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With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration places certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act (CSA)…. For something to be a controlled substance under the federal Controlled Substances Act (CSA), it must be specifically scheduled and assigned one of five scheduling criteria. About Cannabis Policy This section of the APIS website provides information about cannabis policy including: introduction and background, history of cannabis policy in the United States, issues

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Schedules of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements

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Printed version: PDF Publication Date: 09/28/2018 Agencies: Drug Enforcement Administration Dates: Effective September 28, 2018. Effective Date: 09/28/2018 Document Type: Rule Document Citation: 83 FR 48950 Page: 48950-48953 (4 pages) CFR: 21 CFR 1308 21 CFR 1312 Agency/Docket Number: Docket No. DEA-486 Document Number: 2018-21121

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AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

SUMMARY:

With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration places certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act (CSA). Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. This action is required to satisfy the responsibility of the Acting Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. Also consistent therewith, DEA is adding such drugs to the list of substances that may only be imported or exported pursuant to a permit.

DATES:

Effective September 28, 2018.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Kathy L. Federico, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Background and Legal Authority

The United States is a party to the Single Convention on Narcotic Drugs, 1961 (Single Convention), and other international conventions designed to establish effective control over international and domestic traffic in controlled substances. 21 U.S.C. 801(7). The Single Convention entered into force for the United States on June 24, 1967, after the Senate gave its advice and consent to the United States’ accession. See Single Convention, 18 U.S.T. 1407. The enactment and enforcement of the Controlled Substances Act (CSA) are the primary means by which the United States carries out its obligations under the Single Convention. [1] Various provisions of the CSA directly reference the Single Convention. One such provision is 21 U.S.C. 811(d)(1), which relates to scheduling of controlled substances.

As stated in subsection 811(d)(1), if control of a substance is required “by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by [subsections 811(a) or 812(b)] and without regard to the procedures prescribed by [subsections 811(a) and (b)].” This provision is consistent with the Supremacy Clause of the U.S. Constitution (art. VI, sec. 2), which provides that all treaties made under the authority of the United States “shall be the supreme Law of the Land.” In accordance with this constitutional Start Printed Page 48951 mandate, under section 811(d)(1), Congress directed the Attorney General (and the Administrator of DEA, by delegation) [2] to ensure that compliance by the United States with our nation’s obligations under the Single Convention is given top consideration when it comes to scheduling determinations.

Section 811(d)(1) is relevant here because, on June 25, 2018, the Food and Drug Administration (FDA) announced that it approved a drug that is subject to control under the Single Convention. Specifically, the FDA announced that it approved the drug Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. www.fda.gov/​NewsEvents/​Newsroom/​PressAnnouncements/​ucm611046.htm. Epidiolex is an oral solution that contains cannabidiol (CBD) extracted from the cannabis plant. This is the first FDA-approved drug made from the cannabis plant. [3] Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA. See 21 U.S.C. 812(b) (indicating that while substances in schedule I have no currently accepted medical use in treatment in the United States, substances in schedules II-V do); see also United States v. Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483, 491-92 (2001) (same). DEA must therefore take the appropriate scheduling action to remove the drug from schedule I.

In making this scheduling determination, as section 811(d)(1) indicates, it is necessary to assess the relevant requirements of the Single Convention. Under the treaty, cannabis, cannabis resin, and extracts and tinctures of cannabis are listed in Schedule I. [4] The cannabis plant contains more than 100 cannabinoids. Among these are tetrahydrocannabinols (THC) and CBD. [5] Material that contains THC and CBD extracted from the cannabis plant falls within the listing of extracts and tinctures of cannabis for purposes of the Single Convention. [6] Thus, such material, which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.

Parties to the Single Convention are required to impose a number of control measures with regard to drugs listed in Schedule I of the Convention. These include, but are not limited to, the following:

  • Limiting exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of such drugs. Article 4.
  • Furnishing to the International Narcotics Control Board (INCB) annual estimates of, among other things, quantities of such drugs to be consumed for medical and scientific purposes, utilized for the manufacture of other drugs, and held in stock. Article 19.
  • Furnishing to the INCB statistical returns on the actual production, utilization, consumption, imports and exports, seizures, and stocks of such drugs during the prior year. Article 20.
  • Requiring that licensed manufacturers of such drugs obtain quotas specifying the amounts of such drugs they may manufacture to prevent excessive production and accumulation beyond that necessary to satisfy legitimate needs. Article 29.
  • Requiring manufacturers and distributors of such drugs to be licensed. Articles 29 & 30.
  • Requiring medical prescriptions for the dispensing of such drugs to patients. Article 30.
  • Requiring importers and exporters of such drugs to be licensed and requiring each individual importation or exportation to be predicated on the issuance of a permit. Article 31.
  • Prohibiting the possession of such drugs except under legal authority. Article 33.
  • Requiring those in the legitimate distribution chain (manufacturers, distributors, scientists, and those who lawfully dispense such drugs) to keep records that show the quantities of such drugs manufactured, distributed, dispensed, acquired, or otherwise disposed of during the prior two years. Article 34.
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Because the CSA was enacted in large part to satisfy United States obligations under the Single Convention, many of the CSA’s provisions directly implement the foregoing treaty requirements. None of the foregoing obligations of the United States could be satisfied for a given drug if that drug were removed entirely from the CSA schedules. At least one of the foregoing requirements (quotas) can only be satisfied if the drug that is listed in Schedule I of the Single Convention is also listed in schedule I or II of the CSA because, as 21 U.S.C. 826 indicates, the quota requirements generally apply only to schedule I and II controlled substances.

The permit requirement warrants additional explanation. As indicated above, the Single Convention obligates parties to require a permit for the importation and exportation of drugs listed in Schedule I of the Convention. This permit requirement applies to a drug product containing CBD extracted from the cannabis plant because, as further indicated above, such a product is a Schedule I drug under the Single Convention. However, under the CSA [7] and DEA regulations, the import/export permit requirement does not apply to all controlled substances. Rather, a permit is required to import or export any controlled substance in schedule I and II as well as certain controlled substances in schedules III, IV, and V. See 21 U.S.C. 952 and 953; 21 CFR 1312.11, 1312.12, 1312.21, 1312.22. Thus, in deciding what schedule is most appropriate to carry out the United States’ obligations under the Single Convention with respect to the importation and exportation of Epidiolex, I conclude there are two options:

(i) Control the drug in schedule II, which will automatically require an Start Printed Page 48952 import/export permit under existing provisions of the CSA and DEA regulations or

(ii) control the drug in schedule III, IV, or V, and simultaneously amend the regulations to require a permit to import or export Epidiolex.

It bears emphasis that where, as here, control of a drug is required by the Single Convention, the DEA Administrator “shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by [21 U.S.C. 811 (a) or 812(b)] and without regard to the procedures prescribed by [21 U.S.C. 811 (a) or (b)].” 21 U.S.C. 811(d)(1) (emphasis added). Thus, in such circumstances, the Administrator is not obligated to request a medical and scientific evaluation or scheduling recommendation from the Department of Health and Human Services (HHS) (as is normally done pursuant to section 811(b)). [8] Nonetheless, DEA did seek such an evaluation and recommendation from HHS with respect to the Epidiolex formulation. In responding to that request, HHS advised DEA that it found the Epidiolex formulation to have a very low potential for abuse and, therefore, recommended that, if DEA concluded that control of the drug was required under the Single Convention, Epidiolex should be placed in schedule V of the CSA. [9] Although I am not required to consider this HHS recommendation when issuing an order under section 811(d)(1), because I believe there are two legally viable scheduling options (listed above), both of which would satisfy the United States’ obligations under the Single Convention, I will exercise my discretion and choose the option that most closely aligns to the HHS recommendation. Namely, I am hereby ordering that the Epidiolex formulation (and any future FDA-approved generic versions of such formulation made from cannabis) be placed in schedule V of the CSA.

As noted, this order placing the Epidiolex formulation in schedule V will only comport with section 811(d)(1) if all importations and exportations of the drug remain subject to the permit requirement. Until now, since the Epidiolex formulation had been a schedule I controlled substance, the importation of the drug from its foreign production facility has always been subject to the permit requirement. To ensure this requirement remains in place (and thus to prevent any lapse in compliance with the requirements of the Single Convention), this order will amend the DEA regulations (21 CFR 1312.30) to add the Epidiolex formulation to the list of nonnarcotic schedule III through V controlled substances that are subject to the import and export permit requirement.

Finally, a brief explanation is warranted regarding the quota requirement in connection with the Single Convention. As indicated above, for drugs listed in Schedule I of the Convention, parties are obligated to require that licensed manufacturers of such drugs obtain quotas specifying the amounts of such drugs they may manufacture. The purpose of this treaty requirement is to prevent excessive production and accumulation beyond that necessary to satisfy legitimate needs. Under this scheduling order, the United States will continue to meet this obligation because the bulk cannabis material used to make the Epidiolex formulation (as opposed to the FDA-approved drug product in finished dosage form) will remain in schedule I of the CSA and thus be subject to all applicable quota provisions under 21 U.S.C. 826. [10]

Requirements for Handling FDA-Approved Products Containing CBD

As noted, until now, Epidiolex has been a schedule I controlled substance. By virtue of this order, Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a schedule V controlled substance. Thus, all persons in the distribution chain who handle Epidiolex in the United States (importers, manufacturers, distributors, and practitioners) must comply with the requirements of the CSA and DEA regulations relating to schedule V controlled substances. As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA. [11] Thus, persons who handle such items will continue to be subject to the requirements of the CSA and DEA regulations relating to schedule I controlled substances.

Regulatory Analyses

Administrative Procedure Act

The CSA provides for an expedited scheduling action where control of a drug is required by the United States’ obligations under the Single Convention. 21 U.S.C. 811(d)(1). Under such circumstances, the Attorney General must “issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations,” without regard to the findings or procedures otherwise required for scheduling actions. Id. (emphasis added). Thus, section 811(d)(1) expressly requires that this type of scheduling action not proceed through the notice-and-comment rulemaking procedures governed by the Administrative Procedure Act (APA), which generally apply to scheduling actions; it instead requires that such scheduling action occur through the issuance of an “order.”

Although the text of section 811(d)(1) thus overrides the normal APA considerations, it is notable that the APA itself contains a provision that would have a similar effect. As set forth in 21 U.S.C. 553(a)(1), the section of the APA governing rulemaking does not apply to a “foreign affairs function of the United States.” An order issued under section 811(d)(1) may be considered a foreign affairs function of the United States because it is for the express purpose of ensuring that the Start Printed Page 48953 United States carries out its obligations under an international treaty.

Executive Order 12866, 13563, and 13771, Regulatory Planning and Review, Improving Regulation and Regulatory Review, and Reducing Regulation and Controlling Regulatory Costs

This action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and the principles reaffirmed in Executive Order 13563 (Improving Regulation and Regulatory Review), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).

This order is not an Executive Order 13771 regulatory action.

Executive Order 12988, Civil Justice Reform

This action meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

This action does not have federalism implications warranting the application of Executive Order 13132. This action does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or any other law. As explained above, the CSA exempts this order from the APA notice-and-comment rulemaking provisions. Consequently, the RFA does not apply to this action.

Paperwork Reduction Act of 1995

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Congressional Review Act

As noted above, this action is an order, not a rulemaking. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, the DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (CRA), 5 U.S.C. 801-808.

Start List of Subjects

List of Subjects

21 CFR Part 1308

  • Administrative practice and procedure
  • Drug traffic control
  • Reporting and recordkeeping requirements

21 CFR Part 1312

  • Administrative practice and procedure
  • Drug traffic control
  • Exports
  • Imports
  • Reporting requirements

For the reasons set out above, DEA amends 21 CFR parts 1308 and 1312 as follows:

PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for part 1308 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 811, 812, 871(b), 956(b) unless otherwise noted.

End Authority Start Amendment Part

2. In § 1308.15, add paragraph (f) to read as follows:

End Amendment Part

(f) Approved cannabidiol drugs. (1) A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols 7367

PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES

3. The authority citation for part 1312 is revised to read as follows:

End Amendment Part Start Authority

End Authority Start Amendment Part

4. In § 1312.30, revise the introductory text and add pargraph (b) to read as follows:

End Amendment Part

The following Schedule III, IV, and V non-narcotic controlled substances have been specifically designated by the Administrator of the Drug Enforcement Administration as requiring import and export permits pursuant to sections 201(d)(1), 1002(b)(2), and 1003(e)(3) of the Act (21 U.S.C. 811(d)(1), 952(b)(2), and 953(e)(3)):

(b) A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.

Dated: September 21, 2018.

Footnotes

1. See S. Rep. No. 91-613, at 4 (1969) (“The United States has international commitments to help control the worldwide drug traffic. To honor those commitments, principally those established by the Single Convention on Narcotic Drugs of 1961, is clearly a Federal responsibility.”); Control of Papaver Bracteatum, 1 Op. O.L.C. 93, 95 (1977) (“[A] number of the provisions of [the CSA] reflect Congress’ intent to comply with the obligations imposed by the Single Convention.”).

3. The drug Marinol was approved by the FDA in 1985. Marinol contains a synthetic form of dronabinol (an isomer of tetrahydrocannabinol) and thus is not made from the cannabis plant.

4. The text of the Single Convention capitalizes schedules (e.g., “Schedule I”). In contrast, the text of the CSA generally refers to schedules in lower case. This document will follow this approach of using capitalization or lower case depending on whether the schedule is under the Single Convention or the CSA.

It should also be noted that the schedules of the Single Convention operate somewhat differently than the schedules of the CSA. Unlike the CSA, the Single Convention imposes additional restrictions on drugs listed in Schedule IV that go beyond those applicable to drugs listed in Schedule I. All drugs in Schedule IV of the Single Convention are also in Schedule I of the Convention. Cannabis and cannabis resin are among the drugs listed in Schedule IV of the Single Convention.

5. There are numerous isomers of cannabidiol, which will be referred to here collectively as “CBD.”

6. Although the Single Convention does not define the term “extract,” the ordinary meaning of that term would include a product, such as a concentrate of a certain chemical or chemicals, obtained by a physical or chemical process. See, e.g., Webster’s Third New International Dictionary 806 (1976). Thus, the term extract of cannabis would include any product that is made by subjecting cannabis material to a physical or chemical process designed to isolate or increase the concentration of one or more of the cannabinoid constituents.

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7. The provisions of federal law relating to the import and export of controlled substances—those found in 21 U.S.C. 951 through 971—are more precisely referred to as the Controlled Substances Import and Export Act (CSIEA). However, federal courts and DEA often use the term “CSA” to refer collectively to all provisions from 21 U.S.C. 801 through 971 and, for ease of exposition, this document will do likewise.

8. In the House Report to the bill that would become the CSA (H. Rep. No. 91-1444, at 36 (1970)), this issue is explained as follows:

Under subsection [811(d)], where control of a drug or other substance by the United States is required by reason of its obligations under [the Single Convention], the bill does not require that the Attorney General seek an evaluation and recommendation by the Secretary of Health, Education, and Welfare, or pursue the procedures for control prescribed by the bill but he may include the drug or other substance under any of the five schedules of the bill which he considers most appropriate to carry out the obligations of the United States under the international instrument, and he may do so without making the specific findings otherwise required for inclusion of a drug or other substance in that schedule.

9. HHS most recently updated its medical and scientific evaluation and scheduling recommendation for the Epidiolex formulation by letter to DEA dated June 13, 2018.

10. At present, the cannabis used to make Epidiolex is grown in the United Kingdom and the drug is imported into the United States in finished dosage form.

11. Nothing in this order alters the requirements of the Federal Food, Drug, and Cosmetic Act that might apply to products containing CBD. In announcing its recent approval of Epidiolex, the FDA Commissioner stated:

[W]e remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. . . . The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims.

CBD Has Never Been A Controlled Substance

My job is to shed light. Most specifically on the great intricacies of cannabis law, policy, and regulation. The past several years have seen extensive debate about the legal status of cannabidiol (CBD). Is it legal? Was it ever a controlled substance? How is it regulated? Lawyers, industry professionals, and learned scholars debate this with so much vigor that it creates confusion, if not a misstatement of the facts. It hurts my ears and burns my eyes to hear or see an argument that identifies CBD as a controlled substance, because the law is quite clear in this regard.

For something to be a controlled substance under the Federal Controlled Substances Act (CSA), it must be specifically scheduled and assigned one of five scheduling criteria. Schedule I is the most restrictive, which indicates that this controlled substance has no medicinal value and a high potential for abuse. Schedule V, the least restrictive, indicates a drug with currently accepted medical uses and treatments in the United States and a low potential for abuse. Schedule V drugs typically consist of preparations containing limited quantities of certain narcotics, but not always. When one combs through the CSA, the word “cannabidiol” or “CBD” is nowhere to be found — not in the code of federal regulations or in the enacting legislation. One must look deeper to find out what is scheduled and what is not.

Hemp-derived CBD oil

First, let’s look at the definition of marijuana with an “H” (marihuana), which is indeed scheduled. This comprises all parts of the Cannabis Sativa L. plant, excluding non-viable seeds stock and fiber, but including the resins and the remainder of the plant. CBD, of course, is present within the marijuana plant. If you derive CBD from the marijuana plant, it would in fact be controlled, because it came from a controlled substance. This is known as the “source rule” — the source of the material dictates its legality. But what if CBD and other non-psychoactive cannabinoids are derived from a legal source, such as the 25 other plant species that contain levels of cannabinoids or industrial hemp?

The only cannabinoid mentioned in the CSA is tetrahydrocannabinol, THC, the psychoactive compound in cannabis. While it is specifically scheduled, courts have disagreed on whether THC needs to be synthetically or naturally derived to fall within the definition of tetrahydrocannabinol under the CSA. Six years ago, industrial hemp was for the first time ever defined separately from marijuana as holding less than 0.3 Δ9-THC percent by dry weight. The 2014 Farm Bill specifically authorized the use of industrial hemp as a legal substance for purposes of market, scientific, and agricultural-based research. The CBD industry exploded because of the “market-based research exception” — one could only study the plant with a viable market in place for its products. This position was litigated in 2018 in HIA v. DEA III and the restrictions were removed by the 2018 Farm Bill.

The industrial hemp plant is no longer a controlled substance, including all of its derivatives, not the least of which is THC. Even THC from industrial hemp is no longer defined as a controlled substance (we’ll dive into this in more detail at a later time). The 2018 Farm Bill didn’t remove CBD from the Controlled Substances Act, but clarified that it was never on it. To be perfectly clear, if CBD is derived from a lawful substance, it is not and never has been a controlled substance. That’s a fact and the law.

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Yet complexities and legal challenges remain. Greenwich Biosciences (the North American subsidiary of GW Pharmaceutical) had received approval for the new drug, Epidiolex, which was identified and placed on schedule V. While CBD was not defined as schedule V, Epidiolex was because the CBD present in it is derived from marijuana. But as with every other aspect of the growth of the cannabis industry, the law rules. The makers of Epidiolex recently requested that it be removed entirely from the schedule of substances and the DEA agreed with this request.

When derived from lawful materials such as hemp, CBD and other non-psychoactive cannabinoids are not controlled substances because they’re not specifically scheduled. Still, there is pushback. Some folks refer to the Analogue Act, a section of the CSA passed in 1986 allowing any chemical similar to a schedule I or II substance to be listed as schedule I if it’s intended for human consumption. However, CBD is not identified as a chemical in schedule I or schedule II and is one of more than 100 identified cannabinoids contained within the cannabis plant.

The nexus of cannabis law, policy, and regulations has evolved a great deal in the past decade. Prior to the 2014 and the 2018 Farm Bill there was no legal distinction – it was all marijuana. Now, our definitions of cannabis are rooted in science and a plant’s legality is judged based on its chemical makeup.

Despite the perceived uncertainty regarding the legality of the compound CBD, we can officially put it to rest. Unless derived specifically and strictly from a marijuana plant, CBD is not now, and has never been, a controlled substance.

About Cannabis Policy

This section of the APIS website provides information about cannabis policy including: introduction and background, history of cannabis policy in the United States, issues treated by cannabis-related law, Federal law, and citations and relevant text excerpts.

Introduction and Background

APIS addresses laws legalizing the cultivation, sale, or use of recreational (non-medical) cannabis, together with laws imposing various prohibitions and restrictions on such practices.

In this context, “legalized” means that no civil or criminal penalties are imposed for the recreational use of cannabis by an adult resident. “Legalized” should not be confused with “decriminalized,” which means that no criminal penalties are imposed for certain activities, although some activities may result in civil penalties. Some States have decriminalized the recreational use of cannabis but have not fully legalized such use.

Here “cannabis” refers to a genus of flowering plant of the Cannabaceae or hemp family, including Cannabis sativa, Cannabis indica, and Cannabis ruderalis, which together are also commonly known as marijuana. This policy topic covers legal provisions that pertain to the dried tops, leaves, stems, and seeds of the plant, as well as products derived from them, such as concentrates, oils, and edibles.

Cannabis contains chemical compounds called cannabinoids. One important cannabinoid is delta-9 tetrahydrocannabinol, or THC, which has a psychoactive effect and is the chemical commonly associated with recreational use. Another cannabinoid is cannabidiol, or CBD, which has a sedative and mildly analgesic effect and is the chemical most often associated with medicinal use.

History of Cannabis Policy in the United States

Between 1840 and 1900, cannabis was legal and used medicinally in the United States. In 1860, based on concern about possible negative effects of use, the first Federal commission to study cannabis was created. By the 1890s, many members of the medical community considered it a narcotic that should be regulated.

Recreational cannabis use in the U.S. started at the beginning of the 20th century, as did the movement to regulate its use. In 1914 the Harrison Act was enacted, which declared drug use a crime. In 1915, California became the first State to make it illegal to possess cannabis. In the 1930s, the then U.S. Federal Bureau of Narcotics warned of the increasing abuse of cannabis, and by 1937, 23 States had criminalized possession. Also, in 1937, the Marijuana Tax Act imposed a tax on cannabis. In 1942, marijuana was removed from the U.S. pharmacopeia. In 1956, cannabis was included in the Federal Narcotics Control Act, leading to strict Federal penalties for its possession. In the Controlled Substances Act of 1970, the Federal government categorized marijuana as a Schedule I substance, meaning it was considered to have no acceptable medical use and was among the class of drugs having the highest potential for abuse. (See below for information regarding the DEA’s 2018 and 2020 reclassifications of the epilepsy drug Epidiolex, and regarding the 2018 Farm Bill’s removal of low-THC hemp from the Controlled Substances Act.)

Not long after the categorization of marijuana as a dangerous drug, Federal and State-level efforts arose to decriminalize the possession of cannabis. President Richard Nixon appointed a commission to review marijuana laws, and in 1972 the commission recommended that cannabis be decriminalized. President Nixon declined to act on that recommendation, although some States moved to liberalize their laws pertaining to cannabis. In 1978, New Mexico was the first State to recognize its legitimate medical use. In 1996, California became the first State to legalize the use of medical marijuana. As of 2020, more than 30 other jurisdictions have done the same for medical marijuana.

With respect to the recreational use of cannabis, efforts at the State level have typically focused first on decriminalization and then on legalization.

Between 1973 and 1979, eleven States decriminalized cannabis possession. Due to public health concerns about underage cannabis use, further efforts to decriminalize were unsuccessful until the 2000s, when several additional States decriminalized possession.

The next level of lawmaking has been to legalize the recreational use of cannabis in specific and limited ways. As of January 1, 2021, fourteen States and the District of Columbia have legalized recreational use to varying degrees for adults, starting in 2012 with voter referenda in Colorado and Washington.

References regarding History:

The History of the Non-Medical Use of Drugs in the United States. Charles Whitebread, Professor of Law, USC Law School. A Speech to the California Judges Association 1995 annual conference. Drug Library: https://druglibrary.org/schaffer/hemp/history/first12000/1.htm. Accessed 3/23/16.

Huntington’s Outreach Project for Education, at Stanford (HOPES). Medical Marijuana Policy in the United States. May 15, 2012. https://hopes.stanford.edu/medical-marijuana-policy-in-the-united-states/. Accessed 3/24/16.

Historical and Cultural Uses of Cannabis and the Canadian “Marijuana Clash”. Prepared For The Senate Special Committee on Illegal Drugs. Leah Spicer. Law and Government Division. 12 April 2002. Library of Parliament. https://sencanada.ca/content/sen/committee/371/ille/library/spicer-e.htm#A. Accessed 3/25/2016.

Issues Treated by Cannabis-Related Law

Federal Law

The approach taken by the US government to the use of cannabis by its citizens has a long and varied history. See the Policy Descriptions for Recreational Use of Cannabis: Volume 1 and Recreational Use of Cannabis: Volume 2.

Since 1970, the most significant element of this approach has been the classification of cannabis as a Schedule I substance pursuant to the Controlled Substances Act of 1970. 21 U.S.C. § 801, et seq.

Under the terms of the Act, as a Schedule I drug cannabis is defined as having “a high potential for abuse,” “no currently accepted medical use in treatment,” and “a lack of accepted safety for use … under medical supervision.” 21 U.S.C. § 812(b)(1).

The classification of cannabis under Federal law has a number of important consequences. First, the classification as a Schedule I substance involves significant penalties for those who illegally manufacture, distribute or possess the drug (see, e.g., 21 U.S.C. § 841; 21 U.S.C. § 844; 21 U.S.C. § 846).

Second, although numerous States have legalized the use of cannabis for either medicinal or recreational use, the status of cannabis as a controlled substance under Federal law has, for the most part, not changed. (See below for information regarding the DEA’s 2018 and 2020 reclassifications of the epilepsy drug Epidiolex, and regarding the 2018 Farm Bill’s removal of low-THC hemp from the Controlled Substances Act.)

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The classification of cannabis under Federal law has led to reports that cannabis businesses operating lawfully under State law have experienced difficulties in obtaining banking services, claiming tax deductions for operating expenses, and using the US mail, among other issues.

In an attempt to address this tension between Federal and State law, the Department of Justice (DOJ) issued a series of memoranda providing guidance with respect to Federal marijuana enforcement policy in the context of State legalization initiatives.

In 2013 the DOJ indicated that it would focus its enforcement efforts on only those cannabis-related activities that threaten the following specified Federal priorities:

  1. Preventing the distribution of marijuana to minors;
  2. Preventing revenue from the sale of marijuana from going to criminal enterprises, gangs, and cartels;
  3. Preventing the diversion of marijuana from States where it is legal under State law in some form to other States;
  4. Preventing State-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity;
  5. Preventing violence and the use of firearms in the cultivation and distribution of marijuana;
  6. Preventing drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use;
  7. Preventing the growing of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands; and
  8. Preventing marijuana possession or use on Federal property.

In a 2014 memorandum the DOJ indicated that investigations and prosecutions of financial institutions or individuals providing banking services to marijuana-related businesses should be subject to the same eight enforcement priorities outlined in the memorandum of August 29, 2013. (See Memorandum for All United States Attorneys from James M. Cole, Deputy Attorney General, Guidance Regarding Marijuana Related Financial Crimes, Feb. 14, 2014: https://www.justice.gov/sites/default/files/usao-wdwa/legacy/2014/02/14/DAG%20Memo%20-%20Guidance%20Regarding%20Marijuana%20Related%20Financial%20Crimes%202%2014%2014%20(2).pdf.)

Another significant consequence of the classification of cannabis under Federal law has been that research institutions face restrictions in obtaining cannabis for investigating potential medical applications and treatment efficacy.

In response to this situation, in July 2015 a group of eight Democratic senators called for the Federal government to “facilitate scientific research on the potential health benefits of marijuana when used for medical purposes” by, among other things, reassessing marijuana’s classification as a Schedule I substance. (See Letter from Senators Warren, Merkley, Wyden, Mikulski, Markey, Boxer, Booker, and Gillibrand to HHS Secretary Burwell, ONDCP Director Botticelli, and DEA Acting Administrator Rosenberg, July 9, 2015: http://www.warren.senate.gov/files/documents/HHS_ONDCP_DEA_Marijuana_letter.pdf.)

In January 2018, the Justice Department rescinded the Aug. 29, 2013 and Feb. 14, 2014 memoranda referenced above and directed Federal prosecutors to follow “the well-established principles that govern all federal prosecutions” when deciding which marijuana activities to prosecute under Federal law. (See Memorandum for All United States Attorneys from Jefferson B. Sessions, Attorney General, Marijuana Enforcement, Jan. 4, 2018: https://www.justice.gov/opa/pr/justice-department-issues-memo-marijuana-enforcement ; https://www.justice.gov/opa/press-release/file/1022196/download.)

In June 2018 the Food and Drug Administration (FDA) approved the drug Epidiolex, an oral solution containing cannabidiol (CBD) extracted from the cannabis plant, for the treatment of seizures associated with two rare and severe forms of epilepsy, in patients two years of age and older. (See FDA News Release, June 25, 2018: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm.) Following this action, the DEA rescheduled the Epidiolex formulation from Schedule I to Schedule V of the Controlled Substances Act (see DEA Final Order, Sep. 28, 2018: https://www.federalregister.gov/documents/2018/09/28/2018-21121/schedules-of-controlled-substances-placement-in-schedule-v-of-certain-fda-approved-drugs-containing). In 2020 the DEA removed Epidiolex from the Controlled Substances Act altogether (see https://www.jdsupra.com/legalnews/dea-removes-cbd-from-controlled-71065/). In the United States, Epidiolex is currently available to patients by prescription.

In December 2018, Congress passed and the President signed the 2018 Farm Bill (known as H.R.2, the “Agriculture Improvement Act of 2018”), which included a provision removing low-THC hemp (defined as cannabis with a THC concentration of not more than 0.3 percent on a dry weight basis) from the Controlled Substances Act. (See Public Law 115-334 §§ 10113, 12619: https://www.congress.gov/bill/115th-congress/house-bill/2/text.)

Despite numerous State initiatives legalizing cannabis for either medicinal or recreational use, and with the exception of low-THC hemp and the epilepsy drug Epidiolex noted above, the use of cannabis remains prohibited under Federal law as of December 2021.

Citations and Relevant Text Excerpts

21 U.S.C. § 812

§ 812. Schedules of controlled substances

There are established five schedules of controlled substances, to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. * * *

(b) Placement on schedules; findings required

Except where control is required by United States obligations under an international treaty, convention, or protocol, in effect on October 27, 1970, and except in the case of an immediate precursor, a drug or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such drug or other substance. The findings required for each of the schedules are as follows:

(A) The drug or other substance has a high potential for abuse.

(B) The drug or other substance has no currently accepted medical use in treatment in the United States.

(C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.

(c) Initial schedules of controlled substances

Schedules I, II, III, IV, and V shall, unless and until amended1 pursuant to section 811 of this title, consist of the following drugs or other substances, by whatever official name, common or usual name, chemical name, or brand name designated:

(c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) 3,4-methylenedioxy amphetamine.

(2) 5-methoxy-3,4-methylenedioxy amphetamine.

(3) 3,4,5-trimethoxy amphetamine.

(9) Lysergic acid diethylamide.

(13) N-ethyl-3-piperidyl benzilate.

(14) N-methyl-3-piperidyl benzilate.

(17) Tetrahydrocannabinols, except for tetrahydrocannabinols in hemp (as defined under section 1639o of Title 7).

(18) 4-methylmethcathinone (Mephedrone).

(19) 3,4-methylenedioxypyrovalerone (MDPV).

(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).

(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).

(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).

(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).

(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2).

(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4).

(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).

(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).

(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P).

(d)(1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.

(2) In paragraph (1):

(A) The term “cannabimimetic agents” means any substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional assays within any of the following structural classes:

(i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent.

(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent.

(iii) 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent.

(iv) 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent.

(v) 3-phenylacetylindole or 3-benzoylindole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any extent.

(B) Such term includes–

(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497);

(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog);

(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678);

(iv) 1-butyl-3-(1-naphthoyl)indole (JWH-073);

(v) 1-hexyl-3-(1-naphthoyl)indole (JWH-019);

(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200);

(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250);

(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081);

(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122);

(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398);

(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);

(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);

(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS-4);

(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8); and

(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).

21 U.S.C. § 841

§ 841. Prohibited acts A

(a) Unlawful acts

Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally–

(1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or

(2) to create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance.

Except as otherwise provided in section 849, 859, 860, or 861 of this title, any person who violates subsection (a) of this section shall be sentenced as follows:

(1)(A) In the case of a violation of subsection (a) of this section involving–

(vii) 1000 kilograms or more of a mixture or substance containing a detectable amount of marihuana, or 1,000 or more marihuana plants regardless of weight;

such person shall be sentenced to a term of imprisonment which may not be less than 10 years or more than life and if death or serious bodily injury results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of Title 18 or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of Title 18 or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. If any person commits a violation of this subparagraph or of section 849, 859, 860, or 861 of this title after 2 or more prior convictions for a serious drug felony or serious violent felony have become final, such person shall be sentenced to a term of imprisonment of not less than 25 years and fined in accordance with the preceding sentence. * * *

(B) In the case of a violation of subsection (a) of this section involving–

(vii) 100 kilograms or more of a mixture or substance containing a detectable amount of marihuana, or 100 or more marihuana plants regardless of weight;

such person shall be sentenced to a term of imprisonment which may not be less than 5 years and not more than 40 years and if death or serious bodily injury results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that authorized in accordance with the provisions of Title 18 or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a serious drug felony or serious violent felony has become final, such person shall be sentenced to a term of imprisonment which may not be less than 10 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that authorized in accordance with the provisions of Title 18 or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. * * *

(D) In the case of less than 50 kilograms of marihuana, except in the case of 50 or more marihuana plants regardless of weight, 10 kilograms of hashish, or one kilogram of hashish oil, such person shall, except as provided in paragraphs (4) and (5) of this subsection, be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that authorized in accordance with the provisions of Title 18 or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that authorized in accordance with the provisions of Title 18 or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. * * *

21 U.S.C. § 844

§ 844. Penalties for simple possession

(a) Unlawful acts; penalties

It shall be unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by this subchapter or subchapter II of this chapter. * * *

21 U.S.C. § 846

§ 846. Attempt and conspiracy

Any person who attempts or conspires to commit any offense defined in this subchapter shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy.

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