Member Blog: Where Is Delta-8 THC Legal and Where Is It Banned? CBD Oracle’s Map Has the Answers
Delta-8 THC is probably the most controversial cannabinoid on the planet right now. With the 2018 Farm Bill being widely considered to have removed the THC isomer from the federal list of controlled substances, hemp and CBD companies quickly found a use for their excess CBD isolate. But if you’re considering selling delta-8 THC,federal law is only a part of the picture, and at state level, you have a patchwork of different laws and regulatory schemes to contend with.
This is why CBD Oracle, working alongsideNeil Willner co-chair of the Cannabis Group at Royer Cooper Cohen Braunfeld, has produced astate-by-state map of delta-8 THC’s legality based on extensive reviews of state law. If you want to know what’s going on with delta-8 THC in a specific state, this is one of the best resources around to get the answer you’re looking for.
Delta-8 THC Is Legal in 22 States and 1 District With Limited Regulation
Despite the controversy surrounding delta-8 THC, it remains legal in 22 states and 1 district, with only limited regulation. This covers the following states:
Alabama*
Arizona
Arkansas
Florida*
Georgia (?)
Illinois
Indiana (?)
Kentucky*
Maine
Maryland* (?)
Missouri
Nebraska
New Jersey
New Mexico
North Carolina
Ohio
Oklahoma
Pennsylvania (?)
South Carolina (?)
Texas (?)
Washington D.C.
Wisconsin
Wyoming*
Here, a * beside the state’s name means they’ve instituted age restrictions, preventing anybody aged 21 or under from buying delta-8 THC. States marked with (?) are currently involved in legal action about the status of delta-8 THC.
In the majority of these cases, state law basically follows the blueprint laid down by the 2018 Farm Bill with few or no additional rules. In fact, only a handful of states (Alabama, Florida, Kentucky, Maryland and Wyoming) have even passed laws preventing youth from buying delta-8 THC.
Legal actions are ongoing in several states, with the situation being slightly different in each. For instance, in Maryland, thehemp industry won a temporary injunction against the state, preventing the state from enforcing the provisions of House Bill (HB) 556 which relate to hemp until the action is resolved. The bill originally made it so that delta-8 THC products (and most CBD) could only be sold in licensed marijuana dispensaries, but this was deemed by the court to create a monopoly.
Delta-8 THC Is Banned in 17 States and Severely Restricted in 7 More
For every state where delta-8 THC is de facto legal, there is another state which has either banned or severely restricted the cannabinoid. In total, CBD Oracle’s analysis shows that delta-8 THC is banned in 17 states and severely restricted in 7 more. The states with bans are:
Alaska
Colorado
Delaware
Hawaii
Idaho
Massachusetts
Mississippi
Montana
Nevada (technically could be approved for marijuana industry)
New York (isomerization banned, could theoretically be sold in adult use)
North Dakota
Oregon
Rhode Island
Utah (possible in medical industry)
Vermont
Washington
West Virginia
And there are severe restrictions – limiting all THCs to be under 0.3% for hemp products, unless otherwise noted – in the following seven states:
Iowa
Kansas
Louisiana (all THCs must be under 8 mg per serving and 1% by dry weight)
Michigan (all THCs under 0.3% and only marijuana-derived delta-8 allowed)
Minnesota (all THCs under 0.3% and less than 5 mg per serving)
New Hampshire
Virginia (2 mg serving limit or >25:1 CBD:THC ratio)
Exactly how delta-8 THC is banned or restricted varies by state. For instance, while Coloradobans the “isomerization” process used to make delta-8 from CBD, Idahobasically bansanything that contains THC at all, even if it’s just CBD with trace, federally-acceptable levels of delta-9 THC. For the restricted states, most require that all THCs total to under 0.3% by dry weight, which is technically possible for a delta-8 THC product to meet, but essentially none do.
The analysis also revealed that – just like with marijuana – making delta-8 THC illegal doesn’t automatically remove it from a community. In Hawaii and Mississippi, for instance, despite state law banning delta-8 THC, it is still openly sold.
Only Three States Have Substantial Regulations on Delta-8 THC
In California, Connecticut and Tennessee, delta-8 THC is legal but has substantial regulations in place. In California and Connecticut, delta-8 THC is treated as marijuana and is sold as part of the adult use industry. This automatically institutes a wide range of requirements on the cannabinoid, including rules on testing and labeling to ensure safety and transparency for consumers.
Tennessee is the unique case here, where delta-8 THC is regulated as a “hemp-derived cannabinoid” and is legal to sell to adults aged 21 and over.Senate Bill (SB) 378 includes requirements for testing for contaminants, informative labeling and marketing which does not target youths, as well as a 25 mg serving size limit.
The Patchwork of Laws and the Future of Delta-8 THC
The key take-away for sellers of delta-8 THC is that current state regulations are a patchwork, making it very difficult to navigate for even the most responsible of companies. The product you can sell in Arizona without issues is probably not legal in Kansas, and would require batch testing and more to be sold in Tennessee.
This uncertainty may be resolved by the upcoming 2023 Farm Bill, but even this isn’t a sure thing. While the 2018 Farm Bill opened the door to a whole host of products and simply assumed (incorrectly) that the FDA would step up to regulate finished products, the new version might offer the clarity that was lacking. However, it’s just as likely that the bill will redefine “hemp” in a way that excludes delta-8 THC by default.
Pretty much the only thing you can depend on is that you’ll need to keep a close eye on state laws in the coming year. CBD Oracle’s map will be continuously revised to reflect the current legal reality and help responsible hemp companies remain compliant. ______________________________________________________________________________________
Lee Johnson is the senior editor at CBD Oracle, and has been covering science, vaping and cannabis for over a decade. He focuses on research-driven deep dives into topics ranging from medical uses for CBD to industry and user statistics, as well as general guides and explainers for consumers.
CBD Oracle is a cannabis consumer research company working to improve the safety and transparency of cannabis and hemp products, which publishes in-depth scientific, legal and consumer analyses on cannabis and cannabinoids.
Committee Blog: Your Voice Matters – Advocate for Crucial Changes in the American Hemp Industry
The Hemp Industry needs your help. The 2018 Farm Bill, which made it legal to grow and process hemp, was a big step forward for the larger Cannabis industry. After the bill passed, lots of growers, processors, and manufacturers started building the Hemp Industry. Like any new industry, it’s had its ups and downs. But there are some big roadblocks that Congress can remove to help the Hemp Industry grow and set the stage for better rules around all Cannabis in the future.
2023 is a crucial year for American hemp producers as the 2018 Farm Bill is due to expire. Congress is now drafting a new Farm Bill that will direct our agricultural and food systems for the next half-decade. During this critical period, the NCIA Hemp Committee is working tirelessly to rally support for amendments that will not only benefit the industry but also our customers. Our requests are as follows:
Update the legal definition of hemp to allow for up to 1% Total THC: This would offer critical protection for farmers and processors, as the current legal limit can sometimes be exceeded naturally in the crop growth process, leading to crop loss and financial hardship.
Support the Growth of the Hemp Industry by Encouraging Banking and Lending Services: The Treasury department should provide written guidance for banking and lending services to hemp-related businesses, removing barriers to growth in this burgeoning industry.
Support HR 3755 for Non-consumable Hemp: By recognizing the distinction between consumable and non-consumable hemp products, we can encourage the development of a wide range of industrial applications for hemp, from textiles to building materials.
Prevent Misuse of THC by Teens and Young Adults: This requires comprehensive educational initiatives to provide accurate information about THC and its potential effects. In doing so, we can ensure that the growth of the hemp industry does not inadvertently lead to misuse of THC among young populations.
During the recent NCIA Lobby Days, we had constructive meetings with influential decision-makers, including members of the Agricultural Committee and their staff. Our team left these sessions with a sense of hope and determination, having shared our top four priorities and discussed other important issues. Now, we’re calling on you, the supporters of the Hemp Industry, to make your voices heard and contact your members of Congress to showcase broad support for these initiatives.
“NCIA Lobby Days provides the stage and podium, and you bring the voice. We meet with decision makers (congressional staff) who ARE interested in our real-life scenarios, and it educates them to educate their Senate and House of Representative leaders. Education is power. It (Lobby Days) also provides an environment to meet like-minded people in the cannabis industry, share our stores, learn/educate, and collaborate. I plan to attend each year as it is enlightening and empowering!” Jillian Johnson
How can you help?
Remember, members of Congress are elected to represent the interests of their constituents – that’s you. But they can only effectively do so when they’re fully informed about the issues that matter to you. Your voice is powerful and essential to our democratic process. By speaking up, you can provide important insights and help shape the future of the Hemp Industry.
If you are a cannabis-related business, and are looking to accept credit cards, it is only possible to do so if you are selling a product that is defined as legal hemp by the 2018 Farm Bill.
The 2018 Farm Bill provides that:
“The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
For the most part, it’s pretty cut-and-dry. Marijuana is a schedule 1 drug. Hemp is not. If your product has less than .3% Delta-9 on a dry weight basis, it’s not marijuana, it’s hemp. And since it’s hemp, it’s federally legal. And since it’s federally legal, it can be purchased with checks, credit cards, or debit cards. Hemp products are, reductively, as incendiary as a stick of butter.
Of course, there is the law and there is how acquiring banks—banks that offer merchant accounts—interpret the law. Across the U.S., there are hundreds of acquiring banks. Of those, only six or seven offer merchant accounts to hemp businesses.
That’s it, plus payment service provider Square.
The immediate problem for the few acquiring banks that have, laudably, said, “Yes,” to hemp is, “how do we distinguish products that are .3% Delta-9 or less (and therefore, yawningly legal) from those that are over .3% Delta-9 (and therefore, illegal as angel dust)?”
Enter the Certificate of Analysis, or COA, or lab report. While there is nothing in the law stating that COAs are required to prove that a product is within the federally legal limit, their role is sacrosanct during the boarding process. For every hemp-derived product, there must be a corresponding COA proving that the product being sold is hemp, and not marijuana.
Fortunately, there are labs across the nation. The U.S. Department of Agriculture website lists 85, as of May 2023. Manufacturers and businesses ship their samples to these labs. The labs run their tests and the COAs are issued.
Simple, right?
Not really.
There are no standards in place for these reports. No templates. Every laboratory’s COAs—while substantively providing the same information—look a little different. Furthermore, most bankers haven’t seen a lab report since high school chemistry, and you’ve got a recipe for confusion or misunderstanding (frequently both).
This COA, when it was initially presented to the bank, was rejected. To the underwriter, it was an open and shut case.
When the bank opened its door to offering acquiring to hemp businesses, its policy was to reject anything with greater than .3% Delta-9 by weight.
The top of this COA showed an instance of Delta 9 that read .189%. That passed muster, certainly. However, when he delved further into the analyte detail, he noted additional Delta-9 figures in excess of the .3% limit:
10.368 in the mg/unit cell
1.892 in the mg/g cell
It was not clear to the bank’s underwriter which of the two—per-unit or per-gram—corresponded with the by-weight percentage he was to be mindful of, but both were certainly over the .3% limit.
So, open and shut case: DECLINED
The salesperson that brought the merchant to this bank was surprised by the rejection. He hadn’t looked at the COAs very closely, but it seemed unlikely that this merchant had been selling products on her website that were in excess of .3% Delta-9.
Why? Because if the merchant had been selling products on its website in excess of .3% Delta-9, it would have been engaging in egregious felony drug trafficking. The salesperson doubted that was the case.
The salesperson did something he didn’t normally do: he took out his calculator.
He wanted to know why it read .189% Delta 9 at the top, but 10.368 in the analyte table. He noted the unit size at the bottom of the page was a gummy weighing 5.480g.
For the sake of simplicity, he multiplied that by 1000 to convert it to milligrams. That made it 5480 mg
Then he entered the onerous 10.368mg from the mg/unit figure in the analyte table and divided it by 5480mg. The resulting calculation netted the following total: .0018919.
Next, he converted it to a percent, and found that the result was .189%, which matched the figure at the top of the COA, exactly.
The next day, the salesperson presented the COA to the bank, with the markings and The Equation just as shown here.
It was an open and shut case: ACCEPTED
This situation is an example of why banks and credit unions unknowingly reject compliant hemp businesses from merchant processing solutions. As stated, a simple mathematical calculation was the difference between being accepted or rejected for necessary merchant processing services. Without proper merchant servicing not only are cannabis businesses’ profitability affected because they can only take cash; cash is also not as traceable or auditable as electronic transactions.
In general, businesses providing services to the cannabis industry are often challenged with disentangling legal risks with the benefits of their necessary services providing more transparency. With enhanced knowledge of the cannabis industry and its parameters, the cannabis industry will recognize a greater participation by all businesses necessary for the life of the industry thereby enhancing cannabis businesses’ likelihood to succeed but also enhancing the legitimacy and regulation of the industry.
Member Blog: Payment Processing In The Cannabis Space
There is a lot of confusion about payment processing in the cannabis space because payment processing is somewhat confusing to begin with, and because, in the cannabis space, ambiguity is a way of life.
The title of this very blog post could, realistically, seem misleading to some.
So, to be clear, when I say, “Cannabis Space,” I mean the entire industry — from plant-touchers (CBD included) to the ancillary businesses built up around it.
The passage of the 2018 Farm Bill marked an exciting new chapter for the industry. Suddenly, CBD, or, more specifically, any ingestible cannabis product containing .3% THC or less by volume, was classified as hemp. And since it is marijuana, and not hemp, that is defined as a Schedule I substance under the United States Controlled Substance Act, the Farm Bill, technically, made products like CBD as legal as cow milk — federally, anyway.
The upshot of this new classification is that now, at least some players in the cannabis space can market their products to a national base of consumers and clients, and they can do so by accepting credit cards as payment.
However, the myriad Acquiring Banks across the United States have not exactly jumped for joy at the prospect of providing credit card processing in the form of merchant accounts to CBD retailers. Reticence rules. CBD is considered high risk, and four years on, only a handful of them have thrown their hat in the ring.
Jargon Alert I: Acquiring Banks and Issuing Banks
In merchant processing parlance, banks fall into two categories: Acquiring Banks and Issuing Banks. Acquiring Banks, or, Acquirers, provide merchant processing accounts to businesses wishing to accept credit card transactions. Issuing Banks, short for Card Issuing Banks, are banks that offer branded payment cards directly to consumers. For example, if your bank has ever offered you a Visa card, it is an Issuing Bank (not that it couldn’t also be an Acquiring Bank, too).
Jargon Alert II: CBD is ‘High Risk’
CBD is deemed high risk by the card associations (i.e., Visa, MasterCard, American Express), and when the card associations deem a product or industry high risk, most Acquiring Banks tap out. This is because financial institutions are, by nature, risk averse (subprime mortgage crisis notwithstanding).
So let’s talk for a minute about risk. High risk, that compound term, is a truncation of a longer phrase: ‘Higher risk of fraud or chargebacks.’
Why are CBD products at higher risk of fraud? It’s impossible to say for sure since the Visas and MasterCards of the world are publicly traded companies with their own trade secrets and IP, but there are several characteristics unique to CBD, or any cannabis product now federally legal, that likely figured into that decision.
Those FDA disclaimers that CBD retailers must print or paste on all product packaging and webpages are as good a place as any to start. They are mandatory because none of the benefits assigned to CBD have been clinically proven. There just isn’t enough data or testing at this point, and no big story there. That’s what happens when you demonize a plant for 100 years.
Consequently, from the perspective of the FDA, and the card associations, by extension, consumers are making CBD purchases with baked-in expectations based, exclusively, on word-of-mouth advice and anecdotal data. That’s a recipe for dissatisfied customers. And dissatisfied customers tend to charge back transactions.
The card associations, and the banks who provide merchant accounts, worry incessantly about fraud and chargebacks.
Too Close for Comfort
Dissatisfied customers aside, there are onerous legal nuances that make the prospect of boarding cannabis merchants, even those selling products that are federally legal, daunting for banks.
Selling a product with .31% THC across state lines is felonious. It is a federal offense. Violating a law like that could get a bank’s charter revoked, or, at a minimum, result in massive fines.
On the other hand, selling a product with .30% THC across state lines is 100% federally legal. As stated above, safe as milk, federally.
That is a heck of a distinction. If any product contains more than .3% THC by volume, it is ‘marijuana’ in the eyes of the federal government. From the perspective of the banks, that’s a little close for comfort. Furthermore, banks don’t operate laboratories. They must rely on testing data presented to them in the form of third-party lab reports — Certificates of Analysis or COAs for short — to verify that the products being sold are federally legal.
The last thing an Acquiring Bank wants to do is violate a federal law EVER. It could result in a loss of their charter, lawsuits, and massive fines. And it’s important to keep in mind that the Acquiring Banks out there offering merchant accounts to CBD retailers are not giant, publicly traded institutions like Bank of America or Wells Fargo. They tend to be much smaller, and therefore, have infinitely smaller war chests for court cases.
Still, separating the federally legal Tier I cannabis product from the federally illegal Tier I cannabis product should be pretty cut-and-dry. If the product you’re selling is .3% THC by volume or less, it is exempt from the Controlled Substance Act (CSA). If that threshold is documented in the product’s Certificates of Analysis (COA), you ought to be able to sell it.
Unfortunately, it’s not that simple. When bank underwriters look at percentages of Delta 8, Delta 9, and Delta 10 on the COAs that cross their desks, they’re frequently at sixes and sevens trying to figure the whole thing out.
From the perspective of the 2018 Farm Bill, a cannabis product is hemp if it contains .3% Delta-9 THC or less by volume, but what everybody says is “.3% THC or less by volume.” Consequently, when the compliance officer at the bank is performing her due diligence by inspecting the COAs corresponding to each product, she may encounter a lot of crooked numbers, and she may blanch at the results.
Those results, often, look something like the following:
00.195% D9-THC
52.475% d8-THC.
Federally, the Delta-9 threshold is the only threshold that matters. The 2018 Farm Bill says as much, and the 9th Circuit Court of Appeals in California affirmed it in a ruling this past May. Therefore, in the example above, the Delta-9 threshold has not been crossed. It’s not even close. It is textbook HEMP, even if the Delta-8 threshold is off the charts.
However, if the compliance officer was provided the remit, “.3% or lower,” he’s likely to look at this and say, “Fail,” without realizing that the Delta-8 THC information is irrelevant as far as federal law goes.
Complicating the underwriting further is the fact that there is, to date, no standard template for COA reports. Every lab presents them differently. Bank compliance officers rarely moonlight as scientists. Like most of us, these CBD COAs are probably the first lab reports they’ve looked at since high school chemistry.
Furthermore, the banks can set their own rules. They don’t have to board CBD merchants. Few do, and those few that do have their own standards and practices.
Todd Glider has been an e-Commerce leader since the start of the Internet age. He has an MFA in Creative Writing from the University of Miami, and has served as CEO for small and medium-sized technology companies in Spain, Austria and the United States. As our Chief Business Development Officer, Todd introduces MobiusPay’s suite of award-winning financial services to new industries, and implements the development strategies and key partnerships needed to bring value to new customers.
MobiusPay, Inc. is a U.S.-based global financial services organization that is committed to empowering individuals and businesses. For more than a dozen years, MobiusPay has leveraged state-of-the-art secure billing technology, long-standing relationships with financial institutions and award-winning customer support to provide merchant processing and payment solutions to brick and mortar and digital businesses around the world.
U.S. Federal Appeals Court Legalizes Delta-8 THC, Setting Precedent for the Cannabis Industry
By Sadaf Naushad, NCIA Intern
Thanks to the Agricultural Improvement Act of 2018 (2018 Farm Bill), hemp is now federally legal, permitting U.S. farmers to cultivate, process, and sell hemp. Since its passing, however, businesses in the hemp industry have found themselves in a legal gray area.
With the 2018 Farm Bill eliminating restrictions on the psychoactive cannabinoid delta-8 THC, the companies deemed their delta-8 THC products within legal guidelines. Several jurisdictions disagreed, calling for clarification on the status of delta-8 THC.
Last week, the U.S. Court of Appeals for the Ninth Circuit addressed the dilemma, claiming delta-8 THC products as federally legal.
Let’s consider what delta-8 THC legalization means for the future of the cannabis industry.
Because recreational cannabis use remains federally illegal, delta-8 THC products continue to gain popularity nationwide. Manufacturing developments have led to enhanced consumer products, in which cultivators safely extract delta-8 THC cannabinoids from hemp plants.
While delta-9 THC constitutes a major psychoactive cannabinoid in the marijuana plant, delta-8 THC appears in trace amounts of the plant. Its psychoactive properties grant consumers gentler side effects compared to delta-9 THC.
On Thursday, a three-panel judge of the U.S. Court of Appeals published their opinion regarding delta-8 THC, ruling products containing the psychoactive ingredient as federally legal. According to the panel, delta-8 THC qualifies as a legal substance under the present federal definition of hemp. Federal law outlines hemp as “any part of” the cannabis plant, in which “all derivatives, extracts and cannabinoids” with less than 0.3% delta-9 THC by weight are allowed.
Had U.S. Congress unintentionally created a loophole leading to the legalization of delta-8 THC, the U.S. Federal Appeals Court stated that Congress should be responsible for resolving the issue. The panel specified that they would not replace its own judgment with Congress’ policy rulings. In the meantime, the Court defines the federal hemp law as “silent with regard to delta-8 THC.”
According to a Politico article, “Members of Congress have proposed fixes to federal hemp laws that would close this loophole. Rep. Chellie Pingree (D-Maine) introduced a bill in February to limit hemp and hemp products by calculating the total THC rather than focusing on Delta-9 THC. At the same time, state hemp regulators are voicing for a similar change advocating for the 1 percent total THC definition of hemp. Meanwhile, some states have moved to ban the sale of Delta-8 THC products or to regulate them similar to recreational marijuana.”
NCIA takes a strong position that Delta-8 products and any other psychoactive cannabinoids must be restricted to adults over 21 and regulated by the states so that these products are subject to the same testing requirements, track-and-trace rules, and excise taxes as other adult-use cannabis products.
Furthermore, if you are interested in learning more or getting involved with NCIA’s Government Relations work please contact Madeline Grant at madeline@thecannabisindustry.org to schedule a call. As the oldest and largest trade association, our Government Relations team has been hard at work for over a decade educating and working with congressional offices. NCIA held its Virtual VIP Lobby Days last week, May 16-19 on Capitol Hill. NCIA’s Evergreen members participated in congressional meetings all week long to advocate and educate members of Congress(s) and staff on the importance of cannabis policy reform. We discussed the importance of keeping the Secure and Fair Enforcement (SAFE) Banking in the America COMPETES Act and descheduling cannabis at the federal level. You can read more about cannabis and banking from last week’s blog HERE.
NCIA members were able to share their personal stories about being in the cannabis space and relay their expertise to further understanding of the struggles and hurdles cannabis businesses face every day. There is never a time more important than now to support NCIA’s efforts for cannabis policy reform.
Hurry Up And Wait: Descheduling, DEA Licenses, And Other Reform Legislation to Watch
By Morgan Fox, NCIA’s Director of Media Relations
The cannabis world is still eagerly awaiting the introduction of Senate Majority Leader Chuck Schumer’s comprehensive descheduling legislation, but that doesn’t mean things haven’t been moving on the policy front in recent weeks!
First up, the DEA announced that it was finally moving forward with approving applications to cultivate cannabis for research purposes, which would effectively end the federal government’s stranglehold on research production. The agency spent years fending off lawsuits from applicants, who correctly asserted that not only was the monopoly limiting research, but the cannabis being grown at the single licensed facility at the University of Mississippi was basically unusable for research purposes anyway. This announcement comes several years after the DEA publicly stated that it would begin the licensing process. Better late than never.
Next, Sen. Ron Wyden, who is also working closely with Majority Leader Schumer on descheduling along with Sen. Cory Booker, introduced S. 1698 last week. While text of this bill is currently not publicly available, the name suggests that this legislation would direct the FDA to allow hemp-derived CBD, made legal under the 2018 Farm Bill, to be used as a dietary supplement or in food. Some perceive this bill as necessary to get some regulatory clarity from the FDA, which has been dragging its feet and missed several deadlines for CBD regulations. Many in the industry blame this lack of regulation for larger retailers staying out of the CBD market, which has led to massive supply gluts of the substance and has been hypothesized to be a leading cause for the recent boom in Delta 8 THC production.
And earlier this month, Rep. David Joyce, an Ohio Republican who co-chairs the Congressional Cannabis Caucus, introduced a narrowly tailored bill to remove cannabis from the schedule of controlled substances. The bill assigns regulatory responsibilities to the FDA and the Alcohol and Tobacco Tax and Trade Bureau and gives them a one-year deadline to come up with a regulatory structure similar to alcohol. It also contains provisions similar to the protections that exist in the House-approved SAFE Banking Act, calls for studies on how cannabis impacts pain and driving, and improves access for veterans. Notably, this bill does not contain any social equity or restorative justice language.
While the chances of such legislation passing in the Democrat-controlled House are slim, it could serve as a doorway to get fence-sitting Republicans into the debate. It could also be a tool to identify those members of the GOP who are steadfastly opposed to any legalization bill and out of touch with their constituents, many of whom would directly benefit from cannabis policy reforms and who are increasingly in support of ending federal prohibition.
We’re also getting word that the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act is getting reintroduced in the House this week (and may have already been at the time of this publication). This legislation made history last December when it became the first descheduling bill to receive a floor vote – and pass – in either chamber of Congress. We are hopeful that there will be some revisions from the previous bill, including the removal of a provision that would allow federal licensors to deny applications for cannabis business licenses based on prior state or federal felony convictions, and the inclusion of a more sensible and robust regulatory framework.
We are less than halfway through the calendar year, and it is shaping up to be a momentous one for cannabis advocacy! Stay tuned for more updates from Capitol Hill.
P.S. On the state side, Alabama became the latest state to approve an effective medical cannabis law. Yes, Alabama. That brings the count of medical states to 36, after unfortunately losing Mississippi to a shameful court decision. So far in 2021, four states have approved adult-use or medical cannabis legislation, and more are expected to do so in the coming weeks and months.
Member Blog: GMPs – A Way Ahead for Hemp and CBD Firms
The hemp industry is the marijuana industry’s half-sister. Both are variations of the plant cannabis sativa and both were made illegal in 1937 with the passing of The Marijuana Tax Act. Flash forward to the Agriculture Improvement Act of 2018 (known as the 2018 Farm Bill) that was signed into law by Congress on December 20, 2018. One year later, The USDA issued interim regulations that entitled Establishment of a Domestic Hemp Production Program for the cultivation of hemp on October 31, 2019. Both were huge steps forward for public access to hemp and hemp products. FDA legalized the growing of hemp in states with a state-mandated hemp program and removed hemp and its derivatives from Drug Enforcement Administration (DEA) Schedule I status and the U.S. Domestic Hemp Program aims to approve cultivation plans issued by states and Indian Tribes.
Even so, then FDA Commissioner Scott Gottlieb issued a statement hours after the signing of the Farm Bill reiterating that “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
Still today, two years later and counting, FDA only permits CBD products submitted as an Investigational New Drug (IND) Application as a pharmaceutical and there remains only one such accepted CBD product, Epidiolex, manufactured by G.W. Pharma. All other CBD products are illegal for interstate shipment.
In-state production and sales may be a different story, provided that state has a mandated hemp program. In those cases, provided state law is followed, production and sales are legal and protected, but the minute products cross state lines, they become the jurisdiction of the federal government and, more specifically, the FDA. At least 47 states have enacted legislation to establish hemp production programs or allow for hemp cultivation research.
Section 10113 of The 2018 Farm Bill states that (c) Nothing in this subtitle shall affect or modify:
(1) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) section 351 of the Public Health Service Act (42 U.S.C. 262); or
(3) the authority of the Commissioner of Food and Drugs and the Secretary of Health and Human Services- ‘‘(A) under- ‘‘(i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or ‘‘(ii) section 351 of the Public Health Service Act (42 U.S.C. 262); or ‘‘(B) to promulgate Federal regulations and guidelines that relate to the production of hemp under the Act described in subparagraph (A)(i) or the section described in subparagraph (A)(ii).”
The mission of the FDA is “to ensure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” As such, FDA categorizes every product for sale in the U.S. which is either ingested or applied to a human or animals into categories. That means hemp-derived CBD products will have to lawfully fit into one of those categories, however, while there has been positive movement towards the legal sale of hemp products on the USDA cultivation side, the FDA has authority over foods and dietary supplements, and the FDA’s position is that the addition of hemp/CBD to a food or dietary supplement is “violative.” In a Consumer Update statement revised on November 25, 2019, the FDA clearly stated that “it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
That being said, FDA has indicated it would be open to review of safety data for submission of a cannabinoid as Generally Recognized as Safe (GRAS) for Food or as a New Dietary Ingredient (NDI) in a supplement as the lack of any federal regulation runs the potential of putting people at risk. That has sent the industry scurrying to design and initiate studies in the hopes of demonstrating levels of safety that meet FDA’s satisfaction.
In the meantime, those currently operating in states where hemp manufacturing is legal, must ensure Good Manufacturing Practices (GMPs) are adhered to closely. Should the FDA ever allow hemp products with CBD to be sold in the future, a manufacturer’s ability to demonstrate understanding and compliance with GMPs will be critical. Each FDA regulated industry has its own set of GMPs for the development and implementation of quality systems.
21 CFR 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food
21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA Draft Guidance for Industry, Cosmetic Good Manufacturing Practice, June 2013
As the industry waits in the hopes that FDA will come on board with those states that have already legalized CBD’s use in products, it important to take the necessary steps to develop GMP protocols and quality systems as part of documented Standard Operating Procedures and record-keeping that those procedures are being followed, products are being tested and those tests are being validated.
Ensure as you begin to develop or strengthen your GMP programs that you do so with a full understanding of the requirements set forth in 21 CFR 111. Whether these programs are designed in-house or with the assistance of an outside consulting firm, ensure your GMPs are specific to your manufacturing procedures as opposed to a stock one-size-fits-all program. A reputable consulting firm with demonstrable expertise in FDA regulations and in helping to develop these GMPs is a good place to start, one that listens to your questions and concerns before providing you their stock answer. A good consulting firm can walk you through your unique processes.
Ensure your quality systems are robust and documented, including your demonstrations that your cGMPs are being followed.
Charlotte Peyton supports EAS Consulting Group CBD and hemp clients as well as that of dietary supplements and pharmaceuticals. As an independent consultant, she assists with projects ranging from startup through manufacturing and support. Her expertise includes quality, regulatory and management, method development, and method validation for FDA regulated drug, dietary supplement, and bioanalytical samples. She has extensive experience in writing validation protocols, reports, and SOPs and assists with implementation of stability programs and report writing for finished products.
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. Our network of over 150 independent advisors and consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.
Looking Back On #10YearsOfNCIA: 2018-2019
Photo By CannabisCamera.com
by Michelle Rutter Friberg, NCIA’s Deputy Director of Government Relations
Over the last several weeks, I’ve been taking a retrospective look at the progress NCIA has made in the ten years since its inception. This is our last installment, detailing 2018-2019, and brings us up to 2020 (the year that shall not be spoken of). While this timeline is by no means a comprehensive look at everything that’s happened in cannabis policy during those years, here are some highlights:
January 2018
On January 4, 2018, then-Attorney General Jeff Sessions declared in a one-page memo that he had rescinded the Cole Memo, a similar memo related to cannabis activity on tribal land, and two other older memos. Sessions directed U.S. Attorneys to instead “follow the well-established principles that govern all federal prosecutions,” which require federal prosecutors to “weigh all relevant considerations, including federal law enforcement priorities set by the Attorney General, the seriousness of the crime, the deterrent effect of criminal prosecution, and the cumulative impact of particular crimes on the community.”
February 2018
This month was filled with the political fallout of the rescission of the Cole Memo. First, a letter was written by the U.S. Treasury Department’s assistant secretary for legislative affairs to Congress that said, “We are reviewing the [cannabis banking] guidance in light of the Attorney General’s announcement [to rescind the Cole Memo] and are consulting with law enforcement”. Then, following Sen. Gardner’s (R-CO) decision to block the Department of Justice’s nominees over the rescission of the Cole Memo in January, he released his holds on nominees for U.S. attorneys in a dozen federal districts and U.S. marshals in every district. Holds continue on the nominations of seven top Department of Justice nominees.
March 2018
In March, Attorney General Sessions spoke at an event where he acknowledged that the Department of Justice cannot use its limited resources to enforce cannabis prohibition against everyone who violates federal marijuana laws. He said, “We’re not going to be able, even if we desired, to take over state enforcement of routine cases that might occur.”
April 2018
The Trump administration officially began accepting online comments about whether marijuana should be rescheduled under international agreements. That same month, U.S. Senate Majority Leader Mitch McConnell (R-KY) filed a hemp legalization bill.
May 2018
The U.S. Small Business Administration (SBA) quietly issued a document saying that businesses that work with the marijuana industry aren’t eligible for federally backed loans. Fast forward to 2020, this document is largely what prohibited both direct and indirect marijuana businesses from receiving PPP money or federal assistance due to the COVID-19 pandemic.
June 2018
Senators Elizabeth Warren (D-MA) and Cory Gardner (R-CO), introduced the Strengthening the Tenth Amendment Through Entrusting States (STATES) Act. Shortly thereafter, President Trump was asked if he supports new Senate legislation to let states set their own marijuana laws without federal interference, to which he replied, “I really do. I support Senator Gardner. I know exactly what he’s doing. We’re looking at it. But I probably will end up supporting that, yes.” The STATES Act has never had a congressional hearing or moved in any way through the legislative process.
July 2018
In a slight change of tone, U.S. Attorney General Jeff Sessions said that “states have a right to set their own laws and will do so” but that “the American republic will not be better if there are marijuana sales on every street corner” and “we’ll [Department of Justice] enforce the federal law.”
August 2018
A group of the top financial regulatory officials from 13 states sent a letter urging congressional leaders to solve the marijuana industry’s banking access issues. The regulators wrote, “It is incumbent on Congress to resolve the conflict between state cannabis programs and federal statutes that effectively create unnecessary risk for banks seeking to operate in this space without the looming threat of civil actions, forfeiture of assets, reputational risk, and criminal penalties.”
September 2018
NCIA worked with Congressman Lou Correa (D-CA) to send a letter to the Department of Homeland Security Secretary Kirstjen Nielsen that urges the department to develop clear guidance concerning the entry into the United States of foreign nationals with authorized work visas who are associated with the cannabis industry.
October 2018
Well-known pollster Gallup found that sixty-six percent of Americans now support legalizing marijuana. Support has remained near that number to the present.
November 2018
This month, midterm elections were held, and a number of states voted on setting their own cannabis policies. Residents of Michigan and North Dakota both voted on adult-use measures, one passing and one failing, respectively. Additionally, Utah and Missouri both passed medical cannabis ballot initiatives. While the Senate remained in control of the GOP, the House of Representatives switched from a Republican majority to a Democratic majority.
December 2018
Congress passed the 2018 Farm Bill which included hemp legalization. The bill did not create a completely free system in which individuals or businesses can grow hemp whenever and wherever they want — there are numerous restrictions — and the programs are still being adjusted today.
January 2019
The 116th Congress was sworn in and quickly filed a number of cannabis-related bills, including:
H.R. 420: Regulate Marijuana Like Alcohol Act, H.R. 493: Sensible Enforcement of Cannabis Act, and H.R. 127: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2019
February 2019
In February, the Subcommittee on Consumer Protection and Financial Institutions held its first-ever hearing on marijuana and financial services, entitled: Challenges and Solutions: Access to Banking Services for Cannabis-Related Businesses. Up for discussion was the Secure and Fair Enforcement (SAFE) Banking Act.
March 2019
Quickly following the subcommittee hearing, the House Financial Services Committee scheduled a full markup for the SAFE Banking Act. The bill passed out of committee with a bipartisan vote of 45-15.
April 2019
During a House appropriations subcommittee hearing, several lawmakers asked Treasury Secretary Steven Mnuchin about what could be done to provide state-legal cannabis businesses with access to financial institutions. Mnuchin replied, “Let me just say, I hope this is something that this committee can on a bipartisan basis work with since there are people on both sides of the aisle that share these concerns. I will just say I don’t believe this is a failure of the regulators. I want to defend the regulators on this issue.”
May 2019
NCIA hosted our 9th Annual Cannabis Industry Lobby Days, bringing hundreds of professionals to Washington, D.C. Over the course of 48 hours, attendees met with nearly 300 congressional offices to share their stories and experiences and dropped off informational materials to 200 offices that we did not schedule meetings with. In addition to these meetings, we had two briefings, held a PAC fundraiser, and hosted our first-ever VIP Day for members of our Leadership Circle.
June 2019
In June, the Senate Banking Committee held a hearing entitled “Challenged for Cannabis and Banking: Outside Perspectives.” NCIA was proud to have Sen. Jeff Merkley introduce for the record the testimonials of nearly 100 NCIA members during the hearing.
July 2019
The Subcommittee of the House Judiciary Committee held a hearing on ending cannabis prohibition in America. The hearing, entitled “Marijuana Laws in America: Racial Justice and the Need for Reform” will focus on the need to deschedule cannabis, the importance of equity, diversity, inclusivity in this burgeoning industry, and will also cover issues pertaining to cannabis and public health, law enforcement, and the failings of prohibition.
August 2019
When President Trump was asked at the end of August whether or not marijuana will be federally legalized during his administration, he said, “We’re going to see what’s going on. It’s a very big subject and right now we are allowing states to make that decision. A lot of states are making that decision, but we’re allowing states to make that decision.”
September 2019
For the first time in history, a standalone cannabis policy reform bill was brought before the House of Representatives for a vote and passed with an overwhelming bipartisan majority. The Secure and Fair Enforcement (SAFE) Banking Act of 2019, or H.R. 1595, was approved 321-103, including nearly half of voting Republicans, in a suspension vote.
October 2019
The U.S. Tax Court ruled this week that the tax code ban on business deductions by medical marijuana companies is constitutional. The case is Northern California Small Business Assistants Inc. v. Commissioner of Internal Revenue, docket number 26889-16.
November 2019
In a vote of 24-10, the House Judiciary Committee approved a bill that would effectively end marijuana prohibition. The Marijuana Opportunity Reinvestment and Expungement (MORE) Act of 2019, or H.R. 3884, was introduced by House Judiciary Committee Chairman Jerrold Nadler (D-NY) and has been moving through the legislative process steadily. The MORE Act is anticipated to be voted on by the full House of Representatives this month.
December 2019
The Federal Reserve released guidance allowing banks to work with the hemp industry. Financial institutions are no longer required to file suspicious activity reports on customers operating a hemp business.
It’s been a wild ride to look back at the last 10 years of NCIA, and we are looking forward to serving you and your business for another 10 more!
The 2018 Farm Bill and the Return of Hemp to American Farms
by Michelle Rutter, NCIA Government Relations Manager
HISTORY
Farming and agriculture has long been a part of North American history. When the Great Depression hit in the 1930’s, both President Franklin Delano Roosevelt and Congress knew that the United States would struggle until the agriculture industry became prosperous again. As a result, many New Deal programs dealt with farming, but arguably the most notable agriculture related legislation was the Agricultural Adjustment Act of 1938, which was the first version of what we know today as simply the “Farm Bill” that is updated roughly every five years.
TODAY
Now, for the first time since the end of World War II, states are slated to soon be able to create federally legal hemp programs under the 2018 Farm Bill, which President Trump is expected to sign into law any day. The bipartisan legislation, which passed overwhelmingly in the Senate and House last week, would allow states to submit plans created by their respective Secretaries of Agriculture in coordination with their governors and chief law enforcement officers to the Department of Agriculture to grow and process hemp and hemp-derived products.
SEED TO SALE
As the law is written, state applications would need to include methods for tracking land used for hemp production and audit producers to make sure that the hemp they are growing contains less than 0.3% THC. Programs would also need to be approved by the Secretary of Agriculture, Sonny Perdue, in consultation with the Attorney General within 60 days of being submitted. Additionally, states would not be permitted to ban the transportation of hemp and hemp products through their jurisdictions, but production and sales would only be permitted in states with approved programs. The bill also contains a number of directives for research on hemp and hemp cultivation.
SCHEDULING
Hemp-derived cannabidiol (CBD) would be exempted from the Controlled Substances Act (CSA) in states with approved programs, but CBD will remain a Schedule 1 substance under the CSA and illegal at the federal level. The Farm Bill also does not impact the current Food & Drug Administration ban on CBD products or its ability to regulate the substance in the future.
INDUSTRY EMPLOYMENT
The law prevents anyone with a drug-related felony from working in legal state hemp industries, preventing many people who have been impacted by the unequal enforcement of cannabis prohibition from participating in the economic opportunities created by new programs. However, a late compromise led to the inclusion of a ten-year sunset period from either the date of conviction or the start of the state program, whichever is more recent.
THE FUTURE
Marijuana’s “cousin,” hemp, is generally barred because it is part of the cannabis plant, despite the fact that it contains very little of that drug’s key psychoactive ingredient, THC. In 2014, Majority Leader McConnell (R-KY) secured a hemp pilot program in that year’s farm bill. Since then, at least 35 states have taken up the offer and developed industrial hemp programs, and those states will be eligible to pursue a legal, regulated market when the bill is signed into law. The passage of this provision will surely bring about a new era for the agricultural industry, and the cannabis industry — when hemp returns to American farmlands.
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Todd Glider has been an e-Commerce leader since the start of the Internet age. He has an MFA in Creative Writing from the University of Miami, and has served as CEO for small and medium-sized technology companies in Spain, Austria and the United States. As our Chief Business Development Officer, Todd introduces MobiusPay’s suite of award-winning financial services to new industries, and implements the development strategies and key partnerships needed to bring value to new customers.
By Sadaf Naushad, NCIA Intern 
By Morgan Fox, NCIA’s Director of Media Relations
