After Boom and Bust, Could Hemp Market Be Stabilizing?
This article first appeared in the May 2024 issue of Presence Marketing’s newsletter.
By Steven Hoffman
Could the hemp industry be on the cusp of a turnaround? After several years of volatility for U.S. hemp growers, prices and acreage in many states are beginning to stabilize or are rising modestly, according to the National Hemp Report, published by the U.S. Department of Agriculture (USDA) in April 2024.
According to the USDA, the value of U.S. hemp crop production in 2023 totaled $291 million, up 18% from 2022. Based on a survey sent out in January 2024 to producers across the country as part of USDA’s national agriculture census, the report shows signs of renewed market growth and improved on-farm efficiencies. “There was the big boom, then the big falloff, and this year everything is sort of leveling out,” Joshua Bates, a USDA statistician who wrote the landmark National Hemp Report, told MJBiz Daily.
“The hemp industry is stabilizing into its various categories including: 1) cannabinoids, nutraceuticals and flower; 2) food, feed and nutrition; and 3) fiber and industrial materials and applications. At this time, a much clearer picture is emerging as to where these categories can end up over the next three, five and ten years,” said Morris Beegle, publisher of Let’s Talk Hemp and producer of NoCo Hemp Expo, the leading trade show and conference for the hemp industry.
“The past several years posed significant challenges, starting with the pandemic’s onset and exacerbated by the federal government’s regulatory ambiguity regarding CBD and hemp-derived cannabinoids. Add to that burdensome regulations imposed on farmers endeavoring to cultivate hemp fiber and grain – crops that deserve equitable treatment akin to any other commodity. Such circumstances deter participation in this budding industry. What we truly require are coherent federal regulations applicable universally, instead of disjointed state-level initiatives that render the industry vulnerable and unsupported,” Beegle said.
Recovery on the Horizon
Production of industrial hemp for food, fiber and flower took off after it was legalized in the 2018 federal Farm Bill. In the years before the Covid pandemic, hemp acreage was on the rise, entrepreneurs and investors flocked into the market, and there was an explosion in the number of CBD and other hemp-related brands.
However, since 2020, the market for products made from hemp (defined as containing less than 0.3% THC) experienced a significant downturn, sparked by the pandemic and made worse by a lack of regulatory consistency over CBD and other hemp-derived cannabinoid compounds from the U.S. Food and Drug Administration (FDA) and state regulators. Investors pulled back. Brands did everything they could to survive; some didn’t. Overproduction during this time, too, led to steep drops in the price of hemp. As a result, hemp acreage plummeted from an estimated peak of 37,000 acres harvested in 2020 to a little more than 19,000 acres harvested in 2022.
Now, according to USDA’s hemp report, overall hemp acreage harvested in 2023 increased 21% to a total of 23,475 acres, signaling a potential turnaround in the market.
Hemp flowers for CBD and other hemp-derived cannabinoids -- including the intoxicating compounds Delta 8 and Delta 9 – dominated the market in 2023. While flower acreage remained relatively flat at approximately 7,000 acres in 2023, flower producers experienced an income gain of 35%, according to USDA data. Of the $291 million in market value for hemp in 2023, $241 million of that income came from hemp flowers. However, based on regulatory and safety concerns around Delta 8 and other hemp-derived psychoactive compounds, a number of industry observers feel this growth may be unsustainable, as lawmakers could severely limit the sale of these products.
Speaking of the hemp flower sector, economist Beau Whitney of Whitney Economics said, “It is quite possible that the cannabinoid industry has peaked. The excess inventories are mostly depleted and there is not enough acreage, in our view, to backfill with enough supply to sustain the level of sales experienced currently. This is a mistake by legislatures and regulators and now opens the door up for cheaper, but potentially lesser quality imports,” he cautioned.
Hemp grown for fiber – used in textiles and industrial applications – accounted for 52% of all hemp acreage harvested in 2023. While acreage grew, USDA reported that prices dropped and farmers brought in less income. However, says Whitney, “Hemp fiber is where we are forecasting significant growth in the short term, while cannabinoids and grains get sorted out. Hemp for plastics and automotive are already established in the global marketplace and are expanding in the United States. Hemp as a construction material is also increasing, but that growth has been somewhat sluggish in its initial ramp-up.”
Regarding hemp grown for food and grain, Whitney remarked, “The food industry is pretty steady. One major game changer would be FDA approval for hemp grains as an animal feed. It appears that the FDA is setting up unrealistic requirements for cannabinoid content in feed, so much so that consumers/animals would have less strict requirements for heavy metals and poisons than CBD content. There is a huge market for hemp grain internationally, but other supply chain issues and geopolitical tensions are impacting expansion efforts by U.S. hemp operators.”
According to USDA’s National Hemp Report, hemp grown for grain accounted for 17% of all hemp acreage harvested. Canada and China remain the world’s leading countries for hemp grain production, yet, as plant-based foods become more popular, U.S. growers stand to benefit from opportunities in growing hemp for food, as it is one of the richest plant-based sources of protein, essential fatty acids and other key nutrients.
“The use of hemp in automotive, pulp and paper (packaging), and building material applications are all increasing in the pace of growth,” Whitney added. “The major headwind is the narrative that hemp is a drug. The lack of awareness and education by policymakers on the potential of hemp is its limiting factor. Policymakers are using a sledgehammer instead of a scalpel when making hemp policy, and it’s having a ripple effect throughout the industry from an operator, investor and infrastructure perspective,” he said.
Stuck Between FDA and the MJ Industry
“There are two big battles going on in Washington, DC, right now. One is the hemp industry against the FDA. The other is hemp vs. marijuana,” observed Jonathan Miller, General Counsel of the U.S. Hemp Roundtable, the hemp trade’s leading advocacy and lobbying group.
“We’ve been trying to get the FDA to regulate CBD and other extracts. First, they said they were working on it and now they say they need congressional authority. It’s a game of pointing fingers – Congress says it needs guidance from FDA, and FDA says it needs direction from Congress, so we’ve got a stalemate. However, there has been a lot of congressional and public pressure on FDA to act, so that may be a reason why the agency is talking to us now,” Miller said. “We would love to see something resolved this year; there is talk of an interim step where Congress could potentially pass a law to validate existing state programs in the absence of consistent federal regulations. The Farm Bill may not happen until next year; meanwhile our efforts to find a vehicle for this compromise will continue.”
And, Miller said, “As always, we advise companies to act like they are being regulated by the FDA as a dietary supplement or a functional food and beverage product, and to operate within those regulations.”
In referring to competition with operators in the marijuana space, Miller said, “Regarding the marijuana industry, it is not monolithic, but there are a growing number of organizations that have made it their objective to kill the hemp industry as a means to capture competitive gain. This includes ATACH, the American Association for Hemp and Cannabis – though there are no hemp members – and the US Cannabis Council. Both have introduced plans that they would like to see in the Farm Bill to federally criminalize any hemp product that has any level of THC in it. That would criminalize all but CBD isolates,” he said.
“We are fighting both in the public eye and behind the scenes right now, and there’s a big battle going on in California in this regard. This is a threat we have to watch from the left flank. We are hopeful that any effort like this will die in Congress, but we are not banking on it; in fact, we are working very hard to prevent it. Just last week, we met with 55 different members of Congress and staff to discuss these issues and to present the hemp industry's position,” Miller added.
“All sectors of the hemp industry are growing, with the cannabinoid sector growing rapidly, to the point where it is outpacing the marijuana industry,” observed cannabis industry attorney Rod Kight of Kight Law. “The opportunities exist for nimble companies that are willing to take the time to navigate the rapidly evolving regulatory landscape and who can pivot as needed when regulations and markets change. I have hope that hemp can lead the path to true and comprehensive cannabis reform.”
FDA’s Position
When asked if the FDA could envision a scenario in which it would allow the sale of CBD as a dietary supplement without congressional action, Patrick Cournoyer, Senior Science Advisor with the FDA replied with the following:
“The FDA has concluded that the existing regulatory framework for dietary supplements is not appropriate for CBD. Given the available evidence, it is not apparent how CBD products could meet the safety standard for dietary supplements. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements.”
Cournoyer’s office referred to FDA’s statement from January 2023, where the agency concluded that “existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol,” and that it will work with Congress on “a new way forward.”
Added Cournoyer, “The FDA supports sound, scientifically based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds and will continue to work with companies interested in bringing safe, effective, and quality products to market.” Cournoyer referred to guidelines published on FDA’s webpage, “FDA and Cannabis: Research and Drug Approval Process.”
In addition to food, supplements and drugs intended for human consumption, FDA has regulatory oversight of animal feeds. Regarding the use of hemp in animal feed, an FDA spokesperson said, “After comprehensive review of data submitted by a sponsor, in January 2024, the FDA recommended to the Association of American Feed Control Officials (AAFCO) that a proposed ingredient definition for hemp seed meal in the feed of laying hens be included in the AAFCO Official Publication. The FDA has not reviewed any other submissions for the use of hemp seed or hemp seed derived ingredients in animal food.”
Wendy Mosher, VP of the Hemp Feed Coalition, told AgWeb in January 2024 that allowing hemp seed meal into feed mixes for laying hens marks the first hemp feed ingredient to get federal recommendation and interest by AAFCO. “You can’t have a commodity crop without a feed opportunity for that crop,” Mosher said.
In the absence of federal approval of hemp in animal feed, Texas legalized hempseed oil and hempseed meal for chickens and horses in 2023. Kentucky in 2022 allowed a limited amount of hempseed meal and hempseed oil as ingredients in the diets of layer, broiler, and breeder chickens. Montana legalized hemp or hemp-derived products in 2021 for “non-consumption animals,” i.e., pets, specialty pets, and horses, reported Hemp Benchmarks. However, in December 2023, New York Governor Kathy Hochul vetoed bills to allow hemp seed in animal feed, citing the need for more information.
While federal lawmakers and regulators move slowly in allowing the use of hemp in animal feed, USDA is providing grants to universities and others to research the potential use of hempseed, meal and biomass in animal feed. For example, researchers at Prairie View A&M University in Texas in 2023 received a $300,000 grant from USDA to explore hemp as an alternative grain in animal feed.
Building with Hemp
Building with hemp in the United States is increasing year over year, said Jean Lotus, Editor and Publisher of HempBuild Magazine. “Prices on building-grade hemp hurd remain high and the supply chain is neither complete, nor consistent. But hemp building in the United States is capturing the imaginations of developers and motivated owner-builders. Notable projects this year include a multi-unit tip-up hempcrete panel project in Newburyport, MA, and successful attainable hempcrete housing built by the Lower Sioux of Morton, MN,” she said.
“People may say hemp is dying, but it also recently received approval from the IRC (International Residential Codes) for the use of hempcrete in the U.S. for commercial construction,” noted James Johnson, Principal of JJGro in San Antonio, TX. Johnson, who discovered hemp’s healing properties while dealing with PTSD after 21 years of service in the U.S. Air Force, consults with hemp producers throughout the country. “Hemp is starting to be considered as part of the mix in mainstream commercial construction. It’s not going to replace traditional materials, but it will capture between 2% and 5% of the building construction space, Johnson predicted.
Lotus added that research in hemp building materials received significant funding in the past year, including $1.9 million from the U.S. Army; $1.5 million from the Department of Energy; and $1.1 million from the New York State Energy Resource and Development Authority (NYSERTA).
“Meanwhile, the regulatory environment for hempcrete's superior insulation and carbon sequestering properties is improving,” she said. “In April 2024, the U.S. Department of Energy released a roadmap to decarbonize the U.S. building industry. The report, Decarbonizing the U.S. Economy by 2050: A National Blueprint for the Buildings Sector, emphasized building with biogenic, regenerative materials. Hemp-lime and hemp-batt insulation perfectly fit the bill! With new companies developing carbon credits for hempcrete projects, there is more excitement and investment opportunity to come.”
“We are seeing increased interest in hemp across the board from consumers, universities, and large corporations wanting to utilize hemp as an input or ingredient. I think there's opportunities in every sector for savvy, smart business operators. While cannabinoids provide the biggest boom/bust potential, there are long term opportunities in the fiber and grain markets as the regulatory framework within those categories will eventually get to a point of any other commodity crop, for the most part,” said Morris Beegle.
“As to headwinds, it's still all political and bureaucratic,” Beegle added. “The industry needs to be unified in its voice to combat correctly, and I think we have made real progress the last few years with the vast majority of the ‘real’ industry aligning on messaging and action. We’re also seeing progress and persistence of the industry in delivering on the promise of hemp as an alternative resource to many of the world's current and future problems. The future is bright regardless of what some in the media, and some on social media, would like people to believe.”
Save the Date: NoCo Hemp Expo, Aug. 10-12, 2025, Estes Park, CO
U.S. Hemp Leaders Unite on Plan of Action as 2023 Farm Bill Deliberations Approach
FOR IMMEDIATE RELEASE
Key industry stakeholders convened at the NoCo9 Hemp Expo in March to finalize a policy document that 31 nonprofits have now signed.
WASHINGTON, D.C. (April 24, 2023) – As the 2023 Farm Bill deliberations approach, U.S. hemp leaders are united behind a plan of action. And this unprecedented alliance among 31 nonprofit hemp organizations portends promise for congressional enactment of the industry’s agenda.
This winter, three of the nation’s leading hemp organizations – Hemp Industries Association (HIA), National Industrial Hemp Council (NIHC) and U.S. Hemp Roundtable (USHR) – joined in collaboration for the very first time to develop a series of policy priorities for enactment in the 2023 Farm Bill. The three groups then asked industry leader Morris Beegle to convene a meeting of more than 75 key hemp stakeholders at the leading national hemp gathering that he produces, the NoCo Hemp Expo. After an intense discussion, and follow-up breakout groups to expound on the deliberations, a priority policy document was finalized. Since then, 31 state, regional and national nonprofit organizations have signed on in support.
The document, attached hereto, lists nine key policy priorities for consideration by Congress. These include requiring FDA to regulate hemp extracts such as CBD; easing the regulatory burden on hemp farmers; repealing the hemp felon ban from the 2018 Farm Bill; and addressing THC limits for hemp. This document is being shared with key members of Congress and will serve as the foundation for drafting legislative language to be included in the Farm Bill.
NIHC President and CEO Patrick Atagi praised the work of the hemp industry for broadly coming together to endorse hemp priorities and hemp-specific Farm Bill priorities. “’Working Together Works’ are true words taught to me by my mentor, former USDA Undersecretary William ‘Bill’ Hawks,” Atagi said. “I am glad to see the hemp industry come together; it is a sign of great things to come.”
“This is an historic moment for hemp,” stated Jonathan Miller, USHR’s General Counsel. “The five years since legalization have been challenging, and the 2023 Farm Bill is our next and best opportunity to take this industry a step forward. The unity within the industry is remarkable and telling: Our shared voice will resonate with Congress and help us turn this opportunity into meaningful progress for hemp farmers and product consumers.”
Said Morris Beegle, co-founder and president of We Are For Better Alternatives, or WAFBA: “The last five years have taught us a lot, and more than anything, that we as stakeholders need to align our interests and our voices going into the 2023 Farm Bill so that we correct the regulatory deficiencies that have plagued the growth and development of this nascent industry. I’m optimistic and encouraged by so many organizations coming together at this time to collaborate and work in unison to improve the future of the hemp industry.”
Contact
Morris Beegle, WAFBA, info@nocohempexpo.com
Steven Hoffman, Compass Natural, steve@compassnaturalmarketing.com, tel 303.807.1042
WAFBA Announces a Pause for 2023 Southern Hemp Expo in Nashville
SHE became dominated by Delta-8 and other intoxicating hemp-derived cannabinoids popular in areas where adult-use cannabis is not legal.
LOVELAND, Colo. (April 18, 2023) -- WAFBA -- We Are For Better Alternatives, the umbrella organization that hosts and produces NoCo Hemp Expo, Southern Hemp Expo, Hawaii Hemp Conference, Winter Hemp Summit and other hemp-centric conferences, trade shows and events -- is going to pause the 2023 Southern Hemp Expo. The Southern Hemp Expo, aka SHE, launched in 2018 in Nashville as the sister show to NoCo Hemp Expo, the most comprehensive hemp exposition and trade show on the planet.
SHE was a highly successful event in both 2018 and 2019 but was canceled in 2020 due to the Covid pandemic. SHE moved to Raleigh, North Carolina, in 2021 and back to Nashville in 2022. Both shows struggled to regain the momentum that the hemp industry had prior to the pandemic and both shows ended up being dominated by the rise in the intoxicating hemp-derived cannabinoid category, including Delta-8, HHC and other derivatives that have come to be popular with the consumer market in areas of the United States where adult-use cannabis is not yet legal.
Hemp for Health and Wellness
Both NoCo Hemp Expo and Southern Hemp Expo were founded on the decades-long mission and mantra that hemp is for health and wellness for humans and animals and an environmental benefactor for the planet in being able to produce eco-friendly, carbon-neutral to carbon-negative materials for a variety of industrial applications. These include commercial and residential construction products, textiles, automotive components, paper and packaging, bioplastics and biocomposites, animal bedding, biochar and more.
Another long-standing mantra for the hemp industry has been “hemp does not get you high,” which was the case until the domestic oversupply of CBD biomass increased significantly in 2019 and 2020. Additionally, the FDA continued to skirt its regulatory responsibilities given to the agency by Congress in the 2018 Farm Bill to regulate the burgeoning and popular CBD market. The lack of regulatory oversight kept major retailers and major consumer brands on the sidelines as well as investment money out of the industry. This in turn was a factor in the increased oversupply and the eventual development of the synthesized, hemp-derived cannabinoid market that is proliferating today. This market has opened up a variety of concerns, from consumer safety issues to state product bans as well as state legislation approving of these products, and other various regulatory murkiness around the country. To put it simply, it's a mess and extremely complicated to navigate in this new category of the hemp industry. To be clear, WAFBA, Southern Hemp Expo and its management are not in favor of "banning" or making "illegal" this new category of hemp-derived products. This category of products needs federal regulation, which we hope will occur in the upcoming 2023 Farm Bill.
Focus on Flagship Event
With the above-mentioned confusion, complexity and the state of intoxicating hemp-derived cannabinoids, WAFBA has made the decision to focus its trade show and event energy on its flagship event, NoCo Hemp Expo, and to do everything we can to build this event as the international hub and gathering spot of hemp-based heath, wellness, nutrition, environmental, and socially impactful opportunities that can benefit humanity and the planet.
For additional information and to keep abreast of future activities and events, we encourage the industry and interested parties to subscribe to our newsletter and visit our media platform at www.letstalkhemp.com.
Contact
Morris Beegle, WAFBA, info@nocohempexpo.com
Steven Hoffman, Compass Natural, steve@compassnaturalmarketing.com, tel 303.807.1042
Nutrition Industry Up in Arms Over Proposed Dietary Supplements Listing Bill; Could it Be a Slippery Slope to FDA “Preapproval?”
This article originally appeared in Presence Marketing’s June 2022 Industry Newsletter.
“We fully trust FDA will make mischief. We don’t know how, but we do have 60 years of history of FDA authority trying to limit access to supplements.” – Michael McGuffin, President, American Herbal Products Association, in response to S. 4090, the Dietary Supplement Listing Act of 2022
By Steven Hoffman
On April 26, 2022, U.S. Senate Majority Whip Dick Durbin (D-IL), introduced a bipartisan bill co-sponsored by Sen. Mike Braun (R-IN), S. 4090, the Dietary Supplement Listing Act of 2022.
The proposed legislation, according to a statement from Durbin’s office, would require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA), known as a mandatory product listing (MPL). In addition, companies would be required to “provide FDA with vital information about their products, including product names, a list of all ingredients, an electronic copy of the label, allergen statements, health and structure/function claims, and more. This information would then be made available to the public,” Durbin’s office said.
Introducing the bill, Durbin said, “70% of people in America take a dietary supplement, including me. I also believe that Americans who take vitamins, minerals, and herbs for their health and wellbeing have a right to know what’s in those supplements. Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true.”
Reaction to the bill among industry leaders and associations has been mixed, yet many in the nutrition industry are up in arms in that the bill proposes that all dietary supplements sold in the U.S. be listed in a federal database or registry. Opponents are concerned that it may infer that the FDA would end up gaining “pre-market approval” authority over dietary supplements, in that the bill states that upon receiving a company’s listing submission, FDA will “confirm” a “complete listing” and issue an identification number.
According to Nutritional Outlook, the questions dietary supplements companies are asking include: “What could cause FDA not to confirm a listing? Can products automatically go to market after submitting a listing, regardless of FDA’s response? Could FDA, in fact, use mandatory product listing as a premarket-approval lever to keep certain ingredients off the market?”
“This is purely premarket approval and anyone who tells you different is lying,” Daniel Fabricant , Ph.D., President and CEO of the Natural Products Association (NPA), told Nutritional Outlook. Based in Washington, D.C., NPA opposes the bill and has been galvanizing the dietary supplements industry to act quickly to send letters to voice their concerns to their legislators via a web page here.
“Senators Durbin and Braun are one step closer to creating pre-market approval for dietary supplements a reality. Their bill was recently tied to the FDA Safety and Landmark Advancement Act (FDASLA), creating new regulatory barriers and giving the FDA new authority to prevent health and wellness products from reaching millions of consumers. Sadly, Senators Braun and Durbin are using their dislike of the dietary supplement industry to misrepresent its excellent safety record. The FDASLA is intended for drugs, not supplements, and we cannot afford to allow critics to stifle the industry,” Fabricant said in an appeal to members.
NPA asserts that responsible natural products retailers and manufacturers already go to great lengths to ensure consumers have access to safe products. Operating under the framework of DSHEA, the Dietary Supplements Health and Education Act of 1994, “FDA has a robust regulatory framework to understand what dietary supplements are being sold and who is selling them,” NPA said.
“The FDA has several tools at its disposal, with associated penalties for failure to comply. Retailers and manufacturers also have strong market incentives to make safe products. The proposed language in the Dietary Supplement Listing Act of 2022 requires pre-market approval for dietary supplements, thus is more stringent than the NDI (New Dietary Ingredients) provision, which is a notification. The FDA already has access to information regarding who is making dietary supplements, where they are making them, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events,” the association added.
In a recent meeting of the U.S. Hemp Roundtable (USHR), representing CBD supplement companies, Michael McGuffin, President of the American Herbal Products Association (AHPA), said, “We oppose the bill because it is redundant, and we don’t think it is so perfectly written that it doesn’t drift into preapproval. I don’t see this as certain pre-market approval, but it says that FDA will confirm a submission that is complete, so what does ‘complete’ mean? FDA will interpret this as it sees fit. For example, you’re required to list all your claims, but they could say you didn’t list all your claims.”
One thing is certain, McGuffin said. “We fully trust FDA will make mischief. We don’t know how, but we do have 60 years of history of FDA authority trying to limit access to supplements,” he cautioned.
McGuffin added, “We like the word ‘listing’ vs. ‘registry,’ which sounds stronger, but Sen. Durbin said specifically ‘registration.’ Even though we all say listing because we agree not to whip people up over this, but the guy who wrote the bill, Sen. Durbin, said registration, Also, there is no exemption for retailers, so every white label brand also will have to register,” he noted.
“We understand there may be an inevitability here, and then we would switch our focus to how to make it least impactful,” McGuffin said, referring to the proposed legislation. “The details are going to be important, and there is a lot we don’t know in this bill.”
Megan Olsen, Senior VP and General Counsel for the Council for Responsible Nutrition (CRN), told USHR attendees that CRN supports the proposed Dietary Supplement Listing Act. Referring to a product registry, she said, “This could give consumers and retailers a place to look to see if products are legitimate, continuing to ensure that there is transparency over the industry and enhancing consumer trust. However,” she added,” our position is that it cannot be pre-approval. If it looks like it’s going that way, that’s when we would push back very strongly.”
In speaking of the proposed dietary supplements legislation, Karen Farrell, Senior Director of Brand Management, Nutrition and Body Care for Presence Marketing, said, “I feel like the industry should keep its antennas high on this one. We already have existing policy in DSHEA; if something needs to be changed, it should be done under the existing structure of DSHEA rather than write separate legislation outside of what already exists. We still have some people who say the supplement industry is unregulated, and that’s just not true,” she said, adding that the proposed bill could also slow product innovation and launch times.
“Dietary supplement manufacturers are already playing by the rules; they are jumping through all the regulatory hoops and have made a commitment to quality. I’ve been reviewing new products and brands for 10 years at Presence, and I think I only ever saw one brand that I had questions about, and we addressed it right away. FDA already has authority to regulate and send warning letters, etc. I don’t think we need this bill; DSHEA works, Farrell added.
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Hemp Industry Shifts from CBD to Food and Fiber, According to New Report
Photo: Pexels
This article originally appeared in Presence Marketing’s February 2022 Industry Newsletter
By Steve Hoffman
Look for the industrial hemp market to continue to grow in 2022, in spite of a few handicaps caused by continued regulatory uncertainty from the FDA and supply chain bottlenecks, according to the new Hemp Industry 2022 Opportunities Report published by Let’s Talk Hemp Media. The executive-level report provides an overview of the trends and potential strategies ahead in the growing industrial hemp sector, after hemp has been legalized in more than 65 countries this year.
Two things holding the hemp industry back in the U.S. are supply-chain bottlenecks and regulatory uncertainty, said report contributor Beau Whitney of Portland, OR-based Whitney Economics. “Once the market begins to mature, the future looks bright for the hemp industry,” Whitney noted.
The pandemic and a glut in biomass supply saw farmers turn away from hemp last year. Licensed acreage in 2021 dropped by 55% year-over-year to levels seen before the 2018 Farm Bill, according to the report. CBD market prices fell below production costs, due to a glut of product, as well.
However, a “bright spot was the supply and demand for fibers and grain,” the report said. Expect a “pivot” in the hemp industry as more farmers see the potential (albeit less profitable) of hemp fibers and grains, which are predicted to exceed acreage planted for CBD by 2024-25, Whitney projected.
Regulatory uncertainty in the U.S. has hampered the cannabinoid hemp industry because the FDA to date has refused to approve CBD as an ingredient for food and beverage or dietary supplements. However, CBD remains popular with consumers, and recently passed legislation in California sets health guidelines for hemp-derived CBD in food, beverages and cosmetics. That could be the green light for large multinational food companies waiting for FDA approval to add CBD to consumer products, experts believe.
In addition, hemp seed is viewed today as a superfood containing complete protein and omega-3 and omega-6 essential fatty acids. Hemp protein is poised to become a staple ingredient in new plant-protein foods and is expected to grow to $109 billion by 2050, the report predicts.
The Hemp Industry 2022 Opportunities Report is available at LetsTalkHemp.com. The report is published by the producer of the 8th Annual NoCo Hemp Expo, the hemp industry’s most comprehensive trade show and conference, scheduled for March 23-25, 2022, in Denver, CO.
U.S. Representatives Introduce Bipartisan Bill to Regulate CBD in Food & Beverages
Photo: Pexels
This article originally appeared in Presence Marketing’s January 2022 Industry Newsletter
By Steve Hoffman
U.S. Representatives Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-MN) and Dan Crenshaw (R-TX) on December 2 introduced the CBD Product Safety and Standardization Act in the U.S. House of Representatives. If passed, the bipartisan bill would call for the U.S. Food and Drug Administration (FDA) to create a regulatory and enforcement structure for hemp-derived cannabinoids such as CBD as an ingredient in food and beverage products, and to provide recommendations on maximum daily usage and provide packaging and serving guidelines.
Previous federal legislation has been proposed to regulate CBD as a dietary supplement and functional food ingredient, including H.R. 841, introduced in February 2021 in the U.S. House of Representatives, and S. 1698, introduced in May 2021 in the U.S. Senate, reported Let’s Talk Hemp. “CBD products are exploding in popularity, but the lack of federal regulation surrounding them has put consumers at risk and left businesses looking for clarity,” lead sponsor of the new bill, Rep. Rice, said in a press release.
“The hemp industry is grateful to Reps. Kathleen Rice, Morgan Griffith, Angie Craig and Dan Crenshaw for their introduction of The CBD Product Safety and Standardization Act. We strongly support requiring the FDA to regulate hemp extracts like CBD as food and beverage ingredients, U.S. Hemp Roundtable General Counsel Jonathan Miller said in a statement. “We look forward to working with the bill sponsors to ensure that this legislation provides the broadest range of protections for hemp extract products for human and animal consumption, and to serve as a strong complement to H.R. 841, introduced by Rep. Kurt Schrader and supported by 35 co-sponsors, which would require FDA to regulate CBD in dietary supplements,” Miller said.
FDA Objects to CBD Being Sold as a Dietary Supplement; Industry Leaders Speak Out
By Steven Hoffman
FDA’s recent decision to reject New Dietary Ingredient applications for full-spectrum CBD from Charlotte’s Web and Irwin Naturals casts a cloud of market uncertainty; passage of Congressional legislation is only option, say industry leaders
Despite months of diligent communications with the U.S. Food and Drug Administration (FDA), along with the submission of volumes of data demonstrating the safety and efficacy of full-spectrum, hemp-derived cannabidiol (CBD), FDA in a letter posted on August 10 rejected two New Dietary Ingredient notification (NDI or NDIN) applications for CBD submitted by pioneering CBD brand Charlotte’s Web and leading natural supplement brand Irwin Naturals.
The decision, based on the agency’s 2020 ruling to treat CBD as a drug, casts a continuing cloud of uncertainty over the market for dietary supplements and functional food and beverage products made with hemp-derived CBD. FDA’s objection only adds to consumer confusion and investor hesitancy, resulting in stunted market growth, say industry leaders, despite rising interest from U.S. farmers to grow hemp and from consumers in using CBD as a safe and effective dietary supplement and herbal remedy alternative.
It was a disappointing, if not surprising, decision by an agency that has historically shown an aversion to dietary supplements and cannabis-derived products, and that has been criticized for being under the outsized influence of the pharmaceutical lobby.
However, given the FDA’s continuing objection to allowing CBD to be sold as a dietary supplement, the only option left is for the hemp industry to advocate for Congressional legislative action, such as H.R. 841 in the House of Representatives and S. 1698 in the Senate, to mandate the FDA to regulate CBD as a dietary supplement and allow for the growth of the emerging hemp-derived CBD market. See U.S. Hemp Roundtable’s legislative guide to take action.
Writing in New Hope Network, Rick Polito reported, “The agency had signaled willingness to work with brands via the NDI process, but in the end appeared intent on delivering a predetermined verdict that CBD, whether as an isolate or as a component of a full-spectrum hemp supplement, is legally identical to the CBD compound as used in Epidiolex, a pharmaceutical drug used to treat epilepsy. The Food Drug and Cosmetic Act ‘exclusionary clause’ holds that supplements cannot contain pharmaceutical ingredients.”
“Why did the FDA put them through the months of doing this dance back and forth?” Steve Mister, CEO of the Council for Responsible Nutrition, asked New Hope’s Polito, emphasizing that Irwin Naturals and Charlotte’s Web were diligent in the NDI process.
“The FDA’s absence, in all measurable forms of leadership, has not only left the CBD market unregulated, it has also cost the hemp industry hundreds of millions if not billions of dollars in lost revenue and investments, and created obstructive barriers and bottlenecks throughout the entire hemp supply chain,” said Morris Beegle, President of We Are for Better Alternatives and producer of NoCo Hemp Expo.
Read on to hear what Charlotte’s Web and other hemp industry leaders and advocates had to say in response to FDA’s decision.
Charlotte’s Web Official Statement
“Today the U.S. Food & Drug Administration (FDA) published an “objection” to Charlotte’s Web’s New Dietary Ingredient notification (NDI) submitted for our full spectrum hemp extract (FSHE), due largely to its drug preclusion provision. This response from the FDA indicates to Charlotte’s Web that without legislation by Congress, this market will remain unregulated…
Over the last 18 months, Charlotte’s Web collaborated with the FDA, providing information about the cultivation, extraction, manufacturing, use and safety behind our proprietary FSHE with naturally occurring levels of CBD. We also supplied research evidencing our FSHE to be different from purified CBD in isolate form which is an FDA-approved drug.
The FDA letter asserts that a FSHE cannot be used in dietary supplements because it is precluded and expresses safety concerns. Regarding safety, the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application … We requested the FDA correct the record to reflect that data…
The FDA objection to the NDIN does not impact the existing business operations of Charlotte’s Web but does provide useful guidance about what’s required to secure a regulatory framework for FSHE as a dietary supplement.
Both the House of Representatives and the Senate introduced bills that would legislate hemp CBD as a dietary supplement. We believe this legislation is a critical step to protect consumers and to establish guidance for manufacturers, and Charlotte’s Web intends to stay at the forefront of these efforts. Our vertically integrated supply chain and category leadership uniquely position us to work effectively with Congress, and the FDA, to ensure this critical path forward for the hemp industry.”
See Charlotte’s Web’s full statement here.
Jonathan Miller, General Counsel, U.S. Hemp Roundtable, Member-in-Charge, Frost Brown Todd, Washington, DC
“There has been general support for our legislative efforts at U.S. Hemp Roundtable, but there have been some holdouts saying, ‘Let’s give the FDA time to sort it out.’ But this latest NDIN rejection puts that argument to bed. The FDA is clearly not going to take steps to regulate CBD unless Congress tells it to do so. FDA’s objection makes it clear that our top priority is securing passage of legislation such as H.R. 841 and S. 1698.
The U.S. Hemp Roundtable is deeply disappointed to witness FDA’s rejection of two dietary ingredient notifications (NDINs) recently submitted for full-spectrum hemp extracts. FDA’s actions send a discouraging message to the entire hemp and CBD industry, especially in light of the fact that these firms provided more than ample safety data and cooperated with FDA’s requests throughout the process.
When held to the same regulatory standards as other dietary supplements and food ingredients, hemp-derived CBD products have a strong safety profile; the dangers to consumers are only posed by the unregulated marketplace that FDA continues to propagate. This should be a clarion call to Congress that it is time to step in and pass legislation to ensure that CBD products are held to the same standard as all dietary supplements and food ingredients, and to reject an NDIN-only path.
It’s been more than two and a half years since hemp was legalized by the 2018 Farm Bill, and without congressional intervention, the hemp farming industry will continue to struggle, and consumers stand to lose as well.”
See U.S. Hemp Roundtable’s legislative guide to take action.
Janel Ralph, CEO, RE Botanicals and Founder, Harmony CBD
“It is mind blowing to me that FDA is asking us to prove that something is safe when it’s never been proven to be unsafe. It’s FDA’s job to prove it’s unsafe, and it hasn’t been able to do that. The agency claims it’s a drug. Well, at what dose is it a drug? Epidiolex is like 300 mg a day, while full-spectrum supplements are like 25-50 mg a day. FDA could legally make an exemption, but it is choosing not to.
On a personal note, my child Harmony, who was born with Lissencephaly or smooth brain syndrome, has been taking CBD every day of her life for the past seven years. She gets tested regularly for liver enzymes and it has never once affected her liver, yet it has significantly alleviated her suffering from seizures.
At the end of the day, CBD is improving people’s lives across the country and it should be available to everyone as a supplement. FDA needs to start looking at CBD differently. If FDA is going to block something that benefits people, that’s a problem.”
Rachael Rapinoe, CEO and Co-founder, MENDI Co.
“FDA’s objection results in further disconnection from hemp brands, consumers and the education needed to progress the industry as a whole. It shows many of us that the FDA isn’t prioritizing CBD products and bringing a clear path forward in a timely manner. The implications will result in continued confusion and discontinuity of language between brands in the industry.
The FDA is making it increasingly difficult to properly educate and protect consumers from the various types of products on the market and the benefits associated with them. Education is the key to progress and we need the full support of the FDA and medical community if we want to see this industry and its consumers mature.
We will continue to operate in highly restricted grey zones, which is very frustrating. We have a lot research and education to pull real data to educate and empower consumers in the industry. As a brand, we want to protect the public from harmful or dangerous products and guide them in directions that will be more beneficial to their long term health. Also as a brand, we would like to operate in the same capacity as other CPG companies.”
Michael McGuffin, CEO, American Herbal Products Association
“Last month, the U.S. Food and Drug Administration (FDA) replied to two separate new dietary ingredient notifications (NDINs) submitted for ingredients identified as ‘full-spectrum hemp extracts,’ one filed by Charlotte’s Web, Inc., and the other by Irwin Naturals. In its responses, FDA informed both companies that the subject ingredients ‘cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision in 21 U.S.C. § 321(ff)(3)(B)’ on the basis that each qualifies as a ‘CBD product.’
Significantly, the Charlotte’s Web, Inc., ingredient has a cannabidiol (CBD) content of 19.5 mg per serving, and the Irwin Naturals ingredient has a proposed serving limit of approximately 65 mg/day of CBD. In addition, the agency identified ‘concerns about the adequacy of safety evidence’ included in these notifications ‘as a basis for concluding that a dietary supplement containing [the NDI] will reasonably be expected to be safe when used under the conditions’ described in the notifications.
We are fast approaching the three-year anniversary of the enactment of the 2018 Farm Bill, which reflected the decision by the U.S. Congress to support farmers and consumers by establishing a lawful process for production of hemp, which was broadly defined to include the cannabinoids in hemp, including CBD. But ever since FDA has relied on the cited exclusion provision to keep dietary supplements that contain any amount of CBD in a regulatory gray zone, even though the agency already has authority to create a lawful framework for marketing such products.
No one who has been paying attention to this matter should be in the least surprised to see FDA restate its position in these letters. At the same time, it is disappointing and represents another missed opportunity for the agency to bring clarity to the marketplace while using its existing resources to protect the health of the many Americans who already use hemp-derived products.
There are several bills now pending in the U.S. Congress that would resolve this matter and that are supported by the American Herbal Products Association and other organizations who are seeking a resolution that will simultaneously protect the public and the trade. FDA’s NDIN responses should sharpen the focus of all who share such a goal.
At the same time, FDA’s pointed attention to the content of these two NDINs should not surprise any experienced reviewer of the over one thousand such notifications submitted over the past 25 years, and the agency’s replies should be familiar in their scope and tone. Even if Congress acts to remove the current legal barriers to CBD-containing hemp products, companies that intend to bring a new CBD ingredient to market will need to meet the very high standard established for NDINs. In establishing this standard, it is not uncommon for FDA to identify its own specific safety concerns in its response to an initial notification, and the agency often lays out a roadmap for following up with more safety information – as it did for these two full-spectrum hemp extract submissions. These two companies and others who plan to follow their leadership would be well served to study these letters in detail.”
Asa Waldstein, Principal, Supplement Advisory Group; Chair, AHPA Cannabis Committee
“Conducting studies to prove safety is an important part of responsible herbal commerce and Charlotte’s Web should be commended for its time and financial investment. Charlotte’s Web makes the case that a naturally occurring CBD is different from the CBD isolate used in Epidiolex. The FDA comments highlight the agency’s position that any CBD-containing product, including a full-spectrum hemp extract, is not a lawful dietary ingredient due to the Epidiolex drug preclusion provision.
FDA states the Charlotte’s Web (products) are ‘carefully designed to ensure consistent levels of CBD, and that it is produced from your proprietary cultivar (CW1AS1) hemp plants that provide robust levels of CBD.’ FDA’s case here is even though CBD isolate is not added to the products, they still are designed with CBD content in mind. This is a conundrum, as process control and label accuracy are part of dietary supplement regulations. This discussion is further complicated by state requirements in West Virginia and Utah which require CBD content to be listed on the label.
My concern is the FDA response may inadvertently send a ‘do not proceed’ message to companies on the fence about conducting safety studies. I implore companies to continue to add proving product safety into their budgets and strategies.
During this regulatory holding pattern, I suggest companies continue to collect product safety data, as future regulation will likely include a safety component. Acting like a reputable dietary supplement company is the best way forward for hemp-CBD companies. This includes investing in safety studies, but also CFR 111 & 117 compliance, food facility registration, lot number traceability, recall procedures, adverse event reporting, and common allergen labeling.”
Sander Zagzebski, Attorney and Co-leader of Clark Hill LLP’s Cannabis Industry Team
• What does FDA’s objection mean?
“As a technical matter, it means that the person filing the notice (Charlotte’s Web, Inc.) does not have FDA approval to use the dietary ingredient listed in their notification (full spectrum hemp extract) in food products”.
• Why Now?
“The hemp/CBD industry has been operating in a gray area under federal law. While the Farm Bill has legalized certain hemp and hemp derived products, including CBD isolates and full spectrum CBD extracts, under certain circumstances, it is an exaggeration to say the Farm Bill “legalized CBD” in a wholesale fashion. One of the big questions relating to hemp-derived CBD products generally is whether and to what extent manufacturers can include hemp-derived CBD products in food and beverage products that are generally regulated by the FDA. I’m guessing Charlotte’s Web was hoping the FDA under the new Administration would provide some clarity on this issue for the hemp/CBD industry in general and for Charlotte’s Web in particular. By way of background, the law provides that active ingredients in approved pharmaceutical products cannot be sold as dietary supplements in other products. One of the policy purposes behind this law is to encourage companies to undertake the considerable time and expense necessary to get FDA approval for a new pharmaceutical product. If competitors were allowed to sell the active ingredient to a new pharmaceutical product as a dietary supplement, it obviously dilutes significantly the economic benefit of winning FDA approval for a new drug and acts as a strong disincentive to go through the FDA’s drug approval process. When the FDA approved the drug Epidiolex, which is a CBD oral solution for the treatment of epilepsy, that action meant that the active ingredients of Epidiolex, including the CBD compound, could not then be classified as an approved dietary supplement under the law. Left unclear, however, was whether the exclusion would apply only to the specific CBD chemical compound in Epidiolex, or whether it would be applied more broadly to other CBD compounds including ‘full spectrum’ CBD.”
• What was Charlotte’s Web’s objective in applying to the FDA?
“It is likely that Charlotte’s Web was hoping to get clarity on the FDA’s position regarding CBD and to get the FDA’s blessing that, at a minimum, a “full spectrum” hemp-derived CBD products (as opposed to the specific CBD isolate in Epidiolex) would qualify as a permitted dietary supplement.”
• What are the implications going forward re: FDA’s policy toward CBD?
“The broader implications are so far unclear. The hemp-derived CBD industry has existed in this regulatory gray area regarding the FDA for some time, so one could argue that nothing really has changed. On the other hand, the FDA had an opportunity to do the industry a favor, and it declined to do so. Although I don’t have a crystal ball, I think it is likely that the FDA will continue to focus most of its enforcement energy on suppliers that make what the FDA considers to be unsubstantiated health claims, since that doesn’t involve any significant change in their policy stance from the prior Administration. Most federal agencies are loathe to make major policy adjustments when they don’t have a Senate-approved leader at the helm. Since the FDA is currently operating under an Acting Commissioner, it seems a safe bet that the FDA won’t make a major policy decision regarding hemp or CBD until it has its Senate-approved leader.”
• How does that impact companies, consumers and the market?
“In the immediate term, the impact is probably insignificant. The industry had hoped for some clarity, which the FDA has declined to give it, but otherwise the status quo will continue. That said, the industry will have to digest the fact that the FDA hasn’t gone away, and that legislative action is probably necessary to clear the air.”
• What will it take for FDA to allow for and regulate CBD as a safe ingredient in supplements and food and beverage products?
“It is possible that a new FDA Commissioner will, once confirmed, decide to take a more permissive approach to the industry. Absent direction from the top, however, it feels like the career bureaucrats in the FDA do not want to be put in the position of having to make these policy decisions. So legislative action is probably inevitable, eventually.”
• What actions can hemp industry leaders and advocates take to support free access to CBD products in the dietary supplements market?
“Given the regulatory ambiguity, industry leaders would be well advised to be cautious in how they market their products and to be rigid in otherwise complying with all applicable rules and regulations.
• What other comments would you add?
“One coda to this response: The maker of Epidiolex, GW Pharmaceuticals, was sold to Jazz Pharmaceuticals for $7.2 Billion. While GW undoubtedly had other products in the pipeline, the press release announcing the deal describes Epidiolex as GW’s ‘lead product.’ So FDA approval is big business.”
# # #
Hemp Industry to Congress and FDA: “Regulate CBD Now”
This article originally appeared on LetsTalkHemp.com
By Steven Hoffman
The U.S. Hemp Roundtable (USHR) at a press conference on June 18 in Denver called on members of Congress in Colorado and in states across the country to support national legislation that would call on the FDA to regulate CBD like any other dietary supplement.
With approximately 100 people in attendance in person and online via Zoom at its Spring 2021 membership meeting held at the Denver History Museum, USHR underscored its lobbying efforts by announcing the launch of Regulate CBD Now, an online campaign to encourage citizens to contact their representatives about important legislation impacting consumer access to hemp and CBD products in the U.S.
Members of the U.S. Hemp Roundtable announced on June 18 the launch of “Regulate CBD Now,” an online campaign to encourage passage of national legislation allowing access to CBD in dietary supplements and food and beverage products. Photo: Let’s Talk Hemp
According to USHR General Counsel Jonathan Miller, the hemp industry is focused on two bills that Congress is currently considering – H.R. 841 in the U.S. House of Representatives, and S. 1698 in the U.S. Senate – that would call on the U.S. Food and Drug Administration (FDA) to regulate CBD as a dietary supplement or as a food additive. “To have CBD regulated like dietary supplements would be a game changer for the hemp-derived CBD industry,” Miller told Let’s Talk Hemp.
According to a statement by USHR, while the FDA has recognized the significant public interest in CBD, the agency has not yet established a legal pathway for its sale.
“We wanted to raise awareness of this important legislation by hosting our Spring meeting in Colorado, an epicenter of the hemp industry,” said Miller. “We’re grateful to Colorado Representative Ed Perlmutter for co-sponsoring H.R. 841, and we hope that Congresswoman Diana DeGette (D-CO) will co-sponsor H.R. 841, as she serves on the committee of jurisdiction, Energy and Commerce. Also, we hope Senators Hickenlooper and Bennett will support the Senate bill, S. 1698.” Miller noted that in addition to allowing CBD to be regulated like dietary supplements, the Senate bill also calls for CBD to be permitted as an ingredient in food and beverage products.
“Colorado is a hemp state. We need Colorado’s elected officials to stand up and support legislation that gives consumers confidence in our products, protects small businesses and farmers, and allows this new industry to thrive,” said Steve Smith, co-founder of Pet Releaf, a family-owned company based in Littleton, CO. Smith noted that Colorado is home to many hemp and CBD companies. However, regulatory uncertainty has started to dismantle this up-and coming market, he said.
“The only way we’re going to see a regulated CBD market is if everyday citizens make their voices heard,” Miller emphasized. “Taken together, these two bills are a huge step forward in creating more certainty for farmers, greater protections for consumers, and more economic opportunity for…hemp companies,” he said.
About the Bills
H.R. 841 – Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021
Introduced by Rep. Kurt Schrader (D-OR), H.R. 841 allows the use of hemp, cannabidiol (CBD) derived from hemp, or any other ingredient derived from hemp in a dietary supplement, provided that the supplement meets other applicable requirements. Currently, FDA's position is that CBD products may not be sold as dietary supplements. (Source: congress.gov.)
S. 1698 – Hemp Access and Consumer Safety Act
Introduced by Sen. Ron Wyden (D-OR), S. 1698 would allow hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food and beverage products. (Source: congress.gov).
“Regulate CBD Now” Endorsed by Leading Consumer Products Associations
The U.S. Hemp Roundtable is a national advocacy organization comprising a coalition of dozens of leading companies and organizations committed to safe hemp and CBD products. USHR works in partnership with national, regional and state organizations, and helps lead the way forward for hemp and CBD products through education and action.
In addition to USHR, the Regulate CBD Now campaign is supported by organizations including the Alliance for Natural Health, American Herbal Products Association, Citizens for Health, Consumer Healthcare Products Association, Council for Responsible Nutrition, Friends of Hemp, Hemp Alliance of Tennessee, Hemp Industries Association, Midwest Hemp Council, National Grocers Association, Texas Hemp Coalition, United Natural Products Alliance, U.S. Hemp Authority, U.S. Hemp Building Association, Vote Hemp, We Are for Better Alternatives (WAFBA), and the Wisconsin Hemp Alliance.
For more information, visit www.regulateCBDnow.com and www.hempsupporter.com.
Supporting the Juneteenth Holiday, and Diversity and Inclusion in Hemp
In addition to covering a lengthy agenda, members of the U.S. Hemp Roundtable also wrapped up their Spring meeting by honoring Juneteenth – the new national holiday celebrating emancipation from slavery in the United States – with a number of USHR members volunteering to work at the Juneteenth Music Festival on June 19 in downtown Denver. The volunteer opportunity was organized by USHR’s Minority Empowerment Committee (MEC) to advance the association’s efforts to achieve equity, including, diversity and inclusion in the industry hemp and CBD industries.
U.S. Hemp Roundtable members volunteered to work at the Juneteenth Music Festival on June 19 in Denver, CO – Photo: U.S. Hemp Roundtable Facebook Page
Court Rules FDA Violated Environmental Laws in Approving GMO Salmon
Photo: Pixabay
This article originally appeared in the December edition of Presence Marketing’s Industry Newsletter
By Steven Hoffman
A federal judge in San Francisco on November 5 ordered the US. Food and Drug Administration (FDA) to re-evaluate its approval of genetically modified salmon based on ecological concerns if the GMO salmon were to escape into the wild.
FDA in 2015 approved the commercialization of Maynard, MA-based AquaBounty Technologies’ genetically engineered “AquAdvantage” salmon, finding it had no significant impact. Five years later, however, the U.S. District Court for the Northern District of California agreed with environmental groups who shared concern that the GMO salmon could escape to damage wild salmon populations, reported Food Safety News.
According to a statement by Earthjustice, “The court ruled that FDA ignored the serious environmental consequences of approving genetically engineered salmon and the full extent of plans to grow and commercialize the salmon in the U.S. and around the world, violating the National Environmental Policy Act. The court also ruled that FDA’s unilateral decision that genetically engineered salmon could have no possible effect on endangered, wild Atlantic salmon was wrong, in violation of the Endangered Species Act,” Earthjustice said. “FDA must now thoroughly analyze the environmental consequences of an escape of genetically engineered salmon into the wild,” it added.
In a 16-page decision, U.S. District Judge Vince Chhabria rejected FDA’s position that it has no duty to consider environmental impacts when reviewing applications to breed genetically modified animals. “Even if the FDA is correct that environmental considerations writ large were not relevant to its decision, the agency is always required to consider the subset of environmental impacts that directly involve the health of animals or humans,” Judge Chhabria wrote.
“This decision underscores what scientists have been telling FDA for years—that creating genetically engineered salmon poses an unacceptable risk if the fish escape and interact with our wild salmon and that FDA must understand that risk to prevent harm,” said Earthjustice managing attorney Steve Mashuda. “Our efforts should be focused on saving the wild salmon populations we already have—not manufacturing new species that pose yet another threat to their survival.”
According to Alaska Public Media, AquaBounty Technologies President and CEO Sylvia Wulf released a statement saying the company is “disappointed” by the ruling. But she said it won’t impact operations at its egg growing facility on Prince Edward Island, Canada, or its fish farm in Albany, Indiana.
“It’s a terrible idea to design genetically engineered ‘Frankenfish’ which, when they escape into the wild (as they inevitably will), could destroy our irreplaceable salmon runs,” said Mike Conroy, Executive Director of the Pacific Coast Federation of Fishermen's Associations (PCFFA), in the Earthjustice statement. “Once engineered genes are introduced into the wild salmon gene pool, it cannot be undone. This decision is a major victory for wild salmon, salmon fishing families and dependent communities, and salmon conservation efforts everywhere,” he said.
New DEA Interim Final Rules a Trojan Horse to Disrupt the Hemp Industry?
This article originally appeared on LetsTalkHemp.com.
By Steven Hoffman
The U.S. Drug Enforcement Administration (DEA) published on August 21 interim final rules (IFR) on hemp that it says puts the agency in compliance with the 2018 Farm Bill’s legalization of industrial hemp. The new rules seem friendly enough, but hemp and CBD industry watchdogs point to a potential trojan horse that could present a significant threat to the hemp industry.
Introducing the rules, DEA’s language seems benign enough, stating, “The interim final rule merely confirms DEA’s regulations to the statutory amendments to the CSA (Controlled Substances Act) that have already taken effect, and it does not add additional requirements to the regulations.”
Among its four main amendments is language stating that “tetrahydrocannabinol” (THC) does not include “any material, compound, mixture, or preparation the falls within the definition of Hemp.” In addition, it removes any CBD drug product approved by FDA from Schedule V status; and the IFR removes import and export controls over hemp and its derivatives. Lastly, the rules modify the definition of “marihuana extract” to exclude substances that contain less than 0.3% delta-9 THC on a dry-weight basis. The rules add no additional costs resulting from these changes, said DEA.
However, attorney and writer Rob Kight of Kight on Cannabis warned that the rule “could potentially be a fatal blow to the entire hemp/CBD industry, namely, the IFR’s criminalization of ‘work in progress’ hemp extract, a fundamental component of any consumer hemp/CBD product,” he said in a recent report. The catch, he explained, is that DEA wants to measure on a dry weight basis, but hemp extract is an oil – it’s “wet.”
Kight refers to “work in progress hemp extract” as an extract of hemp in a partially processed state that is not intended for consumer use or consumption. “With respect to the Farm Bill’s language, it clearly contemplates that hemp extracts will be created, and that they will be lawful,” he stated in his report. “Otherwise, the term ‘extract’ would not have been included in the definition of hemp,” Kight said.
“Under almost any normal extraction and manufacturing process it is impossible to avoid a stage in which the extract is both ‘wet’ and within the 0.3% THC limitation,” Kight continued. “For example, take the most basic processing method of trimming and separating a hemp plant’s stalks, stems, and seeds from its leaves and flowers. Processing the plant in this way, which occurs on some level for most hemp cultivated in the U.S., increases the concentrations of THC despite not increasing the actual amount of THC.” However, Kight asserted, when final consumer product reaches the market, it is well within the 0.3% limit.
“For these reasons, it is reasonable to assume that Congress intended for extracts to be produced and that such production will necessarily result in a stage during the processing phase when the extract contains THC concentrations in excess of 0.3%. In other words, it is reasonable to conclude that Congress contemplated the existence of work in progress hemp extract, Kight concluded.
DEA’s removal of FDA-approved CBD pharmaceuticals from its schedule is consistent with an action the agency took in April 2020 when it removed GW Pharma’s CBD epilepsy drug Epidiolex from Schedule V of the Controlled Substances Act, reported Marijuana Moment.
As the agency finalizes its enforcement rules for hemp and CBD, DEA has not necessarily been a cooperative partner with the USDA, according to Secretary of Agriculture Sonny Perdue. Marijuana Moment reported in March 2020 that Perdue placed partial blame on DEA for restrictive policies included in its hemp rules that were making it challenging for producers. Perdue said DEA was having an outsized influence on its proposed hemp rules and that DEA “really didn’t like the whole program to begin with,” referring to hemp reform, reported Marijuana Moment.
“The DEA always wants to control the narrative surrounding industrial hemp despite Congress’s clear intent to keep the DEA out of it; that is precisely why the 2018 Farm Bill was written the way that it was written – to remove any strings that the DEA may try to assert re: hemp. They did this in 2016 with the Marijuana Extract drug code, and they are doing it again with this IFR. It is a never-ending battle not between the DEA and the hemp industry, but between Congress and the DEA. Which is a damn shame,” said leading hemp and cannabis attorney Bob Hoban, founder of The Hoban Law Group in Denver, CO.
“We are just starting to dig into the DEA’s new IFR language,” said Jonathan Miller, attorney with Frost Todd Brown in Lexington, KY, and director of the firm’s hemp practice, and general counsel for the U.S. Hemp Roundtable, “There is a concern, if it is read broadly enough, that the DEA would think they’re in the business of policing CBD and other hemp extractors. The 2018 Farm Bill made it clear that is not the case.”
Read DEA’s Interim Final Rules here.
Public comments will be accepted on the proposed amendments until Oct. 20, 2020.