Cannabis News
Direct and Ancillary CBD Liability Under the FD&C Act
Published
8 months agoon
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Not much thought is given to ancillary CBD liability. Why is that? Probably because the Food and Drug Administration (“FDA”) hasn’t taken any serious enforcement action against any company or individual that aids and abets violations of the Food, Drug & Cosmetic Act (the “Act”) when it comes to CBD. Still, secondary CBD liability under the Act isn’t pretty. And if you’re a company or individual that’s helping other companies or individuals make, sell, or distribute CBD products that violate the Act, you’re actually as guilty as they are under federal law.
FDA and CBD
For a while, CBD stakeholders truly believed that the FDA was prepared to regulate the robust CBD market in the U.S. That, however, will not come to pass where as of January 26, 2023, the FDA concluded that it will NOT regulate CBD foods or dietary supplements. The FDA is punting that task to Congress, which essentially means CBD laws and regulations will either never happen or they’re a far, far way off.
What all of that means is that the status quo remains intact: hemp-derived CBD is not an illegal controlled substance under U.S. law, but it also isn’t a supplement and it cannot be an ingredient in food and beverages for humans or pets without violating the Act. And marketing any bodily or curative effects of CBD was (and still is) off limits.
CBD liability for CBD retailers to date has taken the shape of enforcement letters from the FDA. See here for the most recent examples. Those letters get a massive shoulder shrug from the CBD industry on the whole. Especially since a multitude of states actually allow CBD to be added to food and beverages in conflict with the Act.
FDA and the enforcement spectrum
Many in the CBD industry may not be aware of the risk spectrum when it comes to CBD liability with the FDA. Per the FDA’s own guidance, this is how it tees up enforcement, generally:
- Warning Letters. These are sent to the individuals or firms, advising them of specific noted violations. These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy.
- Seizure of CBD products. An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce.
- Injunction from CBD product sales. An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act.
- Criminal prosecution of CBD seller. Criminal prosecution may be recommended in appropriate cases for violation of Section 301 of the Act (this specifically goes to selling or delivering into interstate commerce any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, among other things). Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.
Then there are the criminal fines under the Act. Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1984 (Public Law 98-596) provides for fines for violations of federal law. Although it is not part of the Act, the Criminal Fine Enforcement Act of 1994 applies to all fines levied under the Act, as well as other statutes that contain provisions enforced by FDA.
The following fines are applicable for each offense:
- Up to $100,000 for a misdemeanor by an individual that does not result in death.
- Up to $200,000 for a misdemeanor by a corporation that does not result in death.
- Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
- Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.
The maximum imprisonment for a misdemeanor under the Act remains a year for each offense.
FDA, CBD enforcement, and criminal CBD liability
In its warning letters to a variety of CBD companies, you’ll find the following directive from the FDA:
“Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).”
The typical translation is that because the CBD company is either marketing and/or selling its CBD products as supplements or “drugs” (due to medical, curative, bodily, disease or health claims about the products), it’s violating the Act and must cease the illegal conduct stat. In its letters, the FDA concludes that “failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.” The agency doesn’t mention any criminal liability and it is indeed rare, but it’s possible in certain cases; and criminal conduct under the Act carries a strict liability standard.
There’s a good reason why criminal prosecution under the Act is a bit of a novelty– affirmative defenses. Namely, if corporate officers of an offending company can show that they “exercised extraordinary care”, but weren’t otherwise able to prevent violations of the Act, the burden shifts to the Feds to prove beyond a reasonable doubt that the officer wasn’t in fact helpless to stop or remediate violations of the Act. And persons who in “good faith” merely receive and later deliver an illegal product cannot be subjected to criminal penalties under the Act. Finally, anyone who receives an illegal product in “good faith” and obtained a “written guaranty” that the product doesn’t violate the Act likewise cannot be prosecuted.
Ancillary CBD liability
There are many ancillary service providers propping up the CBD industry– distributors, financial institutions, payment processors, landlords, advertisers, etc. Under the Act, and per the FDA’s own interpretation:
“nearly everyone involved . . . in interstate commerce, such as manufacturers, packers, distributors, and retailers, is responsible for assuring that he or she is not dealing in products that are adulterated or misbranded, even if someone else caused the adulteration or misbranding in the first place. If you introduce it into interstate commerce or receive it in interstate commerce, you are responsible. The law applies to components and packaging as well as to finished products.”
In the case of United States v. Dotterweich, the U.S. Supreme Court found that:
a corporation may commit an offense and all persons who aid and abet its commission are equally guilty. Whether an accused shares responsibility in the business process resulting in unlawful distribution depends on the evidence produced at the trial and its submission–assuming the evidence warrants it–to the jury under appropriate guidance. The offense is committed, unless the enterprise which they are serving enjoys the immunity of a guaranty, by all who do have such a responsible share in the furtherance of the transaction which the statute outlaws, namely, to put into the stream of interstate commerce adulterated or misbranded drugs [emphasis added]. . . Balancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless.
Dotterweich addressed the criminal prosecution of Joseph H. Dotterweich, the president and general manager of The Buffalo Pharmacal Company, Inc., for the company’s violations of the Act by distributing and selling misbranded drugs. And what the case means, in part, is that any person (including a company as is included in the definition of “person” under the Act) can be criminally prosecuted for aiding and abetting violations of the Act namely depending on their “responsible share in furtherance of the transaction” that breaks the law, which will be revealed by evidence produced at trial for a jury to weigh.
Obviously, corporate officers of companies directly violating the Act have personal liability under the Act (including criminal) and the government can pierce the veil accordingly. This is well-established by case law. Does that liability and responsibility realistically extend to CBD ancillary companies that aid and abet violations of the Act? I think it could. In my opinion, it depends on how instrumental they are in getting these illegal CBD products into the hands of consumers (and maybe that’s why Google, for example, is now utilizing an extremely tight CBD advertising policy).
Considering ancillary CBD liability
No matter where you’re at in the chain of CBD manufacture, distribution, or sale, to mitigate your CBD liability, you need to make sure you’re only working with lawful actors (which, in reality, is a super small pool given the FDA’s position on CBD). And it won’t be a defense that state law otherwise allows all kinds of CBD products either, so you need to understand and know what a legal actor even is at this point, given the terrible state of the law. While CBD is obviously a massive growth area no matter what the FDA does or says, the FDA still has teeth to enforce Given the current political climate, everyone needs to be on their toes.
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Cannabis News
How Did You Mess Up Your Cannabis Subchapter S Election?
Published
7 hours agoon
September 27, 2023By
admin
The internet is littered with writings on the relative merits of corporate forms and tax elections for cannabis businesses. Even the best of these articles are as dull as ditchwater, because the topic is tax. Most of the authors mention subchapter S taxation at some point, and the showier ones may even dredge up cannabis tax court opinions on the topic. This post doesn’t get into any of that. Instead, it asks the simple question: how did you mess up your cannabis subchapter S election?
What’s a subchapter S election?
Feel free to skip this section, which is boring, if you already know what an S election is, how it works, etc. If you don’t, I’ll cover this at a very broad, borderline irresponsible level– just to get us through. Please note that the same rules apply here for cannabis businesses as non-cannabis businesses.
An S election is just a business’s determination to be taxed according to a certain part of the Internal Revenue Code. We’re talking about subchapter S here (open to corporations and LLCs), as opposed to subchapter C (also for corporations and LLCs), or subchapter K (partnerships and LLCs only).
An S corporation passes its income, losses, deductions and credits to shareholders for federal tax purposes. Unlike a C corp, the S corp doesn’t pay federal income tax. It is a “pass through.” Note that every S corp begins its life as a C corp, and every S corp once filed something with the IRS called a Form 2553 to gain its new chapter status.
An LLC can also elect to be taxed under subchapter S. Unlike the converting C corp, the converting LLC files two forms: a Form 8832, then the 2553. People are sometimes surprised that an LLC can do this, because LLCs already pass their income, losses, etc., through to owners for federal tax purposes. But, under subchapter S, owners can often take earnings out of the business without paying employment taxes.
There are plenty of other reasons both corporations and LLCs elect to be taxed under subchapter S, either at formation or at some point during their lifecycles. I can tell you that cannabis retailers should stay away from subchapter S as a general rule. Cannabis growers and processors taxed under subchapter S are rare birds as well, but sometimes it makes sense. More on that below.
How did you mess up your cannabis subchapter S election?
I’ve had the displeasure of asking this question to clients a half dozen times over the years. That’s a very small percentage of clients at this point, but it tends to be memorable. Below are three ways this can happen.
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Miscommunication
There’s a reason that CPAs usually ask to see a company’s governance documents before filing a tax election or preparing a return. The CPA needs to know if what they’re advising or being asked to do makes sense. Often, the ownership or structure of a company may be incompatible with subchapter S taxation. For example, a stock ledger may show non-U.S. shareholders or nonviable shareholder trusts; or an LLC operating agreement may delineate multiple classes of units.
On two occasions, I’ve designed waterfalls for cannabis LLCs only to learn those LLCs ended up making subchapter S elections. The owner agreements and tax filings were fundamentally at odds in each case. One of those busted elections came to light in litigation; the other came up when somebody left the company. Neither was satisfactorily “fixed” to my knowledge.
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Missed deadlines
Various deadlines must be observed when electing subchapter S status. It can get pretty complicated for corporations; less so for LLCs. In my experience, founders often miss these deadlines because there is so much going on when starting a company. Late filing relief is often available, but this involves triage, extra paperwork and ultimately, expense. It’s best to calendar any tax filing deadlines upon incorporating or organizing, run down requisite tax advice, and timely file.
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You actually made the election
Sometimes, you can mess up an S election by… timely filing an S election. Again, most cannabis businesses are not taxed under subchapter S for a reason.
In the case of a cannabis retailer, subchapter C is almost always preferred, because this prevents non-deductible expenses resulting from IRC § 280E from passing through to owners. Staying in subchapter C avoids the devastating situation of taxable income to owners on paper, but no real earnings.
Other plant-touching cannabis businesses may decline to make an S election for any number of reasons. Most commonly, a business will be capitalized disproportionately or just “differently” by co-owners (e.g., cash versus services; lots of cash versus a little cash; equity versus debt). These businesses may wish to allocate income in ways that simply can’t work under Subchapter S. Yet, they’ve made a subchapter S election with no appreciation of constraints.
You don’t have to mess up your cannabis subchapter S election
Tax is complex, but it isn’t always complicated. Roadmaps abound in the cannabis business space. If you’re a cannabis business owner looking at subchapter S, the best advice is to: 1) screen your ownership structure; 2) sketch out capital outlays and cash flows, and the way you want money to move through the business; and 3) talk to your legal and tax advisers so that everyone is on the same page. It’s no fun to mess up a Subchapter S election! But it’s also not hard to avoid.
Cannabis News
Let Cannabis Legalization Be Done State-By-State with No Federal Legalization?
Published
9 hours agoon
September 27, 2023By
admin
Republican senators, including the lead GOP sponsor of a bipartisan marijuana banking bill, are gearing up to introduce new legislation designed to thwart any federal legalization of marijuana by the Food and Drug Administration (FDA) without explicit approval from Congress.
Senators Leading the Charge
The fight against potential federal marijuana legalization without congressional permission is being led by Senators Cynthia Lummis of Wyoming (R-WY) and Steve Daines of Montana (R-MT). Regarding cannabis policy, Senator Lummis has continuously defended states’ rights, firmly believing that state-by-state decisions on cannabis legalization should prevail over federal directives. She is committed to preserving state autonomy in cannabis policy, evidenced by her consistent opposition to federal legalization.
Senator Steve Daines, representing Montana, has been a prominent figure in advocating for cannabis banking reform. He plays a central role in the upcoming legislation and sponsors the SAFER Act, which addresses the pressing issue of banking access for state-licensed cannabis businesses. Daines’s dual involvement highlights his dedication to creating a safer and more legitimate financial environment for the cannabis industry while navigating the complexities of federal cannabis policy.
Senators Lummis and Daines represent a growing faction of Republicans who support states’ rights and resist excessive federal intervention in cannabis matters. Their leadership in this legislative endeavor is poised to shape the trajectory of marijuana policy in the United States, focusing on preserving states’ authority to determine their cannabis laws.
The Legislative Landscape and Implications
14 House and Senate Republicans have urged the Drug Enforcement Administration (DEA) to oppose the U.S. Department of Health and Human Services (HHS) recommendation that marijuana be rescheduled. Senators Daines and Lummis were noticeably absent from the letter’s list of signatories.
Whether restrictions on reclassifying marijuana within the Controlled Substances Act (CSA) or a specific mention of the de-scheduling of marijuana from the CSA are included in this upcoming legislation, as well as how it will prohibit the FDA from potentially legalizing marijuana, are all unknowns. In most cases, “legalization” refers to excluding marijuana from the CSA.
While the FDA has endorsed a cannabis-derived CBD medication and a synthetic THC drug, it generally refrains from endorsing holistic or plant-based remedies. If the HHS suggested rescheduling marijuana, it would remain federally prohibited, except for medical use with a doctor’s prescription.
Efforts to obtain further details regarding this impending bill were made, with a spokesperson for Senator Daines directing inquiries to Senator Lummis’s office. However, immediate responses from the latter’s representatives were unavailable.
This announcement was appended to the statements about the SAFER Banking Act introduced on Wednesday. Senator Daines emphasised provisions within the SAFER Banking Act that he helped secure during bipartisan negotiations, designed to shield all legal enterprises from what he perceives as the “woke agenda” of the left.
While the primary focus of the SAFER Banking Act revolves around granting state-licensed cannabis businesses access to conventional financial services, Senators Daines and Lummis highlighted aspects of the legislation intended to prevent federal regulators from taking discriminatory enforcement actions against other sectors, such as the firearms industry.
Senator Lummis contended that Wyoming energy companies frequently face threats from “woke” Environmental and Social Governance (ESG) initiatives, potentially jeopardising their access to banking services and loans. The SAFER Banking Act prevents federal bank regulators from compelling banks or credit unions to terminate accounts based on reputation risk, safeguarding energy firms and gun manufacturers from left-wing challenges to their operations.
Senator Daines’s focus on the bill’s banking regulations provisions and his sponsorship of FDA and marijuana legalization legalization could suggest an attempt to distance himself from the broader marijuana reform movement, notwithstanding his state’s 2020 ballot approval of adult-use legalization.
The SAFER Banking Act is expected to have strong bipartisan support in committee and on the floor, according to individuals like Sherrod Brown, the chairman of the Senate Banking Committee and Chuck Schumer, the majority leader of the Senate (both Democrats). When the legislation reaches the Senate floor, Schumer plans to attach amendments to enable state-level cannabis expungements and support firearms rights for medicinal cannabis patients; Senator Daines has previously expressed openness to this strategy.
On the House side, a well-known Democrat proposed a plan to legalize, tax, and regulate marijuana on a federal level. The bill also included provisions for expunging earlier convictions for cannabis usage.
The Stance of the FDA and Challenges Ahead
Historical FDA Caution: Over the years, the FDA has maintained a cautious stance regarding cannabis, especially its natural, plant-based form. While the agency has approved specific cannabis-derived medicines, it has hesitated to endorse broader cannabis legalization or rescheduling. Instead, the FDA’s primary focus has been on ensuring the safety and efficacy of medical treatments, resulting in a reluctance to embrace holistic or plant-based remedies like marijuana.
Federal Prohibition and HHS Advice: The problem has become more complicated due to the recent HHS (Health and Human Services) suggestion to reschedule marijuana. Acceptance of this recommendation could result in modifications to the Controlled Substances Act’s (CSA) federal classification of marijuana. To be clear, marijuana will likely continue to be federally illegal for recreational use even if it is rescheduled, except for medical uses that a doctor has approved.
Challenges and Uncertainties: The impending legislation championed by Senators Lummis and Daines faces numerous challenges and unresolved issues. Key questions remain, including whether the bill will specifically address rescheduling or de-scheduling marijuana within the CSA and how it intends to prevent the FDA from pursuing marijuana legalization without Congress’s explicit approval. The term “legalization” typically implies removing marijuana from the CSA, a significant step toward federal acceptance. The lack of detailed information about the bill’s mechanics leaves critical aspects, such as preserving states’ rights in shaping cannabis laws, uncertain. In this intricate landscape, the FDA’s regulatory stance and adaptability to evolving perceptions of marijuana will play a pivotal role. While Senators Lummis and Daines advocate for legislative measures to safeguard state autonomy, scrutiny of the FDA’s approach to marijuana will continue among stakeholders in the cannabis industry and beyond. As the legislative process unfolds, the complexities and challenges of federal cannabis policy reform will come to the forefront, ultimately shaping the future of marijuana legalization in the United States.
Bottom Line
As Senators Lummis and Daines lead the charge against potential federal marijuana legalization without congressional approval, the role of the FDA looms large in this unfolding legislative battle. While historical caution from the FDA persists, recent recommendations from the HHS add complexity to the cannabis landscape.
This legislative effort faces various difficulties, including uncertainties about the bill’s details and how it will protect states’ rights. As the FDA’s regulatory stance continues to be a significant component, the future of marijuana legalization in the United States will be formed by a complicated interplay of federal and state authorities and changing attitudes toward cannabis. The road ahead promises to be both complicated and transformational, with big changes in federal cannabis legislation possible.
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Cannabis News
What is Hypersynchrony? – New Study Looks at What is Going on in Your Brain When You are Tripping Balls
Published
10 hours agoon
September 27, 2023By
admin
Ah. Altered states of consciousness. For those of us who have experienced it in our lifetime, it’s definitely one of the best things about being human.
These altered states of consciousness simply refer to times when we have mental states that are not ordinary; there are moments when our sense of time and space is distorted due to pleasure, psychedelics, meditation, sexual intercourse, and much more. These days, there has been a lot of interest going on in the world of psychedelics, given that psilocybin as well as ketamine, LSD, and other hallucinogenic drugs are having a second heyday.
Altered states of consciousness can also be called many different things. To other people, these are mystical experiences, a form of ego dissolution, a trip down the rabbit hole, an awakening, a metaphysical experience… the list goes on. But what exactly goes on in the brain?
Despite the growing body of studies and clinical trials done, we still know very little about psychedelics and how they induce altered states of consciousness, which are oftentimes a precursor to healing, therapeutic experiences, and even recreation. Generally speaking, altered states induce significant changes in cognition, time and space perception, and even visions. That said, the altered states of consciousness brought about by psychedelic use are so varied from one person to another, that it can hardly be standardized or pinned down.
This has piqued the curiosity of researchers for a long time.
And recently, a group of investigators had some success in identifying what occurs in the brain when we consume psychedelics, which leads to altered states of consciousness. This groundbreaking study was conducted by researchers from Sweden’s Lund University.
For this study, researchers used live rats as well as a technique they developed to measure electrical signals taken from 128 various parts of the rats’ brains all at the same time. This was done by implanting arrays with microelectrodes and wires into different regions of the brain. The arrays were critical in allowing the researchers to measure local field potentials (LFPs), which are electrical signals taken from thousands of neurons.
Additionally, various psychoactive substances were injected into the rats. This included ketamine, LSD, phencyclidine, and DOI.
“Consciousness is one of those fundamental questions that have always fascinated me. I think that psychedelics is a great tool to study the neural basis of consciousness in laboratory animals, since we share most of the same neural ‘hardware’ with other mammals,” explains Par Halje, study author. Halje is also a neurophysiology researcher and cognitive scientist at Lund University.
They found some fascinating results, most especially the fact that high-frequency oscillations were taking place at the same time in different parts of the brain. They recorded signals from different brain regions that were almost in sync, though delays occurred that were under a millisecond. The one-of-a-kind synchronization was a surprising discovery for the researchers.
“We assumed that a single brain structure was generating the waves and that it spread to other locations,” Halje told Psypost. “But instead, we saw that the waves went up and down almost simultaneously in all parts of the brain where we could detect them – a phenomenon called phase synchronization.” This meant that even though the brain cells were acting differently when exposed to different psychedelic drugs such as ketamine and LSD, it had an impact in the greater activity affecting brain communication, resulting in quick and synchronized signals.
“One might think that a strong wave starts somewhere, which then spreads to other parts of the brain,” explains Halje. “But instead, we see that the neurons’ activity synchronises itself in a special way – the waves in the brain go up and down essentially simultaneously in all parts of the brain where we are able to take measurements,” says Halje. “Likely, this hyper-synchrony has major effects on the integration of information across neuronal systems and we propose that it is a key contributor to changes in perception and cognition during psychedelic drug use,” write the authors.
Other Studies
This area of study is still so mysterious, but the theories we have today are no less as interesting than the phenomenon itself.
Aside from the Lund University study, there have been other efforts to understand what goes on when we get high on psychedelic drugs and go into non-normal mental states. The exact process that occurs when our consciousness gets transported to another dimension may not be clearly understood yet, but a lot of it has to do with 5-HT2A, a serotonin receptor. Many psychedelics including psilocybin, ayahuasca, and LSD activate this receptor upon consumption so using chemicals to block 5-HT2A binding locations will nullify its effects.
One study in particular found that when people consumed LSD, they experienced a blurring of boundaries with other people. When the 5-HT2A receptors were blocked using ketanserin, this effect was nullified. “The real tell-tale, or at least the most impressive nature of a mystical experience, is having this notion of oneness where the sense of subject and object break down,” explains Dr. Matthew Jonson, a behavioral science and psychiatry professor at Johns Hopkins University.
Conclusion
Psychedelics are unique in their ability to interrupt otherwise normal processes in the brain – for the best. Because of that, no other substance on earth can match psychedelics’ ability to help humans heal from a myriad of mental and emotional conditions. How that happens is still largely not understood, but we’re all here for it. Let’s see what the upcoming studies on psychedelics and altered states of consciousness have to say.
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