How Should the FDA Regulate CBD and Hemp?

The 2023 Farm Bill is coming, and with it, the opportunity to reflect on how the regulation of CBD and hemp has gone so far. On July 27^th, the House Energy and Commerce Committee announced a bipartisan request for information (RFI) to subject matter experts about the Food and Drug Administration (FDA) regulation of CBD. In particular, the committee wants information that would help the FDA come up with a regulatory pathway for CBD that protects consumers while still providing certainty to the market.

The question, in a nutshell, is: what should the FDA and the federal government do about the massive explosion in hemp products as a result of the 2018 Farm Bill, and how can the 2023 bill improve on it? We’ve gathered experts in law, medicine, analytical chemistry and the hemp industry to give their insight into the issues and make a final submission to the committee.

Here’s what we learned.

The Expert Panel

Our expert panel comprises specialists in cannabis and hemp from across a range of different fields, including both industry stakeholders and those who work with cannabis and hemp as part of their practice in medicine, law or chemical analysis.

Medical Professionals

Industry Stakeholders

Lawyers

Testing Laboratories

American Council of Independent Laboratories – These answers were submitted on behalf of members of the American Council of Independent Laboratories (ACIL). Dr. Erik Paulson (InfiniteCAL), Dr. Josh Swider (InfiniteCAL), Sarah Otis (Anresco Laboratories), and Zachary Eisenberg (Anresco Laboratories).

The RFI: 29 Questions on the Market, Regulations and the Legal Challenges of Hemp

The full RFI document lists 29 questions covering a range of topics related to CBD and hemp. Some examples include:

How is the lack of national standards for CBD products affecting the market?
How should CBD and/or cannabinoid-containing hemp products be defined? What compounds should be included and excluded from a regulatory framework?
How should Congress or FDA identify appropriate limits for THC and other cannabinoids in finished products? Relatedly, how should a framework account for “total THC,” including tetrahydrocannabinol acid (THCA), in FDA’s regulation of intermediate and finished products?
Should FDA regulate the manufacture and sale of “semisynthetic derivatives,” or “biosynthetic cannabinoids,” which are still scheduled under the CSA?
How has the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P, and others?

Overall, the questions cover a wide range of issues and ultimately read like a fact-finding mission, with even basic points like the current state of the market being included. The goal is pretty admirable, though: get insights from the experts in the area before making choices that you’ll regret in a year or two when the industry finds new loopholes.

The Problem in a Nutshell: How the 2018 Farm Bill Missed the Mark

Before we get onto how things should change in the future, it’s important to understand what the 2018 Farm Bill did, and more importantly, didn’t do.

The famously-broad definition of hemp is responsible for most of the issues lawmakers have struggled with over the past five years. The fact that “hemp” includes, “all derivatives, extracts, [and] cannabinoids” provided that the delta-9 THC level remains under 0.3% means that any other natural cannabinoid – including delta-8, delta-10 and more – is basically included in this definition. When the industry picked up on this, the products hit the shelves, proudly bearing a “federally legal” veneer of legitimacy.

This wouldn’t have been so bad if the Farm Bill had considered the consequences. It set up the baseline rule, but didn’t consider final products, instead just weakly leaving this issue for the FDA to handle. However, the FDA has only taken very minimal action so far.

What Should the FDA Have Done and What Has It Done?

Shawn Hauser offers a detailed overview of what the FDA is expected to do:

The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. FDA regulates food, dietary supplements, cosmetics, and other consumer products pursuant to the FFDCA [Federal Food, Drug and Cosmetic Act] to ensure that such products are safe, including that they are not adulterated or misbranded. Unless FDA has specific excepted or limited authority over a consumable good (i.e., its more limited authority over tobacco or alcohol), FDA has longstanding authority to approve or require compliance with certain standards for safety, quality, and effectiveness of ingredients before they enter the market, and to enforce FFDCA standards.

Different standards apply to the respective product types. The FFDCA requires that any substance added to a food be either generally recognized as safe and effective for its intended use (“GRAS”) or approved by FDA as a “food additive,” both of which require “reasonably certainty” of safety. Similarly, if cannabinoids are sold as or in a dietary supplement, the FFDCA requires producers to substantiate the safety of each of the dietary ingredients in a dietary supplement.

A substance that will be added to food is subject to premarket approval by the FDA unless it is generally recognized, among qualified experts, to be generally recognized as safe under the conditions of its intended use (“GRAS”). Only when a food producer establishes GRAS status may it send products to market without pre-market approval. Therefore, it is unlawful to manufacture or sell food products containing cannabinoids (such as CBD) unless the manufacturer has demonstrated, prior to bringing the product to market, that the cannabinoid(s) are GRAS for their intended use. Under the FFDCA, as per its nature, prior sanctions and food additive regulations do not exist for new ingredients or new uses of old ingredients.

Notably, the FDA does not require manufacturers or distributors to obtain approval about the GRAS status of an ingredient prior to marketing it and recognizes that companies may market food ingredients based on a company’s self-determination of GRAS status. If a company makes a self-determination of GRAS status and the FDA disagrees with that self-determination, the FDA has the right to bring regulatory action against the product on the grounds that it is an illegal food additive.
Shawn Hauser

The FDA does have authority when it comes to enforcement, too:

Enforcement actions for FFDCA violations can be civil or criminal in nature. The types of enforcement actions by FDA can include advisory actions (usually warning letters), seizures, injunctions, recalls, criminal and civil penalties. Liability can attach to any entity in the chain of distribution.
Shawn Hauser

However, some respondents criticized the minimal action taken so far on hemp products:

To my knowledge the FDA has not engaged in any substantive federal enforcement activity against intoxicating, synthetically-produced cannabinoid compounds. Federal enforcement on this industry has been through the DEA and subject to DEA resource priorities of which the priority is very low.

Different states have approached enforcement in different ways but all states seem to have some level of confusion coordinating state law with their investigatory and enforcement efforts. Often regulatory agencies tasked with addressing intoxicating synthetically-produced compounds have little knowledge on how to identify priority target manufacturers, how to best use their investigatory powers to understand the industry and apply state law in an effort to enforce compliance.
Robert Hoban

To be frank, the enforcement on hemp-derived cannabinoids, particularly hemp-derived intoxicating cannabinoids, has been insufficient to this point. The onus should be on the FDA to provide enforcement, and to this point they themselves have admitted that their enforcement has focused on the most egregious of public health violations like marketing and packaging intoxicating cannabinoids to make them more appealing to kids.

In the absence of sufficient enforcement, some states have drafted and introduced legislation and even regulation of hemp products to mimic cannabis regulations, but the rigid enforcement frameworks that exist for marijuana/cannabis in these states are not used for hemp and therefore enforcement is more lax that would be needed to make the regulations effective.
American Council of Independent Laboratories (ACIL)

What Is the State of the Industry in the Absence of Regulation?

Many of the RFI questions are attempts to gain perspective on how the industry looks now and particularly, how the lack of regulation has influenced its progression since 2018. We spoke to hemp industry insiders who offered many insights into the way things stand and how we got here.

The market for CBD products has passed the honeymoon phase. A majority of the consumer population that was willing to try CBD after the passage of the 2018 Farm Bill has made their purchases and tried the products with varying degrees of success. Unfortunately, many brands are their own worst enemies. Low potency and quality have dominated the market due to their lower price points and many consumers have moved on.

More and more manufacturers are transitioning to GMP compliance and instituting QA/QC measures into their production process, but until it is required and enforced, a majority will continue without them.

The largest consumers of CBD isolate are companies using it as a starting material to make intoxicating cannabinoids, such as Delta-8 THC, for vape and edible products. The greatest demand for intoxicating compounds are in states where marijuana has not been legalized.
Russell Lombard

Since the 2018 Farm Bill, the hemp cannabinoid industry has expanded greatly. From minor cannabinoids to alternative cannabinoids, we have seen the industry expand beyond CBD. This is in part [due] to consumers’ appetite for more than just a single molecule solution and more effective products. From ingestibles to topicals, hemp cannabinoid products have expanded in delivery systems and in psychoactivity.

In the early days the market was saturated with zero THC CBD products, but the consumers demanded more. They want to feel effects and experience the most effective products, which has shifted the market exponentially. High doses in dispensaries, the proliferation of recreational cannabis markets with high taxes, and products that don’t speak to the wellness side of the plant has given the hemp industry huge growth. From c-stores to major chains, CBD and hemp cannabinoid products are everywhere.
Olivia Alexander

The progression of the market since 2018 is a big topic in the RFI, with a notable shift from CBD products early on to more intoxicating products on the market today.

When the 2018 Farm Bill passed, the hemp industry’s focus was on how non-intoxicating cannabinoids such as CBD, CBN, and CBG could enter the mainstream wellness and health supplements market. As the industry grew, production of these compounds quickly outpaced consumer demand and companies were forced to get creative. By the end of 2019, many manufacturers were starting to explore the production of minor cannabinoids by converting the abundant CBD molecule into other minor cannabinoids. It is the ambiguous wording in the Farm Bill, coupled with the persistent prohibition of marijuana, that opened the door to hemp-derived, intoxicating minor cannabinoids, such as Delta-8 and Delta-10 THC.

Since late 2019 and early 2020, the proliferation of converted cannabinoids has, for better or worse, kept the hemp industry alive. The price of wholesale CBD isolate has dropped nearly 95% since the passage of the Farm Bill and the sale of converted minor cannabinoids continues to dominate the market.
Russell Lombard

In 2019, the CBD market boomed with exuberance and potential, expecting FDA regulations to be forthcoming. But the FDA’s refusal to issue those regulations, combined with the onset of COVID in 2020, reduced the growth of the industry significantly and pushed a lot of CBD brands out of business. In the years since COVID, the CBD market has stabilized and continues to grow, but not as robustly as it would with appropriate FDA regulations.
Jim Higdon

When the 2018 Farm Bill authorized the production of hemp, the intention was for the hemp to be primarily processed into fiber for textiles. As a result, it lacked key structure over whether the extraction of CBD and its use in finished products was federally legal.

Initially, much of the market for hemp cannabinoid products solely centered around CBD, but as the market became less lucrative for CBD, manufacturers started to push the envelope and create other intoxicating cannabinoids. Their argument was that as long as the final product contained less than 0.3% delta-9 THC and the original starting material (CBD) came from hemp, that it could be called “hemp-derived” and was therefore legal under the Farm Bill. This assumption was rarely challenged by the FDA, and the envelope is continuing to be pushed today with ‘THCA hemp flower’ which is essentially just cannabis/marijuana that has a lab result for delta-9 THC of less than 0.3%.
ACIL

And while there is some disagreement among stakeholders, most point to the lack of federal regulations as creating confusion for both stores and consumers:

Without national standards and oversight, State legislatures have formed a complicated and evolving mosaic of rules and restrictions for all types of hemp products. For consumers who have enjoyed full access to a spectrum of cannabinoids, their new local regulatory landscape can seem arbitrary or uninformed. The nuances between state requirements are particularly difficult now for manufacturers, distributors, retailers, and nationwide brands. Specifics for packaging, labeling, content restrictions and potency limits are all over the place.

Without regulation, Capitalism rules. Companies are allowed to prioritize profitability, sacrificing production safety, product quality, and testing to make a cheaper product.
Russell Lombard

The absence of a Federal regulatory framework for the hemp industry has led to a chaotic market. Lack of guidance and enforcement has resulted in thousands of brands with very few companies that follow basic quality standards. The current regulatory vacuum is being filled by a very messy, disjointed patchwork of State regulations, that are hurting the CBD industry much more than helping. The handful of higher quality companies are being punished for following rules, while thousands of brands are free to participate in the CBD industry, putting almost anything in a bottle, creating a “gray market” for their products.

This situation creates mistrust of the entire industry, stifles investment, and creates unnecessary headwind for legitimate companies to produce high-quality products that consumers are looking for.
Joseph Dowling

In my opinion, the lack of “National Standards” is not affecting the market at all because the best brands, producers, and products are all self-regulating at a very high level. There are of course bad actors in every space. There are some in hemp using the Farm Bill to traffic cannabis nationwide, but this is not new. This has always been happening.

People across the country love hemp cannabinoid products and low dose options. My business and many others are still booming and growing. There is a perpetuation of the idea that the hemp cannabinoid market has no standard and it’s untrue. Anyone processing transactions or banking is forced into regulation by banks and other partners. Every brand I know is lab testing, transparent in ingredients, and holding product liability policies. It is a shame we are facing a new stigma that our businesses are unsafe or unregulated all because the government isn’t involved. We are all paying taxes both federal and state (some of us in every state) and contributing massively to our economy. The idea that the FDA, a completely corrupt organization funded by big pharma, needs to regulate us is crazy.
Olivia Alexander

Overall, though, the hemp industry seemed happy with a push towards more regulation:

The lack of federal standards has caused states to create their own rules. This is bad for the market because brands cannot serve retailers in various states when each state has its own rules on CBD, which can contradict the rules of other states. This is one of the many reasons why we need Congress to instruct the FDA to issue national standards for CBD products.
Jim Higdon

Every legitimate hemp company making quality products is in favor of smart regulation for the industry. Product traceability and consistent testing requirements would be a good start. Ideally, the FDA will formally address CBD and other cannabinoids so the hemp industry and consumers can move forward with greater confidence. On the other hand, what other supplement ingredient or nutraceutical faces as much scrutiny and legislative resistance as CBD? Unfortunately, regulators appear to be unable to separate CBD from its Original Sin: it came from the Cannabis Sativa plant.
Russell Lombard

How Should We Regulate Hemp and CBD? Setting Up Definitions

Most of the products we’ve seen stem from the Farm Bill ultimately come down to the definition it chose for “hemp” and implications of its solution. Naturally, the RFI calls on stakeholders to suggest a better way to do this.

However, experts were more likely to be opposed to tweaking the definition of “hemp” slightly and in favor of broader changes, which often challenge the whole foundation of the split between “hemp” and “marijuana.”

Due to the complex structure and development of the hemp industry over the past several years, in order to have effective oversight at this point, cannabinoid-containing hemp products have to be quite broadly defined as a product containing any cannabinoid that is either naturally extracted from hemp or converted from hemp-extracted starting material into another cannabinoid in a synthetic process. Even this broad of a definition may not be enough to provide oversight for other routes of acquisition, including biosynthesis of cannabinoids from yeast using starting materials not derived from hemp.

Proper legislation would not focus on defining a whole set of compounds as hemp or cannabis/marijuana, but rather:

1) Individually identifying each cannabinoid,

2) Determining its possible routes of acquisition (extraction from either hemp or marijuana, chemical synthesis, biosynthesis, etc),

3) Determining the risk profile of the compound itself (regardless of route of acquisition), both in terms of its intoxicating ability and its toxicity,

4) Determining the risk profile of each route of acquisition, both in terms of the risk of the side products and the reagents/solvents used to synthesize/obtain the material,

5) Placing the cannabinoid + route of acquisition into the proper category for regulatory oversight, in terms of oversight of manufacturing, required testing, restrictions on sales, etc.
ACIL

Naturally occurring cannabinoids like CBD or CBG (which is, comparatively, one of the most well-known cannabinoids with lesser intoxicating potential) are oft-referenced as being proposed to be allowed, along with full spectrum and broad-spectrum extracts, so long as the potency of THC is low enough. More recently, semi-synthesized cannabinoids – ranging from CBN to delta-8 THC – are receiving more support, depending on the cannabinoid’s potential for intoxication.

Ultimately, I would not be surprised to see the distinction between “hemp” and “marijuana” removed, and the industries collapsed – resulting in “non-intoxicating cannabis products” being sold akin to hemp products today and “intoxicating cannabis products” being sold akin to marijuana today, but where the supply chains are consolidated.

Thus, in spirit, I could envision for a “hemp product” to allow not only for CBD, CBG, full spectrum and broad spectrum extracts, but also other minor cannabinoids (even if synthesized) if the end product still falls below a threshold of likely intoxication of the consumer.
Garrett Graff

Broadly speaking the simplest way to do this that would also not be confusing would be to apply a definition that’s consistent with the definition from the Farm Bill, which identifies as legal “hemp” any product derived from the hemp plant that does not contain more that .3% by dry weight Delta-9 THC.

A number of other naturally-occurring or novel cannabinoids can be derived from hemp, but several courts to have considered the issue have concluded that these derivative compounds are legal. Further federal regulation on the issue is unlikely to add clarity to the market as it exists.
Nathan Lennon

Congress and FDA should consider the appropriate regulation of finished goods for their intended use, including what levels of THC are intoxicating and require a different regulatory model designed for ensuring safety for intoxicants. Congress needs to consider regulating cannabis products in a proven regulatory model like alcohol which accounts for product safety for various levels of the intoxicating substance through TTB, FDA, and state oversight.

For CBD and other cannabis-derived products that, at certain levels, clearly have safety profiles consistent with food and dietary supplement ingredients, Congress and FDA should review the science and existing data (including state reports assessing this issue) informing safe and non-intoxicating levels of THC and utilize existing FDA product safety review processes to ensure the safety levels of specific cannabinoids and product types.
Shawn Hauser

How Should We Regulate Hemp and CBD? Establishing Product Standards for CBD

While the fate of intoxicating cannabinoids is anybody’s guess at this stage, one thing regulators must grapple with very soon is product standards for CBD. With long-accepted medical use and as a generally non-controversial part of the industry, CBD is bound to survive this round of regulatory changes. But what should we actually do to make sure the products on the market are safe:

The reality is that, despite the lack of large scale clinical trials demonstrating efficacy, most consumers of CBD products are seeking some type of therapeutic effect, whether it be reduction of anxiety, pain relief, insomnia, muscle recovery or some other health problem. Thus, in my mind, manufacturing and quality control requirements for this industry should match what is required for other OTC and prescription medications.

Whether we call it a medication, dietary supplement or nutraceutical doesn’t matter. Much of the harm that can come from CBD products currently stems from pervasive inaccuracy in product labeling, inadequate disclosure of other substances in these products, and contamination of the product with harmful substances. Quality control regulations would address these concerns.
Ryan Vandrey

It would be nice to see a framework that establishes over the counter dosing and products so that consumers can try cannabinoids products on their own and then consult a healthcare provider when the product is not effective or if they need more guidance around drug-drug interactions, side effects, and dosing.
Eloise Theisen

As with intoxicating products (more on this in a moment), regulators are also interested in whether we should establish dose limits for CBD. However, Eloise Theisen points out that evidence is lacking in this area:

In general, I think there is still an opportunity for us to learn more about how cannabinoid doses affect consumers in the short and long term. It has been established that CBD is recognized as generally safe and we still need more evidence to support safe dosing amounts when consumed regularly and consistently for long periods of time.

There are many products on the market that offer 50-100mg per serving and little evidence to support the need for those amounts. Amounts would be best determined by more human clinical trials.
Eloise Theisen

How Should We Regulate Hemp and CBD? The Intoxicating Hemp Problem

While the RFI is ostensibly asking about CBD, the broader issue of regulating hemp products always comes back to the same thing: what should we do when the product is intoxicating? Lawmakers didn’t get the “rope, not dope” they thought they were legalizing, and ever since delta-8 THC hit the market, states have been grappling with the issues brought about by intoxicating cannabinoids sold as hemp.

Currently, Congress has very little to work with in order to meaningfully regulate intoxicating, synthetically-produced cannabinoid compounds. Their first order of business should be either encourage federal regulatory agencies to address regulations of these compounds or, in the event regulatory agencies fail to do so, hold their own Congressional hearings on the issue.

The lack of coordinated government efforts to understand the pros and cons of these compounds leaves the merits of these compounds subject to self-serving private sector forces. Marijuana opponents will always tout the destructive nature of these compounds and marijuana advocates will always promote their beneficial qualities. Without coordinated government led investigations it is impossible to implement meaningful regulations.
Robert Hoban

Delta-8 THC is a great example for this discussion because it is manufactured from hemp-derived CBD in a lab, despite being a natural compound as well. These “hemp” products have been referred to in many different ways, but the RFI calls them “semi-synthetic derivatives” and asks if the FDA should regulate their manufacture and sale.

At this point, I think FDA likely has no choice but to regulate some semi-synthetic derivatives or biosynthetic cannabinoids (but potentially to the exclusion of truly synthetic cannabinoids, like THC acetates for example) – as one example, even CBN is highly popular, but often synthesized (through delta-8 THC).

It is important to note that synthesis itself is not bad or foreign necessarily (for example, vitamin C is often synthesized). But, it’s the types of solvents being used, and the potential for byproducts being created, and ensuring that testing requirements captures for any residual solvents, byproducts, etc. that is crucially important. […] I believe this cat is out of the bag, proverbially speaking, and FDA may have to wrangle it as best it can, without outright prohibitions. Generally speaking, the cannabis industry overall is anti-prohibitionist, and I think that sentiment should largely extend to semi-synthesized cannabinoids too.
Garrett Graff

Yes, regulation should include the manufacture and sale of semisynthetic/bio-synthetic cannabinoids, as most of the intoxicating and non-intoxicating cannabinoids not named CBD or delta-9 THC are currently produced by these routes of acquisition. The restrictiveness of regulation can depend on the risk profiles of each cannabinoid and their route of acquisition.
ACIL

Given the puzzling and confusing scheduling decisions that FDA/DEA have historically made for both Delta-9 and CBD, I doubt there would be much value here (as an example, CBD was listed as Schedule I, even though there is zero evidence that it poses a high potential for “abuse” by users, and abundant evidence that it poses legitimate medical uses – as ultimately demonstrated by the history of Epidiolex (CBD-containing), which was a schedule V drug, and then later delisted altogether). It may be that regulation is appropriate, but the clear leaders in innovation on the regulatory front are the states where these compounds are legal.
Nathan Lennon

Regulation is a double edged sword. On the one hand, it is nigh impossible for government to meaningfully regulate a market it does not understand and knows very little about. The only path to understanding how to regulate any market is to allow it to exist, understand how it operates and address consumer safety concerns relevant to that industry. On the other hand, not every entrant into the industry approaches the industry in a responsible manner and prioritizes consumer safety issues.

The government regulatory process is a slow process and will always be one to several steps behind the industry. Harmonizing free market industry growth with sensible government regulatory oversight is a balancing beam act and fraught with errors but complete federal dissociation with the expanding intoxicating synthetically-produced cannabinoid industry seems irresponsible.
Robert Hoban

How Should We Regulate Hemp and CBD: How Much THC Is Too Much?

One of the biggest issues to come out of the application of the Farm Bill is the simple math of the 0.3% delta-9 THC by dry weight limit. Just like it’s possible to get drunk on light beer if you drink enough of it, a limit of 0.3% doesn’t prevent intoxicating products from being sold. If you have a 10 g gummy, it can contain almost 30 mg of delta-9 THC and still be legally classified as hemp.

Most of the suggested solutions for this problem include a hard cap on the amount of THC per serving of a hemp product. However, proposing a specific limit is challenging, and the RFI asks experts and stakeholders to weigh in:

This is a conundrum, and ultimately, one that will likely lead to the collapsing of the “marijuana” and “hemp” industries as we know them today. On the one hand, FDA is generally rejecting the data provided to date as to the safety of hemp products, which makes it difficult to constructively engage in determining appropriate thresholds.

Furthermore, as to the data that is available as to potency that does exist, there is a decent range of data supporting different outcomes depending on your perspective on hemp products – many marijuana industry stakeholders advocate for <1.0 mg / serving of THC in hemp products, where some states have enacted hemp product regulatory schemes allowing for 5+ mg THC / serving, and there is data supporting potencies above 2.5+ mg THC / serving. Ultimately, similar to how kombucha is distinct from alcohol based upon ABV, I think we will see intoxicating and non-intoxicating cannabis products (not marijuana or hemp) down the road.
Garrett Graff

As per the above, I doubt federal regulators would be likely to add helpful guidance here. As noted, several state regulators have provided thoughtful approaches. One thing to keep in mind with any labeling approach is that “total THC” is not likely to give the consumer meaningful information about a particular product, due to the differing psychoactive qualities of different cannabinoids (i.e. the very different psychoactive qualities of Delta-8 versus Delta-9 THC).

A better framework here would be for prospective regulators to require the identification of presence and quantity for each specific type of THC contained in a given product, above a certain de minimus threshold.
Nathan Lennon

The state-regulated cannabis industries have placed limits on THC in some products, particularly non-inhalable edible products, both on a per-serving and per-packaged unit basis. I presume that this is more of a safety concern in regards to public intoxication (safe operation of automobiles, for example) than a personal health concern.

If we approach limits for intoxicating cannabinoids from the public intoxication perspective, a greater concern, and perhaps more restrictive limits, should be placed on cannabinoids that have more potent intoxicating effects than less potent analogues.

If we use delta-9 THC as a benchmark, cannabinoids that provide similar or greater intoxicating effects would include THCH, THCjD, THCP, HHC (and all analogues with varying chain length like HHCP, etc), THC-O-Acetate (and all analogues with varying chain length). This is not an exhaustive list, and any legislation or regulation should include a broad generalization that allows for addition of new cannabinoids to the list as they are brought to market.
ACIL

How Should We Regulate Hemp and CBD? The Best Answers So Far

Luckily, congress doesn’t have to “re-invent the wheel” when it comes to hemp and CBD regulation. In the absence of federal guidance, many states have devised sensible regulatory schemes for their own borders already. The RFI asks for pointers as to where specifically regulators should look for guidance:

Rather than cherry pick the best regulations from the best states on this issue I posit Oregon has one of the leading CBD regulatory models in the US and should serve as a starting point for Congress to consider when implementing their own CBD regulations. Oregon’s CBD product regulations are based in common sense and consumer safety oriented. Their packaging and labeling regulations are simple and clear to follow with multiple guidance memos to help manufacturers comply with their regulations and help consumers understand what they are purchasing.

Along these lines other states should look to Oregon’s model as a starting point and adjust as needed to address state specific public policy priorities.
Robert Hoban

No particular state is doing a perfect job of regulation, but some are really hitting their stride in terms of providing regulation that provides safety for the consumer, while also still enabling businesses to have the flexibility to innovate and do well. Some of the standards that I believe are helpful include:

1) Allowing hemp processors to import hemp from other states, so long as the imported hemp meets labeling requirements, including such important basic facts as CBD concentration/origin, etc. (Colorado; Oregon)

2) Permitting hemp growers or processors to sell their products to the in-state recreational cannabis market, so long as labeling requirements are met. (Oregon). This is particularly important, as many cannabis products deliberately include CBD as a compliment to certain strains of cannabis.

3) Requiring labeling disclosures for CBD in foods and beverages that will make it possible for a food borne contamination recall to be swift and effective, such as lot number and producer origin. (Vermont)

4) Low licensing fees, enabling greater access to the market for those willing to comply with regulations. (Vermont)
Nathan Lennon

As a baseline, Congress and FDA can easily utilize existing consumer safety frameworks – GMP standards and certifications, which address things like preventing cross-contamination and adverse event reporting. From there, Congress and FDA can employ regulations targeted specifically toward cannabis industry-specific issues – regulations which could contemplate synthesis (and denoting certain approved solvents); potency (and denoting certain potency thresholds and/or other warnings or age-gating); and testing panels.

Each of these types of standards are certainly appropriate for consideration; but, these standards all weave together in different ways, depending how the regulations are structured, so the precise combination of all these standards is what will dictate whether there is broad-based support for such regulation or not – such could equate to a “death knell” to an industry.
Garrett Graff

For low dose CBD and other cannabinoid products with safety profiles consistent with food, dietary supplements, and cosmetics, Congress should look to existing FDA food and dietary supplement labeling and fundamental product safety standards, including cGMP requirements and critical safety standards that ensure safe manufacturing processes when using chemical catalysts. This framework allows Congress to consider FDA precedent and warning labels applicable to vulnerable populations and safety risks.

For intoxicating or impairing products, Congress should look at effective standards proven in mature state marijuana markets designed to safely regulate THC and intoxicants, as well as the federal alcohol model designed for various forms of intoxicants and its respective TTB and FDA regulation.

Congress should also consider well-informed and public safety focused standards developed specifically for cannabis by reputable organizations such as ASTM International. There are a number of other reputable trade groups and non-profits who certainly will be providing data-driven recommendations to Congress in this RFI process that should be seriously considered.
Shawn Hauser

What We Still Need to Know

While the expert panel addressed many of the key issues legislators have to grapple with in the coming months, the RFI and our panel identified areas where the necessary knowledge is simply lacking. Unfortunately, most of these issues will need to be researched in-depth before there are good answers, but the committee rightfully asked respondents to highlight some key areas to focus on.

Firstly, there are many problems for people using hemp cannabinoids for medical purposes, because effective doses often haven’t been established:

There needs to be more research on dosing and potential drug-drug interactions. The research has been inconclusive largely in part because we do not have large, robust double blinded clinical trials. Many consumers take cannabinoids for perceived benefits and can spend hundreds of dollars out of pocket to try and alleviate symptoms. Cannabinoids have the potential to help alleviate pain, anxiety, sleeplessness and possibly other ailments that are yet to be discovered.
Eloise Theisen

Eloise Theisen also pointed to the increasingly-common combinations of cannabinoids with melatonin, marketed to people with trouble sleeping:

We see more and more companies offer cannabinoids with melatonin to help market the product for sleep. There is growing concern around the overuse of melatonin long term and we do not know how the combination of melatonin and cannabinoids affects consumers in the short and long term. There is an opportunity to study cannabinoids on their own and with other ingredients to see if the benefits outweigh the risks. Unfortunately the market has supplied these products and consumers are using them without evidence to support the marketing claims.
Eloise Theisen

Beyond the more traditional products, many of the rare and novel cannabinoids on the market today have barely been studied at all:

It is largely unknown what the long-term public health impact of these novel cannabinoids are, because unlike some of the naturally-occurring cannabinoids, many of these compounds have not been consumed on a large scale for more than a couple of years. While the unknown nature of the effects of these compounds does not necessarily warrant a full ban on their sale and use, regulations should attempt to push the industry to proceed with more caution than they have to this point.

The focus should be on ensuring proper manufacturing protocols are put into place, that testing is tailored to the processes used to manufacture these compounds, and that clinical-type studies are performed to assess the health risks of the compounds themselves.
ACIL

Conclusion: Regulation Is “a Balancing Beam Act”

It’s clear that legalizing a whole raft of different products without setting up a basic regulatory system was a mistake, and it’s one legislators aren’t keen to repeat in 2023. But as many on the expert panel pointed out, taking an extreme stance in one direction or the other may be a simple approach to the problem, but it is not good enough for the hemp industry as it stands today.

Regulators, more than anything, need to take account for the huge array of products on the market, limiting the most egregious issues like inaccurate labeling and sales to youth while simultaneously offering a clear route forward for the many American businesses and consumers who depend on hemp every day. The 2023 Farm Bill is a unique opportunity to do things right, even if we don’t all agree on what exactly “right” means.

How Should the FDA Regulate CBD and Hemp? Here’s What the Experts Think

Lee Johnson