After the House Energy and Commerce Committee requested information about CBD and hemp in late July, the industry had just under a month to put together submissions. We collected responses from industry experts and submitted them, but many hemp and cannabis organizations also did the same thing. The core question at the heart of all this is: how should we regulate CBD and hemp products?
As you might expect, there are lots of points of agreement and some definite points of disagreement too. But the request for information (RFI) is a great opportunity for some insight into what the industry thinks of the upcoming plans and could even give an indication of what will happen with the coming Farm Bill.
So we’ve read through the submissions from several organizations:
- American Trade Association for Cannabis and Hemp (ATACH)
- US Hemp Roundtable
- Hemp Beverage Alliance
- cbdMD
- Cannabis Regulators Association (CANNRA)
- Council for Responsible Nutrition (CRN)
- Natural Products Association (NPA)
- Council on Governmental Relations (COGR)
- Hemp Food Association (HFA)
- One Hemp Coalition
And have collected some key takeaways here. Here’s what we learned.
Most Organizations Complain About the Patchwork of Laws
The US Hemp Roundtable, cbdMD, Hemp Beverage Alliance, Cannabis Regulators Association (CANNRA), the Council for Responsible Nutrition, the American Trade Association for Cannabis and Hemp (ATACH) and the Natural Products Association all took issue with the current patchwork of laws and regulatory schemes for hemp across the US.
The reason for this complaint is obvious. Moving from state-to-state means there will be different rules for hemp products, especially considering intoxicating ones, with states like Tennessee instituting substantial regulations, places like Idaho banning basically anything with THC in it and others like Alabama doing very little other than banning it for youths.
The Natural Products Association explains, “The state-led regulatory environment for CBD has resulted in a complicated — and constantly changing — state patchwork of laws that is challenging for businesses and consumers to navigate. Businesses selling CBD products must not only comply with this patchwork of state laws, but also with applicable FDCA provisions, which in some cases may conflict with state laws.”
Clearly, this situation isn’t helping anybody. Not only is it hard to comply with all of these contradictory laws as a company, as a consumer it leaves no consistency with regard to product safety and even contents. Some coherent and uniform standards are sorely needed, according to many of the submissions.
Hemp Products Should Be Split Into Two Categories: Intoxicating and Non-Intoxicating
While there are differences in how the organizations envisioned or described this, the US Hemp Roundtable, Hemp Beverage Alliance, cbdMD, Council for Responsible Nutrition, ATACH and the Hemp Food Association call attention to the split in hemp products and believe this should be accounted for.
Although their focus is mainly on non-THC-containing foods, the Hemp Food Association describes the phenomenon as they see it: “It’s obvious that a bifurcation of the Hemp industry into grain/fiber and cannabinoids has already occurred, therefore Congress needs to recognize that reality in the next Farm Bill. All aspects of Hemp will continue to be hurt until then.”
But this is a specific take on something that many organizations touched on: there are intoxicating products sold as “hemp” and these should be separated from non-intoxicating products in how they’re regulated.
Many of the organizations drew analogies with alcoholic beverage regulation, and how kombucha, for example, contains alcohol but is not considered an alcoholic beverage when it comes to regulation. Society recognizes that under a certain level, there isn’t too much to worry about from the alcohol in kombucha. The commercial cutoff is less than 0.5% ABV, for which it’s pretty easy to see that getting wasted is hardly an issue here.
There was less agreement, though, on what exactly this cutoff should be. Generally speaking, hemp-focused organizations (e.g. the US Hemp Roundtable, Hemp Beverage Alliance and cbdMD) advocated a higher limit and organizations with cannabis stakeholders or a cannabis focus (CANNRA and ATACH) advocated a lower cutoff.
For example, the US Hemp Roundtable argues that 5 mg of THC per serving is a good cutoff, beyond which the product would be considered “intoxicating” and have different regulations. CANNRA, alternatively, suggests it should be around 0.5 mg per serving and 1 to 2 mg per package. These have a ten-fold difference and it’s clear how their decision here reflects the interests of their members.
Regardless, somewhere between the politics, there is a reasonable middle-ground that would likely achieve the shared goal in a more reasonable fashion. For example, 5 mg is a low dose for an edible, but it’s still a possible dose for an edible (e.g. in Connecticut), and CANNRA goes even further in the other direction and suggests a THC limit of 0.0002% for THC, i.e. 2 parts per million, to match the alcohol limit in kombucha. Perhaps something around 2.5 mg per serving would keep everyone happy, but probably not.
Many Argue That the Alcohol and Tobacco Tax and Trade Bureau Could Regulate Intoxicating Products
One common suggestion, made in some form by the US Hemp Roundtable, the Hemp Beverage Alliance, cbdMD and ATACH, is that the Alcohol and Tobacco Tax and Trade Bureau (TTB) should regulate intoxicating products, leaving non-intoxicating products to the FDA.
The reasoning here is pretty straightforward, and is well-described by ATACH’s submission:
The US already has a proven model for the regulation of intoxicants – alcohol – the lessons from which should be utilized in the case of the intoxicating products that contain cannabis, and regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). We do not believe the FDA should create an entirely new regulatory regime along with a new regulatory body within the agency to regulate intoxicants, when the actual purpose of the agency is to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.
American Trade Association for Cannabis and Hemp (ATACH)
Generally speaking, the support for this approach comes down to not wanting to “reinvent the wheel” – why create a new agency when a suitable option exists – and not wanting to outright prohibit intoxicating products.
Inhalable Hemp Products May Require a New Framework – Others, Not So Much
The FDA suggests that a “new framework” may be needed to handle CBD and hemp, but not many of the responses to the RFI agree with this. The US Hemp Roundtable, cbdMD and the Council for Responsible Nutrition all make this point explicitly, usually with a concession that inhalable products are relatively new ground.
The US Hemp Roundtable puts it like this:
[T]he existing frameworks for dietary supplements and food/beverage, as well as FDA’s current authorities under the FD&C Act, provide the Agency with the tools to effectively regulate these products, just as they do for the many thousands of other botanically-derived products currently on the market. Indeed, nearly the entire FDA ‘wish list’ for regulatory authority could be achieved without the development of new pathway specific to hemp cannabinoid products. We again note that this is not only the opinion of the U.S. Hemp Roundtable, but represents the consensus position of the hemp industry, as indicated by the support of 31 leading hemp industry organizations.
US Hemp Roundtable
The Council for Responsible Nutrition also offers a strong rebuttal to the FDA’s objections to using the dietary supplement pathway for CBD. One of these is the “drug preclusion” rule, which basically means that something which has been approved (or substantially studied) as a drug can’t be a supplement. The Council notes that vast differences in dosage could be used to differentiate CBD supplement products from Epidiolex (the approved CBD pharmaceutical drug), or it could use its rulemaking authority to make an exception for CBD.
While many organizations argue that a new framework isn’t needed for most CBD products, things are a bit different when it comes to inhalable products. The US Hemp Roundtable and cbdMD suggest that the Center for Tobacco Products could be responsible for the regulation of these, but in any case this is an area that existing regulations aren’t particularly well suited to.
Should Federal Regulations Set a “Floor” or Create a Level Playing Field?
There is some disagreement about how federal regulations should interact with state laws. Both cbdMD and the US Hemp Roundtable explicitly state that federal regulations shouldn’t be a “floor” (i.e. a minimum set of rules that could be exceeded by states) but that they should be used to counter the issues with the current de facto “patchwork” system. CANNRA, in contrast, believes a federal “floor” is the right approach.
The US Hemp Roundtable makes its case like this: “We oppose legislation that sets a ‘federal floor’ of standards, allowing states to be more prescriptive, particularly as it relates to cGMPs, testing, packaging, and labeling. The current patchwork of state requirements has left both consumers and industry confused, and therefore preemption is necessary to establish comprehensive, uniform requirements that help ensure consumer health, safety, and transparency in labeling.”
While CANNRA argues, “Federal standards are needed, given the current patchwork of cannabinoid hemp regulations across states. However, these standards should set a floor, not a ceiling. The current landscape of legal, unregulated intoxicating hemp products that pose risks to public health and consumer safety was created by federal regulations. Assigning clear, broad federal regulatory authority over this market should alleviate some of these issues, but if regulatory gaps remain, states have a significant interest in being able to address any potential gaps at the state level.”
These issues aren’t easy to solve, with both sides having fair points and clearly recognizing the issues with the “patchwork” of requirements at present. However, while creating uniformity would be beneficial to the industry, removing some of the ability of states to set their own laws leaves a bad taste in the mouth for many.
Defining Hemp: The 0.3% THC Limit and the “Derivative” Issue Should Be Rectified
While some organizations (like the Council for Responsible Nutrition) argue that nothing needs to change with the current definition of hemp, ATACH and CANNRA both point to the same issues: the 0.3% THC limit in hemp has led to chaos and the loose definition of “derivative” leading to the legalization of many compounds likely not originally intended.
ATACH explains the issues with the 0.3% limit: “For instance, most marijuana programs in the US limit the intoxicating presence of delta-9 THC to either 5 or 10 mg per serving, with most at 10mg, including Colorado, Washington, California, Nevada, and others. However, if the limit were simply based on ‘less than 0.3% dry weight,’ without a physical limit on the amount of THC and no limit on serving sizes, the product can contain a very high amount of THC – far greater than the serving size of a regulated marijuana product.”
This is simple math. A 10 g gummy can contain 10 g × 0.3% = 30 mg of THC, way beyond what would be allowed in a regulated marijuana market. No matter how much you like hemp, it’s clear that this is not a reasonable or particularly wise way to limit how intoxicating something can be.
The problem with the “derivatives” of hemp being included is explained by CANNRA: “The derivatives issue […] has resulted from a broad definition of hemp that legalized anything to come from the plant, including intoxicating cannabinoids derived chemically from CBD, many of which have not been well studied for human consumption or safety.”
The counter-argument from the “no change needed” camp is more that no further changes are needed and that regulation can be done through existing channels, particularly those for dietary supplements.
What Is Delta-8 THC, Anyway? “Semi-Synthetic Derivatives” and Clear Definitions
The RFI includes questions about “semi-synthetic derivatives,” which can be roughly understood as a way to describe delta-8 THC and other similarly-made cannabinoids. They aren’t “synthetic” because they do naturally occur in the plant, but they’re a bit synthetic because they’re made in a lab. The US Hemp Roundtable, Hemp Beverage Alliance and cbdMD all point out that a clear definition of this term would be needed.
This seems like an incidental point but it hits right at the heart of something you see a lot in this space. An Arkansas law was recently shot down in federal court, in part because it contained undefined and messy phrases like “synthetic substance,” noting that, “These terms are paired with, at best, fuzzy standards—and record no explicit statutory definition– making it next to impossible for the typical person to know what to do. “
While the RFI isn’t the written law, it’s important to note that if these issues aren’t ironed out, the 2023 Farm Bill will only create as much confusion as the 2018 one did.
Finally, Something We Can All Agree on: No THC for Kids
Through all of the varying perspectives, it’s good to note that there’s one area of general consensus: THC shouldn’t be available to people aged under 21. cbdMD, the US Hemp Roundtable, Hemp Beverage Alliance and ATACH all explicitly endorse this policy. While the others don’t say anything explicit on the topic, it’s clear both the Council for Responsible Nutrition and CANNRA support age restrictions to some extent.
The only exceptions here are the HFA, which seems opposed to all cannabinoid-focused products from hemp, and the Council on Governmental Relations (COGR), who mainly writes to argue that CBD should be easier to research. Essentially nobody would be bothered by a minimum age of 21 on intoxicating hemp – so Congress can go ahead and get it done so we don’t have to individually beg each state to take what is really quite a straightforward step.
Conclusion: You Have the Information, Now Use It
The Council for Responsible Nutrition sums up one key issue in their RFI response:
We believe that if FDA had worked expeditiously on a regulatory pathway to legally market CBD when the 2018 Farm Bill was enacted, the questions raised in this RFI would have already been addressed. Instead, FDA has spent the past five years metaphorically wringing its hands about this authority, ignoring Congress’ directive, watching from the sidelines as a sizable, but unpredictable CBD marketplace evolved without meaningful enforcement of legal requirements, and ignoring (even denying the existence of) credible, well-conducted research that was presented to the agency to demonstrate the safety of well-made CBD products.
Council for Responsible Nutrition
The truth is that the FDA has, so far, failed at its job of regulating products designed for human consumption. While everybody wants to point the finger at the industry – and this is sometimes justified – we should not forget this five year period where the FDA did nothing about an influx of often-untested products aside from sending a couple of letters. Here we are, five years later, and finally they requested some basic information about the problem they haven’t solved since 2018.
Now they know everything they need to, theoretically, but somehow it still seems like we’re a long way from a coherent regulatory structure for hemp from the FDA.