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Direct and Ancillary CBD Liability Under the FD&C Act

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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:

  1. 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.
  2. 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.
  3. 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.
  4. 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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California Appeals Court Rejects Marijuana Grow Permit, Citing Federal Illegality

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In a landmark decision that highlights the tension between state and federal cannabis laws, a California appellate court ruled on October 29th that property owners can refuse to allow the transportation of cannabis across their land via easements, even when the cannabis operation is approved by local authorities.

The Second District Court of Appeal’s unanimous decision draws attention to private property rights in a context where cannabis remains federally illegal, but state law allows licensed cultivation, distribution and sale. Presiding Justice Albert Gilbert stated, “No matter how much California voters and the Legislature might try, cannabis cultivation and transportation are illegal in California as long as it remains illegal under federal law.” JCCrandall LLC v. County of Santa Barbara, Case No. B333201, 2024 WL 4599304, Oct. 29, 2024.

Unless the California Supreme Court grants review – which I would not rule out – the decision empowers private property owners to refuse to contract with cannabis businesses, and restricts local government from approving cannabis operations that implicate the property rights of neighbors who object.

The case at hand

The dispute centered around a cannabis cultivation operation in Santa Barbara County, where JCCrandall LLC challenged a conditional use permit granted by the County to its neighbor, Santa Rita Holdings Inc. The critical issue was that Santa Rita Holdings could only access its 2.5-acre cannabis farm via an unpaved road crossing JCCrandall’s property through a pre-existing easement. JCCrandall grows oats and barley.

JCCrandall’s primary concern? It raised a number of complaints with the Santa Barbara County Supervisors about truck traffic and night operations, which did not gain traction, but in the Court of Appeal JCCrandall focused on what it claimed was potential liability associated with having federally illegal substances transported across its property, even though County regulators found that the Santa Rita operation was fully compliant with state and local laws.

Key legal findings

The appellate court’s decision hinged on several crucial points:

  1. Property Rights: The court emphasized that “the right to exclude others is the essence of the right of property ownership” and classified it as a fundamental vested right.
  2. Federal Supremacy: The panel determined that allowing cannabis transportation across private property “defies the Supremacy Clause” of the U.S. Constitution.
  3. State vs. Federal Law: While cannabis might be legal under California law, the court ruled that federal law’s prohibition takes precedence in this context.

California cannabis industry implications

Legal experts suggest this ruling could have far-reaching consequences for California’s cannabis industry. Section 1550.5(b) of the California Civil Code makes contracts within California involving cannabis lawful and enforceable, and Santa Rita Holdings bet the ranch on that argument. But the Court of Appeal held that the statute could not compel a landowner to allow cannabis to travel across its property on a pre-existing easement. Licensed operators may find it harder to do business because neighbors who have property rights affected by a cannabis business can object, and, under the JCCrandall ruling, local government must yield to those objections.

An example might be a cannabis dispensary that depends on access to its parking lot via an easement or is located in a shopping center where other lessees have rights to object to tenants notwithstanding the approval of the landlord. In cultivation, many cannabis farms depend on vehicular access through easements because they are remote and do not always have direct access to public thoroughfares, or they depend on water sourced from other properties pursuant to agreements made by prior owners who grew traditional crops. These neighbors might not need to show any negative impact on their property, but can argue that they could be found complicit in federally illegal activities.

I think the most problematic language in the JCCrandall ruling is the following, which might draw the attention of the California Supreme Court and cause it to grant review: “For as long as an easement is enjoyed, its mode and manner of use shall remain substantially the same as it was at the time the easement was created. The County argues the easement was used for agricultural purposes. But there is a vast difference between legal and illegal agricultural purposes.” (Emphasis added.) If California has determined that cannabis cultivation is legal – as it has – and state courts routinely enforce contracts involving cannabis, it is a pretty bold step to declare the use of a lawful pre-existing easement illegal simply because the agricultural crop is cannabis and take away easement access from Santa Rita.

Looking ahead

This decision creates new challenges for cannabis businesses in California, and will result in more disputes among neighbors. While the Biden administration has shown signs of easing federal marijuana restrictions, this ruling demonstrates that the federal-state law conflict continues to create significant legal hurdles for the cannabis industry.

California court decisions also can be persuasive authority in other states, so we might see similar litigation (and decisions) elsewhere in the country where cannabis has been legalized.

The case serves as a reminder that despite California’s progressive stance on cannabis, federal prohibition continues to cast a long shadow over the industry’s operations and development. As the cannabis landscape continues to evolve, this ruling may prompt businesses to reassess their property arrangements and local governments will certainly have to reconsider their permitting processes to give more careful consideration to objections by neighbors who claim that their property rights are implicated by cannabis operations.

Note: This post was first published earlier this month on the Alger ADR Blog.



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Autoimmune Conditions Are Rising Fast in American Medicine, Can Cannabis Help?

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cannabis autoimmune problems

Why Are Autoimmune Conditions On The Rise? And How Cannabis Can Help

 

Autoimmune diseases refer to a group of medical conditions that occur as a result of the immune system attacking your own tissues.

 

In a normal human body, the immune system is responsible for protecting the body by producing antibodies that prevent toxins, cancer cells, and viruses from harming the body. However, when one is struck by an autoimmune disorder, the immune system is no longer able to distinguish the difference between dangerous cells and healthy cells. As a result, the healthy cells are attacked, too.

Today, we know of around 100 different kinds of autoimmune conditions. Some of the most common examples of autoimmune conditions include rheumatoid arthritis (RA), lupus, inflammatory bowel disease, celiac disease, Type 1 diabetes, multiple sclerosis (MS), and the Guillain-Barre syndrome (GBS) to name a few. Others include Graves’ disease, Hashimoto’s thyroiditis, psoriasis, and vasculitis.

 

According to the National Health Council, around 50 million Americans are affected by autoimmune diseases today. This is a conservative estimate, considering that several autoimmune conditions are tricky to treat and so many people go undiagnosed for long periods of time. It’s worrisome to note that there are more people developing autoimmune diseases these days, many of which have reached levels comparable to epidemics.

 

But cannabis can help!

 

How Cannabis Can Help Curb And Manage Autoimmune Diseases

 

Not one single cause is responsible for the alarming growth of autoimmune diseases, though there are several factors at play. While there isn’t just one cause we can point at, it’s certain the reasons lie in our environment. After all, human genetics haven’t changed significantly yet the chemicals, toxins, and pollutants in our food and everyday items have risen dramatically.

 

In addition, people are getting less sleep than ever; stress rates are through the roof, and people are constantly worried. There is a clear link between psychological stress and physical health as well as immunity, which is why it isn’t unusual – it’s even common – to see many autoimmune disease cases flare up after people experience severe stress caused by grief, an accident, job loss, or the death of a loved one. These highly stressful and traumatic conditions wreak havoc on the body’s immune response, causing inflammation all over the body.

 

Conventional treatments prescribed to treat autoimmune conditions are focused on taming inflammation; these usually include steroids but also some non-steroidal drugs. These drugs often come with unwanted side effects, but research has shown that cannabis can work with the endocannabinoid system through THC and CBD, as well as other cannabinoids, to simulate similar results. In one study for example, we can see the clear association of the endocannabinoid system for neurodegenerative and inflammatory processes seen in Multiple Sclerosis and Amyotrophic Lateral Sclerosis.


There has also been an increasing number of studies proving the efficacy of cannabis for treating several autoimmune conditions.

 

Cannabis For Multiple Sclerosis

 

Multiple sclerosis is one of the autoimmune conditions where a growing number of studies have come out supporting the therapeutic benefits of cannabis for. In a 2024 study, patients with multiple sclerosis reported several improvements in quality of life after using cannabis-based medical products (CBMPs). For the study, British investigators analyzed the impact of cannabis based medicinal products made from either oil or extracts in 141 patients who were enrolled in the UK Medical Cannabis Registry.

 

The researchers then analyzed the changes in patient outcomes after a month, then three and 6 months after. According to the patients themselves, they were able to sustain improvements in their mental and physical health after marijuana therapy.

 

“This case series demonstrates a potential association between the initiation of CBMPs and improved patient reported outcomes in sleep, anxiety, and general HRQoL [health-related quality of life] measures, over six months,” said the study authors. “Additional measures for HRQoL, including various physical and mental health subdomains, also exhibit improvements up to six months when compared to baseline,” the authors concluded.

 

In another study from 2023, patients with multiple sclerosis reported significant improvements in symptoms after cannabis use. For the study, researchers from the Dent Neurologic Institute in Buffalo, New York, analyzed the medical records of 141 patients with multiple sclerosis, who were also legally authorized to consume medical marijuana products. They then analyzed data from the patients after one up to 4 follow-up sessions after the initial session of cannabis therapy. Sixty-five percent of patients consumed 1:1 THC:CBD tinctures.

 

According to the authors: “The results of this study indicate that use of MC [medical cannabis] to alleviate symptoms of MS is largely efficacious, with improvement in pain (72 percent of patients), muscle spasticity (48 percent of patients), and sleep disturbance (40 percent of patients) frequently reported.”

 

“More than half of opioid users at baseline were able to either discontinue or decrease their opioid use after starting MC. The mean daily MME [morphine milligram equivalents] was significantly reduced from the initial visit (51 mg) to the last follow-up visit (40 mg). This is consistent with previous literature showing that MC legalization is associated with decreased opioid use and that MC use is associated with decreased opioid use in patients with chronic pain. These findings indicate that MC may represent an alternative analgesic to opioids for some patients,” they wrote. 

 

Anecdotal Evidence

 

While more studies are needed to determine cannabis’ effect on other autoimmune conditions such as rheumatoid arthritis, we can rely on anecdotal evidence. In 2020, data from the medical journal, Rheumatology, revealed that patients who have this condition, along with those who have lupus and fibromyalgia, consume cannabis.

 

In fact, it was reported that marijuana was extremely common especially for patients with fibromyalgia. “In this meta-analysis, we found that one in six patients suffering from rheumatologic disease actively consumes cannabis, reducing pain reduction… A favorable effect of cannabis on pain in our meta-analysis reinforces the idea that cannabis could be used for analgesic purposes,” the authors concluded.

 

Conclusion

Cannabis is a safe and natural way to help prevent and treat the symptoms of autoimmune disease. It targets inflammation at its root, and is a proven natural way to help cope with stress, pain, insomnia, and inflammation all while protecting the brain. However, it’s important to ensure you medicate with clean, organic sources of marijuana.

 

AUTOIMMUNE AND CANNABIS, READ ON…

AUTOIMMUNE DISEASES THAT CANNABIS CAN HELP

CANNABIS FOR 9 DIFFERENT AUTOIMMUNE DISEASES!



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Hemp and the New Senate Farm Bill

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The U.S. Senate’s version of the Farm Bill finally landed this week. They’re calling it the Rural Prosperity and Food Security Act of 2024 (the “Senate bill”). The Senate bill follows on the House’s proposal, called the Farm, Food and National Security Act of 2024 (the “House bill”), offered in May. Neither the Senate bill nor the House bill would preempt state or Indian law regarding hemp or the regulation of hemp products. This means states and tribes will retain a lot of latitude in regulating hemp and hemp-derived products– which gets people fired up.

Aside from giving states some runway, the Senate bill and the House bill differ in key respects regarding hemp. Therefore, these august bodies must confer and reconcile their sundry proposals. That could happen in 2024, but seems more likely in 2025 when the new Congress convenes. As of this week, though, we finally have a framework.

The Senate Bill re-defines “hemp” and defines “industrial hemp”

Section 10016 of the Senate bill (“Hemp Production”) amends the definition of “hemp.” Hemp was defined in the 2018 Farm Bill and removed from the federal Controlled Substances Act (CSA), taking us on a truly wild ride. See: What Happened to Hemp? (“What Happened”). The Senate bill also gives us a definition for “industrial hemp.” Here are those definitions, with points of emphasis in bold:

(1) Hemp. The term “hemp” means (A) the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 total tetrahydrocannabinol concentration (including tetrahydrocannabinolic acid) of not more than 0.3 percent on a dry weight basis; and (B) industrial hemp.

(3) Industrial Hemp. The term “industrial hemp” means the plant Cannabis sativa L. if the harvested material (A) is only (i) the stalks of that plant, fiber produced from those stalks, or any other manufactured product, derivative, mixture, or preparation of those stalks (except cannabinoid resin extracted from those stalks); (ii) whole grain, oil, cake, nut, hull, or any other compound, manufactured product, derivative, mixture, or preparation of the seeds of that plant (except cannabinoid resin extracted from the seeds of that plant); or (iii) viable seeds of that plant produced solely for production or manufacture of any material described in clause (i) or (ii); and (B) will not be used in the manufacturing or synthesis of natural or synthetic cannabinoid products.

The new regime

Again, the definitional stuff in bold is what I want to emphasize.

First, the Senate bill keeps the THC threshold at 0.3 percent, which is an arbitrary number we’ve been advocating against for years. The Senate bill mirrors the House bill in this respect, though, so we are stuck with this, unless Ron Paul gets his way.

Second, the Senate bill keeps the 2018 Farm Bill’s total THC standard, including THCA. The House bill does this too. This was fairly predictable: in What Happened, I wrote that we could “expect the total THC standard to remain, which means that actual Delta-9 THC won’t be the only metric for calculating THC content.”

We’ve also explained on this blog that the 2018 Farm Bill and USDA rules mandate total THC testing on pre-harvest hemp batches, but do not mandate such testing on post-harvest hemp or hemp products. The Senate bill doesn’t change this paradigm, which means the “loophole” for gas station weed remains open. This proposal is a big win for opponents of the House bill’s “Miller Amendment,” which would narrow the definition of “hemp” to exclude intoxicating hemp-derived substances.

Third, the Senate bill introduces a new definition and framework for industrial hemp. The House bill does this too, albeit slightly differently. The idea here is to invite farmers to grow hemp for fiber and grain purposes, while freeing them from regulatory burdens with the Department of Agriculture and criminal exposure with the Department of Justice. More specifically, for “industrial hemp” growers, the Senate bill:

  • removes background check requirements;
  • instates “relaxed regulatory requirements” for sampling and inspection methodologies (which will need to be adopted by rule); and
  • develops a certified seed program. 

The Senate bill also makes any hemp producer ineligible to grow hemp for five years if that producer, “with a culpable mental state greater than negligence, produces a crop of hemp that is inconsistent with that license.”(Hint: use the seed program.) The proof standard here seems like it could be an issue, and even if anyone has been adjudicated as growing marijuana under the guise of hemp, Farm Bill ineligibility seems like a far-off concern.

Bottom line

The big takeaway for me is that the Senate bill leaves the door open for intoxicating hemp products, whereas the Miller Amendment to the House bill does not. Something’s gotta give. And it needs to happen soon, because we’re already long overdue. As I explained in a webinar last week, the Farm Bill deals with the nation’s entire food supply, not just hemp. Therefore, this is not like with the SAFE Banking Act, where we have a proposed law specific to cannabis that may or may not ever pass. The Farm Bill must pass, and soon.

Stay tuned and we’ll keep you updated on any major happenings. For more on this topic, check out our massive hemp and CBD archive, or these specific, recent posts:



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