Federal law and policy

hemp cbd transport arrestBack in September 2018, I wrote about how important it was for hemp businesses to carefully plan the routes they would use to ship hemp and hemp products, including hemp-derived CBD. This is because some states are hostile towards hemp and do not recognize a difference between hemp and marijuana.

My article was written prior to the passage of the Agricultural Improvement Act of 2018 (“2018 Farm Bill”), which expanded federal law to cover a wider range of commercial hemp activity and gave the US Department of Agriculture (“USDA”) regulatory authority over the cultivation of hemp. With regards to the interstate transfer of hemp, section 10114 (b) of the 2018 Farm Bill states the following:

TRANSPORTATION OF HEMP AND HEMP PRODUCTS.—No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with subtitle G of the Agricultural Marketing Act of 1946 (as added by section 10113) through the State or the territory of the Indian Tribe, as applicable.

In plain english, this means that states and Tribes can’t prohibit hemp or hemp products from passing through their state or territory if the hemp or hemp products were produced in compliance with Section 10113 of the 2018 Farm Bill. On it’s face this provision may look like hemp businesses no longer need to fear state-level enforcement against hemp or hemp products entered into interstate commerce. However, that is not necessarily the case and businesses who hang their hat on section 10114 do so at their own risk.

The problem with relying on section 10114 is that it appears to be contingent on Section 10113 of the 2018 Farm Bill. Section 10113 of the 2018 Farm Bill covers hemp production (which you can read about here). In summary, Section 10113 indicates that the USDA will oversee hemp production at the federal level by approving of state and Tribal plans covering the cultivation of hemp. States and Tribes will submit plans to the USDA for approval. Section 297C of the 2018 Farm Bill requires that the USDA establish its own plan and and issue licenses to cover the cultivation of hemp in states or Tribal territories where that state or Tribe’s plan for hemp cultivation has not been approved.

The USDA has not yet approved of any state or Tribes plan. It also has not created its own plan under Section 297C. That means that any hemp legally cultivated in the US was done so under Section 7606 of the 2014 Farm Bill. The 2014 Farm Bill allows states to implement agricultural pilot programs to research the cultivation of industrial hemp. State departments of agriculture can issue licenses for the cultivation of hemp. Some states have interpreted this to cover commercial activity. However, the 2014 Farm Bill provides no explicit protection for the interstate transfer of industrial hemp.

Returning to the 2018 Farm Bill, Section 7605 (b) of the 2018 Farm Bill extends Section 7606 of the 2014 Farm Bill for one year after the USDA establishes a plan under 297C. That provision is not contained within Section 10113. Section 10114’s prohibition on interference with the interstate transfer of hemp does not reference the 2014 Farm Bill. Therefore, Section 10114’s protection against interference with the interstate shipment of hemp or hemp products may not currently apply to hemp or hemp products currently in transit because they cannot yet be cultivated “in accordance with” Section 10113.

On the other hand, the intent of Congress seems to indicate that hemp and hemp products should be commercially distributed throughout the country. The 2018 Farm Bill changes the Controlled Substance Act (“CSA”) by explicitly removing “hemp” from the definition of marijuana. It also defines hemp as an agricultural commodity that is eligible for federal crop insurance. Additionally, it allows the USDA to license the cultivation of hemp in a state or Tribal territory that does not have an approved plan. Additionally, an administrative law judge has held that products containing CBD derived from 2014 Farm Bill industrial hemp are allowed to be distributed in the US mail. Also, a federal judge in West Virginia recently lifted a restraining order that limited a hemp cultivator from transporting processed hemp to a Pennsylvania lab that would process it into CBD isolate, because “the Court has become increasingly doubtful of the Government’s case on the merits.” This is due, at least in part, to the 2018 Farm Bill’s removal of hemp from the CSA. (A copy of the order is provided by Hemp Industry Daily, which also wrote about the decision here.)

We’ll likely get additional insight into the question of whether companies can ship 2014 Farm Bill hemp across state lines as there is currently a lawsuit pending between Big Sky Scientific, LLC (“Big Sky”) and the Idaho State Police. I’ll provide some additional insight on this case later this week.

For now, the bottom line is that hemp businesses must still carefully consider their shipping plans for hemp and hemp products. Blind reliance on Section 10114 to protect against local law enforcement is ill advised. Until the 2018 Farm Bill is fully implemented by the USDA, states may seize hemp shipments. Hemp businesses should avoid transporting their products through states that show hostility towards hemp. If you have questions about other ways to mitigate the risk of state level enforcement, please contact our regulatory attorneys.

federal law cannabis FDAAs more and more states legalize cannabis in some form or another, and as more and more Senators and Representatives introduce legislation that would relax the federal pot laws, it’s important not to lose sight of reality: cannabis is still a Schedule I drug and is unlawful under federal law. That said, in the years since cannabis has become legal in various states, the federal government has taken an increasingly less active role in enforcement in those states. Sure, the feds could start ramping up enforcement even against state-lawful operators, but it doesn’t seem like that’s going to happen any time soon.

To understand the future of federal pot enforcement, we need to look back a few years. Most readers of this blog are familiar with the Cole Memo, an Obama-era Department of Justice policy memo which essentially says that the federal government wouldn’t prioritize marijuana enforcement where operators follow state laws and would instead follow focused enforcement priorities. Since President Trump took office, Attorney General Jeff Sessions rescinded the Cole Memo but didn’t go full-enforcement, instead leaving it up to more local federal authorities to decide whether to enforce. But Sessions was removed, and the newly appointed William Barr has indicated that he probably isn’t going to spend federal resources enforcing the Controlled Substances Act against state-lawful operators.

What is clear about future enforcement is that until the Controlled Substances Act (“CSA”) is amended to de-schedule cannabis, the feds will still be targeting cannabis businesses that don’t follow state laws. Just last month, an owner of an unlicensed cannabis company in Washington State pleaded guilty to crimes in federal court stemming from the operation of a dispensary without a state license. This plea followed an investigation, which obviously means that federal offices are investigating what they view to be criminal activities. We wouldn’t expect this to stop anytime soon, and so unlicensed operators (either in state which still have prohibition or in states with licensing regimes) will need to worry about federal—and state—enforcement.

It’s less clear how the federal government will handle state-lawful operators who violate state law—in other words, will the federal government allow the states to deal with violations of state law, or will they step in and interfere? Because of the CSA, any sale of cannabis is federally prohibited, so state-licensed cannabis businesses that make illegal sales risk both federal and state enforcement. It seems, however, that unless there is serious or egregious misconduct by a state-licensed operator, the federal government will keep deferring to the states.

One agency that those rules may not apply so much to is the federal Food & Drug Administration (“FDA”). After President Trump signed the Agriculture Improvement Act of 2018 (or “Farm Bill”), the FDA (the same day) released a memo saying it retains jurisdiction over hemp and other cannabis products in foods. Pretty much immediately thereafter, the FDA began enforcing its position. It’s certainly plausible that the FDA could step in if manufactured cannabis products (especially edibles) contain what the FDA views as prohibited hemp-derived CBD, or if manufactured cannabis products make false health claims (we already know that the FDA has in the past sent a number of warning letters to state operators).

The future of federal enforcement isn’t completely hashed out. Until the CSA is amended, however, it’s not going to end. Stay tuned to the Canna Law Blog for more updates.

EU CBD food export

We’ve been writing a lot on this blog about the regulation and sale of cannabidiol (“CBD”) products at the state and federal levels. The United States is not the only international actor, however, that is concerned with regulating the sale of CBD products, including CBD-infused foods. The European Food Safety Authority (“EFSA”), the European equivalent of the U.S. Food and Drug Administration (“FDA”), recently changed guidance on cannabinoids, declaring that all new food products infused with the plant or its derivatives should receive a pre-market approval under the European Union “novel food” regulation.

Regulation 2015/2283, which is the latest food regulation adopted by the European Parliament and the European Union (“EU”), defines “novel food” as “food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of the Member States to the Union.”

The EU Novel Food Catalogue entry for CBD, which contains a non-exhaustive list of ingredients that inform member nations on whether a product will need an authorization under the Novel Food Regulation, now refers to a broader class of “cannabinoids” and provides that:

Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.

This new EFSA guidance drastically expands the categories of cannabinoids that would require pre-market approval–note, however, that hemp seeds, flour and seed oil remain permitted–and it suggests that CBD-infused food could be off the European market for some time. Generally, it takes 3 years for an ingredient to gain novel food status.

A handful of European countries such as Spain, Italy, and Austria have already taken enforcement actions against CBD products on the basis of being “novel foods.” As such, it seems likely that these EU member nations will adopt the new EFSA guidance and continue their efforts in regulating CBD-infused foods as “new foods.”

The EU or its affiliates are expected to provide further guidance on this issue; however, due to administrative procedures and time required for adequate data collection, such publication won’t likely be released until 2020.

This new EFSA guidance will further complicate U.S. CBD companies’ ability to export their products overseas. In addition to potential international law violations, CBD companies run the risk of FDA and Customs and Border Protection (“Customs”) enforcement actions. The FDA has yet to release guidelines on shipping CBD products to other countries; however, the main FDA inquiry for the purpose of exporting CBD would likely be whether the CBD products were adulterated or mislabeled due to the fact that they were not manufactured or labeled in compliance with the target country’s law. Another risk in exporting CBD products is that Customs agents may not have a sophisticated understanding of the difference between hemp and marijuana, as demonstrated in recent state enforcement actions. If such confusion were to occur, Customs would likely seize the CBD shipment and potentially involve the Drug and Enforcement Administration.

In light of those regulatory changes, CBD companies should remain informed on domestic and international shipping laws and consult with experienced lawyers to assess the risks of exporting their products overseas.

For more on cannabis and international law, check out the following:

william barr federal law
Hopefully, anyway…

Back on January 4, 2018, the industry was in a slight tailspin due to then acting Attorney General Jeff Session’s (renowned marijuana hater) rescinding of all marijuana enforcement guidance from the Department of Justice (“DOJ”). Reactions in the media ranged from treating the Sessions announcement as nothing more than an attempt to frighten the cannabis industry to claiming that it was the first step in an organized crackdown of the marijuana industry that could affect cannabis businesses and users. Both possibilities are arguably realistic. And the drama that followed Sessions’ moves was pretty satisfying, including when Cory Gardner vowed to (and did) block DOJ appointments until the issue was resolved in favor of the states, culminating in a deal with President Trump to back off of state-legal marijuana. However, now that Sessions is out at the helm of the DOJ, industry folks can breathe a little easier where new Attorney General nominee William Barr has gone on record stating that state-law abiding cannabis businesses will not be prosecuted by the DOJ and essentially that the 2013 Cole Memo will be back from the dead.

In rescinding all DOJ guidance on marijuana enforcement, Sessions torpedoed the famous 2013 Cole Memo, which outlined eight specific enforcement priorities of the DOJ in states with legal marijuana and which, between the lines, indicated that “robust” state regulations would keep the DOJ at bay regarding enforcement of the federal Controlled Substances Act. After that memo, entire states built their comprehensive cannabis licensing and taxation systems on those eight enforcement priorities, ensuring that compliance restrictions and barriers to entry were strong enough to support the same. Instead, Sessions put in place the “Sessions Memo,” which was short on specifics. It doesn’t contain an outright directive ordering U.S. Attorneys to go after marijuana businesses. It simply withdraws all of the earlier marijuana-specific guidance memoranda and directed U.S. attorneys to treat marijuana sales like any other federal crime. The withdrawn memos include, the 2013 Cole Memo, the February 2014 Cole Memo that extended low enforcement priority status to apply to banking activities (although the FinCEN guidelines are, importantly, still alive); and the 2014 Wilkinson Memo that was a sort of Cole Memo for tribal lands.

Right now, U.S. attorneys have full discretion to determine to what extent they can/should enforce federal law in the context of marijuana crimes in states with legalization and medicalization–which they always had anyway–but the 2013 Cole Memo helped them prioritize certain marijuana issues across the DOJ. In his memo, Sessions referred to the principles of enforcement in the U.S. Attorneys’ Manual, but that document reinforces the level of discretion and authority that each U.S. attorney has already. The Cole Memo was ultimately useful in providing a consistent nationwide federal policy. Under Sessions Memo, we are back to the days of having potentially 93 different enforcement policies — one for each U.S. Attorney. To date, there haven’t been any reported incidents of the Feds going after state-law compliant cannabis operators in states that have legalized and regulated.

A new sheriff is coming to town though, and that could be a very good thing for the momentum of state-by-state legalization in that states will better know what to expect from Big Brother as will marijuana businesses and their investors. William Barr may end up becoming a very unlikely helper when it comes to state-legal cannabis. He was Bush I’s attorney general from 1991-1993, and he’s a dyed in the wool conservative who, as Attorney General, was “tough on crime” and put many, many people in prison. As reported by Marijuana Moment, Barr in a mid-January hearing with Congress testified that:

My approach to this would be not to upset settled expectations and the reliant interests that have arisen as a result of the Cole memorandum . . . However, I think the current situation is untenable and really has to be addressed. It’s almost like a backdoor nullification of federal law . . .

While Barr also testified that he wouldn’t go “after companies that have relied on [2013] Cole memorandum . . . ,”  he also didn’t completely kowtow to state legal cannabis. He further testified that “we either should have a federal law that prohibits marijuana everywhere, which I would support myself because I think it’s a mistake to back off marijuana. However, if we want a federal approach—if we want states to have their own laws—then let’s get there and get there in the right way.”

In reading the tea leaves, it sounds like, personally, Barr would have no issue with continuing the War on Drugs as it relates to cannabis. As a department under his watch and command, however, the DOJ probably wouldn’t spend time and valuable resources on state-legal operators — even if Barr is concerned that the current dynamic is breeding “disrespect for the federal law.” Reasonable minds can differ, but I’d say that most cannabis operators and states are very mindful of federal law enforcement and it’s really Congress, the DOJ, and the President to blame for creating legal confusion because of varied enforcement over the years.

In the end, Barr’s testimony ultimately serves to show the country that Congress has been woefully impotent and ignorant when it comes to cannabis as a whole and especially as the topic relates to states’ rights. What’s good to know though is that if Barr is confirmed, we’re very likely returning to the 2013 Cole Memo principles, which will at least create a political atmosphere of certainty in that the DOJ has bigger fish to fry than state-legal marijuana. Right now, Barr is pretty much a lock for U.S. Attorney General, so hopefully he’ll make good on his cannabis compromises.

Earlier this year, the Food and Drug Administration (“FDA”) began seizing various cannabidiol (“CBD”) products from store shelves. These enforcement actions reflected the implementation of the agency’s position that CBD, regardless of the source from which it is derived, cannot be lawfully sold for human consumption.

A few states, including states that have adopted industrial hemp pilot research programs under the 2014 Farm Bill, now seem to have embraced this FDA position by banning certain CBD-infused products from local stores.

Last Friday, several New York restaurants, bakeries, and bars were forced to stop selling CBD-infused foods and drinks. Officials with the New York City Department of Health confiscated those products, marking them as “embargoed.” The embargo process consists of identifying, itemizing and removing products. The Department has yet to issue a public statement or to provide further information on these actions, but it appears state health inspectors explained to the business owners that CBD cannot be used as a “food additive”.

This argument was similar to that used by the Maine Department of Health and Human Services (“DHHS”). Earlier last week, Maine health authorities notified various businesses that they needed to remove all CBD-infused foods, tinctures, and capsules from their shelves. Relying on an internal report by the state Maine Attorney General’s Office which concluded that CBD could not be used in mass-market food until Maine’s hemp pilot program receives federal approval pursuant to the 2018 Farm Bill, the Maine DHHS determined that CBD was an unapproved food additive the FDA does not recognize as safe.

Section 201(s) of the Food, Drug, and Cosmetic Act (“FD&C Act”) defines “food additive” to encompass any substance that may reasonably be expected to directly or indirectly affect or become part of a food. Until a food additive is tested and found safe for its intended use, it is deemed unsafe. A food additive is considered safe if there is a reasonable certainty that it is not harmful under its intended use and condition. If a food additive is added to a food prior to FDA approval, its presence renders the food adulterated and subject to enforcement action.

Because the FDA has yet to approve CBD as a food additive, Hemp-CBD products, particularly edibles and infused drinks are  deemed unsafe under the FD&C Act.

Though state health authorities embargoed CBD edibles and other CBD products used for human consumption, they told affected business owners they could continue selling CBD products that “could be smoked, vaped, worn as a patch or applied as lotion.” This is because cosmetics and smokable products are subject to less onerous FDA regulations than foods and dietary supplements. This all may change when the FDA soon releases its plan to regulate Hemp-CBD products.

These recent enforcement actions in New York and Maine should remind industry players that business and legal considerations surrounding Hemp-CBD products are in a constant state of flux.

qualified opportunity zones cannabisQualified Opportunity Zones, which provide a tremendous benefit to investors and low income communities, are the hot new topic in the real estate investment world. The cannabis industry is buzzing about investment opportunities in these zones, but we remain hesitant to recommend them without reservation. Congress disqualifies certain businesses from participation in Qualified Opportunity Zones, and we have seen some indications Congress is considering disqualifying cannabis businesses as well.

Qualified Opportunity Zones were created under the relatively new federal tax law, known as the “Tax Cuts and Jobs Act.” That law authorized each state to nominate certain low-income communities as “qualified opportunity zones.” A list of qualifying census tracts can be found here.

To take advantage of the benefits of these zones, taxpayers must invest in a Qualified Opportunity Fund, which is an investment vehicle organized as a corporation or partnership for the purpose of investing in qualified opportunity zone property that holds at least 90 percent of its assets in qualified opportunity zone property.

The benefits to investors include (1) a deferral of tax on capital gains from the sale of existing property that are reinvested into a Qualified Opportunity Fund, (2) subsequent basis increases on deferred capital gains reinvested into a Qualified Opportunity Fund, and (3) the elimination of capital gains tax on growth attributable to gain reinvested in a Qualified Opportunity Fund held for at least ten years.

The State of California explains that Opportunity Zones will support new investments in environmental justice, sustainability, climate change, and affordable housing, and has created a website to educate investors about various opportunities.

This brings us to cannabis. Commercial cannabis activity, outside the industrial hemp context, is federally prohibited. As such, marijuana businesses are treated as criminal enterprises in the eyes of the feds. We’ve previously written extensively this. (See here, for example). Marijuana’s criminality colors how all federal agencies, including the IRS, treat cannabis businesses.

We have written extensively about Section 280E and its implications for taxation of cannabis businesses (See here, here, here and here). Section 280E disallows deductions and credits for any amount paid or incurred in carrying on any trade or business if such trade or business (or the activities which comprise such trade or business) consists of trafficking in controlled substances.

The benefits provided in connection with Opportunity Zones are not deductions or credits, but deferrals. The new Opportunity Zone clause provides a list of business activity that is disqualified from tax benefits, which includes “any private or commercial golf course, country club, massage parlor, hot tub facility, suntan facility, racetrack or other facility used for gambling, or any store the principal business of which is the sale of alcoholic beverages for consumption off premises.” The disqualified list does not include cannabis businesses.

Because the statute omits “cannabis activity” or “marijuana activity” from the list of disqualified businesses, some contend that marijuana qualifies as an opportunity zone business. However, many tax practitioners worry that cannabis businesses being omitted from the list of disqualified businesses was an oversight that Congress will fix in a technical corrections bill. The list of disqualified businesses isn’t limited to illegal businesses — even if Congress is inclined to relax criminal marijuana laws, it hasn’t shown any indication that it wants to provide tax benefits to marijuana businesses. The final regulations governing Opportunity Zones have not yet taken effect.

Cannabis businesses that invest in Opportunity Zones hoping to benefit from the tax benefit need to weigh the risk that Congress will pull the rug out from under them by adding marijuana businesses to the list of disqualified businesses. If marijuana businesses are able to avoid that fate, however, Qualified Opportunity Zones could provide a great opportunity for investors and low income communities.

oregon industrial hemp cbd OLCC
Oregon hemp will see a little bit of each in 2019.

Last year was a big one for the Oregon industrial hemp program. If you recall, the state legislature enacted House Bill 4089, which provided a much needed regulatory framework for the crop and authorized its processing and sale into the Oregon Liquor Control Commission (“OLCC”) recreational market. To administer a portion of these statutory changes, OLCC drafted rule changes in September, which will soon be adopted.

However, a lot has happened since September. Indeed, the Agriculture Improvement Act of 2018, more famously known as the “2018 Farm Bill,” became law last month. Specifically, the 2018 Farm Bill legalized industrial hemp by removing the crop from the Controlled Substance Act—this means no more risk of enforcement action by the U.S. Drug and Enforcement Agency because industrial hemp, including concentrates and extracts, is no longer treated as a Schedule I substance—and delegated authority to states to regulate and limit its production.

The federal legalization of industrial hemp has triggered numerous inquiries from our Oregon clients regarding the impact, if any, of the new federal bill on the most recent set of OLCC rules. This post aims to answer this question.

Although industrial hemp is no longer illegal under federal law, states are not yet authorized to hold primary regulatory authority over the production of the crop. Before they can exercise this option, states will need to submit a regulatory plan (the “Plan”) to the U.S. Department of Agriculture (the “USDA”) for approval. However, approval won’t be given until the USDA promulgates rules and regulations regarding those Plans, a process that will most certainly take months, possibly more if the government shuts down again.

Section 7605(b) of the 2018 Farm Bill further provides that:

Effective on the date that is 1 year after the date on which the [USDA] Secretary establishes a plan under section 297C of the Agricultural Marketing Act of 1946, section 7606 of the Agricultural Act of 2014 (7 U.S.C. 5940) [the 2014 Farm Bill] is repealed.”

In other words, the 2018 Farm Bill won’t become effective until one year following the adoption of rules and regulations for the Plans by the USDA. Until then, the 2014 Farm Bill remains the legal framework under which state industrial hemp pilot programs operate.

Accordingly, states that have adopted an industrial hemp pilot program will continue to operate the way they have since before the passage of the 2018 Farm Bill into law. This means that the legal framework for interstate sales of Oregon hemp should not be affected. As far as sales into the OLCC market, growers, processors, and distributors will need to familiarize themselves with the new OLCC rules.

Under the OLCC rules, hemp handlers and growers will need to be certified by the Commission in order to place their products in the recreational market. The OLCC will then monitor and track this new input into the market via the Cannabis Tracking System (“CTS”). But hemp growers and handler certificate holders won’t be the only actors obliged to comply with these rules. Recreational licensees, processor licensees, and wholesale licensees will also be subject to a new set of guidelines.

For more information on these rules and how they might affect your business operations, don’t hesitate to contact our Portland office.

fda cannabis dietary supplement foodWith the passage of the 2018 Farm Bill and the proliferation of food products containing CBD, we’ve been writing extensively about how the United States Food and Drug Administration (FDA) and in particular, the United States Food, Drug, and Cosmetic Act (FDCA) apply to the interstate sale of CBD products. Unfortunately, however, we have little guidance from the FDA regarding how hemp-CBD products such as foods, beverages, dietary supplements and cosmetics should comply with basic FDA requirements, including labeling rules.

What we do know is that the FDA has consistently taken the position that that CBD is excluded from the definition of “dietary supplement” under the Federal Food, Drug & Cosmetic Act (“FDCA”) because CBD is an active ingredient in FDA-approved drugs and was the subject of substantial clinical investigations before it was marketed as a dietary supplement. Therefore, the FDA maintains, as stated by Commissioner Scott Gottlieb, that:

[It is] unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

On January 15, 2019, in light of the FDA’s current position on hemp-derived CBD and the recent passage of the 2018 Farm Bill, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) sent a letter to FDA Commissioner Gottlieb urging the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. The Senators began their letter by stating,

As authors of the Hemp Farming Act, which removed the outdated restrictions on the production and marketing of industrial hemp, we urge the U.S. Food and Drug Administration (FDA) to immediately update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.”

The Senators go on to note that the Act removed from the federal list of controlled substances the hemp plant, and “derivatives of cannabis, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of less than 0.3 percent on a dry weight basis. Under this definition, Congress legalized the production and sale of industrial hemp and hemp derivatives, including hemp-derived cannabidiol (CBD).”

Because of the removal of hemp-derived CBD from the list of controlled substances, as well as growing interest from the public in CBD products, the Senators argue that the FDA’s regulations are outdated, and urge the agency to “immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and [to] give U.S. producers more flexibility in the production, consumption, and sale of hemp products.” The Senators also requested a response from the FDA to the following questions within thirty days:

  1. What steps are the agency advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?
  3. Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?
  4. Will the agency consider issuing a regulation, or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

Given the ongoing government shutdown that has left the FDA short on staff, we will be waiting to see if they are able to respond to the Senators’ questions within the requested thirty days. There is no doubt that thorough responses to these questions would provide the hemp-CBD industry with some much needed clarity regarding the FDA’s position on the sale of these products.

sonoma county cannabis RICOFor a while, criminal conspiracy lawsuits against cannabis operations looked like a potentially promising strategy for cannabis prohibitionists to try and use litigation to reverse the trend of legalization. The idea is to use the Racketeer Influenced and Corrupt Organizations Act (“RICO”), a federal statute intended to combat organized crime–and which allows private rights of action for lost property value resulting from criminal operations–to enjoin cannabis operations and recover damages to force the operators out of business. The typical set of facts is that a residential neighbor plaintiff claims that his or her property value is damaged by the existence of a nearby cannabis operation, usually outdoor cultivation, and names as a defendant every single person and business that had any conceivable connection to that operation.

There were a handful of relative successes with this strategy early on, culminating in a 10th Circuit Court of Appeals decision allowing a RICO claim against cannabis cultivators to move forward on a theory of diminished property value. However, that victory was soon followed by a resounding defeat in a jury verdict finding no such diminution of property value. Subsequent U.S. District Court decisions from Oregon continued the backward slide, finding that although the residential neighbor plaintiffs might have potential personal injury claims for nuisance, they were unable as a matter of law to demonstrate a plausible claim for injury to the value of their property.

That trend has now found a secure foothold in California, where a San Francisco federal court recently dismissed a lawsuit by residential plaintiffs in Sonoma County alleging RICO claims against a neighboring cannabis cultivator. While the court acknowledged that the plaintiffs could potentially move forward with their claims for “diminished sense of serenity” and various “cleaning, medical, legal, and other expenses,” it found those damages would have to be pursued though traditional state law nuisance claims, not federal RICO claims, noting that “RICO was intended to combat organized crime, not to provide a federal cause of action and treble damages to every tort plaintiff.” Ouch.

Furthermore, California law added another unique element to the court’s decision. Although California recognizes claims for diminution in the market value of their homes, including prospective future losses, and such losses could potentially be compensable under RICO, under California law, “a plaintiff in a continuing nuisance case may not recover diminution in value damages because the plaintiff would obtain a double recovery if she could recover for the depreciation in value and also have the cause of that depreciation removed.” And in this case, the court found that the alleged cannabis cultivation issues would be better classified as a continuing nuisance and that the defendants had already abated the nuisance while the lawsuit was pending. Therefore, the plaintiffs’ property loss claims were effectively moot.

In the end, although the defendants prevailed on the motion to dismiss, the case was more of a pyrrhic victory because the defendants had to shut down, as they were not properly permitted by the county or licensed by the state, and the court granted leave to amend the complaint to still allow the nuisance claims to proceed. But at least in terms of the viability of RICO lawsuits as a tool to reverse cannabis voter initiatives, this was another nail in the coffin.

For more on RICO cannabis litigation, check out the following posts in our series:

fda hemp cbd red yeast rice

This is the second installment in our series on the Food and Drug Administration (“FDA”) and hemp-derived CBD (“Hemp-CBD”). Our last post focused on the Drug Exclusion Rule, which essentially states that an article cannot be marketed as a dietary supplement if it was investigated or approved as a drug before the article was marketed as a dietary supplement (or food). Today, we’ll take a look at what that use of “before” really means.

Prior Market Clause

A key component of the Drug Exclusion Rule is that the article at issue was not previously marketed before the article was evaluated or approved by the FDA (the “Prior Market Clause”). So what does it mean to “market” a product? Helpfully, the FDA FAQs link to Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (“NDI Guidance”) to provide an explanation of the phrase “marketed as.”

The NDI Guidance, which like the FDA FAQs is nonbinding, elaborates on the idea of “marketing”:

FDA considers ‘marketing’ a dietary ingredient to mean selling or offering the dietary ingredient for sale (1) as or in a dietary supplement, (2) in bulk as a dietary ingredient for use in dietary supplements, or (3) as an ingredient in a blend or formulation of dietary ingredients for use in dietary supplements. A dietary ingredient may be “marketed” by offering the article for sale online or at a retail establishment, listing it for sale in a catalog or price list, or through advertising or other promotion, if the promotion makes clear that the article is available for purchase. ‘Coming soon’ advertisements would not qualify.”

The NDI Guidance goes on to state “[i]n considering whether a substance has been ‘marketed as a dietary supplement or as a food,’ FDA looks for evidence of one of the following:”

1. Evidence that the substance itself was sold or offered for sale in the U.S. as a dietary supplement, dietary ingredient for use in dietary supplements, or conventional food. For example, a catalog listing a product identified as a ‘Substance A supplement’ would establish the marketing of Substance A as a dietary supplement. Similarly, business records documenting that a substance was sold or offered for wholesale or retail sale for use as an ingredient in a conventional food would establish the marketing of the substance as a food.

2. Evidence that the substance was a component of a food or dietary supplement that was sold or offered for sale in the U.S., and that a manufacturer or distributor of the food or dietary supplement marketed it for the content of the substance by, for example, making claims about the substance or otherwise highlighting its presence in the product.  For example, in Pharmanex v. Shalala, the firm marketed lovastatin, a component of its red yeast rice product Cholestin, by promoting the lovastatin content of Cholestin. Merely showing that the substance was present as a component in a marketed food would not be enough to show that the substance was ‘marketed,’ however.”

Red Yeast Rice

The NDI Guidance’s reference to Pharmanex v. Shalala is of note as that case may have a major bearing on Hemp-CBD. Back in April 1997, the FDA issued a warning letter to Pharmanex, stating that it was selling a drug as a dietary supplement. Pharmanex manufactured Cholestin, a dietary supplement derived from red yeast rice intended to promote healthy cholesterol levels. Cholestin contained the substance mevinolin. Mevinolin was chemically identical to lovastatin, the active ingredient in the prescription drug Mevacor. The FDA approved Mevacor back in 1987. The FDA advised Pharmanex that it considered Cholestin to be a drug which could not be marketed without FDA approval. Pharmanex argued that red yeast rice had been used a food ingredient for thousands of years. The FDA was not convinced, ultimately holding that Cholestin containing lovastatin did not meet the definition of a “dietary supplement”  because lovastatin was an “article” that had already been approved as a drug. The FDA determined that Cholestin did not satisfy the Prior Marketing Clause because it did not contain red yeast rice as that product had traditionally been manufactured and marketed. The FDA ran tests on samples of red yeast rice and found small amounts of lovastatin. In the FDA’s view, Pharmanex had manipulated red yeast rice  to increase the lovastatin content and therefore the Drug Exclusion Rule applied.

Pharmanex challenged the FDA’s ruling in district court. The district court set aside the FDA’s decision, agreeing with Pharmanex that the term “article” as used in the FDCA did not refer to a single ingredient in a drug. The Court of Appeals for the Tenth Circuit reversed, holding that “article” could include the active ingredients of approved new drugs, such as lovastatin, which would exclude them from the dietary supplement definition. On remand, the district court affirmed the FDA’s original conclusion that lovastatin was not marketed as a dietary supplement or food before the FDA approved Mevacor as a prescription drug.

Cholestin containing lovastatin is no longer on the market in the US. There are still red yeast rice supplements available but the FDA monitors whether those supplements contain more than the naturally occurring amount of lovastatin.

The Future of Hemp-CBD 

The Pharmanex case could dictate how the FDA treats Hemp-CBD. Hemp contains many active compounds, including cannabinoids like CBD and terpenes. Hemp can be processed in a number of ways, some of which will isolate these active compounds. Chemical extraction methods can isolate these active compounds while removing water, fiber, and other unwanted material.  Alternatively, hemp can be processed without the use of chemicals (e.g., dried flowers; chopped up plant material placed in pellets, etc.).

“Full spectrum” extracts are the extracts that contain a wide array of compounds found in the hemp plant, including cannabinoids and terpenes. Processors can also isolate specific compounds by repeatedly extracting and refining the compound. Epidiolex is an example of a CBD isolate. A CBD isolate generally contains almost no other compounds. In turn, full spectrum extracts contain trace amounts of CBD and their compounds.

Following the reasoning in Pharmanex, CBD isolate may be subject to the Drug Exclusion Rule, but processed hemp, including full spectrum extracts may not due to the Prior Marketing Clause. This is because like Red Yeast Rice, hemp has been consumed as food and medicine for thousands of years. Hemp is not the same as the CBD isolate. The Pharmanex case turned on the an interpretation of the term “article.” CBD isolate is the article that was approved as a drug. Full spectrum extracts and other processed hemp products that contain naturally occurring CBD also may be outside of the scope of the Drug Exclusion Rule by way of Epidiolex. In turn, CBD isolate or processed hemp that had isolated and increased CBD could only legally be sold as drugs.

Though the parallel between Hemp-CBD and red yeast rice are impossible to ignore, there is no gaurantee that the FDA will take the same exact approach. For one, perhaps it can be established that CBD, in its isolated form was marketed prior to the Epidiolex studies being made public. CBD was first discovered by Dr. Roger Adams at the University of Illinois in 1940. However, any marketing of CBD isolate prior to the first Epidiolex investigations in 2014, would have likely violated federal law because the 2014 Farm Bill was not yet in effect, making it illegal under federal law.

However the FDA’s statement following the 2018 Farm Bill included some very interesting language:

[P]athways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.”

The FDA Secretary can override the Drug Exclusion Rule by issuing “a regulation, after notice and comment, finding that the article would be lawful under [the FDCA].” The statement also went onto ask for input on the future of Hemp-CBD:

Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.”

We will continue to monitor the FDA for additional updates on Hemp-CBD.