Breaking Down the Recent Cannabis Rescheduling Recommendation

For more than fifty years, the federal government has maintained that cannabis is a Schedule I drug, meaning that it has a high potential for abuse and no accepted medical value. That changed last week (somewhat) when the Department of Health and Human Services (HHS) recommended to the Drug Enforcement Administration (DEA) that cannabis be placed in Schedule III, meaning that it has moderate to low abuse potential, a currently accepted medical use, and a low potential for psychological dependence. 

Why now?

In October 2022, the Biden Administration announced that it would ask the Secretary of HHS and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law. As the Brookings Institute outlined years ago, the Executive process for rescheduling is much more complex than the Legislative path. 

It’s no secret that the presidential election is barely more than a year away, and the President seems to be looking to make good on his campaign promise to reform the nation’s marijuana laws.

What does this mean?

First off, it’s critical to note that HHS’ recommendation to DEA is just that: a recommendation. It is non-binding. The DEA may come to the same conclusion that HHS did, but is not required to. 

If cannabis is moved to Schedule III of the Controlled Substances Act, one positive outcome would be that 280E would no longer apply to plant-touching businesses, removing an incredibly punitive and debilitating provision in the tax code.

According to NCIA’s board chair emeritus, Khurshid Khoja, Esq., “…it’s important to remember that rescheduling would not apply the federal Food Drug and Cosmetic Act (FDCA) to marijuana for the first time—it applies right now, and like the federal Controlled Substances Act (CSA), would continue to apply after rescheduling. But absent any statutory authority permitting FDA to do otherwise, the FDCA would continue to apply after descheduling too, just as it does to hemp products.” 

Others claim that the shift to Schedule III would have minimal impact on businesses and individuals. Here at NCIA, we’re cautiously optimistic but recognize that moving cannabis to schedule III could have some limited benefit but does nothing to align federal law with the 38 U.S. states which have already effectively regulated cannabis for medical or adult use.

What now?

Now that HHS has made their recommendation, the DEA will begin its scheduling review process. 

Many are divided about what a move to Schedule III would actually look like. Yes, there would be the elimination of 280E, but what about enforcement priorities? Interstate commerce? Criminal penalties? There are so many unknowns. 

NCIA has previously produced a common sense, workable roadmap for that federal comprehensive reform and provided detailed feedback on legislative efforts. It is time for Congress to follow the will of the American people. Don’t get me wrong, there’s no doubt that this recommendation is a step in the right direction and is long overdue. But we can’t lose sight of the ultimate goal: removing cannabis from the Controlled Substances Act entirely.

Have questions?

Join NCIA on September 14 at 1 pm ET for an engaging webinar where we will unpack all your questions! Register today and don’t miss your chance to hear more about what this means for the cannabis industry and your business.

ACTION ALERT: Congress to Vote on Historic MORE Act

The Marijuana Opportunity, Reinvestment, and Expungement Act (H.R. 3884) is expected to come to a vote in the U.S. House of Representatives in December 2020. NCIA has been building support for this bill in Congress for the last year and now we need your help!

Please call your member of Congress and ask them to vote YES on the MORE Act today! 

Look up your congressional representative and contact info by zip code, here.

Reference our congressional scorecard to find out if your representatives are sponsoring NCIA’s priority legislation, including the MORE Act.

Sample script to help guide your call:

Hello! My name is _______________ and I am a constituent of yours in (city, state, zip code). I am calling today to ask that Representative _____________ votes “Yes” on H.R. 3884, the MORE Act, when it comes to the Floor for a vote in December.

This bill would remove cannabis from the Controlled Substances Act at the federal level, leaving marijuana policy up to the individual states. It also creates avenues towards expungement, re-sentencing, and assists those communities that have most been impacted by the failed war on marijuana. Additionally, legal cannabis is a huge economic driver and would help both the federal government and states’ revenue shortfalls during this pandemic. 

Thank you for your time today. Again, I hope Representative _____________ will vote “Yes” on H.R. 3884, the Marijuana Opportunity, Reinvestment, and Expungement Act. 

*Feel free to tell a personal story if you feel it is relevant or powerful, but remember that staffers are busy so sometimes short and sweet is best!*

Summary of the Marijuana Opportunity, Reinvestment, and Expungement Act of 2019:

The Marijuana Opportunity, Reinvestment, and Expungement Act (H.R. 3884, S. 2227), commonly known as the MORE Act, was introduced in 2019 by House Judiciary Committee Chairman Jerry Nadler (D-NY) and Senator (now Madam Vice President-Elect) Kamala Harris (D-CA).

This bill would: 

  • Decriminalize cannabis federally: The bill removes cannabis from the Controlled Substances Act, leaving cannabis policy up to the states
  • Allow for expungement of marijuana convictions and arrests, sealing of records, and re-sentencing: Requires federal courts to expunge prior convictions and arrests and seal court records for those not under a current criminal justice sentence and requires courts, on motion, to conduct re-sentencing hearings for those under a criminal justice sentence.
  • Establish sales tax and “Opportunity Trust Funds”: Authorizes the assessment of a 5% sales tax on marijuana and marijuana products to create an Opportunity Trust Fund, which includes three grant programs: 
    • The Community Reinvestment Grant Program, administered by the Department of Justice, would provide services to the individuals most adversely impacted by the War on Drugs, including job training, re-entry services, legal aid, literacy programs, youth recreation, mentoring, and substance use treatment. 
    • The Cannabis Opportunity Grant Program, administered by the Small Business Administration (SBA), would provide funds for loans to assist small businesses in the marijuana industry that are owned and controlled by socially and economically disadvantaged individuals. 
    • The Equitable Licensing Grant Program, also administered by SBA, would provide funds for programs that minimize barriers to marijuana licensing and employment for the individuals most adversely impacted by the War on Drugs. 
  • Make available SBA programs and services to cannabis businesses: Specifies that the SBA may not negate eligibility for loans and other services based on a business being cannabis related. 
  • Clarify federal public benefits: Prohibits the denial of any federal public benefit (including housing) based on the use or possession of marijuana, or prior conviction for a marijuana offense. 
  • Protects immigrants: Provides that the use or possession of marijuana, or prior conviction for a marijuana offense, will have no adverse impact under the immigration laws. 
  • Provide for data Collection: Requires the Bureau of Labor Statistics to collect data on the demographics of the industry to assess whether people of color and those who are economically disadvantaged are participating in the industry. 
  • Age equity for juveniles: The bill applies equally to juveniles and adults, protecting young people from harmful criminal records.

Member Blog: Advice for Surviving and Thriving in the New Era of Legal Cannabis From Those Who Have Climbed The Mountain (Part 1)

by James Schwartz, CEO of Cascade High Organics

Look to the past to see the future

The challenges facing companies pioneering a new industry where each state deals with its own issues are numerous. The importance of strategic business planning and the ability to predict future problems are essential to survival. Colorado, Washington, and Oregon have each dealt with their unique issues and challenges but there are also common problems that every cannabis business experiences: burdensome regulation, unfair taxation, and banking prohibition to name a few. Building your company and brand is dependent on your ability to maneuver your company through the obstacles that will arise in your state market while also planning for a future of legal interstate commerce through a change in federal policy. To place your company in a position to be successful, you should understand the past to predict the future. 

Quick Summary of Cannabis History

The history of cannabis is long and distorted, however a few basic points of what brought us to the current state of federal prohibition and individual state markets should be noted for context.

Cannabis use as medicine dates back to 2700 BC in China, and has been used throughout history. In 1850, it was added to the U.S. Pharmacopeia. Prior to state and then Federal prohibition, cannabis was an elixir/tincture used in many common household cough/cold syrups and other medications for stomach-aches, asthma, depression, and many others. In the 1930s, cannabis was regulated as a drug in all states, and in 1937, the passing of the Marihuana Tax Act regulated it federally. Then in 1970, the Controlled Substances Act determined cannabis to be a Schedule 1 drug meaning it has no medical benefit and a high risk for abuse. From 1970 to 1996 the manufacture, use, or possession of cannabis was illegal in all fifty states.

CALIFORNIA

In 1996, California became the first state to legalize the medical use of cannabis through Proposition 215. California was the first domino to fall and further background of the early days of California medical cannabis will be addressed in later blogs in this series focusing on California. Over the next twenty years, 37 states have joined California with medically legal cannabis, and nine states have passed and implemented legal “recreational” (now referred to as “adult use”) cannabis programs.  

OREGON

Oregon was the second state to pass medical cannabis in 1998 and that was the start of this author’s journey through the cannabis industry. Prior to 1998, Oregon had been a bastion of black market cannabis cultivation due to its climate and wide open spaces especially in rural southern and eastern Oregon. After 1998, the state “protections” offered by medical cannabis state law allowed the cultivation industry to flourish. However, as opposed to California the state was more focused on growing weed and selling it around the country rather than setting up a distribution system to the medical patients of Oregon. This led to some of the early challenges of the medical cannabis program in Oregon. At this time, the Oregon population was relatively small compared to the state’s cannabis production. Oregon was on its way to being one of the largest cannabis producers in the country. But because cannabis was so easily accessible there was little effort put into a healthy distribution system to Oregon patients. Most patients either grew for themselves or had a designated “grower” and that is where I started in the industry.  

OREGON: FORMATION OF RETAIL ESTABLISHMENTS

As a nurse who had self medicated with cannabis for ADHD, I began growing for patients because I wanted to provide others with access to the amazing health benefits of cannabis. This was the common way most patients accessed their cannabis. There were no dispensaries when the program started and patients who didn’t have a grower were relegated to barter trade types of acquisition. In 2005, the Oregon Legislature allowed growers to be reimbursed for the cost of production and in 2010, the first dispensaries began to pop up. However, it wasn’t until 2012 that legal retail entities were allowed. This lack of a retail access point for patients was one of the first impediments to the program and allowed states like Colorado and California to take the mantel on progress of a robust program of medical cannabis distribution.

COLORADO

In 2000, Colorado became the sixth state to allow medical cannabis with Amendment 20. Its medical program remained low key until 2010 when the Colorado Medical Marijuana Code was created, which provided for licensing of production and retail establishments. This change was a giant step to the progress of cannabis legalization.

Colorado followed the early model presented in California and began implementing licensed retail establishments for card carrying medical cannabis patients. Retails stores began to flourish and this laid the groundwork for the establishment of the Adult Use program. In 2012, Colorado became the first state to legalize what was originally referred to as recreational cannabis now called “Adult Use” cannabis, which allowed the sales of cannabis to all adults aged twenty-one and older and the boom began. Colorado’s medical program developed into a rapidly growing Adult Use system and with the new federal guidance of the Cole Memo in 2013 canna-businesses began growing rapidly.

COLORADO: SEED TO SALE TRACKING

The primary language of the Cole Memo highlights a “robust tracking system” of all products produced and sold. The Cole Memo did not provide protections for cannabis businesses but provided guidance that helped assure businesses of some safety from federal interference. With the advent and implementation of a tracking system we could now be assured of where products came from and be able to track them back to their origin.

COLORADO: LAB TESTING

Once tracking was in place, lab testing for the safety of the consumer came to the forefront of industry progress. This was one of the first problems Colorado realized it had with its blossoming industry. As opposed to Oregon which required all products sold through its immature dispensary system since 2012, Colorado had not required lab testing of all its products until 2016 after several large quarantines and destruction of unsafe contaminated products. Many Colorado producers struggled with new pesticide regulations and was an early sticking point to growth of the industry. Over the first years of Adult Use cannabis program, Colorado struggled with the infancy of a brand new industry and how to regulate it and consequently, businesses suffered.

Other early challenges that the first legal state dealt with were allowable dosages and changes to dosing, as well packaging changes and the look of products, specifically how or if the products were attractive or marketed to children. The obstacles of a new industry most directly affect the businesses and their bottom lines. These are important points to consider when strategizing your business model and planning for inevitable changes to regulations. The time spent preparing for a system that will change will go a long way to ensuring for success.

WASHINGTON

Now let’s talk about Washington.

Washington was the third state to approve medical cannabis but had problems with implementation due to legislative issues. As multiple pieces of legislation were offered, adopted, and repealed, the lack of clarity prevented the medical cannabis industry from launching. Washington passed its adult use cannabis program at the same time as Colorado in 2012. In Washington, the two major obstacles the industry faced were licensing issues and taxes. A previously existing strong medical program in Colorado allowed for a seamless transition to an adult use program, but that was not present in Washington and this added to difficulties with implementing an adult use program.

Because the industry was just getting off the ground, both states relied on their medical programs as a foundation to the adult use. However, Washington’s medical program was murky and disorganized which lead to complications, Washington also limited licenses and put unfair taxes on the industry.  These two factors aided in keeping the black market as the primary driver of the industry, rather than pulling people or businesses into a controlled, tracked, and regulated system.

280E TAX CODE

This provides a nice segue to one of the challenges all cannabis business face: unfair taxes in the 280E tax code. Internal Revenue Code section 280E specifically denies a deduction or credit for any expense in a business consisting of trafficking in illegal drugs “prohibited by Federal law or the law of any State in which such trade or business is conducted” which translates to only “Cost of Goods Sold” as the only deductible expenses. This means administrative costs, executive salaries, marketing and advertising, banking fees, etc., are non-deductible expenses for any cannabis business and subjects them to much higher taxes as most normal business deductions are prohibited. This challenge is one all cannabis businesses deal with and must be factored into financial modeling.

BANKING

While we are on the the subject of taxes and non-allowable deductions, banking is the other major challenge all cannabis businesses face. Due to federal policy around an illegal substance, FDIC insured institutions force canna-businesses to operate in all cash for fear of prosecution under racketeering and money laundering laws. There are a handful of financial institutions, credit unions, or state banks that offer “Enhanced Monitoring Accounts” for cannabis companies. However, they are highly priced and rare. The average cannabis bank account is likely to run $1,000.00 a month, just to have access to banking services, not including additional fees. This $12,000 a year budget line item, while not only expensive, is not a tax write-off per 280E tax code.

One can quickly see from just these two major hurdles or challenges to the industry, normal operations can be difficult. These obstacles are not to be taken lightly; they can be addressed but it must be factored into operating procedures, financial planning/budgeting, and strategic vision.  

NOW BACK TO STATE SPECIFIC ISSUES

As Washington and Colorado dealt with its issues, Oregon voted to approve “Adult Use” cannabis in 2014. Using Colorado and Washington as a guide, Oregon implemented their system with more deliberation and vision based on what had been experienced in the first two states. But as was seen with the unique challenges in the first two states, Oregon encountered an entirely different set of problems. Oregon currently faces a massive oversupply problem which has affected all facets of business across the industry. In normal business and supply and demand economics, if an area is oversupplied, business move their products to where the demand is higher or the supply is lower. However, cannabis remains a federally illegal product and therefore interstate commerce remains illegal.

Oregon’s unique problem originated from two main issues:

  • Oregon had already established itself as a cultivation mecca
  • The regulatory authority decided against a cap on licenses

This lack of license caps has allowed the number of licensees to explode and thereby allowed the oversupply issue to occur and continue to grow. As stated, this is not a problem exclusive to cultivator/producers. Because of a 75% drop in value, cannabis attorneys, electricians, HVAC, security companies and other ancillary businesses are not getting paid. The oversupplied market and decreased revenue has reverberated across the industry and driven otherwise thriving companies into bankruptcy.  

As you can see, each state deals with its unique challenges when implementing its Adult Use cannabis program, while we all deal with some issues that affect us all. The key to thriving… or surviving is to prepare your company to deal with the current challenges shared by us all and predict the challenges that your business will face in your state while preparation is taken for a national and international market.


James Schwartz RN, BSN, LNC, is an experienced medical legal consultant and CEO of CascadeHigh Organics with 20 years experience cultivating legal cannabis. James is a self-described organic minimalist cultivating in the most sustainable manner. James believes in clean cannabis and its use as a wellness drug. His Oregon licensed cultivation, Cascade High, has been featured in Dope Magazine and on the cover of Oregon Leaf’s Sustainability issue (March ‘18). James was featured as the Inaugural Stoner Owner by OR Leaf in Dec 2018. He has articles published by Dope Magazine about Cannabusiness and the Pharmaceutical Industry (May 2017), as well as a medical cannabis article in the Jan. 2019 Healthcare issue of OR Leaf. James is currently on the NCIA Cannabis Cultivation Committee and has presented Cannabis topics to multiple audiences at conferences including Cannabis Science Conference, PDX Hempfest, Cannabiz Convention, CBD Expo and Webinar series, Cannabis Collaborative Conference(CCC), Cannabis Nurse Conference, NCIA and educational industry mixers. His business, legal, medical, and agricultural knowledge provides a unique perspective on the industry. James has lobbied for Cannabis on both the national and state level with Oregon Cannabis Association and is a fierce advocate for the plant and all who use it.

The Marijuana Freedom and Opportunity Act (Finally) Makes Its Debut

After more than two months since Senate Minority Leader Chuck Schumer announced forthcoming marijuana reform legislation, this week finally saw the bill’s introduction. The Marijuana Freedom and Opportunity Act removes marijuana from the schedule of controlled substances, allowing states to determine their own cannabis policies without fear of federal interference.

The Marijuana Freedom and Opportunity Act, cosponsored by Senators Bernie Sanders (I-VT), Tim Kaine (D-VA), and Tammy Duckworth (D-IL), would specifically remove marijuana from the Controlled Substances Act, effectively decriminalizing the substance at the federal level and allowing states to determine their own cannabis policies without the threat of interference.

The full text of the bill describes further provisions, including providing funding to cannabis businesses owned by women and people of color through the Small Business Administration; funding studies on traffic safety, impairment detection technology, and health effects of cannabis; restricting advertising that could appeal to children; and setting aside $100 million over five years to help states develop streamlined procedures for expunging or sealing prior cannabis convictions.

“We commend Senator Schumer for joining the growing chorus of Congressional leaders stepping forward with alternatives to the failed prohibition of marijuana,” said Aaron Smith, executive director of the National Cannabis Industry Association (NCIA). “With millions of Americans already living in states that successfully regulate adult-use cannabis and support for national legalization at record levels, this legislation would finally align federal marijuana policies with mainstream voter sentiment.”

 

Member Spotlight: LivWell Enlightened Health

In December’s member spotlight, we speak with Neal Levine, who serves on NCIA’s Board of Directors, and is Senior Vice President of Government Affairs for NCIA Sustaining Member LivWell Enlightened Health. LivWell is a Colorado-based medical and adult-use cannabis dispensary with 14 locations across the state, employing hundreds of staff.  

LivWell Enlightened HealthLivWell - Logo

Cannabis Industry Sector:
Medical and Adult-Use Cannabis

NCIA Member Since:
February 2012

Tell me a bit about your background in cannabis and why you joined the team at LivWell.

Neal Levine, VP of Government Affairs
Neal Levine, Sr. VP of Government Affairs

I have been working on cannabis policy reform on the state and national level for the majority of my professional career. Specifically, I led or played a key role on the teams that first passed medical marijuana laws in Maryland, Vermont, Montana, Rhode Island, and Michigan; decriminalization in Massachusetts; and legalization in Alaska. I also led several teams which qualified initiatives via signature drives in several states, including the adult-use initiative that just passed on November’s ballot in Nevada. And I have been involved in some form or another in helping to develop industry regulations in many different states throughout the country after these laws have passed.

At some point I realized that I had switched from the lobbyist and campaign guy who was working on cannabis to the cannabis guy who was working on campaigns and lobbying. So I decided to shut down my political consulting practice and shift to the industry full time about a year and a half ago. Of all the cannabis companies existing today, LivWell Enlightened Health struck me as best placed, not only in terms of being successful in the industry but also in terms of presenting a positive example to cannabis entrepreneurs everywhere about how cannabis companies should engage with their industry peers, the legalization movement, their customers and patients, and the communities in which they operate. LivWell Enlightened Health has demonstrated time and again our willingness to fight for and defend the industry, and it has been my honor to lead the company’s continuing efforts in this regard.

What unique value does LivWell offer to the cannabis industry?

livwell_budtenderEvery single day we try to live up to our reputation as the industry leader. It starts with taking care of our people, whom we view as our number-one asset. Our entry-level positions pay several dollars above the minimum wage, we offer full health care to all of our employees at no cost to them, and we put 3% into a 401(K) annually for all of our employees which vests instantly and is not a match – they do not have to put in a penny of their pay, although they are certainly welcome to contribute as well.

Beyond the high-quality cannabis products we sell, the well-paying jobs we create, and the tax revenue we generate for Colorado, LivWell Enlightened Health has determined to be involved in events and initiatives throughout the communities in which we operate. That’s why we established LivWell Cares, a program designed to work hand-in-hand with our local communities both as good neighbors and as fully-involved partners in community development. Through LivWell Cares, we have participated in numerous charitable activities, sponsored several local events, and educated community leaders and public service officials on the products we sell and the industry that we help to lead. Our deep and committed involvement in working with our neighborhoods and engaging with the communities whose lives we touch through our business, including those who may not patronize our stores, is a value that is nothing less than a part of the fabric of our company and an important piece of our culture.

Cannabis companies have a unique responsibility to shape this growing industry to be responsible and treated equally as any other industry. How does LivWell help work toward that goal for the greater good of the cannabis industry?

You’ve touched on something that is very important. First and foremost, we strive every day to be the industry that we want to be a part of. We take our position as an industry leader very seriously, and conduct ourselves accordingly. If you are a part of our industry, you simply must be engaged in your communities. You must join together with allies to defend against the seemingly endless threats to our advancement. We must all band together and work collaboratively on big picture projects like tax reform, banking, and removing cannabis from the Controlled Substances Act, while running responsible and compliant businesses that take care of the people who chose to join our teams. If this is not a key component of your company culture, I believe that you will eventually fail.

As a company, LivWell Enlightened Health is very focused at developing industry-wide best practices, helping to shape state and federal lobbying priorities, working to end the unfair taxation of 280E, and making it easier for cannabis businesses to receive the banking services they need to operate successfully. I ran for the NCIA Board promising to focus on these issues, and having won the seat, I feel that I have a mandate and responsibility to do what I said I would do from the membership that elected me.

From the beginning, the leadership at LivWell Enlightened Health has been determined to be the most compliant company in the industry and to support policy-makers and regulators from throughout the country and the world as they build a common-sense regulatory regime in which we can operate. This was one of the primary aspects of our culture that first attracted me to the company. We frequently host delegations of government and elected officials who tour our facilities and speak with our executives to learn more about how legal cannabis actually works, and offer to share our expertise and work with them to construct a regulatory environment conducive to both business success and public health and safety. We believe these efforts have already helped encourage more regulatory consistency in cannabis policies across the country, and have helped remove the stigma our industry faces in the eyes of officials who previously had little to no experience with cannabis in any form. We have been highly encouraged by the reactions of those officials with whom we have worked, as they quickly realize that we are just like any other business and deserve to be treated as such.

livwell_farmBuilding a better environment for our industry also requires sustained engagement with our patients and customers, particularly when it comes to education. We call ourselves LivWell Enlightened Health for a reason. Education has always been an important part of our company, a point best evidenced by our industry-leading employee training program, LivWell University. This two-week intensive course includes classroom, online, and on-site components, and covers everything from the science of the endocannabinoid system to how to complete a compliant transaction. We view our employees as company and industry ambassadors. The training our employees receive allows them not simply to be good at their jobs, but also to be knowledgeable enough to answer our customers’ tough questions while being advocates for responsible use. We have even begun taking components of our employee training program and developing them into customer-facing materials so that our customers can feel more empowered to make intelligent choices when it comes to their cannabis consumption.

Why did you join NCIA? What’s the best part about being a member?

NCIA is our national industry association, and every single business either in our industry or supplying our industry has an obligation to join and support NCIA. Being an NCIA member means supporting our efforts to end the scourge of 280E, open up banking, remove cannabis from the Controlled Substances Act, and be diligent in our efforts to make sure the new administration does not roll back any of our progress. Outside of the financial obligation, I believe every member should participate in Lobby Days, where we get to engage with Congress as an industry.

The best part of being a member is the ability to be part of our amazing national cannabis community, and work collaboratively with so many intelligent and dedicated people on the normalization of our industry on the path to ending prohibition once and for all.


 

Guest Post: The ABC’s of CBD Claims

by Shawn Hauser, Vicente Sederberg

As we learn more about the cannabis plant and its potential uses and benefits, Cannabidiol, or “CBD,” continues to emerge as one of the most beneficial, and non-intoxicating, parts of the plant. Although there is significant research on the safety and efficacy of CBD, and some forms of CBD derived from hemp are arguably not regulated under the federal Controlled Substances Act (CSA), the Drug Enforcement Administration still considers CBD a marijuana derivative and Schedule I drug that is being illegally marketed in violation of the CSA and the Federal Food, Drug, and Cosmetic Act (FDCA).

In addition to food and drugs, nutrients and other supplements are regulated by the Food and Drug Administration (FDA) under the FDCA. The purpose of the FDCA is to forbid “the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics.” Disregarding the legality of CBD product sales under the CSA, any company contemplating the sale of such products should consider whether the products can be lawfully sold under the FDCA. Any product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease is classified by the FDA as a drug, regardless of the product’s form or how it is marketed or labeled. Drug approval requires an extensive process involving collecting and submitting for review clinical and non-clinical data about the proposed use of the drug. While FDA has not yet attempted to regulate marijuana products sold in licensed marijuana establishments, the proliferation of states legalizing CBD for medical purposes and legalizing the cultivation and sale of hemp products has complicated the legal landscape. As CBD products move out of marijuana establishments and into retail and internet stores, they are catching the FDA’s eye.hempfibre

In February 2015, the FDA sent letters to companies marketing CBD products stating that the companies were violating the FDCA by making therapeutic claims about the products, which are not approved as “drugs” under the FDCA. The FDA also recently confirmed that CBD cannot be marketed as a dietary supplement, stating that “Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.”

In marketing products, the FDA classifies products based on intended use. Any website selling the product or providing references to sites where the product is sold will likely be examined for content by the FDA in determining the product’s intended use. Evidence of intended use includes claims on labels and literature, the citation of publications related to the product, and claims made on any forum where a consumer may see the product. Products may be considered “drugs” if claims are made related to the product’s use for the cure, mitigation, treatment, or prevention of diseases. Evidence of such claims may include therapeutic claims, claims that the product possesses certain medical properties, or the commercial use of scientific publications to promote the product’s sale. Even simple references to scientific studies or general research, such as “cannabinoids are emerging as an effective treatment for infections,” may be considered evidence that the product is a drug.

Shawn Hauser, Esq., of Vicente Sederberg
Shawn Hauser, Esq. of Vicente Sederberg

To further complicate matters, CBD has been granted orphan drug status by the FDA for treatment of Dravet’s Syndrome and Lennox-Gastaut Syndrome. However, the FDA has acknowledged the mixed signals sent by the present controlled substance classification of cannabis, and of CBD specifically, and has publicly supported research regarding CBD’s potential medical uses in testimony before the House Subcommittee on Government Operations.

Prior to marketing CBD products, companies should consult with an attorney who specializes in FDA compliance. This due diligence can not only ensure compliance and prevent action by the FDA, but may also promote the business’s reputation as one that is professional, thorough, and trustworthy. The FDA is less likely to target medical marijuana companies that a) avoid engaging in interstate commerce and only sell products within states that have legalized medical marijuana, and b) do not make claims about the proven efficacy of CBD products. As cannabis and CBD products proliferate, recent FDA activity indicates that the FDA is monitoring retailers and manufacturers of these products and will continue to do so going forward.

Nothing herein is intended to create an attorney client relationship. This article is for educational purposes only and shall not be considered legal advice. Please consult the appropriate legal professional prior to relying on anything mentioned herein.


Shawn Hauser, Esq., is the senior associate at Vicente Sederberg, Sustaining Members of NCIA. Shawn has been working in marijuana and law in policy for almost 7 years, starting with internships in marijuana law while she was studying at the University of Denver Sturm College of Law, where she chaired the school’s chapter of NORML. Prior to joining Vicente Sederberg LLC, Shawn worked at a small law firm specializing in marijuana law, criminal defense and family law. Shawn is the director of the “Local Implementation Project” for the non-profit Sensible Colorado Action, where she works with local governments across the state to pass marijuana laws that foster responsible businesses. Shawn also serves on the board of National Hemp Association, a Denver-based organization dedicated to the re-birth of industrial hemp in America. Shawn came to Denver in 2008 from Austin, Texas, where she fostered her love for live music, while studying psychology at the University of Texas at Austin.

 

This site uses cookies. By using this site or closing this notice, you agree to the use of cookies and our privacy policy.