In the Weeds: Navigating the Shifting Federal Regulation of Medical Marijuana

by K&L Gates LLP

K&L Gates LLP

The federal government’s view of medical marijuana is evolving as the U.S. Food and Drug Administration (“FDA” or “Agency”), on June 25, 2018, approved Epidiolex, the first drug containing cannabidiol (“CBD”) [1], a marijuana derivative, and the U.S. Congress considers several bills aimed at relaxing regulatory standards for medical marijuana. In a press release regarding this recent approval, FDA Commissioner Scott Gottlieb reiterated the Agency’s commitment to “careful scientific research and development,” noting that the “approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.” Before Epidiolex can be made available to patients, CBD must be rescheduled by the U.S. Drug Enforcement Administration (“DEA”) from its current Schedule I classification under the Controlled Substances Act (“CSA”).

This alert provides an overview of the roles of FDA and other federal agencies in regulating the research, development and marketing of medical marijuana, along with a discussion on DEA’s rescheduling process for controlled substances and its past actions related to marijuana. This alert also provides information on key proposed congressional legislation focused on relaxing medical marijuana regulations and considerations for stakeholders in light of this shifting regulatory landscape.

FDA’s Regulation of Marijuana in Development and Marketing

FDA takes the position that the drug approval process, which it regulates, is the most appropriate manner to determine whether a product derived from marijuana or its derivatives is safe and effective and has an acceptable medical use. Utilizing this pathway, on June 25, 2018, the Agency approved GW Pharmaceuticals’ Epidiolex, a CBD oral solution for the treatment of seizures in two rare forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. The drug is approved for such uses in patients 2 years of age and older. Epidiolex will be marketed in the United States by GW Pharmaceuticals’ U.S. subsidiary Greenwich Biosciences and is the first FDA-approved drug that contains a drug substance derived from marijuana. [2] FDA’s recent approval decision aligns with the FDA Peripheral and Central Nervous System Drugs Advisory Committee’s unanimous vote (13–0) in favor of the benefit-risk profile of Epidiolex issued on April 19, 2018. Research and development programs for products containing or derived from marijuana are ongoing for a variety of other diseases and conditions, including pain, substance use disorder, and graft-versus-host disease.

FDA’s approval of Epidiolex does not, however, change the Agency’s laws and regulations prohibiting the use of marijuana and its derivatives, including products containing CBD and tetrahydrocannabinols (THC), in food, dietary supplements and over-the-counter (“OTC”) drug products, such as oil drops, capsules, teas, and topical lotions and creams. Consistent with its previous actions, FDA’s enforcement priorities in this area will focus on marketing of unapproved drugs where firms have made health claims for products containing or derived from marijuana.

DEA Scheduling of Marijuana

Currently, marijuana and its derivatives, including CBD, are classified as Schedule I substances by DEA. [3] In accordance with the CSA, DEA classifies substances into five categories based on medical use, potential for abuse, and safety or dependence liability. As a Schedule I drug, marijuana is considered to have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and lack an accepted safety for use under medical supervision. Under federal law, manufacturing and distributing marijuana is illegal and punishable by fines and/or imprisonment.

Before Epidiolex can be made available to patients, DEA will have to reschedule CBD from its current Schedule I classification. As part of this process, FDA will provide a scientific and medical evaluation, through the Secretary of Health and Human Services (“HHS”), and a rescheduling recommendation to DEA. DEA is required to make a rescheduling determination within 90 days. [4]

Federal Agencies and Medical Research Involving Marijuana

Numerous federal agencies currently regulate the clinical research of marijuana and its derivatives. Researchers must submit an Investigational New Drug (“IND”) application to FDA’s Office of New Drugs within the Center for Drug Evaluation and Research (“CDER”) in order to conduct research on marijuana. DEA oversees registration and licensure requirements for researchers and research sites. The National Institute on Drug Abuse (“NIDA”), which is part of the National Institutes of Health (“NIH”), oversees the cultivation of marijuana for medical research and supplies such product to researchers.

For many years, FDA and DEA have been in favor of expanding legitimate research into the medical use of marijuana and its derivatives. In 2003, FDA formed a Botanical Review Team to provide scientific and quality control advice to researchers developing drugs derived from plants, such as marijuana. In December 2016, this team published revised guidance on clinical studies involving botanical drugs and recommendations for quality controls for lot-to-lot consistency. [5] Further, in December 2016, DEA announced a new policy to increase the number of entities under the CSA permitted to grow marijuana for legitimate research purposes. [6] Prior to this policy, DEA relied on a single grower, the University of Mississippi, to produce marijuana for research purposes. The policy allows registrants to grow marijuana not only to supply federally funded and academic researchers, but also the private sector for medical product development. Since then, DEA has received at least 25 applications from entities seeking to grow marijuana for research purposes.

Congressional Bills on Medical Marijuana

There are currently several bills pending in the U.S. Congress that would impact the regulation of medical marijuana. H.R. 2020, authored by freshman Representative Matt Gaetz (R-FL), would direct DEA to transfer marijuana from Schedule I to Schedule III of the CSA. Representative Bob Goodlatte (R-VA), who chairs the House Judiciary Committee, is one of the bill’s co-sponsors. Rep. Goodlatte has long blocked marijuana-related legislation from advancing, so his co-sponsorship signals a shift in Congress.

Another bill seeking to amend the CSA is H.R. 3391, the Medical Marijuana Research Act of 2017, which would establish a new, separate registration process to facilitate research of marijuana for medical purposes. If passed, DEA would register practitioners to conduct medical marijuana research and manufacturers and distributors to supply marijuana for research. Interestingly, this bill is sponsored by Representative Andy Harris (R-MD), who has previously taken actions against marijuana legalization. Rep. Harris indicates that by sponsoring the bill, he expects such research to demonstrate that marijuana is not medically useful.

H.R. 2920/S. 1764, the Compassionate Access, Research Expansion, and Respect States Act of 2017 (“CARERS Act of 2017”), addresses enforcement of the CSA in states in which medical marijuana is legal. The bill would amend the CSA to provide that the administrative, civil, and criminal penalties do not apply to a person who produces, possesses, distributes, dispenses, administers, tests, recommends, or delivers medical marijuana in compliance with state law. This bill was first introduced last session and was re-introduced this session after Attorney General Jeff Sessions sought greater latitude in prosecuting medical marijuana cases. [7]

Moreover, Senators Cory Gardner (R-CO) and Elizabeth Warren (D-MA) recently introduced the Strengthening the Tenth Amendment Through Entrusting States (“STATES”) Act (S. 3032), which would amend the CSA so that it would not apply to persons or entities acting in compliance with state laws that allow for the manufacture, production, possession, distribution, and delivery of marijuana for recreational and medical purposes. Representatives David Joyce (R-OH) and Earl Blumenauer (D-OR) introduced a companion bill (H.R. 6043) in the House. Notably, President Trump has signaled that he would support the STATES Act, which is viewed as a compromise with Senator Gardner, who has held up several Department of Justice (“DOJ”) nominees since Attorney General Sessions announced that he would rescind the Obama Administration hand-off approach to enforcing federal marijuana laws.


The federal regulatory landscape for marijuana will shift depending on DEA’s rescheduling determination related to FDA’s recent drug approval of Epidiolex. This approval, however, does not change FDA’s prohibition on the use of marijuana and its derivatives in food, dietary supplements and OTC drug products. [8]

Further, while FDA has acknowledged that some states have legalized medical marijuana, it has continuously emphasized to states the importance of clinical research regarding the safety and effectiveness of products containing marijuana and its derivatives. Federal agencies have also supported efforts to enhance the generation of valid scientific data regarding marijuana’s safety and efficacy for medical use. Such research should demonstrate that products containing marijuana or its derivatives can be delivered in reliable dosages through reproducible delivery routes. Additionally, the regulation of medical marijuana may be relaxed based on pending congressional legislation.

Accordingly, opportunities exist for stakeholders, including growers, manufacturers and researchers, interested in advancing the development of medical marijuana. The K&L Gates FDA and Public Policy and Law practices will continue to monitor and provide updates on future developments in this area. Given our substantive experience in and knowledge of FDA-regulated industries, K&L Gates is well-positioned to facilitate engagement and help you assess risks and opportunities in this area.

[1] CBD is a chemical component of the Cannabis sativa plant, also known as marijuana.

[2] While, to date, FDA has not approved an NDA for a drug product containing or derived from botanical marijuana, FDA has approved two drug products, Marinol and Syndros, containing dronabinol, a synthetic form of the marijuana derivative delta-9-tetrahydrocannabinol (“THC”) as the active ingredient. Marinol is classified as Schedule III, and Syndros is classified as Schedule II. Both Marinol and Syndros are indicated in adults for the treatment of anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients. In addition, FDA has approved Cesamet, a Schedule II drug that contains a synthetically-derived active ingredient with a chemical structure similar to THC.

[3] THC and marijuana extract are also classified as Schedule I drugs.

[4] DEA has denied all past requests to reschedule marijuana. As recently as 2016, after receiving two requests for rescheduling and subsequently requesting from HHS a medical evaluation and scheduling recommendation, DEA concurred with HHS’ recommendation not to reschedule marijuana. While DEA has acknowledged that medical research in this area has progressed over the past years, it takes the position that available evidence has not been sufficient to demonstrate that marijuana and its derivatives have an accepted medical use. Denial of petition to initiate proceedings to reschedule marijuana, 81 Fed. Reg. 53,687 (Aug. 12, 2016); Denial of petition to initiate proceedings to reschedule marijuana, 81 Fed. Reg. 53,767 (Aug. 12, 2016).

[5] Botanical Drug Development, Guidance for Industry,

[6] Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States, 81 Fed. Reg. 53,846 (Aug. 12, 2016).

[7] In January 2018, Attorney General Sessions rescinded the Department of Justice’s (“DOJ’s”) previous hands-off approach, adopted under the Obama Administration, of enforcing federal marijuana laws in those states where marijuana is legal for medical or recreational use, and Session directed all U.S. Attorneys to enforce federal law when pursuing marijuana-related prosecution.

[8] See, e.g., FDA Warning Letter to That’s Natural (Oct. 31, 2017),


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© K&L Gates LLP | Attorney Advertising

Written by:

K&L Gates LLP

K&L Gates LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide

JD Supra Privacy Policy

Updated: May 25, 2018:

JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.

This Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to our website (located at (our "Website") who view only publicly-available content as well as subscribers to our services (such as our email digests or author tools)(our "Services"). By using our Website and registering for one of our Services, you are agreeing to the terms of this Privacy Policy.

Please note that if you subscribe to one of our Services, you can make choices about how we collect, use and share your information through our Privacy Center under the "My Account" dashboard (available if you are logged into your JD Supra account).

Collection of Information

Registration Information. When you register with JD Supra for our Website and Services, either as an author or as a subscriber, you will be asked to provide identifying information to create your JD Supra account ("Registration Data"), such as your:

  • Email
  • First Name
  • Last Name
  • Company Name
  • Company Industry
  • Title
  • Country

Other Information: We also collect other information you may voluntarily provide. This may include content you provide for publication. We may also receive your communications with others through our Website and Services (such as contacting an author through our Website) or communications directly with us (such as through email, feedback or other forms or social media). If you are a subscribed user, we will also collect your user preferences, such as the types of articles you would like to read.

Information from third parties (such as, from your employer or LinkedIn): We may also receive information about you from third party sources. For example, your employer may provide your information to us, such as in connection with an article submitted by your employer for publication. If you choose to use LinkedIn to subscribe to our Website and Services, we also collect information related to your LinkedIn account and profile.

Your interactions with our Website and Services: As is true of most websites, we gather certain information automatically. This information includes IP addresses, browser type, Internet service provider (ISP), referring/exit pages, operating system, date/time stamp and clickstream data. We use this information to analyze trends, to administer the Website and our Services, to improve the content and performance of our Website and Services, and to track users' movements around the site. We may also link this automatically-collected data to personal information, for example, to inform authors about who has read their articles. Some of this data is collected through information sent by your web browser. We also use cookies and other tracking technologies to collect this information. To learn more about cookies and other tracking technologies that JD Supra may use on our Website and Services please see our "Cookies Guide" page.

How do we use this information?

We use the information and data we collect principally in order to provide our Website and Services. More specifically, we may use your personal information to:

  • Operate our Website and Services and publish content;
  • Distribute content to you in accordance with your preferences as well as to provide other notifications to you (for example, updates about our policies and terms);
  • Measure readership and usage of the Website and Services;
  • Communicate with you regarding your questions and requests;
  • Authenticate users and to provide for the safety and security of our Website and Services;
  • Conduct research and similar activities to improve our Website and Services; and
  • Comply with our legal and regulatory responsibilities and to enforce our rights.

How is your information shared?

  • Content and other public information (such as an author profile) is shared on our Website and Services, including via email digests and social media feeds, and is accessible to the general public.
  • If you choose to use our Website and Services to communicate directly with a company or individual, such communication may be shared accordingly.
  • Readership information is provided to publishing law firms and authors of content to give them insight into their readership and to help them to improve their content.
  • Our Website may offer you the opportunity to share information through our Website, such as through Facebook's "Like" or Twitter's "Tweet" button. We offer this functionality to help generate interest in our Website and content and to permit you to recommend content to your contacts. You should be aware that sharing through such functionality may result in information being collected by the applicable social media network and possibly being made publicly available (for example, through a search engine). Any such information collection would be subject to such third party social media network's privacy policy.
  • Your information may also be shared to parties who support our business, such as professional advisors as well as web-hosting providers, analytics providers and other information technology providers.
  • Any court, governmental authority, law enforcement agency or other third party where we believe disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect our rights, the rights of any third party or individuals' personal safety, or to detect, prevent, or otherwise address fraud, security or safety issues.
  • To our affiliated entities and in connection with the sale, assignment or other transfer of our company or our business.

How We Protect Your Information

JD Supra takes reasonable and appropriate precautions to insure that user information is protected from loss, misuse and unauthorized access, disclosure, alteration and destruction. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. You should keep in mind that no Internet transmission is ever 100% secure or error-free. Where you use log-in credentials (usernames, passwords) on our Website, please remember that it is your responsibility to safeguard them. If you believe that your log-in credentials have been compromised, please contact us at

Children's Information

Our Website and Services are not directed at children under the age of 16 and we do not knowingly collect personal information from children under the age of 16 through our Website and/or Services. If you have reason to believe that a child under the age of 16 has provided personal information to us, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at:

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit
  • New Relic - For more information on New Relic cookies, please visit
  • Google Analytics - For more information on Google Analytics cookies, visit To opt-out of being tracked by Google Analytics across all websites visit This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at:

- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.