UPDATED

Last week, the U.S. Food and Drug Administration (FDA) announced that instead of approving CBD as a food or dietary supplement, it was recommending that “a new regulatory pathway for CBD is needed,” and that it “is prepared to work with Congress on this matter.” In doing so, the agency also denied “three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.”

The FDA countered, “The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

Concluding that its existing authority is inadequate “for managing many of the risks associated with CBD products,” the agency instead concluded, “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”

For most stakeholders and knowledgeable observers, the decision by FDA to punt was deeply disappointing because of the four-plus years it took the agency to come to a decision that could prolong the end-result by years, and also because of the ongoing risks faced by consumers exposed to an increasing array of untested and potentially unsafe formulations making their way to the market. But neither was it unexpected. Indeed, it would have been a surprise to most if FDA had not erred on the side of caution and instead had approved CBD as a food or dietary supplement.

Cannabis Business Executive has compiled a sampling of reactions from trade associations with skin in the hemp/CBD game, and others, and spoke with Jonathan Havens, a former counsel with the FDA, to get his insight on the FDA’s decision and what to expect going forward. We also include a dire warning from Christopher J. Hudalla, Ph.D., President and Chief Scientific Officer of Milford, Massachusetts-based ProVerde Laboratories, who anticipates “the long-term health impacts resulting from this inaction will be experienced for generations to come.”

The Cannabis Regulators Association (CANNRA), in a statement released the day of the FDA announcement, struck a more hopeful but urgent tone without directly critiquing the decision. “While CBD is largely the focus of today’s announcement,,” it stated, “CANNRA feels strongly that clarity is urgently needed on a more comprehensive regulatory pathway that addresses the growing number of cannabinoid products (many of which are intoxicating) that are being chemically and synthetically derived from hemp and CBD, including cannabinoids like Delta-8-THC, Delta-10-THC, HHC, and THC-O-Acetates.

“These types of products pose a myriad of consumer safety and public health risks and create challenges for state cannabis and hemp regulators because they largely fall outside of any current federal regulation,” it continued. “Consumers see these hemp-derived cannabinoid products at retail and, understandably, presume they are federally regulated, when that is not the case.”

The association urged “Congress and the FDA to follow the lead of a number of CANNRA-member states by proposing and implementing a comprehensive federal regulatory framework for hemp- derived cannabinoid products, and not just for CBD,” and added, “Furthermore, state cannabis and hemp regulators have a unique perspective on this issue and need to be at the table as federal regulatory frameworks are discussed and implemented.”

The U.S. Hemp Roundtable also responded to the news quickly via a statement from its general counsel, Jonathan Miller, who roundly disagreed with the decision. “When it comes to the safety of CBD, the FDA gets it wrong,” he wrote. “Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues.”

To that end, he said the Roundtable “recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe,” but added, “The FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.”

Arguing that FDA has the requisite tools in place to appropriately address CBD, and calling the decision “unwise,” Miller nonetheless expressed the group’s desire to work toward a legislative solution, which he said was “necessary to allow the marketing of hemp-derived cannabinoids including CBD as dietary supplements and foods. We look forward to working with the large, bi-partisan coalition that has developed in Congress to re-introduce legislation in this new Congress in the coming days to direct FDA to utilize the existing regulatory pathways for CBD and other hemp-derived cannabinoids, one that ensures the safety and quality of products.”

TRUCE, a Utah-based patient advocacy organization for cannabis education and policy reform, also issued a press release condemning the decision. “The FDA’s refusal to recognize CBD as a dietary supplement undermines the legalization of CBD in the 2018 Farm Bill,” said TRUCE President Christine Stenquist. “The Farm Bill legalized hemp cultivation, defined as cannabis with less than 0.3% THC, and removed it from the controlled substances list. This means that hemp and hemp-derived products, including CBD, should not be subject to the same restrictions as cannabis with higher THC levels.”

The TRUCE release further argued, “The FDA’s lack of regulation and oversight has led to a proliferation of CBD products being sold everywhere, including gas stations and online retail stores. Many of these products need to reflect accurate labeling, raising concerns about the product’s safety, purity, and quality. Additionally, the explosion of the Delta 8 and the unregulated hemp-derived THC market has led to confusion and uncertainty about the legality and safety around the extraction practice of those products.”

The organization is calling on the FDA to recognize CBD as a dietary supplement, and more. “Federal agencies and Congress must create a consistent and sensible framework for cannabis that acknowledges the different uses and benefits of the plant. This would involve declassifying cannabis and hemp-derived products such as CBD to a schedule that reflects their potential medical benefits and low risk of abuse.”

Inside the FDA

Jonathan Havens is Partner and Cannabis Practice Co-Chair at Saul Ewing LLP, where he represents cannabis (both hemp and marijuana), life sciences, food and beverage, and cosmetics companies on “how to get and keep their products on the market,” according to his profile. Prior to entering private practice, he worked as regulatory counsel at FDA, where he gained unique insight into the agency mindset, a mindset that prioritizes caution and protecting public health over quick action.

“I don’t know anybody that was surprised by this development,” he told Cannabis Business Executive a day after the announcement. “Disappointed, for sure, but not surprised.”

The reason why can be found in the language of the 2018 bill that first allowed hemp and hemp-derived ingredients to be sold legally. “Before that, they were federally illegal marijuana products, but then Congress passed the Farm Bill, the president signed it into law at the end of December of 2018, and it created an opportunity,” explained Havens. “What some people didn’t pay attention to within that legislation was a provision that said essentially that nothing in this bill undermines the U.S. Food and Drug Administration’s authority to regulate the products within its purview. Translation: if the FDA says hemp-derived CBD cannot be put into a food or dietary supplement – which is exactly what they just said, then that’s the law of the land – and the Farm Bill doesn’t affect that.”

The intervening years, he said, have been a “period of waiting with bated breath to see if the FDA will create some sort of framework to allow CBD products to be sold as dietary supplement and as food.” The FDA did at first address the subject. “They had a May 2019 hearing I attended, and that many in the industry were at, where they said, ‘We’re looking at this, we’re evaluating it, and we’re looking at the data. But 2019 became 2020, 2020 became 2021, and then, within recent weeks, we heard some quotes out of FDA officials – Janet Woodcock, Norman Birenbaum, and others – saying, essentially, ‘We’ll have something soon.’”

What it had was entirely anticipated by Havens. “What the FDA came out with yesterday was, basically, ‘We do not think we have the authority to deal with this, and we need Congress to intervene,’” he said. “It was not a surprising development. I and many others have said we don’t think FDA is busy working on CBD regulations, and I don’t think this is something they’ve ever wanted to deal with. They’ve consistently pointed to their purported concerns over safety issues with CBD – liver toxicity and others – and it just didn’t seem like something they were inclined to deal with. Yesterday, they said, in fact, we don’t think the food and supplement pathways are appropriate for CBD, and we need Congress to provide us additional authorities to deal with this.”

Havens said he mostly concurred with the assessment of the U.S. Hemp Roundtable. “I don’t take safety lightly, but the FDA has for a very long time talked about this, quote, cumulative exposure concern that they have,” he explained. “What that really means is, ‘We don’t know how much CBD people are consuming. If they’re getting it from a gummy product and then a tincture product, and then they’re putting it on topically, we don’t know how much they’re consuming, and we’re concerned that people could be consuming a lot and that there could be a liver toxicity issue or some sort of other toxic issue to deal with.’”

Havens noted that there have been other westernized countries “that have talked about toxicity that could occur from consuming very large quantities of CBD and have established safe usage levels based on daily intake significantly below those levels. Liver toxicity was certainly discussed when GW Pharmaceuticals submitted their new drug application for Epidiolex, although the starting dose of Epidiolex is significantly higher than the amount of CBD a typical consumer is consuming.”

Even if he disagrees with it, however, the decision is comprehensible. “As a former FDA regulatory counsel, I don’t fault the FDA for making decisions in order to protect the public health.  At the same time, I don’t know that their responses to the citizen petitions are necessarily appropriate – it seems a stretch to say that the available scientific evidence does not allow CBD products to meet the applicable safety standard for dietary supplements,” said Havens. “They didn’t say, ‘We have concluded that definitively and we’ve moved on.’ They said, ‘That’s our impression today.’ But I don’t think the issue is as grave as the FDA sees it. I’m not a scientist, I’m not a doctor, and I’m not saying my judgment should supplant theirs, but I align myself in this particular instance with the Roundtable and Jonathan Miller’s comments.”

During his time at the FDA, Havens worked in the tobacco division, and would likely have not been involved with these decisions were he still there. “But it’s important to understand, the FDA doesn’t want to endorse a class of products with the result that people use products and there’s an unknown safety risk,” he said. “We’ve seen that with vaping products. There are countries that treat vaping products as an off-ramp from combusted cigarettes and a medical product. We were having those discussions when I was at FDA, so I’m kind of familiar with the ‘You want to make sure that you’re not doing something that’s going to encourage behavior that has unintended consequences’ position.”

The difference here, noted Havens, is CBD is already out in the market in a big way, despite inaction by the FDA. “It’s a burgeoning market,” he added, “and I think there is a little bit of denial on the part of FDA to say, ‘Look, we’re just not sure we can go down this path, and we need additional authorities from Congress.’ Meanwhile, the result of all of this is that it goes to Congress, Congress comes up with the law with apparent FDA input, and then at some point it’s likely going to go back to the FDA to promulgate regulations to implement whatever Congress passes.”

That means any notion that this is going to be quick is incorrect, since there seems to be no sense of urgency on the part of the FDA. “These products are already out there and frankly are being consumed seemingly safely,” said Havens of CBD. “I’m not aware of massive safety issues that have been recognized, and these products have been around for a number of years. Look, it is possible that there are safety concerns lurking that no one knows about, but you would think if there were serious safety risks with these products, they would have become apparent already. So, I think the notion that FDA says, ‘We don’t think our existing regulatory pathways support action on these products,’ I’m not so sure that’s the case.”

Havens sees the Delta-8 issue as related but not that intertwined with the recent statement on CBD. “With regard to Delta-8, Delta-9, and Delta-10,” he said, “part of FDA’s inactivity in this space has led to a few things. One, it’s led to inconsistent products out there. So, if a state is not actually regulating this and FDA is not actively regulating it – save for the handful of firms that received warning letters because they made aggressive therapeutic claims on their products, like it treats cancer, AIDS, COVID, or diabetes – the FDA really hasn’t done much. In fact, in the absence of federal regulation, some states have taken it upon themselves to write their own frameworks – like Minnesota, Louisiana, and others – and I think they’ve done a pretty good job in the absence of federal regulation.”

Havens noted a similar dynamic at work with clients of his firm. “We are very fortunate to be able to select who we work with,” he said, “and in the absence of federal requirements, our clients in this space are doing independent third-party testing, they have QR codes on their products so you can know what’s in there and what’s not in there, and they make sure they’re testing for heavy metals and pesticides. But I totally appreciate what doctors are saying, which is, ‘That’s all well and good, but until we can ensure that everybody does that, there are still risks.’”

I noted that doctors and scientists I’m hearing from say the testing labs don’t know what they’re looking for in this testing, and so no one can actually put a stamp of approval on these tests. Their concern is that products will receive stamps of approval that are misleading.

“All the more reasons for the federal regulator that protects the public health and regulates drugs and dietary supplements and foods to be active rather than passive,” he replied. “There is an argument to be made that FDA needs additional authorities, and if they act without sufficient authority, industry would sue the FDA, which they’ve done before in other spaces, certainly in tobacco. It is a balancing act.”

Despite understanding why FDA did what it did, and even anticipating it, the decision still stings. “I knew all along that this was going to be the case based on the immediate reaction from FDA when the Farm Bill passed in 2018, when it seemed like they didn’t t want any part of this,” said Havens. “But it would have been nice to have the past four-plus years back, to have Congress advance a solution when there wasn’t so much rancor in Congress as there is now. It’s hard to get any bill passed regarding CBD or otherwise, so we’ve wasted four-plus years and now it’s back to the drawing board, and FDA is going to presumably promulgate rules to implement whatever Congress does. So, again, the passage of time is the most disappointing part. It’s not necessarily the fact that they decided or didn’t decide to do what people wanted them to do; it’s the fact that we’ve wasted four-plus years and it’s back to the drawing board.”

Is it business as usual until then? “I’ve received that question a lot over the past 24 hours, and here is my high-level answer,” said Havens. “I think for today, it’s status quo, meaning, if you’re selling a CBD product, or a Delta-8 or Delta-9 product, and you’re not making aggressive therapeutic claims, you’re selling a product in the category, and that’s it. I think it’s status quo short of you selling in a state that is really anti these products, and there are some states out there that are not friendly to have derived products, but short of making claims and or selling in a state that doesn’t want you there, I think it’s status quo.

“There is the possibility that yesterday’s actions could bring some more scrutiny to the space,” he added, “but just like FDA didn’t have a ton of resources to police the space before yesterday, I still don’t think they have the resources to police the space, and they will continue to focus on those products that promote particularly aggressive treatment claims. Maybe over time, as Congress gets involved and we see the writing on the wall and the proposals, it might either have a boost-in-the-arm effect or a chilling effect, depending on the tenor of whatever the legislative solution is.”

In the meantime, he concluded, “I don’t think much will change other than a lot of people talking about the developments, trying to read the tea leaves, and prognosticating about the path forward, but I think this year certainly could be pretty interesting. We have the Farm Bill coming up for reauthorization, which it does every five years. It would be somewhat poetic justice to have the 2023 Farm Bill do what the 2018 farm bill failed to do, which is open up the market fully. It removed hemp from the definition of marijuana, but didn’t address the Federal Food, Drug, and Cosmetic Act legality of all hemp-derived products.”

I asked if he has clients who continue to produce new products in this area. “I definitely have clients who are creating new products, and they’re doing it in a way that they’ve always done,” he said. “The products are third-party tested by an independent lab, they have labels that would comply with FDA’s dietary supplement labeling regulations if FDA saw that these are legitimate supplement products, they’re not making claims, and they’re selling in states they should be in and not in states they should not be in. So, absolutely, people are creating new products every day, as they should, because there are certain states that have frameworks, and the FDA has essentially said, ‘We’re not going to go after products unless you make therapeutic claims.’

“Look,” he added, “the FDA can say that these products aren’t legal, but if they were really truly concerned about them, they would be going after products in the space regardless of therapeutic claims, and that’s what strikes me about the actions yesterday from FDA saying that they’re concerned about safety. If this is a safety crisis, I would think they’d be more aggressively policing the space, and they’ve really never done that.”

An excellent point, I wondered how complicated a subject CBD could be for an agency like FDA. “If you take FDA at their word that they don’t think that foods or supplements are the right pathways, and they are suggesting a completely new product pathway gets created, it’s complicated,” said Havens. “By the same token, if you look at some of the pretty simplistic measures that have already been introduced in Congress, it’s just an amendment of the Federal Food, Drug and Cosmetic Act to say that CBD is allowed as a dietary ingredient. That’s a pretty simple fix.

“Now, FDA might say that doesn’t address safety concerns, but it’s not like the FDA’s view on this is the only view,” ‘he added. “There are others that think the safety concerns are overblown. I don’t want to say that I know better than the FDA, but I do read a lot of studies, I am aware of what other countries are doing, and I know trade groups have looked at this issue, and not just hemp trade groups. It’s the Council for Responsible Nutrition, it’s the American Herbal Products Association, the Consumer Healthcare Products Association. I don’t represent those groups and I don’t want to speak for them, but I don’t think they’d be pushing for this just because their members want it if it wasn’t safe. So, I do think there’s a dispute here about what in fact is the safety profile of these products. I don’t know if it’s as complicated as FDA is making it.”

In the absence of oversight, the industry must police itself. “I would say to monitor what’s going on and think about opportunities to engage with policymakers,” advised Havens. “Continue to be reputable operators, comply with whatever state regimes are out there, do not make claims, and make sure your products are third-party tested and that you’re meeting dietary supplement Good Manufacturing Practice requirements. In other words, comply with the framework many of us hoped FDA would have established years ago.”

A Threat to the Status Quo

In response to a request for comment, ProVerde Lab’s Chris Hudalla sent Cannabis Business Executive the following statement regarding a decision he believes comes with significant and protracted consequences.

“The FDA’s notice was incredibly disappointing. These products are already ubiquitous, available online as well as many brick and mortar retail operations throughout the country. Right now, with little to no oversight, consumers are paying the price by gambling with their health and safety. Hemp/CBD was one thing, but in the last year we have seen an incredible pushing the limits of what is acceptable. We see new synthetic compounds that are declared as ‘hemp derived’ hitting the market every week. Many of these chemical compounds that are on the market are not hemp derived (e.g., THCP), but the mere claim that they are, throws off all regulatory, DEA or law enforcement, allowing these contaminated products to be distributed without any responsibility or accountability. If there are consumer health concerns, these producers are nebulous, no chain of custody or ability to track down the source of these products. Even today, with the whole knowledge base gained from the EVALI crisis, we still see new product, formulated with Delta-8-THC in Vitamin E Acetate, hitting the online retail space. The Vitamin E Acetate was believed to be responsible for multiple deaths associated with EVALI, and yet, without oversight, people are still using this to create products.

“I was optimistic that if the FDA stepped in and was going to monitor or govern CBD and how it’s used, they would be quick to shut down these synthetic shenanigans. But their decision to punt it down the road to congress for another 5 years, seems like no one is going to be willing to address this. Not the DEA, not law enforcement, and state regulators are creating pathways for inclusion of these synthetic compounds within their regulatory frameworks.

“I hear regulators frequently say, ‘we’ll just make the labs test these products better,’ without any understanding of what that means, and the complexity of that statement. It would be analogous to regulators passing legislation that all commercial airline travel will be on solar-powered airplanes. While that may be a hopeful reality someday, we do not currently have the technology to make that happen and getting there is a very slow process. Similarly, the understanding of the chemistry and biological implications to these synthetic compounds will require years to achieve, to be able to ensure any level of consumer safety.

“So, with this decision, I do not expect the status quo to remain. Without oversight, I expect the boundaries to be pushed further and further, until the long-term health impacts resulting from this inaction will be experienced for generations to come……”

UPDATED

Lezli Engelking, founder of FOCUS (Foundation of Cannabis Unified Standards), whose separate editorial on the FDA decision was published Wednesday, also provided the following statement for inclusion here:

“Prolific amounts of unsafe synthetic cannabis products are now being sold to uneducated consumers online and in every gas station and convenience store across the country. These products are sold without warning labels, age restrictions, or safety protocols. Unsuspecting American’s have unknowingly become the test subjects in a real-world, uncontrolled, unregulated experiment using contaminated products.

“From a health and safety perspective, the most problematic aspect of FDA’s decision not to regulate CBD is that it took the agency almost 5 full years to reach that conclusion.  FDA’s lack of action since the passage of the 2018 Farm Bill has already caused an immeasurable detrimental impact to society and created extensive risks to public health and safety that are sure to impact Americans for decades.

“Prompt oversight and enforcement are desperately needed.  Without it, things will only continue to get worse…but what reason does anyone have to believe prompt oversight and enforcement are coming?  How much faith should any of us put in Congress to get this done effectively and efficiently?

“If public health was the concern, this wouldn’t have taken 5 years in the first place.”