Examination Guide 1-19 Examination of Marks for Cannabis and Cannabis-Related Goods and Services
after Enactment of the 2018 Farm Bill May 2, 2019 I. Introduction
Use of a mark in commerce must be lawful under federal law to be the basis for federal
registration under the U.S. Trademark Act. See generally Trademark Manual of Examining
Procedure (TMEP) §907. The United States Patent and Trademark Office (USPTO) refuses to
register marks for goods and/or services that show a clear violation of federal law,
regardless of the legality of the activities under state law. A determination of whether
commerce involving cannabis and cannabis-related goods and services is lawful requires
consultation of several different federal laws, including the Controlled Substances Act, 21
U.S.C. §§801 et seq., the Federal Food Drug and Cosmetic Act, 21 U.S.C. §§301 et seq.,
and the Agriculture Improvement Act of 2018, Pub. L. 115-334 (the 2018 Farm Bill), which
amends the Agricultural Marketing Act of 1946 (AMA). The USPTO issues this examination
guide 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.
II. Examination of marks for cannabis and cannabis-derived goods such as
cannabidiol
**Under the Controlled Substances Act (CSA), the drug class “Marihuana” (commonly referred **
**to as “marijuana”) is defined as “all parts of the plant Cannabis sativa L., whether growing **
or not; the seeds thereof; the resin extracted from any part of such plant; and every
compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or
resin” (subject to certain exceptions). 21 U.S.C. §802(16). Cannabidiol (CBD) is a chemical
constituent of the cannabis plant that is encompassed within the CSA’s definition of
marijuana. See Clarification of the New Drug Code (7350) for Marijuana Extract, Clarification of the New Drug Code 7350 for Marijuana Extract, last
accessed April 23, 2019; see also, 21 C.F.R. §1308.11(d)(58). The CSA prohibits, among
other things, manufacturing, distributing, dispensing, or possessing certain controlled
substances, including marijuana. 21 U.S.C. §§812, 841(a)(1), 844(a). Therefore, the USPTO
refuses registration when an application identifies goods encompassing CBD or other
extracts of marijuana because such goods are unlawful under federal law and do not
support valid use of the applied-for mark in commerce. The 2018 Farm Bill, which was signed into law on December 20, 2018, amends the AMA and
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.” Section 297A. These changes include
removing “hemp” from the CSA’s definition of marijuana, 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. For applications filed on or after December 20, 2018 that identify goods encompassing
cannabis or CBD, the 2018 Farm Bill potentially removes the CSA as a ground for refusal of
registration, but only if the goods are derived from “hemp.” Cannabis and CBD derived from
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marijuana (i.e., Cannabis sativa L. with more than 0.3% THC on a dry-weight basis) still
violate federal law, and applications encompassing such goods will be refused registration
regardless of the filing date. 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. For applications filed before December 20, 2018 that identify goods encompassing CBD or
other cannabis products, registration will be refused due to the unlawful use or lack of bona
fide intent to use in lawful commerce under the CSA. Such applications did not have a valid
basis to support registration at the time of filing because the goods violated federal law.
However, because of the enactment of the 2018 Farm Bill, the goods are now potentially
lawful if they are derived from “hemp” (i.e., contain less than 0.3% THC). Therefore, the
examining attorney will provide such applicants the option of amending the filing date and
filing basis of the application to overcome the CSA as a ground of refusal. Specifically, the examining attorney will advise the applicant that it may request to amend
the filing date of the application to December 20, 2018. The applicant must specifically state
for the record that such a change to the filing date is being authorized and must establish a
valid filing basis under 37 C.F.R. §2.34 by satisfying the relevant requirements. See 37
C.F.R. §§2.34 et seq., TMEP §§806 et seq. If the application was originally based on use of
the mark in commerce under Section 1(a) of the Trademark Act, 15 U.S.C. §1051(a), the
applicant will be required to amend the basis to intent to use the mark in commerce under
Section 1(b), 15 U.S.C. §1051(b). Because of the new legal definition of “hemp” under the
2018 Farm Bill, the applicant will also be required to amend the identification of goods to
specify that the CBD or cannabis products contain less than 0.3% THC. If the applicant
elects to amend the application, the examining attorney will conduct a new search of the
USPTO records for conflicting marks based on the later application filing date. TMEP
§§206.01, 1102.03. The examining attorney will also advise the applicant that, in lieu of
amending the application, it may elect to abandon the subject application and file a new
application. Alternatively, the applicant may respond to the stated refusal by submitting
evidence and arguments against the refusal. Applicants should be aware that even if the identified goods are legal under the CSA, not all
goods for CBD or hemp-derived products are lawful following the 2018 Farm Bill. Such goods may also raise lawful-use issues under the Federal Food Drug and Cosmetic Act
(FDCA). The use in foods or dietary supplements of a drug or substance undergoing clinical
investigations without approval of the U.S. Food and Drug Administration (FDA) violates the FDCA. 21 U.S.C. §331(ll); see also 21 U.S.C. §321(ff) (indicating that a dietary supplement
is deemed to be a food within the meaning of the FDCA). The 2018 Farm Bill explicitly
preserved FDA’s authority to regulate products containing cannabis or cannabis-derived
compounds under the FDCA. CBD is an active ingredient in FDA-approved drugs and is a
substance undergoing clinical investigations. See FDA Regulation of Cannabis and Cannabis-
Derived Products: Questions and Answers, available at https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#whatare, last
accessed April 23, 2019. Therefore, registration of marks for foods, beverages, dietary
supplements, or pet treats containing CBD will still be refused as unlawful under the FDCA,
even if derived from hemp, as such goods may not be introduced lawfully into interstate
commerce. 21 U.S.C. §331(ll); see also 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
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III. Examination of marks for services involving cannabis and cannabis
production
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. Applicants refused registration under the CSA will have the same options outlined in
section II above of overcoming the refusal by requesting amendment of the filing date and
basis of their application, and amending the identification of services to specify that the
involved cannabis contains less than 0.3% THC on a dry-weight basis. In lieu of amending
the application, an applicant may elect to abandon the subject application and file a new
application. Alternatively, the applicant may respond to the stated refusal by submitting
evidence and arguments against the refusal. 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. However, the 2018 Farm Bill directs that states, tribes, and
institutions of higher education may continue operating under authorities of the 2014 Farm
Bill until 12 months after the USDA establishes the plan and regulations required under the
2018 Farm Bill.
the bold tells you theat shcedule 1 says marijuana and the seeds there of now just read section 2 or read it all Section @ tells you the farm bill doesnt alter the Dea;s shcedule
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)
On this page:
There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.
Consumer Information
- What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
- What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding
- Some Medicines and Driving Don’t Mix
FDA Communications
- Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products
- FDA Warns Companies Illegally Selling CBD Products
- FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
- FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research
- FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
- Congressional Testimony: Cannabis Policies for the New Decade
- FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
- Remarks at the Council for Responsible Nutrition Conference
- Remarks at the National Industrial Hemp Council 2019 Hemp Business Summit
- FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
- Congressional Testimony: Hemp Production and the 2018 Farm Bill
- FDA is Committed to Sound, Science-based Policy on CBD
- Remarks at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds
- Statement on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
- Statement on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
- Statement on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
- FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
Regulatory Resources
- Scientific Conference on November 19, 2020: CBD and Other Cannabinoids: Sex and Gender Differences in Use and Responses
- Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry
- Information on CBD Data Collection and Submission
- FDA and Cannabis: Research and Drug Approval Process
- FDA Regulation of Dietary Supplement & Conventional Food Products Containing Cannabis and Cannabis-Derived Compounds
- Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing
- Warning Letters and Test Results for Cannabidiol-Related Products
- State, Local, Tribal, Territorial (SLTT) Regulatory Officials: FDA is committed to working with our SLTT public health regulatory partners as developments occur in the regulatory landscape. Please contact the Intergovernmental Affairs team with any questions at IGA@fda.hhs.gov.
Questions and Answers
Below are a number of frequently asked questions and answers on this topic.
- What are cannabis and marijuana?
- How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
- Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
- Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
- Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
- What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
- Has the agency received any adverse event reports associated with cannabis use for medical conditions?
- Is it legal for me to sell CBD products?
- Can THC or CBD products be sold as dietary supplements?
- Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
- In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
- Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?
- What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
- Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
- Can I import or export cannabis-containing or cannabis-derived products?
- What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
- Does the FDA object to the clinical investigation of cannabis for medical use?
- How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
- Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
- Does the FDA have concerns about administering a cannabis product to children?
- Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
- What does the FDA think about making CBD available to children with epilepsy?
- What should I do if my child eats something containing cannabis?
- I’ve seen cannabis products being marketed for pets. Are they safe?
- Can hemp be added to animal food?
- Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
1. What are cannabis and marijuana?
A. 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)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.
2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law 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 concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.
The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). 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.