A path forward for hemp cultivation and production collaterally potentially imposes additional requirements of state, territory, or tribal governance impacting the registrability of cannabis and cannabis-related trademarks under federal law
Marks for cannabis and cannabis-related goods and services are potentially registrable under the U.S. Trademark Act, if the use of such marks in commerce is lawful under federal law. Recent changes in federal laws have put into place a definition for “hemp” and “hemp” as so defined is no longer considered to be a controlled substance under the Controlled Substances Act (“CSA”).
So does this mean that the path is now clear to seek federal protection under the U.S. Trademark Act for your cannabis and cannabis-related business’ brilliant branding (trademarks, stylized designs, logos, etc.)? Yes, in some circumstances; however, use of the mark and the goods/services with which it is associated must comply with all applicable federal laws in order for there to be a valid basis for registration of marks under federal law. In this regard, Food and Drug Administration (FDA) requirements and those of the 2018 Farm Bill (discussed below) are baked into the pursuit of this tasty IP confection. A confluence of federal and local laws (state, territory, or tribal governance) impacting the registrability of marks for cannabis and cannabis-related goods and services under federal law would appear to be the eventual result in some locations.
As summarized by the FDA: “Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class "Marihuana" (commonly referred to as "marijuana") [21 U.S.C. 802(16)].” FDA Regulation of Cannabis and Cannabis- Derived Products: Questions and Answers, https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#whatare.
The Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. The new law amended Section 297A of the Agricultural Marketing Act (AMA) such that “hemp” would be defined to mean “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” and modified the definition of “marihuana” within the Controlled Substances Act (“CSA”) to exclude “hemp, as defined in section 297A of the Agricultural Marketing Act of 1946”, which means that cannabis plants and derivatives such as CBD that contain no more than 0.3% THC on a dry-weight basis are no longer controlled substances under the CSA. The 2018 Farm Bill also amended Schedule I of the CSA to exclude “tetrahydrocannabinols in hemp”.
On May 2, 2019, the United States Patent and Trademark Office (USPTO) issued Examination Guide 1-19, Examination of Marks for Cannabis and Cannabis-Related Goods and Services after Enactment of the 2018 Farm Bill, https://www.uspto.gov/sites/default/files/documents/Exam%20Guide%201-19.pdf, “to clarify the procedure for examining marks for cannabis and cannabis-derived goods and for services involving cannabis and cannabis production following the 2018 Farm Bill.” Examination Guide 1-19, p. 1.
Section 297D(c) of the 2018 Farm Bill explicitly preserves the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food Drug and Cosmetic Act (FDCA) or the Public Health Service Act. As summarized by the FDA: “Under the FDCA, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.” FDA Regulation of Cannabis and Cannabis- Derived Products: Questions and Answers, https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#whatare. Moreover, the FDA has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. Id. “FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.” Id. Thus, lawful-use issues (impacting the registrability of marks) can arise under the FDCA.
Although it is unlawful under the FDCA to introduce food containing added CBD or THC (or any added substances that are active ingredients in any drug) into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived, there are pathways for lawful marketing that “include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis. For example, in June 2018, the FDA approved a drug, Epidiolex (/news-events/press-announcements/fda- approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe- forms), that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.” Statement of former FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm.
The FDA has noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. In this regard, the FDA has recently completed its evaluation of three Generally Recognized as Safe (/food/cfsan-constituent- updates/fda-responds-three-gras-notices-hemp-seed-derived-ingredients-use-human-food) (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. “Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.” Id. See also, Agency Response Letter GRAS Notice No. GRN 000765; Agency Response Letter GRAS Notice No. GRN 000771; Agency Response Letter GRAS Notice No. GRN 000778.
“The GRAS notices are for three different hemp seed-derived ingredients. The GRAS conclusions can apply to ingredients from other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses [as set forth in these notices] for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.” FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food: Constituent Update, December 20, 2018,
In respect to examination of marks for cannabis and cannabis-derived goods, the USPTO examination guide states: “If an applicant’s goods are derived from “hemp” as defined in the 2018 Farm Bill, the identification of goods must specify that they contain less than 0.3% THC. Thus, the scope of the resulting registration will be limited to goods compliant with federal law.” Examination Guide 1-19, p. 2.
In respect to examination of marks for services involving cannabis and cannabis production, the USPTO examination guide states: “When applications recite services involving cannabis-related activities, they will be examined for compliance with the CSA and the 2018 Farm Bill. As discussed above, the CSA prohibits, among other things, manufacturing, distributing, dispensing, or possessing cannabis that meets the definition of marijuana. Therefore, the USPTO will continue to refuse registration when the identified services in an application involve cannabis that meets the definition of marijuana and encompass activities prohibited under the CSA because such services still violate federal law, regardless of the application filing date. If the identified services involve cannabis that is “hemp” (i.e., contains less than 0.3% THC), the applications will also be examined for compliance with the requirements of the 2018 Farm Bill.” Examination Guide 1-19, p. 3.
Further as to the requirements of the 2018 Farm Bill, cultivators/producers of hemp seeking federal registrations of marks may also need to demonstrate (provide evidence or statements) that they have satisfied state, territory, or tribal licensing/authorization requirements and forthcoming USDA regulations and hemp-production plans as applicable. “For applications that recite services involving the cultivation or production of cannabis that is “hemp” within the meaning of the 2018 Farm Bill, the examining attorney will also issue inquiries concerning the applicant’s authorization to produce hemp. Applicants will be required to provide additional statements for the record to confirm that their activities meet the requirements of the 2018 Farm Bill with respect to the production of hemp. The 2018 Farm Bill requires hemp to be produced under license or authorization by a state, territory, or tribal government in accordance with a plan approved by the U.S. Department of Agriculture (USDA) for the commercial production of hemp. To date, the USDA has not promulgated regulations, created its own hemp-production plan, or approved any state or tribal hemp-production plans.” Examination Guide 1-19, p. 3.
In relation to regulation/governance of hemp cultivation and production under the new law, in his excellent article, John Hudak wrote that “[u]nder section 10113 of the Farm Bill, state departments of agriculture must consult with the state’s governor and chief law enforcement officer to devise a plan that must be submitted to the Secretary of USDA. A state’s plan to license and regulate hemp can only commence once the Secretary of USDA approves that state’s plan. In states opting not to devise a hemp regulatory program, USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses and comply with a federally-run program. This system of shared regulatory programming is similar to options states had in other policy areas such as health insurance marketplaces under ACA, or workplace safety plans under OSHA—both of which had federally-run systems for states opting not to set up their own systems.” The Farm Bill, hemp legalization and the status of CBD: An explainer, December 14, 2018,
As discussed in the USPTO’s Trademark Manual of Examining Procedure (TMEP) §907: Use of a mark in commerce must be lawful use to be the basis for federal registration of the mark. Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir. 1987); see 15 U.S.C. §§1051, 1127; 37 C.F.R. §2.69; In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993) ; In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB 1968). Thus, the goods or services to which the mark is applied, and the mark itself, must comply with all applicable federal laws. See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976) (“In order for [an] application to have a valid basis that could properly result in a registration, the use of the mark [has] to be lawful, i.e., the sale or shipment of the product under the mark [has] to comply with all applicable laws and regulations. If this test is not met, the use of the mark fails to create any rights that can be recognized by a Federal registration.”). In addition, “the fact that the provision of a product or service may be lawful within a state is irrelevant to the question of federal registration when it is unlawful under federal law.” In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016).
While the 2018 Farm Bill is federal law, satisfying the requirements of the 2018 Farm Bill with respect to the production of hemp will likely in many states require that applicants for federal registration of marks satisfy licensing/authorization requirements imposed by a state, territory, or tribal government in accordance with a plan approved by the USDA -- potentially creating incentives for those involved with cannabis and cannabis-related goods and/or services who are interested in protecting their trademark intellectual property to operate their businesses at locations where satisfying the requirements of the 2018 Farm Bill are least burdensome or in some way more readily or advantageously accomplishable.
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Author: Peter L. Holmes - solo practitioner
Patent/IP Attorney, B.S.E.E. (Los Angeles)
Peter L. Holmes (Patent/IP Attorney)
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