By Melissa Kuipers Blake, Osiris Morel No Comments
After nearly a decade of conversation and education on the Hill, the Senate Banking, Housing and Urban Affairs Committee finally held a markup on the Secure and Fair Regulation (SAFER) Banking Act. Previously known as the SAFE Banking Act, the “R” was included to account for Sen. Jack Reed’s (D-RI) concerns with Section 10. The senator shared his concerns publicly on May 11 during the “Examining Cannabis Banking Challenges of Small Businesses and Workers” hearing. Sen. Reed said that Section 10’s language “would make it more difficult for federal regulators to raise the alarm about relationships with any customer that presents significant risks to the bank” and shared that such a provision is “not limited to the marijuana industry or the cannabis industry,” but that it “could allow pyramid schemes or all sorts of other interesting activity to go on without an effective response by the regulator.” Since then, he and a group of bipartisan members, including Majority Leader Chuck Schumer (D-NY), Senate Banking Committee Chair Sherrod Brown (D-OH), and Sens. Steve Daines (R-MT), Cynthia Lummis (R-WY), Kevin Cramer (R-ND) and Kyrsten Sinema (I-AZ), have worked endlessly to develop language to resolve such concerns while maintaining GOP support, leading to the SAFER Banking Act.
Number of Depository Institutions Actively Banking Cannabis-Related Businesses in the United States (Reported in SARS)
The difference between the SAFE Banking Act and the SAFER Banking Act can mainly be found in Section 10. Changes focus on and determines:
How regulators terminate bank accounts;
How the Federal Deposit Insurance Corporation (FDIC) develops guidance for financial institutions serving state-licensed cannabis businesses;
How income derived from state-legal cannabis business activity is managed;
That personal and political beliefs cannot impact a financial regulator’s decision making;
That federal banking regulators and state banking supervisors and their secretaries of Commerce and Treasury would create rules to increase access to deposit accounts and how such individuals would enhance customer relationships with rural, low- and moderate-income, unbanked and tribal communities; and
How the FDIC would conduct a biennial survey and report on barriers for small- and medium-sized businesses.
During the markup on Wednesday, members introduced and discussed a range of amendments related to criminal justice reform, the racial wealth gap, federal regulators and their processes, rescheduling and the opioid epidemic. In total, there were six amendments, one by Chairman Brown, as well as Sens. Mike Crapo (R-ID), Bill Hagerty (R-TN), Mike Rounds (R-SD) and two by Sen. Raphael Warnock (D-GA). Sen. Brown’s amendment, which would make technical changes to the bill, was the only amendment to prevail on a 17-6 vote.
Senate Majority Leader Chuck Schumer (center), Senate Finance Committee Chair Ron Wyden (right) and Senator Cory Booker (left)
To begin the markup, Chair Brown said that propelling this legislation is a critical step in reversing the damage done by the war on drugs and clarified that the SAFER Banking Act would create a better financial system for small and medium-sized cannabis businesses that lack access to such traditional banking services. Sen. Daines, who served as the committee ranking member in place of Sen. Tim Scott (R-SC), who was in California preparing for the Republican presidential debate, shared that although he opposes legalization or decriminalization, he agreed to sponsor and support the SAFER Banking Act because it would fix the current banking system for cannabis businesses nationwide. After hearing remarks from Sens. Lummis, Catherine Cortez Masto (D-NV) and Sinema, the committee voted on the bill, and approved its passage to the Senate floor on a 14-9 vote. Senators voting in favor of the bill were Brown, Tester, Warren, Reed, Menendez (by proxy), Smith (by proxy), Warner, Fetterman, Cortez-Masto, Sinema, Van Hollen, Lummis, Cramer and Daines, and voting against the measure were Sens. Warnock, Scott (by proxy), Crapo, Tillis, Kennedy, Haggerty, Vance and Britt.
After the vote, Sen. Jeff Merkley (D-OR) thanked Sen. Rand Paul (R-KY) and former Republican Sen. Cory Gardner (CO) for their early efforts and for bringing the legislation and issue to the chamber’s attention and concluded that he hopes to have a robust discussion with the full Senate chamber.
With the bill out of committee, it heads to the Senate floor for additional input, discussion and potentially a vote. Majority Leader Schumer has said he intends to bring the SAFER Banking Act to the floor “with all due speed” and noted that he is committed to attaching Rep. Dave Joyce’s (R-OH) Harnessing Opportunities by Pursuing Expungement (HOPE) Act and Rep. Brian Mast’s (R-FL) Gun Rights and Marijuana (GRAM) Act to the final legislation. Sen. Schumer also shared that such provisions would address the war on drugs, bolster social equity and criminal justice reform and protect Second Amendment rights for medical cannabis patients.
When the SAFER Banking Act will receive floor time remains unclear, but Leader Schumer has made numerous representations that he would like to see it done this year.
Even a cursory review of cannabis reveals that the market has been notoriously wasteful, polluting the environment with chemical fertilizers, misused pesticides, contaminated plants, and—perhaps most problematically—thoughtlessly excessive packaging.
The industry is in dire need of sustainable practices, and the easiest way to start an impactful new trend is from the outside in: a.k.a., adjusting how you’re parceling your products.
Honing in on sustainable packaging isn’t just a good move for the environment. It’s also more cost-effective, less labor-intensive and allows you to provide consumers with the best possible version of your flower—no matter how far through the supply chain it’s had to travel before hitting retail shelves.
Cannabis has progressed: It’s time for its packaging to do the same
By the time legalization began sweeping the nation, the industry already had several decades of experience operating underground. With that discretion came a lot of built-in habits around not attracting attention, and for packaging, the focus was solely on not looking like a cannabis product.
An overabundance of plastic isn’t cutting it anymore—not only when it comes to environmental friendliness, but for the integrity of the product itself.
Today, increased legalization grants operators the freedom to expand without the fear of being seen, and as a result, there’s no longer any excuse for wasteful packaging to be the industry’s norm. Glass jars, Ziplocks and an overabundance of plastic isn’t cutting it anymore—not only when it comes to environmental friendliness, but for the integrity of the product itself.
“I’ve been designing packaging in the cannabis industry since 2013, and a lot of trends have come and gone. We used to put flower in plastic Rx jars and paper envelopes. In general, there was a lot of waste: excess boxes and jars that all get thrown away,” says Legacy’s Chief Cannabis Officer Ryan Hedrick. “And when consumers pull the products out of those containers, your marketing doesn’t remain intact. The box gets thrown away, and now they’re just carrying around a labelless jar. Not only is it bad for the environment, but it isn’t helping you promote your brand at all.”
How sustainable storage optimizes curing and shelf life of flower
As for the curing process, Hedrick used to use airtight buckets, which both took up a lot of room and wasn’t at all effective for maintaining cannabis’s ideal humidity levels. He’s since switched to passive atmospheric packaging, which utilizes increasingly popular technology to keep humidity—and sustainability—in mind. “The buckets weren’t letting any moisture out. On top of that, you can imagine how much room 165 five-gallon buckets takes up in a grow space,” Hedrick says.
The same goes for long-term storage. With humidity-controlled bags, operators can rest assured that their product will maintain its efficacy, because as soon as that pack is sealed, the humidity level is guaranteed to stay the same.
Cannabis brand Lava Leaf Organics relies on passive atmospheric packaging for efficient storage—mainly because of the reduction in carbon footprint and increase in terpene preservation.
“When we think about the energy involved in packaging and shipping large amounts of heavy glass jars compared to TerpLoc bags, it was an easy decision for us,” said Lava Leaf Organics CEO Tony Martinez.
“The bags are recyclable, and compared to glass jars with child-resistant lids, they’re much better at preserving terpenes. Using sustainable packaging allows us to put our best foot forward and to better control our customer’s brand experience.”
Tips for making sustainable storage work for you
Sustainable storage is an environmentally-responsible move for the cannabis industry to make, but when weighing the pros and cons of a big switch like this, operators should also keep in mind how positively it will impact their end product, consumer’s experience, and, subsequently, their industry-wide reputation.
Some product packaging examples in the market today
Placing your products in eco-friendly bags is just the start. There are definitely more tips and tricks operators can take advantage of to prolong the use of sustainable materials and ensure they’re leaving as small a footprint as possible. For example, Hedrick’s team reuses their passive atmospheric packaging for maximum efficiency—especially when it comes to bulk storage or curing.
“We mark all of our storage bags with the original strain, so we can reuse that bag for the same strain as long as it passes testing along the way. When I do so, I take a mixture of SaniDate and water to make sure everything is sanitized and clean,” Hedrick said. “That allows me to reuse them for about 3-4 months’ worth of curing and storage. You can reuse a bucket in that same way, but when it’s time to replace it, you’re still spending another $15-$17.”
Sustainable, humidity-controlled packaging is also ideal for testing consistency. If you send in five buckets of the same strain to be tested, you run the risk of them all sitting at wildly different humidity levels, which means some might pass, and others might be rendered trash.
All of the environmental benefits aside, using sustainable packaging just makes cents—literally. “Essentially, I’m saving a minimum of half a million in packaging every year. That’s my entire staff’s salary for two months. That’s incredible, impactful, significant savings that can make a huge difference for a business trying to expand.”
By Abraham Finberg, Rachel Wright, Simon Menkes No Comments
A Uniquely Texas Approach to Cannabis
The last few decades have seen the United States move forward state-by-state with the legalization of cannabis. Every state is charting its own unique path, and nowhere is this truer than with the state of Texas.
The Lone Star State has made its way from being staunchly anti-cannabis to expressing its own blend of temperance and careful action, combined with a medical cannabis program that’s expanding.
Any predictions regarding the future of cannabis in Texas must take into consideration both the state’s past and its values. In the end, it’s clear that Texas will embrace cannabis in its own individual way and at its own pace, but with a timeframe that appears to be arriving sooner rather than later.
The Debate Continues
108 years after Texas first banned cannabis and the debate continues. Even though Texas has a medical cannabis program, cannabis is still illegal in the state, with possession of less than two ounces a misdemeanor. Possession of more than four ounces is a felony punishable by a $10,000 fine and from 2-99 years in jail.
Texas’s 2015 Compassionate Use Act created the state’s medicinal cannabis program, which now makes treatment available only in the form of low-THC oil of a maximum strength of 1%, and only to a small list of serious conditions: epilepsy, terminal cancer, autism, multiple sclerosis, amyotrophic lateral sclerosis (ALS), seizure disorders, incurable neurological disorders such as Alzheimer’s, Parkinson’s, Huntington’s Disease and PTSD.
Support for a Stronger Medicinal Cannabis Program Comes from Prominent Politicians
Texas Department of Agriculture Commissioner Sid Miller, a leader in Texas politics and one of the architects of Texas’s burgeoning hemp industry, has encouraged Texas legislators to create a more complete medical cannabis program.
Texas Department of Agriculture Commissioner Sid Miller
“I am for medical use,” Miller said in an August 2023 interview. “We have so much good science now. And we know what diseases it can treat, yet our legislature picks winners [and] losers. If you’ve got this disease, you can get treated, but if you’ve got this disease and cannabis will help you, you can’t get treated. We need to let the doctor-patient relationship make those medical decisions and not some bureaucrat or some politician … I’m not a supporter of recreational marijuana, but if someone has a condition that this chemical will help, they should be able to use it.”
Texas Representative Joe Moody from El Paso has worked for many years to promote adult-use cannabis. He recently co-authored two pro-cannabis bills, HB 1805, which would have expanded covered medical conditions and defined a per-doze THC limit instead of a percentage limit on cannabis products, and HB 218, which would have decriminalized cannabis.
Although both bills passed the House of Representatives, they were stopped in the Senate. The next session of the state legislature, which happens every two years, won’t begin until January 2025, so that is the earliest any change in cannabis statutes could take place.
The Future of Medicinal Cannabis
There are currently only three dispensaries in Texas. They appear to be servicing the state’s 268,000 square miles through a series of weekly drop-offs to satellite “partner locations,” which are open an average of only two days per week. This is not exactly a corner-CVS type of arrangement, and the need for new dispensaries for the state’s 61,000 registered patients is high.
The Texas Department of Public Safety took applications for new medical dispensary licenses between January and April 2023. Tony Gallo, managing partner of Sapphire Risk Advisory Group, which helped twelve licensees prepare their applications during this round, anticipates around ten new dispensaries being approved.
All licensees must be vertically integrated – product must go from seed-to-sale under one license – and each applicant paid $7,356 to apply. If approved, the applicants will owe another $488,520.00 for a two-year period.
Many knowledgeable Texans, including Agriculture Commissioner Sid Miller, predict a fully-functioning medicinal cannabis market is just a few years away. “If you can get it to the floor, probably 70% or 80% of the legislative body will vote in favor of it because we have such good science on it. [Originally] we thought, ‘Well, that’ll lead to recreational use or more drug use,’ but it’s not. It’s a plant derivative. Medical marijuana is not nearly as addictive as some of the prescription drugs we use now.”
The Push is On for Adult-Use
Representative Joe Moody believes that adult-use is not too far away in Texas’s future either, and that the way to speed its arrival is through education. He recently sponsored HB 3652, the Texas Regulation & Taxation of Cannabis Act, in order to start a dialogue on what a retail cannabis market will look like in Texas.
Texas Representative Joe Moody
On April 26, 2023, Moody and his bill received a public hearing in the House Committee for Licensing and Administrative Procedures in which many points about setting up a retail market in Texas were discussed. A 10% cannabis tax was proposed by Moody, to be split evenly between the state and local government. Licenses would be required for those growing, selling, transporting or testing cannabis, although individuals would be allowed to grow or possess it in small amounts for personal use. Legal sale and consumption would be limited to adults 21 years of age and older, like alcohol. And of course, cannabis possession would be decriminalized.
How Strong is the Market Potential for Cannabis?
One indication of how strong even a fully-open medical cannabis market might be in Texas came during Moody’s hearing from the testimony of Estella Castro. Castro owns two medical dispensaries in Oklahoma just across the state line from Texas and suspects most her buyers are from Texas. “They have a Texas plate and they come in and buy $500 to $600 worth of product,” she said. Her two shops generated $158,000 in taxes to Oklahoma, most of which she believes should have gone to Texas.
New Mexico recently legalized adult-use cannabis, and the small towns along the Texas-New Mexico border are seeing a lot of traffic from Texas. In the first week of adult-use sales, the New Mexico did adult-use sales totaling $6 million. Of those sales, $1.5 million came from dispensaries in 5 small border towns.
Florida and California Suggest the Scope of a Mature Cannabis Market in Texas
The potential for a fully developed medical cannabis market can be gleaned by studying the next smaller state, Florida, which has an open, mature, medical cannabis market. Florida, with 20 million people, is about two-thirds the size of Texas, which has 30 million inhabitants. Right now, Florida boasts 700,000 cannabis patients whereas Texas only has 61,000. Simple math suggests a fully open, mature, medical cannabis market in Texas could see over a million patients gain relief.
California is the nation’s most populous state with 39 million inhabitants, and its cannabis revenue gives some perspective as to the size of a Texas adult-use market. 2024 estimates of California’s cannabis revenue suggest the Golden State will see $7.2 billion legal cannabis sales while the illegal market will generate another $6.4 billion for a total of $13.6 billion. With a reduction for Texas’s smaller size, these numbers suggest a fully-mature Texas adult-use cannabis market could generate close to $10 billion in annual revenue.
Large adult-use states like California and New York are notorious for having an illicit market that threatens to derail their legal, tax-paying cannabis license holders. Texas’s strong business-friendly focus should help deter such an illicit marketplace from gaining too significant a foothold.
The Back-Door Cannabis Industry
Meanwhile, an extensive “back door” cannabis industry is in full swing in Texas. CBD shops now sell delta-9 (fully psychoactive) THC/CBD gummies and tinctures made from the hemp plant, which is the low THC-version of the cannabis plant. These THC/CBD products adhere to the 0.3% definition of hemp as required by the federal 2018 Farm Bill and are legal and available for over-the-counter or online purchase in Texas’s CBD stores.
Gummies, tinctures and other products made form them hemp plant
Current estimates are that there are over 5,000 hemp, CBD and cannabinoid retailers, manufacturers and distributors in Texas that employ more than 50,000 workers and generate more than $8 billion in annual revenue. With these numbers, the 1,100+ licensed Texas hemp growers are sitting well where they are and are poised to take advantage of a legal adult-use market if and when Texas decides it is ready to go down that path.
Next Steps for Texas’s Cannabis Market
People familiar with Texas’s cannabis market believe that adult-use is a ways down the road for the Lone Star State, and that the near-term focus needs to be on decriminalization and achieving an unincumbered medical cannabis system. Tony Gallo of Sapphire Risk Advisory Group advises the Texas cannabis community to concentrate on “increasing what conditions are allowed for medicinal use” and “increasing what areas of the state it’s allowed to be sold.”
There is a groundswell of public support for decriminalizing cannabis as well as for allowing adult-use. A December 2022 poll showed 55% of Texans support legalizing at least small amounts of cannabis for recreational purposes, and another 28% said it should be legal for medicinal purposes.
A February 2023 poll by the University of Houston found that 82% of Texans support the Legislature passing a bill that would allow people to use marijuana for a wide range of medical purposes with a prescription. The belief that cannabis is a “gateway drug” that would make people more likely to use other illegal drugs is losing traction as well – 70% said it would make people less likely to do so or would have no impact.
Final Thoughts
The demand for cannabis in the Lone Star State is strong. With the likelihood of a fully-functioning medical cannabis market coming soon, and the possibility of decriminalization not too far behind, it’s clear that the future of cannabis is bright in Texas.
While the legalities around adult-use will take longer to work out, and the place of hallucinogenic hemp in the mix needs to be examined and clarified, one fact is certain. The path forward that Texas cannabis takes will certainly be a unique one, as unique and as individual as the Texan people themselves.
A review of these various jurisdictions, the EU, the UK, and the USA, makes it clear that testing of CBD to ensure public safety is paramount to staying in business, and indeed to the survival of the industry. In the UK it is imperative to be active in the Novel Food licensing regime to remain on the market. In the EU, it is imperative for a legitimate market at all.
In the USA, it may very well become an imperative, if not because of the FDA or even Congress, but rather because as the U.S. market matures, lawsuits over product liability are almost inevitable, pointing to the lack of toxicology reporting or to the way a product was manufactured or marketed. Until the FDA plays a more robust role in establishing standards for the safety of CBD in food products, the best means for companies to protect themselves is with a Novel Food inspired testing regime to confirm product safety.
What this means for the CBD industry
Companies want a clear path forward for investments in the CBD sector. Litigation is predictable, especially in a litigious society like the U.S., as companies prepare themselves with toxicology reporting that satisfies the FDA. There will be clear winners and losers in the CBD market place, most likely based on a toxicology report.
The EFSA, FSA, FDA, the various state level hemp associations dotted across America and more intriguingly, businesses who see testing requirements as a legal means of ousting the less-well-financed competition, are all advocating for testing. This makes sense: There is no future in betting on the unknown. Anything short of a clear safety standard is just guessing with people’s health and thus the company’s future.
So, what are we left with?
Clearly, there is a need for a toxicology report prepared on behalf of the CBD sector. And one about CBD as a food supplement, not as a medicine. It is worth noting that Miller also remarked on how Epidiolex contained high doses of CBD. It needs to be made clear that the medical study of Epidiolex is not consistent with a study of non-medical levels of CBD when used as a supplement.
At present, the biggest challenge facing CBD product manufactures, whether in the USA, EU or UK, is the lack of controlled studies and thus the inability to illustrate the necessary toxicology reporting in their portfolio. Even in the US, the FDA has said it can’t conclude that CBD meets the standard of “generally recognized as safe” (GRAS) for use in human or animal food. Thus, the future of CBD lies in a company’s ability to illustrate by means of a study and accompanying toxicology reports that their brand is firmly in line with the required safety and data standards.
Just some fo the many CBD products in the U.S. market out there
Here is where the EU and the UK may have an advantage, through involvement in the Novel Food application and licensing procedures. The needed legal security for the marketing of CBD products can only be achieved by their approval as Novel Foods. Projected costs for an individual company registering CBD isolate and full spectrum distillate under the Novel Food guidelines requires an investment of €3.5 million. As this is prohibitively high for most companies, at the June 2019 General Assembly, the EIHA proposed the creation of a consortium, with the aim of submitting a joint Novel Food application and sharing these costs among the members.
How the “EIHA projects GmbH” Partnership Works
The founding members of the EIHA projects GmbH have a preferential partnership rate. As a partner, I am able to sub-license products or brands in the EU and this license will be valid in the UK when the application is validated and on the Union list, and is equally valid in the USA.
The Atlantic Ocean is getting smaller and it appears that the FDA might very well decide that the US needs the same European safety standards applied to products at home. Sub-licensing is clearly an inexpensive pathway for an American brand to claim toxicology and safety testing PLUS get access to the EU market. It is imperative for businesses going forward to take a serious look at their future business goals and align themselves with an advancing regulatory environment confirming their commitment to approved quality products.
This is Part Three of a four-part series discussing European cannabis regulations. Click here for Part One and here for Part Two. Part Three dives into dosage, approvals and more. Stay tuned for the final Part Four, coming next week.
But does CBD harm the liver?
Here, it is important that we compare apples to apples. Supplements are intended in addition to one’s usual diet. Medicines, on the other hand, are meant to alter a condition to solve a problem. Epidiolex is a medicine, not a supplement. According to Epidiolex the recommend dosage of Epidiolex, a highly purified form of CBD, is between 5mg and 25mg per kilo body weight per day. That means that an average 70 kilo adult would need to take between 350mg and 1750mg per day!
At this moment, even the FSA states that a recommended dosage should not exceed 70mg per day and most recommendations are much lower. This is because supplements are not medicines.
The point is that Epidiolex is an FDA-recognized medicine and should not be compared to a supplement. Supplements may range from vitamins, minerals, herbal products and botanicals, and are offered without a prescription to people who wish to maintain or improve their health. Purchasers of supplements, as the word suggests, are supplementing their diet or lifestyle, they are not seeking a doctor prescribed medicine.
The supplement or additive industry has no desire to confuse the objective of a supplement with one of a medicine. The objective of testing CBD is to confirm its usage as a supplement, so a firm line can be drawn between what is a medicine, formed to make conditional changes to the body, and what is a supplement to a normal diet.
Despite the FDA’s website warning that CBD is not a legal additive to food or drinks, at this point, the Agency seems to limit actions to claims, and not the safety of the product itself.
This position may be about to change.
The FDA has made inquiries with the European authority, EFSA, concerning testing and safety requirements. It is quite possible the FDA prefers the ‘EU approach’ over the current ‘wild west approach’ driving the American CBD industry.
In response to interview questions directed to FDA spokesperson, Courtney Rhodes says:
“CBD cannot lawfully be sold as a dietary supplement or as an ingredient in food under the FD&C Act. (Bold italics by the FDA) Food ingredients must be shown to be safe to be lawfully added to food. That means, there must be a reasonable certainty that an ingredient’s intended use won’t cause harm”.
If this is the case, one may well wonder why the FDA is not enforcing the FD&C Act. The answer might lay in great part to the specifics of the 2018 Farm Bill (formally, the Agriculture Improvement Act), where the only statutory metric for cannabis as a controlled substance is the reference to the 0.3% delta 9 THC level. Many see this poorly written bill as an open door for cannabinoids to hit the markets legally, much to the chagrin of many state lawmakers.
FDA spokeswoman Rhodes says that the 2018 Farm Bill effectively “removed hemp from [DEA] regulation.” By defining hemp as Cannabis sativa L. with a delta-9 concentration of 0.3% or less, “hemp derivatives, [like] CBD, …meet that definition of hemp and [are] not prohibited under the Controlled Substances Act.”
Thus, any enforcement on the part of the FDA is legally hamstrung due to the way the 2018 Farm Bill was written.
But is change in the air?
Research has yet to settle on “how much CBD can be consumed, and for how long, before causing harm,” says FDA Principal Deputy Commissioner Janet Woodcock. The existing regulatory framework for food and supplements are inappropriate for CBD, she says, and the FDA does not, in fact, intend to pursue rulemaking that would allow for the inclusion of CBD in dietary supplements.
So, what does the FDA intend to pursue?
While the FDA has generally focused on unsubstantiated health claims for food and beverage products, it is also on record stating that available data did not show CBD products as meeting the safety standard for a human or animal food supplement. “A new regulatory pathway for CBD is needed,” the Agency says, “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
What would such “a new regulatory pathway” look like? Most likely, that new testing requirements for CBD could come into effect. This could eventually mean testing requirements much like those in the EU.
Have the studies of Epidiolex, with findings based on extremely high dosage levels tainted the CBD discussion?
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
“The FDA is relying on pharmaceutical studies that show risks at larger doses,” says Jonathan Miller, general counsel for the U.S. Hemp Roundtable, adding that there is a decade of clear and established evidence of the safety of CBD products sold at retail. This is hard to deny: The industry has been selling CBD products for the last 10 years without any significant health issues arising. Thus, says Miller, creating a new regulatory pathway would not be necessary as the dietary supplement and food pathways are already provided for under the FD&C Act.
Authorities and industry leaders alike want regulations that promote business while at the same time protecting consumers. “The FDA’s inaction for the past year has facilitated an unregulated marketplace — which is bad for consumers and bad for business. It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements,” says Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), quoted on the crnusa.org website.
It is clear that the FDA does not want CBD in food and beverages and likewise claims there is no clear regulatory pathway, citing scientific data on CBD based on the Epidiolx study, which has little room for claiming CBD could be safely used as a supplement because the study is based on medicine, not a supplement.
Parallel to this, the US Hemp Roundtable and other industry stakeholders are urging the U.S. House Committee on Oversight and Accountability to move forward with an investigation into the lack of regulatory action on CBD products by the U.S. Food and Drug Administration (FDA). Does this mean that hemp lobbyist Jonathan Miller for Hemp Roundtable wants toxicology testing? “Yes,” he definitively answered.
Serious business requires the security that only toxicology reporting can give. Most of the large industry stakeholders have been engaged in toxicology testing for years, as time, not just funds, is a crucial factor. The EIHA projects GmbH began testing in 2020 and is not yet finished.
If congress and the FDA were to require toxicology reporting tomorrow, would your company be ready?
Recently, Congress requested detailed information regarding the regulation of CBD and other cannabinoids. This comes on the heels of frustration around federal inaction with regards to cannabinoid-containing products produced from Cannabis sativa L. plant extracts that can be classified as “hemp” products amidst the clear need for safety standards that goes above and beyond state minimum compliance requirements.
A Historical Deja Vu?
The author will be joined by his colleagues leading the Seed to Sale Safety Workshop on October 16 at the Cannabis Quality Conference. Click here to learn more. Product safety standards predate the birth of our nation (and many others). From the days of the first pharmacopeias which rival the oldest documented use of the cannabis plant, to modern regulations, the quest for safety has been a constant theme. But as the saying goes “Old habits die hard,” but so do safety issues. From peanuts to thalidomide and tobacco, we’ve seen this movie before – and it is time for a new ending.
A Universal Desire for Safety
Whether you are an investor, executive, technician or anywhere in between – nobody in the cannabis industry (and all its end uses, including industrial hemp) wants to knowingly produce unsafe products. The risks of ignoring safety are real and tangible. Whether it is 20+ years in jail for being an executive of a company that knowingly sold adulterated products and was linked to seven deaths or 10,000+ deformed children, many of whom died at birth because of a drug approved for morning sickness – there is no shortage of case studies we can learn from. Even cannabis has been known to cause injury and death in consumers – not because of the d9-THC, but the impurities. As the industry continues to innovate and develop new product form factors – whether it is new delivery methods of d9-THC in soluble beverage forms, or the rise of manufactured cannabinoids in unregulated marketplaces – it’s critical to understand the risks of your entire production process and to mitigate them. No cannabis company is immune from making costly and dangerous mistakes. It’s not just about compliance – it’s aboutpublic health and safety.
Safety Can Be a Sticky Subject
Safety is indeed a complex subject, especially when it comes to cannabis products. For instance, acceptable limits for microbial contaminants for the inflorescence of a Cannabis sativa L. plant are quite literally all over the map. What about the route of administration? Take an inhaled product (like a vape pen) vs. an ingested product (e.g. an edible). Many outdoorsy people like myself may enjoy the smell of cooking s’mores over a campfire, but the particles and VOCs can irritate our lungs, especially when exposed over long periods of time. We aren’t inhaling those s’mores – so the production of the marshmallow, chocolate and graham crackers come with different risks we need to evaluate. It’s not just about the product – it’s how it’s consumed.
Safety Standards – the Fabric of Our Society
Standards are unsung heroes of our daily lives. Whether it’s to keep planes from falling out of the sky, cribs and dressers from crushing young children, preventing train derailments or ensuring the safety of our food and medical products – standards keep us protected – just like grandma’s quilt. The absence of standards can be expensive, and anyone familiar with the accusations of d9-THC lab-shopping and inflated label claims knows that the cannabis industry is the poster child for this.
Congress has long recognized the importance of standards in protecting everyday consumers, as demonstrated by numerous legislative acts. A few notable and relevant ones to cannabis are below:
1848 Drug Importation Act: First major act that combated the importation of substandard – adulterated drugs imported from overseas into the nation which was having a major impact on soldiers of the Mexican-American War. This Act included legal requirements for drugs to meet the US Pharmacopeia’s standards for strength, quality, and purity.
1906 Food and Drugs Act: After an increase in adulterated and misbranded foods and drugs – made famous by Upton Sinclair’s The Jungle, the relentless work of Dr. Harvey Wiley, a Chief Chemist with the then US Department of Agriculture and his “poison squad” – led to significant oversight of adulterated food and drugs including legal adherence to the US Pharmacopeia and paved the way for the current FDA.
1938 Food Drug, Cosmetic Act: Shortcomings in the 1906 Food and Drugs Act were catalyzed by over 100 deaths after a wonder drug that was analogous to antifreeze led to an outcry that led to the passage of the FDC&A. From factory inspections, to strict marketing and label requirements, to legally enforceable food standards and tolerances for certain poisonous substances – the FDA was given substantial more oversight to protect the growing United States. It also expressly recognized USP quality standards for medicines with USP standards also binding for any dietary supplement manufacturer that labels their products as being compliant with USP specifications.
1994 Dietary Supplement Health Education Act (DSHEA) defined and regulated dietary supplements which carved out significant exemptions for the dietary and herbal supplement industry from most FDA drug regulations. This act has been met with significant controversy as it greatly limited the FDA’s capacity to ban or restrict supplements until evidence of a major safety or adverse event is tied to the product of concern.
1995 National Technology Transfer Advancement Act (NTTAA) – A lesser known act that is focused on standards and technology that requires participation of federal agencies in voluntary consensus standards bodies. Extending beyond foods and medicines – this act covers a broad array of infrastructure and technology regulations that ensure the fabric of our society operates (largely) without issue.
Over 1,000 ASTM standards are incorporated by reference in the US Code of Federal Regulations across nearly 30 federal agencies (searchable here), a demonstration of the value and impact public voluntary standards have in our society.
At the FDA, ASTM standards are used every day to keep us safe. Whether it is to measure the absorbency of tampons (21 CFR 801.430), enforce safety specifications of synthetic and natural wax coatings that are used to coat much of our produce, gummies and more (21 CFR 178.3770), quantifying the impurities in our bottled water (21 CFR 165.110) and many more.They have long been recognized as the de facto minimum standards that balance the need to protect consumers without imposing undue burdens on innovation by industry.
The process of developing an ASTM standard, which was developed and used to keep our trains from derailing 125 years ago, is now the home of 510+ cannabis industry specific standards. Whether it’s acceptable water activity levels in cannabis flower, a truly universal symbol to alert consumers of intoxicating cannabinoids, medical cannabis flower specifications developed in close guidance of the US Pharmacopeia, or how to apply the principles of HACCP to cannabis products, a lot of the hard work has already been done for the industry. It’s simply a matter of knowing where to look and how to use them!
The path to safe and sustainable cannabis products is clear, and the tools are available. It’s time that we learn from the past, apply the standards of the present and mitigate the risks of the future. Now more than ever before, it’s easy to make safe cannabis products and a credible marketplace not just a goal, but a reality.
In the wake of the 2018 Farm Bill, the horizons of hemp-derived cannabis products expanded, offering nearly limitless opportunities for businesses and brands in the CBD industry to expand what they could offer to their customers. However, threading the path to prosperity within this new regime has not been easy, given the fluctuating legal status of cannabinoids and the regulations surrounding them. Within this labyrinth of legal intricacies, one significant hurdle stands out: payment processing. For online CBD suppliers, finding a payment processor amenable to cannabis commerce has been an uphill battle. The winds, though, are shifting and some payment processors are paving the way toward a more harmonious future for cannabis and e-commerce.
What Merchant Account Will Process CBD Website Payments?
Finding a merchant account or payment processor that simplifies the transaction process can be frustrating, especially if you’re not well-versed in the world of e-commerce. The good news is that more and more payment processors are hopping onto the trend, but why?
The 2018 Farm Bill changed everything for the cannabis industry. Now, hemp-derived CBD products are considered federally legal. Since then, some states have passed their own restrictive legislation aimed at specific cannabinoids and others may choose to do the same. But for the rest of the country, the Farm Bill states that as long as cannabis products are hemp-derived and contain less than 0.3% THC in dry weight, they can be legally produced and sold.
While this doesn’t mean that cannabis is entirely legal, the Farm Bill has brought about just enough change to ease the concerns of some in the financial industry. Where legal uncertainties have kept financial institutions away from the cannabis industry, there some companies that have become reliable partners for CBD brands. This registered merchant account provider, works with major credit card networks, making it possible for CBD companies and their customers to process payments online and offline.
Payment processors like GETTRX, Inovio, Square and Bankful are well-versed in the CBD landscaped and equipped to handle the legal intricacies of processing high-risk industries like hemp, making them excellent options if you’re on the hunt for a way to simplify the transaction process.
But, how does a CBD company choose the payment processor they want to work with?
What to Look for in a CBD Payment Processor
Choosing the right merchant account and payment processor is essential to making your business run smoothly and providing a seamless and intuitive experience for customers. Here’s a condensed guide on some key factors to consider:
High-risk expertise should be a priority, as you want someone who is on your side. Being well-versed in high-risk industries can give you peace of mind when navigating the ups and downs of the complex CBD industry.
You’re only as good as your worst customer, so making sure to find payment processors with a good industry reputation and an excellent track record will be a plus when handling CBD.
Being transparent about your needs with potential payment processors can help set expectations, and using the term “high-risk” will always be a way to break the ice. This helps set the scene and gives reputable processors context and peace of mind about your intentions and products.
Instead of rushing to the most well-known payment processors, take your time and really balance out the possibilities. Some processors may be popular, but lacking stringent underwriting standards can lead to unforeseen shutdowns.
Why Don’t All Payment Processors Work for Cannabis?
If you’re deep into the world of cannabis, you’ve probably already noticed that navigating the CBD landscape isn’t an easy task for processors. This is a case of two highly complex and regulated industries having to find common ground, but since CBD products often have THC, they’re considered high-risk for many mainstream payment processors.
Due to compliance intricacies, federal-state law conflicts, product safety concerns, credibility of labs, and ambiguous federal regulation, not all payment processors are up for the challenge. Despite these obstacles, companies like GETTRX have managed to handle these intricacies and become a reliable partner for CBD brands.
These intricacies aren’t easy to navigate, and Roberto Sato, president and CIO of GETTRX, understands why some payment processors might not want to get involved: “Typically, processors categorize CBD merchants as high risk, particularly Card Not Present merchants,” says Sato. “This classification predominantly arises from legal and regulatory compliance concerns, the rigorous due diligence executed during onboarding and risk monitoring by ISOs, processors, and sponsor banks, as well as the interplay between federal and state laws and regulations. Aspects such as product quality, safety, and overall reputational risk further compound this assessment.”
So, what can CBD companies do to ensure that their products stand the test of payment processors? Basically, it’s about making it easier for the payment processor to see you as a partner rather than a risk. Things like registering with Visa and MasterCard as a high-risk entity, and allotting $500 for each association, show payment processors that your CBD company is going to be easier to work with. “Ensure your products have valid and updated lab reports, with a certificate of analysis for each listed item,” says Sato. “Include comprehensive ingredient labels and ensure your billing descriptor matches the business name on your URL. Exclude products like flower, loose items, seeds, and pre-rolled goods, including delta 8 – 10 with THC levels surpassing 0.3%.”
In any industry that is labeled as the “Wild West,” the ability to discern your target market, collect accurate data and strategically drive success has become paramount. With factors such as invisible shoppers, anyone who is a customer of a brand or dispensary and does not personally purchase what they consume, it’s critical to understand how and where the data an organization is using to make decisions is sourced. Effective market research is the cornerstone upon which cannabis brands can build their trajectory to growth, armed with a diverse array of methodologies designed to provide insightful data-driven insights. Through leveraging the power of dependable data, organizations can navigate the intricacies of the cannabis industry across a wide variety of markets, develop solutions that address actual pain points and position themselves as leaders in their niche.
Not to mention, in an industry where competition is fierce and resources have become increasingly scarce, market research emerges as the North Star guiding businesses along their decision-making path. The era of relying on intuition and gut feelings alone is behind us. As this industry matures, making decisions based on inadequate syndicated data has proven detrimental. This is where robust market research steps in, instilling confidence in decision-makers by offering comprehensive and intelligent data for well-informed and defensible choices. Market research naturally falls into two overarching categories: qualitative and quantitative methodologies. Within these categories, various research approaches can be employed to collect actionable insights across the industry.
Your research can hone in on consumers’ preferences, perceptions, motivations and pain points.
Qualitative research delves deep into the intricacies of human behavior, motivations and preferences. Techniques like in-depth interviews and focus groups—whether conducted virtually or in person—unearth nuanced insights that transcend mere numerical data. This type of research is particularly invaluable for discerning the human side of B2B interactions within the cannabis industry.
On the other hand, quantitative research focuses on the collection and analysis of numerical data. Through surveys, questionnaires and statistical analysis, companies can glean valuable insights into demographics, preferences and market trends. This data can be powerfully visualized through charts, tables and infographics, providing a clear picture of the market landscape.
A wide spectrum of methodologies can be put in place to garner actionable insights across various aspects:
Precision Product Testing: This methodology empowers businesses to amass authentic feedback regarding product quality, user experience and overall satisfaction. By employing a hybrid approach of qualitative and quantitative methods, companies can refine and develop their offerings, ensuring alignment with the expectations of customers. This approach ensures not only a product’s efficacy, but also its appeal in the context of the consumer’s interaction with the product.
In-Home Usage Tests (IHUTs): IHUTs involve providing cannabis products to customers for testing within their operational or natural environments. Often conducted as “diary studies” over a designated time frame, IHUTs provide invaluable insights into aspects like usability, practicality and long-term effects. For instance, conducting an IHUT study on cannabis-infused products designed to aid sleep can assess factors like taste, texture and efficacy, thereby tailoring products to meet specific needs.
Hands-On Collaboration Sessions: Site-based, central location or mobile product testing enables real-time observation of product trials, enabling an immediate evaluation of sensory attributes and practical effects. These collaborative sessions can involve consumers directly engaging with the products, such as the scenario where consumers grind, roll and smoke their joints. This hands-on approach fosters deeper understanding and involvement, leading to more actionable insights for product enhancement.
Strategic Online Surveys: While online surveys are a well-established approach for capturing quantitative data from a broad consumer base, by designing targeted questionnaires tailored for specific market segments, companies can assess preferences, satisfaction levels, brand perceptions, and even purchasing intentions. These insights are invaluable in engineering products and services to specific consumer needs.
Focus groups can provide unique insights from many different perspectives.
Nuanced Focus Groups (FGs): Focus groups bring together a small group of individuals for facilitated discussions. These discussions can be conducted in a central location or even virtually, allowing geographically diverse participants to contribute insights. This approach is perfect for delving into perceptions, motivations and pain points. For instance, a focus group centered on testing prototypes for cannabis-related accessories can provide valuable input for refining products catering to specific needs.
Tailored In-Depth Interviews (IDIs): In-depth interviews, conducted either in person or virtually, provide an opportunity for one-on-one engagements. These interviews are particularly useful for exploring sensitive or controversial topics. For example, assessing the suitability of a prototype product for budtenders through in-depth interviews ensures candid feedback without the influence of group dynamics.
When embarking on cannabis market research, it’s imperative to navigate the intricate landscape of state regulations, especially when dealing with THC-based products. The cannabis industry operates within a patchwork of regulations, which vary from state to state, impacting the feasibility and logistics of product testing. Adhering to and understanding these regulations ensures compliant product testing, upholds participant safety and generates indispensable insights for product development.
At the end of the day, market research is actively emerging as the linchpin for the short- and long-term prosperity of our industry. Leveraging a blend of qualitative and quantitative approaches, such as surveys, focus groups and product testing, equips businesses with a profound understanding of preferences, motivations, and feedback. By embracing data-driven decision-making, cannabis companies position themselves at the vanguard of data-driven achievement, fortified with confidence and assurance.
This is Part Two of a four-part series discussing European cannabis regulations. Click here for Part One. Part Two analyzes the differences between the UK, the EU and the US. Part Three, coming next week, dives into dosage, approvals and more. Stay tuned for more.
EU Regulatory Environment
We Europeans look with envy at the American market and wonder, why can’t we be more like that? The differences between the American market, the UK and the EU economic zone couldn’t be more different, but changes seem to be on the horizon. While both the UK and the EU apply the Novel Food law, implementation varies significantly.
In the EU, applications are submitted to the EU Commission, and approval can take up to nine months – just for approval of the application – not the testing that will follow. And while the application carries no fee, collecting the required data just to make the application can be expensive, and can run into six figures or higher. Once the application is approved, there may still be data gaps and uncertainties, with toxicology testing that can take years to complete, and ultimately must be approved and validated by EFSA (European Food Safety Authority). The required toxicology testing is where things get really expensive, with both the EIHA (European Industrial Hemp Association) and EFSA estimating costs around €3.5 million.
The EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications thus far for CBD as a novel food, with more in the pipeline. According to their website, NDA chair Prof. Dominique Turck reported that they “have identified several hazards related to CBD intake” and that many data gaps need filling before evaluations can go ahead. However, she concluded, “It is important to stress that we have not concluded that CBD is unsafe as food.”
As always, with food and drug reviews, it is up to the applicant to prove that a product is safe for human consumption. And for the EU Commission, EFSA is conclusive. And while initial testing is with animals, it also includes human testing, which helps explain the high cost.
At present, the EFSA has been unconvinced by the applications submitted so far, and seeks more data regarding the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being, as well as the impact on human reproduction.
Thus, in 2019, the EIHA formed a German corporation, the “EIHA projects GmbH”, formed for the purpose of pooling partners money to pay for the application and toxicity testing. The Novel Food applications (NFAs) for CBD isolate and synthetic CBD were submitted on November 4, 2022 and full spectrum will follow in April/May of 2023. It should be noted that the application for synthetic CBD has been completely dropped as no testing was ever preformed.
The applications must be reinforced by a series of tox studies under the auspices of the EFSA and for the UK, the FSA. The EFSA will start the risk assessment as soon as the suitability check is performed. The suitability check is a process performed by EFSA to make sure that they have enough data to perform the risk assessment. According to their webpage, the risk assessment can take nine months.
In the case of the application put forth by the EIHA projects GmbH, the CBD isolate dossier will be submitted to the EFSA in September and enter the risk assessment phase. In this phase, the EFSA will go over the data and can ask for more data, should they feel it necessary. They are allowed 9 months to complete this task and submit their recommendations to the EU commission for a 27-member vote, whereby the EIHA projects GmbH application will be valid and legally binding. The EIHA projects GmbH is expecting a validation during the course of 2024. This is a huge game changer!
The application for Full Spectrum distillate should be readied by the end of 2023, whereby the EFSA should be finished with the risk assessment near the end 2024. As Full Spectrum takes into account minor cannabinoid as well as limited THC, it is more complex. It should be noted, that testing full spectrum distillate with a 0.2% THC limit, tests the limit for how much THC can be ingested by humans without side effects. This study is unprecedented and might well have an enormous impact on the issue of THC and its possible future legalization. It is also costing a further one million euros to bring to fruition.
The UK Regulatory Approach
The UK Novel Food approach differs greatly from the EU’s, which has both strengths and weaknesses. What makes the UK CBD market so robust is that the FSA allows products to be sold as long as they were on the market prior to February 13, 2020 and are linked to applications submitted before March 31, 2021. As a result, the FSA was flooded with applications – many later denied on technical grounds, in great part because they didn’t meet these terms. Currently, some 11,000 products worth a projected 1 billion GBP in revenue remain on the FSA list, having passed pre-validation while the FSA awaits the final toxicology report. Only 400 CBD products have been culled from the list, but to date, not a single application has yet been approved. Pre-validation status is incumbent upon a toxicology report, and it remains to be seen how many companies are able to produce such a report.
Important to note is that due to Brexit, a UK validation when it does come, will not be valid in the EU, but products with an EU application accepted on the Union list will be valid in the UK.
Still with a projected 1 billion GBP at stake, it is easy to why UK CBD manufacturers work to appease the FSA despite the regulatory hurdles. By keeping the door open, the UK has managed to keep investors interested in the CBD market and the public safe from unmonitored products.
This is certainly not the case in the EU, where despite a smattering of products still ducking the authorities, the EU market remains thin by comparison. Their approach has stymied growth compared to the UK where robust Novel Food regulation is in place, but approached differently.
At present, a market comparison of the EU to the UK or North America seems bleak, at least for now, but following approval, future EU-wide distribution could be highly profitable. As we inch closer to a Novel Food listing, the European market may yet prove to be one of the largest markets for the safest CBD products in the world.
The American Market
Still, it is the American market that makes our mouth water; where oils, tinctures, candies, cakes, and drinks with every cannabinoid from CBD to Delta 9, Delta 8, and HHC are available and producers are on their way to becoming millionaires. With a market currently estimated at $6 billion, forecasts reach upwards of $16 billion by 2026.
And the health-related concerns, the testing requirements? Are these limited to the UK and the EU? Let’s take a closer look! A mood of caution is emerging in the American cannabis market, that includes producers and lawmakers alike, who are pushing for stricter laws and enforcement.
In America, the FDA (Food and Drug Administration) has alerted the public to CBD’s potential harmful side effects on their website and hope to force congress to deal with the issue.
Many of their concerns validate those of the FSA and the EFSA. For example: on their website the FDA makes a reference to only one CBD product that has been approved: a medicine called Epidiolex. The FDA cites the review of the Epidiolex’s application in 2018 when they identified certain safety risks, including potential for liver damage. The EFSA requires testing on the same issue.
This is Part One of a four-part series discussing European cannabis regulations. Part One serves as an introduction. Part Two, coming next week, will analyze the differences between the UK, the EU and the US. Stay tuned for more.
As I walk through any European cannabis expo – events like Cultiva Hanfexpo, Cannafest Prague or Spannabis – it is easy to be struck by the differences to those in the U.S. First, there are no THC products, nor are there any CBD food products such as drinks or confectionaries. This is because of the EU Novel Food regulations: “which applies to any food stuffs not commonly used for human consumption before 15 May, 1997.”
As a result, American CBD manufacturers – with virtually no regulation of cannabinoid infused products – have an enormous advantage. In the EU, any “novel food” must be tested and proven to be safe for human consumption.
Still, hemp was not always considered “novel.” In 1997, hemp plant products were considered outside the scope of the regulations EC 258/97.” And more specifically, “that hemp flowers … are considered to be food ingredients” (e. g. used for the production of beer-like beverages).Hence, not ‘novel.’
So, right until the end of 2018, nature more or less aligned with the legal establishment, and many products made it safely to market because extracts of cannabidiol (CBD) were considered ‘novel’ only if the levels of CBD were “higher than the CBD levels in the source of the plant itself: Cannabis sativa L.”
However, in January 2019, the catalogue entries for “Cannabis sativa L.” were updated, such that even a naturally occurring level of cannabinoids are now excluded. For the industry, this was a frustrating turn of events, affecting any and all food products to which CBD might be added – confectioneries such as gummies, brownies or cakes, but also includes oils and tinctures containing CBD extracts and other cannabinoids.
Technically, all products on the EU market containing natural CBD or an isolate or distillate are illegal. So, the industry has been playing a cat and mouse game, where consumer labels display vague information or simply state ‘not for human consumption’. The result is a well-developed gray market, that hinges on benign authorities in your jurisdiction.
Sometimes, a producer is able to convince authorities that their product is allowed under Article 4 submission, whereby the producer claims that any CBD content in the food is naturally occurring and a traditional food.
Article 4 is a provision of the Novel Food Regulation (EU) 2015/2283 that allows an operator to check with the national authority on the status of a particular food before bringing the product to market. In the framework of this EU regulation, the operator checks whether the food is traditional or novel. If the food is considered traditional, then the food can be placed on the market immediately. But, if it is novel, it requires a Novel Food authorization.
Good news emerged on June 2, 2023, where in the EU, it has been agreed that once again, hemp leaves are considered a traditional food and are no longer considered Novel. Hemp leaves and tea can be marketed in the EU without further hurdles, but this does not include extracts.
In the case of extracts, CBD isolate and distillate are Novel, not traditional, and a firm must provide toxicology reporting. Both EU and UK law provides that any product containing a CBD extract placed on the market falls under the Novel Food regulations. Ultimately, tests must verify with a high degree of certainty whether CBD is safe to ingest in any amount. And how much is safe before changes occur to internal organs such as the liver or reproductive systems. The FSA will verify results in the UK, while the EFSA is responsible for the EU.
In the EU, the EFSA will send their final recommendation to the EU commission for approval, where after a 27-member vote, the item will be added to the Novel Food Catalogue. Approval at the individual state level, is next to impossible to acquire, for example, Austrian law states: “Oils/extracts containing cannabinoids placed on the market as such or in foods are considered novel foods and must be authorized in the EU.” No such approval is currently available. Placing it on the market is therefore not permitted.
No ambiguity there!
Some EU countries, such as Greece for example, appear more lenient and others not, but it is retail that is first in line for fines if an investigative authority walks in the door. The situation is certainly nerve-wracking, and having suffered through several of these AGES investigations, I closed my store as a result. Others have had similar experiences. One large retail chain owner reported that he fears the check by the authorities, as each one leads to a fine of some sort, or the demand to remove products. Without notice, he says, the health authorities could decide on even harsher punishments such as larger fines or even removing his business license. Then what, he wonders?
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