merced, Modoc, Mono, Monterey, Napa, Nevada, Orange, Placer, Sacramento, San Bernardino, San Joaquin, Santa Barbara, Shasta, Sierra, Siskiyou, Sonoma, Tehama, Trinity, Tulare, Tuolumne, Yolo, and Yuba.

It remains unclear how these current regulations will be affected by the Agricultural Improvement Act of 2018 (2018 Farm Bill). Under the 2018 Farm Bill, the CDFA is required to submit its hemp-production plan to the United States Department of Agriculture (USDA) for approval but as of the date of this post the USDA has not issued regulations relating to that review. Additionally, it is unclear how this program will operate in the interim under the 2014 Farm Bill. We will continue to watch as this program develops alongside the USDA’s 2018 Farm Bill program.

USDA Issues Guidance on Importation of Hemp Seeds

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USDA has issued its first guidance since the passage of the 2018 Farm Bill. Because the Farm Bill removed hemp from the Controlled Substances Act, the importation of hemp seeds will now be regulated by USDA as an agricultural product, not DEA.  USDA stated that by removing hemp from the CSA, the Act “removed hemp and hemp seeds from DEA authority for products containing THC levels not greater than 0.3 percent. Therefore, DEA no longer has authority to require hemp seed permits for import purposes.” Importation of hemp seeds from international sources will now be permitted if accompanied by the appropriate phytosanitary certification and will be subject to inspection by Customs and Border Patrol.

The reference to DEA authority is significant and confirms that DEA no longer has jurisdiction over hemp or products derived from hemp such as CBD oil.  DEA  needs to update its own guidance documents in light of the 2018 Farm Bill. USDA is working on regulations to implement the state cultivation program provisions of the Farm Bill.  They are expected to be in place in time for the 2020 growing season.