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Committee Insights | 7.26.23 | Concepts for Regulatory Consideration – Shifting the Conversation from “Cannabis vs. Hemp” to “The Cannabinoids”

NCIA’s #IndustryEssentials webinar series is our premier digital educational platform featuring a variety of interactive programs allowing us to provide you timely, engaging and essential education when you need it most.

In this edition of our NCIA Committee Insights series, originally aired on July 26, we were joined by leading cannabinoid product manufacturers and Cannabis Regulators Association (representing cannabis and hemp regulators across more than 40 states and U.S. territories) to examine different approaches to regulating consumer products containing cannabinoids across the US and discuss the potential for harmonized regulations in the future.

Regulating the cannabinoids is difficult enough, but throw in the challenges associated with cannabinoids derived from marijuana or hemp and the challenges can get even more complicated. Not to mention the debate between intoxicating and non-intoxicating cannabinoids and how to address the risks to public health and safety from these different types of cannabinoids. Then you have the proverbial “cherry on top” with how to address cannabinoids, both naturally occurring and novel, being produced by genetically modified organisms and scientists in the lab. There has got to be a logical way to solve this problem.

One potential solution is shifting the conversation away from cannabis vs. hemp and toward the constituents of concern, the cannabinoids. By regulating the cannabinoids, we can focus the debate on what matters, how to regulate cannabinoid ingredients in a way that is proportional to the level of risk to public health and safety. This ensures we have both a functional and vibrant cannabinoid products market and the means to protect consumers.

Learning Objectives:

• Learn about the similarities and differences between marijuana and hemp regulations for consumer products containing cannabinoids
• Find out what a consumer product containing cannabinoids is and how this concept can be used to promote more common sense regulations
• Listen to new perspectives on the challenges facing the cannabinoid-containing consumer products space and how to more efficiently regulate this marketplace

Curious about the complex world of cannabinoid regulation? Sit back and settle in for an insightful webinar where we delve into the challenges (and solutions!) surrounding cannabinoids derived from marijuana and hemp.

Panelists:

Gillian Schauer
Executive Director
Cannabis Regulators Association

James Granger
Chief Political Officer
Cliintel Capital Group

Keith Butler
CEO
OP Innovates / Naturia+

Cassin Coleman
Founder
Cassin Consulting

Chris Hope
Founder and Consultant
Sequoia Management Group

Darwin Millard (Moderator)
Chief Scientific Officer – Canada
Final Bell

This is fifth and final program in a multi-part series of #IndustryEssentials webinars. You can watch Parts I-IV at the links below.

Defining the Conversation: Minor, Novel & Synthetic Cannabinoids (Part I): https://bit.ly/3D2LReB

Meet the Minors (Part II): https://bit.ly/3qUD8Ip

Safeguarding Consumers in the Cannabinoid Product Landscape (Part III):

Know Your Hazards – Occupational Health and Safety Considerations in Cannabinoid Ingredient Manufacturing (Part IV): https://bit.ly/3rEUeKP

Video: NCIA Today – August 20, 2021

FDA Punts on Regulating CBD Again

by Morgan Fox, NCIA’s Director of Media Relations

Last week, the hemp and CBD industries took another blow from the Food and Drug Administration when the agency refused to grant a request from prominent CBD producer Charlotte’s Web to regulate the substance as a dietary supplement. This is the latest in a series of delays and setbacks on the part of the FDA when it comes to regulating hemp-derived cannabinoids and products since they became technically legal at the federal level under the 2018 Farm Bill.

Bloomberg reports: “The company’s bid to sell its full-spectrum hemp extract with CBD as a dietary supplement won’t be considered because of the FDA’s own prior decision to treat CBD as a drug, according to a letter posted on the agency’s website Wednesday. This shouldn’t disrupt the business of Charlotte’s Web or prevent other companies from continuing to sell such products, which already exist in a gray area without the agency’s oversight. The decision shows the agency’s ongoing hesitancy to regulate cannabidiol, the non-psychoactive ingredient in cannabis plants better known as CBD… The FDA’s objection rested in part on its prior approval of Epidiolex, a CBD drug to reduce seizures, which the agency said precludes it from authorizing CBD for dietary purposes. Even if the drug hadn’t been approved, though, the FDA said in the letter to Charlotte’s Web dated July 23 that it “has concerns about the adequacy of safety evidence” that the company submitted.”

You can read the full FDA letter here.

This position is likely to create serious problems for the CBD industry. Without allowing CBD products to be regulated as dietary supplements or food additives, the FDA will be forcing producers to get federal approval for their products under the Investigational New Drug program. This process can often take years and cost applicants millions of dollars.

This casts even more doubt on what the future of the CBD market will look like as producers continue to operate in an uncertain landscape. The legality of CBD combined with the lack of federal regulations has created a lot of opportunities for responsible producers to bring products to market without dealing with the often overly strict state cannabis programs, but it has also opened the door to irresponsible operators who have been accused of actions from making misleading or unsubstantiated health claims to selling mislabeled or adulterated products.

Furthermore, the lack of federal regulations has discouraged many larger retailers from selling CBD or hemp-derived products altogether, drastically limiting the market options for producers. Some industry insiders have theorized that lack of access to those retailers has directly led to some producers desperately searching for ways to unload their excess CBD, including processing it into unregulated Delta 8 THC and flooding the markets in both legal and prohibition states, creating concerns among regulators, lawmakers, licensed cannabis operators, and consumers.

This troubling news follows on the heels of another memo issued by the Farm Credit that suggests that financial institutions that provide financing to hemp businesses should only do so if the company is operating under the auspices of a USDA-approved state hemp program.

“While many states and federally recognized tribes have since submitted those plans, 20 states are still operating under an earlier provision: a hemp pilot program created by the 2014 Farm Bill. That program, which is still valid and would be further extended under pending legislation that has passed the House and is pending in the Senate, requires less federal oversight than the new USDA-approved programs,” Marijuana Moment reports.

Some in the industry are concerned that the memo will lead to lenders dropping their hemp clients operating under the pilot programs, but others have suggested that it will not have a significant impact on the lenders who are already working with hemp businesses given the amount of reporting that they must already complete for the federal government and the lack of federal prosecutions for doing so historically.

It seems pretty clear by this point that the FDA will not move forward with regulating CBD in a timely and reasonable manner without outside pressure. You can add your voice to the chorus calling for sensible CBD regulations by visiting RegulateCBDNow and urging Congress to take action.

Felony Provisions, Harvest Schedules, and ‘Hot Hemp’ – NCIA Responds to USDA Hemp Rules

by Vince Chandler, NCIA’s Social Media Manager

On October 31, 2019, the USDA released its Final Interim Rule governing the domestic production of hemp within the United States. Going into effect immediately upon its issue, the interim rule regulates industrial hemp after the 2018 Farm Bill removed its Schedule I listing under the Controlled Substances Act. While the IFR is in effect, there is a public comment period happening right now, allowing for early input as the federal agency begins to “test drive” the program. Sunsetting after two years, the interim rules will inform permanent oversight and regulatory infrastructure after a full crop cycle has occurred. 

National Cannabis Industry Association Director of Public Policy Andrew Kline formed a coalition of more than 100 leading hemp and CBD entrepreneurs, scientists, medical doctors, and FDA lawyers in May to provide comments and testimony to the FDA on their regulations and rulemaking for CBD. The committee produced 60 pages of formal comments to the FDA, as well as providing expert testimony. After the submission of the coalition’s comments, the NCIA Hemp Committee absorbed the effort to voice the cannabis industry’s position on federal regulation of low-THC cannabis.

On Wednesday, NCIA hosted a webinar with our Hemp Committee Chair Cindy Sovine and committee member Alex Buscher to discuss the cannabis industry’s official response to the USDA hemp rules. Concerns about definitions, the feasibility of harvest windows, and DEA oversight of testing laboratories all pose as potential hurdles in the program’s viability, and NCIA is committed to ensuring our members have all the resources they need to submit feedback to the USDA before the deadline.

It is important to note that, while the 2018 Farm Bill descheduled hemp with less than 0.3% THC, the federal agency has left it up to individual states to submit plans for regulations and oversight. Until a state has submitted their regulatory plan, and had it approved, the sale of hemp is not legal in that state. While states draft and submit their plans, NCIA is leading the quest for information on how federal rules will apply. 

The administrative procedure for the USDA requires that they consider any comments put forth by the public, but do not have to adopt any of them. All indications are that they are open to influence and input from those, like National Cannabis Industry Association, with institutional knowledge on the matter. 

Highlighted in the webinar as an action item deserving immediate attention and commentary is the USDA’s planned rule for “hot hemp.” The agricultural governing agency appears to have taken the position that they lack regulatory jurisdiction over cannabis plants that test above the 0.3% THC threshold, deferring instead to the Drug Enforcement Administration.

NCIA’s Hemp Committee recommends that, instead of handing oversight to the DEA, USDA should adopt particular procedures that will allow for the remediation of those hemp plants. This re-processing should render non-compliant plants compliant, thus allowing for their use rather than requiring the immediate mandatory disposal, per DEA regulations.

Remediation options could include:

  • Removal of THC through processing
  • Conversion of THC
  • Diversion to fiber market

Interstate commerce, harvest scheduling, and DEA testing laboratory registration need to be addressed, along with specifying definitions for ambiguous terminology. These issues can be changed through public comment at the USDA rules level. 

Requiring legislative procedure to change is the felony provision rules in the USDA Final Interim Rule. Currently, the Farm Bill’s statutory felony provision reads, “any person convicted of a felony relating to a controlled substance under State or Federal law, before, on, or after the date of enactment on this subtitle shall be ineligible…” 

The USDA could have interpreted this provision broadly, blanketing the ban to apply to anyone working in any capacity in the industry. Instead, the USDA has limited this provision in their licensure by stating that it will apply only to “key participants.” While NCIA wishes to see felony provisions removed as barriers of entry from working in the legitimate cannabis industry, our committee recognizes this liberal interpretation of the provision as a best-case scenario, until the Farm Bill is up for renewal and specific language can be amended or abandoned. 

Public commentary is open until December 30, 2019, and all NCIA Members are encouraged to submit their thoughts. For suggested language or guidance shaping your comment, we’ve made available our slide show from the webinar with samples of copy and more information on individual recommended steps. If you are interested in shaping NCIA policy recommendations for hemp, CBD, or many other cannabis sectors, inquire about joining our Policy Council.

 

FDA Rulemaking on Hemp/CBD – Hurry Up And Wait?

by Andrew Kline, NCIA’s Director of Public Policy

In April of 2019, the National Cannabis Industry Association (NCIA) formed a coalition of more than 100 CBD/Hemp entrepreneurs, scientists, medical doctors, and FDA lawyers to inform and influence FDA rulemaking on cannabis and cannabis-derived compounds. Over the past two months, coalition members worked tirelessly to draft public comments. Our goal was to answer all of the questions posed by FDA (including scientific questions), to be helpful to FDA by informing their rule-making process, and to influence the direction of their rule-making.

NCIA Files Public Comment And Testimony

On May 30, 2019, we filed 60 pages of formal comments which can be found here. I’m really grateful for the coalition’s collaborative work and quite proud of our final product. I’m also extremely grateful to the authors, including Alena Rodriguez of RM3 Labs, Dr. Paul Murchowski of Dr. Pauls, Khurshid Khoja of Greenbridge Corporate Counsel, Vanessa Marquez and Chris Elawar of CBD Care Garden, Jonathan Havens from Saul Ewing, Andrew Livingston from VS Strategies, and many others who devoted time to produce a great submission.

On May 31, I testified before the FDA and listened intently as dozens of others spoke. My takeaways were that most of the industry echoed our sentiment – that CBD is generally safe, but that safety issues do arise with adulterated products and with irresponsible manufacturing and marketing practices. I spoke about the need for consensus-driven industry standards, to include marketing and labeling practices, and for mandated lab testing. These practices will go a long way toward making certain that the industry is safe for consumers.

Concerns And Misinformation

I am genuinely concerned that there is currently great confusion in the market. People seem to think that CBD is federally legal as a result of passage of the Farm Bill of 2019. But, that is only partially true. While CBD was de-scheduled, the FDA still retains the authority to regulate the industry as a result of their prior approval of a prescription drug for epilepsy, Epidiolex. In the absence of clear regulatory guidance, people are making health claims that violate federal law. And banks and payment processors are shutting off accounts for CBD businesses because they are having difficulty assessing whether a particular business is operating lawfully.

We hope that FDA will act with deliberate speed in drafting regulations for the industry. If FDA takes its time in crafting regulations, there is danger that many CBD companies will shudder because of a lack of banking and payment processing. And we will inevitably lose market share to Canada and other international players. As always, NCIA stands ready to help.

Looking Forward

On Wednesday, July 24, 2019, NCIA will host a panel at our next trade show, NCIA’s 6th Annual Cannabis Business Summit and Expo) in San Jose, California, entitled “A look into the future: An FDA Regulatory Framework for Hemp/CBD.”

Photo By CannabisCamera.com

Learning objectives for the panel include, (1) what the FDA was interested in learning about and why, (2) understanding how our industry coalition responded to the FDA’s scientific questions, (3) predictions for how the FDA will regulate CBD/Hemp and what it might mean for cannabis regulation in the future. Panelists will include members of the coalition who drafted our public comments to FDA.

In the coming weeks, NCIA will be releasing some new policy papers via NCIA’s Policy Council – the think tank for the state-legal cannabis industry. As always, if you’re interested in joining the Policy Council or have any thoughts about how we can propel this industry, please reach out me at andrew@thecannabisindustry.org.

Member Blog: 2018 Farm Bill – What Does This Mean For Hemp-Derived CBD?

by Robyn Ranke, Eskaton Law

For marijuana businesses, the 2018 Farm Bill is landmark legislation. Congress passed the Bill yesterday awaiting the President’s signature into law.

Transportation Of Hemp Across State Lines Allowed  

Federal legalization of Hemp will be astounding for the cannabis industry nationwide. Drafted into 807 pages of law is Sec. 10113 [Hemp Production] and Sec. 10114 [Interstate Commerce] of Title X.  Sec. 10113 adds “Hemp” to the list of “agriculture commodities” among other things.  Sec. 10114(a) allows for “the interstate commerce of hemp or hemp products” and “the transportation or shipment of hemp or hemp products produced in accordance with [section 10113] . . . through the State or the territory of the Indian Tribe, as applicable.” [Sec. 10114(b)] 

Hemp Means CBD

Federal Legislators defined “Hemp” as:

“[T]the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” 

States May Regulate Hemp Production, But Not Interstate Commerce

The bill allows States and Indian Tribes to regulate Hemp and expressly provides for “No Preemption” of any law of a State or Indian tribe that “regulates the production of hemp” and is “more stringent” than federal law [Sec. 10113.] 

However, Federal lawmakers went on to expressly provide for interstate commerce of Hemp and Hemp products [Sec. 10114] – the express language of the bill further states that “No State or Indian Tribe shall prohibit the transportation or shipment of hemp or hemp products produced in accordance with [Sec. 10113.]”  

While the Federal government occupies the field of interstate commerce under any circumstances, it will be interesting to see what happens in light of existing state cannabis regulations which make illegal the transport of marijuana across state lines. 

Either way, when the President signs this landmark legislation into law, the entire cannabis industry, and commerce alike, will finally have breathing room. For marijuana businesses, hemp would be fully legal according to the Federal Government. Every barrier to entry in banking, commercial real estate, intellectual property and everything in between will lift – advancing the industry one monumental step further to social acceptance of marijuana as simply a commodity just like any other commodity – like cabbage perhaps.  

If you would like a highlighted copy of the legislative text for the hemp sections under the 2018 Farm Bill, contact Eskaton Law.


An experienced corporate litigator having worked in both the private and government sectors, Attorney Robyn Ranke has taken a modern business approach to the cannabis industry and in working with cannabis business startups. Throughout her legal career, Robyn has represented a diverse base of business clientele in a variety of industries involving both complex and novel legal matters. Her diverse experience as a business litigator provides a valuable legal platform from which she is uniquely postured to address the regulatory hurdles, costly pitfalls, unique business transactions, and business litigation risks that confront California cannabis business owners today and into the future as state regulations continue to evolve. 

Member Blog: Hemp & CBD Legalization, Regulation & Compliance – Key Language in the Farm Bill

by Michael Cooper, co-founder of MadisonJay Solutions

Few developments in the world of cannabis — whether marijuana or hemp — could match the impact of the 2014 Farm Bill. But the 2018 Farm Bill, approved by the House and the Senate this week, promises to do just that.

As a quick reminder, the 2014 Farm Bill created an exception to the federal laws that prohibit the cultivation and sale of cannabis. To simplify, to the extent that a state created a pilot program to study hemp cultivation and the plants were of a sufficiently low level of THC, the resulting plant would be considered “Farm Bill hemp” and not subject to the prevailing federal prohibitions. To state the obvious, this was a very significant change. In fact, as a result of a combination of the magnitude of the change and the narrowness of the exception, apparent confusion led to periodic enforcement actions and court challenges.

As 2018 draws to a close, Congress must once again reauthorize the Farm Bill. It’s worth noting that the periodic reauthorization has nothing to do with hemp policy, and everything to do with the federal legislative process.  

And the relatively narrow “exception” for hemp in the 2014 Farm Bill is on the cusp of significant expansion. Hemp, defined as cannabis plants and all their parts, extracts, “cannabinoids,” and derivatives with a THC concentration of less than 0.3%, will be subject to a regulatory scheme devised by the federal Department of Agriculture and will be removed from the federal Controlled Substances Act. States that wish to regulate hemp may propose regulations that the state “shall submit to the Secretary” of Agriculture. Notably, no state “shall prohibit the transportation or shipment of hemp or hemp products” produced in compliance with these new rules.

So, inquiring minds might wonder, what happens if 2018 Farm Bill hemp turns out to have a THC concentration of 0.31% instead of the permissible 0.3%? To the extent that higher THC concentration is the result of an honest mistake, Section 297B(e)(2) provides the answer: if the state has developed hemp regulations, and the state concludes the violation was the result of “negligence” (e.g., an unintentional oversight), the producer will be required to take corrective action. If that happens 3 times in a 5-year period, the producer will be ineligible to produce. If the state has not developed hemp regulations, the same standard will be applied by the federal Secretary of Agriculture pursuant to Section 297C(c)(2).

That is, a “negligent” mistake should not place the cultivator at risk of being placed outside of the protections of the Farm Bill (discussion of the reach of those federal laws is fascinating, but beyond the scope of this post). As a result, it will remain advisable for hemp cultivators to implement sufficient compliance efforts to avoid any potential inference that they are intentionally seeking a higher THC concentration.  

Barring the unexpected, the 2018 Farm Bill will have a seismic impact on the hemp and hemp-derived CBD industry. With the nation watching, a smooth, well-regulated transition can only help to bolster calls for broader cannabis reform. As a result, once the 2018 Farm Bill becomes law, the industry will undoubtedly be paying close attention to the regulations promulgated by federal and state hemp regulators. And they will be working hard to demonstrate that they are staying within those guidelines.


Michael Cooper is the co-founder and managing member of MadisonJay Solutions LLC, a leading regulatory advisor to the adult-use cannabis industry that helps businesses understand the latest rules and build effective compliance infrastructure to address risk. He is the Vice Chair of the NCIA’s State Regulations Committee, and publishes and speaks frequently on cannabis regulation.

He is a graduate of Harvard College and Harvard Law School, and previously served as General Counsel of MHW, Ltd. and in the litigation department of Cravath, Swaine & Moore LLP.  He began his legal career as a law clerk on the U.S. Court of Appeals for the Fifth Circuit. He can be reached at mcooper@madisonjaysolutions.com.

Hemp: One of the Nation’s Oldest, and Now Newest, Agricultural Commodities

by Michelle Rutter, NCIA’s Government Relations Manager

HISTORY

Farming and agriculture has long been a part of North American history. When the Great Depression hit in the 1930’s, both President Franklin Delano Roosevelt and Congress knew that the United States would struggle until the agriculture industry became prosperous again. As a result, many New Deal programs dealt with farming, but arguably the most notable agriculture related legislation was the Agricultural Adjustment Act of 1938, which was the first version of what we know today as simply the “Farm Bill” that is updated roughly every five years.

TODAY

In 2018, a new Farm Bill was introduced with a price tag upwards of $800 billion. One of the most notable provisions in this year’s bill was led by Senate Majority Leader Mitch McConnell (R-KY): hemp legalization. Industrial hemp refers to the cannabis plant with less than 0.3 percent THC content and would include CBD medicinal products — so long as it contains less than 0.3 percent THC and is derived from industrial hemp.  

While leadership in the House of Representatives blocked the hemp provision in its version of the bill, the Senate’s version of the bill that passed overwhelmingly in June does include it. That means that when the bill goes to conference in early September, that hemp legalization will be debated. Considering that the Senate Majority Leader is championing this provision, it stands a good chance at being included, though nothing is guaranteed.

Marijuana’s “cousin,” hemp, is generally barred because it is part of the cannabis plant, despite the fact that it contains little of that drug’s key psychoactive ingredient, THC. In 2014, Sen. McConnell secured a hemp pilot program in that year’s farm bill. Since then, at least 35 states have taken up the offer and developed industrial hemp programs, and those states will be eligible to pursue a legal, regulated market if the 2018 Farm Bill is passed with the hemp provision included.

If passed, the Farm Bill would legalize hemp as an agricultural commodity by removing it from the federal list of controlled substances and giving states the opportunity to be the primary regulators of hemp production. In addition to removing hemp from the federal controlled substance list, the Senate farm bill would allow industrial hemp to be eligible for crop insurance, a perk already enjoyed by other, more traditional crops. The bill would also reauthorize commodity, trade, agricultural research, rural development, and food and nutrition programs. Under current law, authorizations will expire September 30 or the end of the applicable crop year.

The first farm bill conference committee meeting has been set for September 5, 2018. The conferees from the House and Senate will try to iron out differences between their two bills in the panel. Included in the discussions will be 47 members of the House of Representatives and nine Senators. The results of this could mean a new era for the agricultural industry if hemp returns to American farmlands.

 

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