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
From Dry January to Sober October, Non-Alcoholic Beverage Trend Extends Throughout the Year
This article first appeared in Presence Marketing’s February 2024 newsletter.
By Steven Hoffman
From Dry January to Sober October, sales of adult-oriented, non-alcoholic beverages are taking off throughout the year, as Gen Z consumers, older health-minded individuals and others increasingly prioritize wellness and moderation in their drinking habits.
With New Year’s resolutions in mind, sales of non-alcoholic (NA) beverages consistently surge at the beginning of the year, when many adults take a break from drinking during what has become known as “Dry January.” However, according to Nielsen IQ, non-alcoholic drinks “are now a staple during all major drinking holidays, especially the 4th of July and year-end celebrations,” Fox Business News reported in September 2023.
As more Americans embrace alcohol-free options, sales of non-alcoholic beer, wine and spirits at off-premise locations such as grocery stores increased 31% to $510 million in the 12 months ended July 29, 2023, Nielsen IQ reported. While NA beer dominates the segment with 86% of the market share, followed by NA wine at 11%, alcohol-free spirits, which comprise only 3% of the category, saw sales grow by 94% over the previous year. Non-alcoholic adult beverage sales grew by double digits in terms of dollar amount spent, and five states —California, Colorado, Massachusetts, Michigan and Ohio — accounted for 30% of the total amount.
Retailers, manufacturers, restaurants, bars and others are capitalizing on this trend by offering more non-alcoholic options, including “mocktails” and mixers that can be enjoyed with or without alcohol. Products are proliferating, such as booze-free beer and wine, functional beverages made with adaptogens, nootropics and other botanical and nutritional ingredients, energy drinks and other adult-oriented drinks made to take the place of cocktails and spirits.
According to Beverage Daily, online seller Drizly reported that there were over 80% more non-alcoholic brands available on its platform in 2023 compared to the previous year. Today, consumers can opt for many innovative beverages beyond the timeworn choices of a few non-alcoholic beers, seltzer water, conventional soda or juice as the only alcohol-free options.
While still representing only 1% of the overall alcoholic beverage market, such robust growth in the popularity of NA beverages inspired the formation of a new trade association, dryly named the Adult Non-Alcoholic Beverage Association (ANBA), launched in 2021 and based in Washington, D.C. Together with New Hope Network, in September 2023 ANBA sponsored a pavilion at Natural Products Expo East devoted to brands specializing in NA adult beverages including sparkling wine, canned cocktails and IPAs.
Gen Z Drives Reduced Alcohol Consumption
America’s younger Gen Z demographic is leading the way in reducing alcohol consumption. The share of adults aged 18 to 34 who say they drink dropped 10%, from 72% in 2001-03 to 62% in 2021-23, according to a Gallup poll published in August 2023.
“Younger adults are drinking less alcohol — and it has been moving in that direction for two decades,” said Akhil Anand, M.D., of the Cleveland Clinic. There are a lot of theories as to why, including increased mental health awareness, healthier lifestyles, education and possibly increased cannabis use, though binge drinking is still a concern among younger adults, Anand noted. “When people give up drinking, even for a month, they often note that they feel better,” Dr. Anand said. “That’s not by coincidence.”
Yet, the majority of people who buy non-alcoholic beverages actually do drink, Marcos Salazar, CEO of the Adult Non-Alcoholic Beverage Association, shared with New Hope Network. According to Salazar, recent data revealed that 94% of non-alcoholic beverage consumers do drink alcohol. They purchase alcohol-free products because they embrace moderation, or they appreciate the products’ flavors or, when they entertain, some guests don’t drink, or all three, he said.
For Laura Taylor, founder of Mingle Mocktails, one of the fastest-growing brands in the NA sector, her challenge was how to feel included at social gatherings while choosing not to drink. Taylor quit drinking nearly 10 years ago after a battle with alcoholism, she shared with Forbes in November 2023. Experimenting with juices and mixers, Taylor in 2017 created a line of sparkling mocktails targeted toward women, available in ready-to-drink cans and bottles. “I wanted everyone to feel included and proud of their choice to give up alcohol instead of feeling like it was something to hide,” Taylor told Forbes. “Mingle Mocktails were created for anyone who chooses to give up alcohol for a night, a week or as a lifestyle choice but still wants to feel part of the party.”
“As consumers’ beverage preferences change, functional benefits and exceptional product quality are more important than ever,” said Alex French, co-founder and CEO at Bizzy Cold Brew. “At Bizzy, we’re strategically positioned to meet evolving beverage trends quickly while remaining true to our brand promise of caffeine strength.”
“We’re hearing it daily — ‘I quit drinking, and instead I reach for a Sati.’ It’s what we want to hear; we are a replacement for alcohol,” said David McLaughlin, founder of Sati Soda, maker of certified organic beverages containing functional ingredients such as ashwaganda and rhodiola, as well as a line of CBD-infused sparkling beverages. “We are seeing athletes, celebrities, musicians and other influencers opting for non-alcoholic alternatives. They’re saying, ‘I’m treating myself better and you don’t have to drink to be cool. Now I can drink something and feel good, and wake up feeling great.’ While functional beverages are still in their infancy (even though there are a lot of us in the space!), I don’t see this trend going back. Dry January is spilling into the rest of the year, is what’s happening,” McLaughlin observed.
Where to Merchandise NA Beverages?
For retailers, where to locate category-crossing NA beverages can present some challenges. Many merchandisers place NA beverages in the grocery section near sodas, waters and functional beverages, as well as in refrigerated cases, as opposed to the alcoholic beverages section, so shoppers who don’t drink alcohol will feel more comfortable. Grocers also worry that shoppers in the alcohol section might accidentally buy non-alcoholic products and be disappointed.
“There was some confusion about where we should place products in stores,” Beth Johnson told Douglas Brown at New Hope Network. Johnson is the senior category manager at PCC Community Markets in Seattle. As people were emerging from the pandemic, she decided to create a separate non-alcoholic set. “It’s working for us. At first, it was just one shelf, but now it’s like three,” she added.
For food service, restaurants, bars, hotels and event producers, “the profit potential of mocktails cannot be underestimated,” according to Shivani Vora, contributor to Forbes. “While the cost of ingredients for alcoholic cocktails can be high, mocktails are typically made with less expensive components, meaning higher profit margins for every mocktail sold. Only adding to that profit potential is the fact that patrons are generally willing to pay a similar price for mocktails as they would for alcoholic cocktails, making them a lucrative addition to menus. … By serving mocktails, bars and restaurants can expand their customer base and increase the likelihood of repeat business from a diverse range of patrons. This approach enhances customer loyalty and patronage among those who appreciate a venue that respects their choices.”
Steven Hoffman is Managing Director of Compass Natural, providing public relations, brand marketing, social media and strategic business development services to natural, organic, sustainable and hemp/CBD products businesses. Compass Natural serves in PR and programming for NoCo Hemp Expo and Southern Hemp Expo, and Hoffman serves as Editor of the weekly Let’s Talk Hemp Newsletter, published by We Are for Better Alternatives. Contact steve@compassnaturalmarketing.com.
Forget Superfoods—Support Total Body Wellness With Surthrival Colostrum, Nature's Complete Whole Food
Surthrival Colostrum offers a pure, high-potency colostrum supplement optimized for human health at all ages
BIDDEFORD, Maine (June 15, 2023) – We’ve long heard about the health benefits of the colostrum found in breast milk. Study after study shows that colostrum is packed with nutrients that are key for the development and survival of baby humans and other mammals. Because it’s often the first nutrition infant humans receive, colostrum contains more than 90 compounds our bodies and brains need to develop and thrive.
But colostrum’s health benefits aren’t just restricted to infants. Thousands of published studies show colostrum can optimize health at all stages of human life. That’s why Surthrival, a Maine-based company dedicated to providing dietary supplements that support peak nutrition and optimal wellness, is proud to offer a highly potent, responsibly sourced, non-GMO colostrum dietary supplement designed to be consumed by people of all ages.
Surthrival Colostrum is the only colostrum dietary supplement optimized for human health. Research shows that supplementing with Surthrival Colostrum powder or capsules can:
Balance immune function
Promote healthy digestion and overall gut health
Improve cognitive function
Increase endurance and lean muscle mass
Maintain healthy joints, cartilage and musculature
Shorten recovery time after exercise
Considering all of these health benefits, is it any wonder that Surthrival Colostrum is referred to as “immune milk” and the “first food for second chances”?
Surthrival's natural, ethically harvested colostrum
Research shows that colostrum is a complete food packed with all of the essential amino acids used to build protein, immunoglobulins that play a key role in immune defenses, prebiotics that help protect the gut microbiome, and major growth factors that can help increase lean muscle mass and the body’s fat-burning capacity. Colostrum is also an excellent source of vitamins A, B, D, E and K, along with key minerals like calcium, iron, magnesium and phosphorus.
Because most of the compounds in bovine colostrum are functionally identical to those in human colostrum, Surthrival Colostrum is ethically harvested and sourced from cows raised on dairy farms throughout the United States. Colostrum is vital for a newborn calf to thrive into adulthood, as it contains all of the immune factors necessary for the calf to survive. Consequently, Surthrival Colostrum is collected only after the newborn calf consumes all of the colostrum it needs.
To transform this colostrum into a dietary supplement, it must be processed from a liquid into a powder. But unlike other colostrum powders on the market today, Surthival Colostrum retains its whole-food form after processing. This ensures that Surthrival Colostrum contains all of its bioactive nutrients in their purest forms—just as nature intended.
No excipients or fillers are ever added, and Surthrival Colostrum is transported to and processed in a U.S. GMP-certified facility using strict refrigeration protocols. The end result is a clean, high-potency colostrum dietary supplement optimized for human health.
The sumptuous health solution
Surthrival Colostrum comes in two easy-to-use versions: a shelf-stable powder (6.5 ounce, 1 kilo or 2 kilos) or 180-count capsules. Rich and creamy-tasting, it’s available unflavored or in three naturally sourced flavors:
Chocolate, made with organic, unroasted cacao powder
Strawberry, made with real strawberry juice powder
Vanilla, made with organic vanilla bean extract
Simply blend 1 teaspoon of unflavored Surthrival Colostrum Powder into your favorite smoothie recipe twice a day to support and sustain your daily life. Flavored Surthrival Colostrum Powder is water soluble, so your twice-daily teaspoon can be blended into a smoothie, water, juice, or even coffee.
Whether you’re working your movement game hard or trying to build a healthy baseline, Surthrival Colostrum is your “Plan A” to “level-up” along your journey!
Exclusive Discount on Surthrival Colostrum
Use promo code PRESS20 at checkout to receive an exclusive 20% discount on Surthrival Colostrum. Code expires July 15.
About Surthrival
Based in Biddeford, Maine, Surthrival was founded in 2008 by LeighLon Anderson and Daniel Vitalis, star of the Outdoor Channel’s WildFed, to provide powerful, regenerative nutrients to support peak nutrition and optimal wellness. In addition to its best-selling bovine colostrum powder, Surthrival’s products include sustainably foraged black walnut protein powder, elk antler concentrate, reishi mushroom extract, vitamin D3/K2, and CBD for pets and people.
Follow Surthrival on Facebook, Instagram, Twitter and LinkedIn.
For wholesale inquiries, contact wholesale@surthrival.com.
Media Contact
Steven Hoffman, Compass Natural, steve@compassnaturalmarketing.com
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
NoCo9 Speakers Urge Industry Unity Moving Forward
FOR IMMEDIATE RELEASE
The ninth annual NoCo Hemp Expo featured numerous speakers who emphasized the importance of the hemp industry heading into the future with shared goals and values.
LOVELAND, CO (April 4, 2023) – The 9th annual NoCo Hemp Expo, the world’s most comprehensive hemp business conference and trade show, featured speakers from all over the hemp business world, who came together to move the industry forward with examinations of policy, processing, supply chain and opportunity. Over three days of programming, speakers and workshops focused on the need for a united voice if the industry is to achieve its potential.
In his opening remarks, show producer Morris Beegle noted that industry leaders agree on 95% of what needs to be done to advance the hemp supply chain. “We need to leave the 5% behind and join hands to march with one voice to make this hemp industry what we know it can be,” he said.
Longtime industry leader and cannabis legal expert Bob Hoban echoed the message, urging hemp industry participants to look at their competition as “co-opetition” and reminding the audience that the hemp supply chain is complex. “Everyone is under the misconception that they can do things on their own,” he said.
Unprecedented Partnership and Collaboration
Jared Stanley, chief operating officer of CBD company Charlotte’s Web, said partnerships like the one his firm has with Major League Baseball will propel the hemp industry’s success. “Education is the foundation of our partnership,” he said. Stanley also noted that the company’s mission and vision “aligned” with the MLB’s, with both organizations dedicated to player wellness. It is the first such partnership for a CBD brand and a national athletic league.
In an unprecedented meeting, over 50 participants from more than 10 hemp advocacy and policy organizations gathered to emphasize the points where they agree on moving federal policy ahead. U.S. Hemp Roundtable General Counsel Jonathan Miller opened the meeting by saying that he hoped participants would stay positive and work together to gain more policy advantages for the industry.
Expo producer Morris Beegle was upbeat.
“I have always focused on optimism, positivity and bringing industry stakeholders together,” Beegle said. “I’m pleased with the energy and outcome of this year's three-day show.”
NoCo Hemp Expo will take place again next year at The Broadmoor Resort in Colorado Springs, from March 20-22, 2024.
First Citizens Bank, EarthX, Patagonia Led Distinguished Group of Sponsors
NoCo Hemp Expo is pleased to recognize our Sponsors, including Presenting Sponsor First Citizens Bank. “Having a leading, agriculture-focused financial institution such as First Citizens Bank, with its 100-plus-year history of serving farmers and ag-related businesses, step up and serve as Presenting Sponsor of this year’s NoCo Hemp Expo is a huge statement, providing vital credibility and legitimization for the industry at a time when it’s needed most,” said Beegle. “We’re also thrilled to welcome EarthX as our Environmental NGO partner and Patagonia as Sustainable Apparel Sponsor. Additional lead sponsors include Global Fiber Processing, Michael Best, CannaConsortium, Advanced Bio-Materials Technologies, Divita Hemp Block & Weaving Vibes. We are very excited about these categories that bring focus to areas where hemp can make a difference in sustainability and improving the environment.”
2024 NoCo10 Announced
The 10th NoCo event will be held at The Broadmoor from March 20-22, 2024. To exhibit or sponsor, click here.
About NoCo Hemp Expo
For a decade, NoCo Hemp Expo — the world’s most comprehensive industrial hemp exposition and conference — has brought together international business and government leaders, academics, nonprofits, media and the public to collaborate on important initiatives, opportunities and solutions for the future of a crop and an industry that can have significant positive impact on human, animal and planetary health.
NoCo is produced by We Are For Better Alternatives (WAFBA), a leading organization dedicated to the advancement and advocacy of hemp farming, processing, production, innovation, education and legalization. WAFBA also is the publisher of Let’s Talk Hemp, the industry’s leading news source. Learn more about the hemp and cannabis industry and subscribe to the latest news at www.letstalkhemp.com.
Contact
Morris Beegle, WAFBA, info@nocohempexpo.com
Steven Hoffman, Compass Natural, steve@compassnaturalmarketing.com, tel 303.807.1042
Outdoor Channel’s WildFed Season 3 Emphasizes Modern-Day Hunting and Gathering, Ecology, Wild Foods and Culinary Adventure
WildFed host and Surthrival co-founder Daniel Vitalis helps people deepen their connection with the natural world.
BIDDEFORD, Maine (March 27, 2023) – WildFed, the wild-food culinary adventure series that offers a fresh take on outdoor television, is currently airing its third season on the Outdoor Channel and the Frndly TV app. In its biggest and best season ever, WildFed 2023 includes 10 shows highlighting adventures like prairie dog hunting in the Dakotas, the iconic alewife run in Maine, feasting with the world-renowned foraging expert Sam Thayer, hunting invasive species on the rugged island of Molokai and more.
WildFed, which airs on Mondays at 7:30 p.m. ET as part of the Outdoor Channel’s “Taste of the Wild” block, takes a thoughtful, artistic approach to modern-day hunting and gathering, with a strong emphasis on ecology. Every episode ends with a beautiful and delicious meal made with hunted, fished or foraged ingredients.
“We’ve been working hard to create a new niche in the hunting and outdoor media space, with a focus more on wild foods than hunting specifically,” says WildFed founder and host Daniel Vitalis. “We emphasize culinary adventure, ecological literacy, relationship with the landscape and great storytelling about species, people and food.”
After learning to hunt, fish and forage as an adult, Vitalis created WildFed to inspire others to start their own wild-food journeys. Along with his work with WildFed, Vitalis is a Registered Maine Guide, writer, public speaker, interviewer and lifestyle pioneer who co-founded the supplements and superfood company Surthrival in 2008.
Surthrival’s products, which include sustainably foraged black walnut protein powder, elk antler concentrate, bovine colostrum powder, reishi mushroom extract, vitamin D3/K2, and CBD for pets and people, are designed to help ordinary people accomplish extraordinary things.
“I think of it as ‘empowerment fuel’ for performance, health, recovery and peace of mind,” Vitalis says.
Both Surthrival and WildFed are key parts of Vitalis’ mission to help people reconnect with wildness, both inside and outside themselves. For instance, in WildFed Season 3 Episode 10, “Snowshoe Hare and Black Walnuts,” Vitalis and Chef Tony Seichrist chase snowshoe hares with beagles across the frozen landscape, and then prepare a feast made with the snowshoe hares and black walnuts Vitalis harvested in Missouri alongside members of a family company devoted to wild food.
WildFed’s Season 3 lineup includes:
Episode 1 - Turkey and Brackenfern
Episode 2 - Alewives and Birch Syrup
Episode 3 - Black Buck and Wild Salad
Episode 4 - Prairie Dog and Prairie Turnip
Episode 5 - Wisconsin Crayfish, Berries and Cattails with Sam Thayer
Episode 6 - Axis Deer and Tropical Fruit Foraging
Episode 7 - Swordfish and Maryland Fish and Crabs
Episode 8 - Archery Deer, Mackerel and Mushroom
Episode 9 - Sea Duck and Autumn Olive
Episode 10 - Snowshoe Hare and Black Walnuts
Previews for each episode are available on the Outdoor Channel website, and all episodes are streamed on the Frndly TV app.
You can also deepen your connection with the natural world through hunting, fishing, foraging and, of course, food, via the WildFed podcast — which one user called “the most forward (yet backward) thinking hunting show out there, presenting the most well-rounded approach to being a human that is possible in the 21st century.”
About WildFed
WildFed is a show, podcast and lifestyle brand that integrates hunting, fishing, foraging and ecology with nutrition, cooking, community and outdoor adventure. Hosted by lifestyle pioneer Daniel Vitalis, co-founder of supplements and superfood company Surthrival, WildFed is designed to reconnect people with wildness through food. WildFed is dedicated to modern-day hunting and gathering methods that support healthy lifestyles for both people and the planet and that help sustain our wild future.
About Surthrival
Based in Biddeford, Maine, Surthrival was founded in 2008 by LeighLon Anderson and Daniel Vitalis, star of the Outdoor Channel’s WildFed, to provide powerful, regenerative nutrients to support peak nutrition and optimal wellness. In addition to its best-selling bovine colostrum powder, Surthrival’s products include sustainably foraged black walnut protein powder, elk antler concentrate, reishi mushroom extract, vitamin D3/K2, and CBD for pets and people.
Follow Surthrival on Facebook, Instagram, Twitter and LinkedIn.
For wholesale inquiries, contact wholesale@surthrival.com.
Media Contact
Steven Hoffman, Compass Natural, steve@compassnaturalmarketing.com
Broad Spectrum Meets The Broadmoor: 9th Annual NoCo Hemp Expo Set for Historic Colorado Springs Resort, March 29-31, 2023
Broad Spectrum Meets The Broadmoor: 9th Annual NoCo Hemp Expo Set for Historic Colorado Springs Resort, March 29-31, 2023
September 6, 2022
Exhibitor, Sponsor and Speaker Applications Are Now Open as the Industrial Hemp and CBD Industry Is Set to Gather in Colorado Springs at the Historic Broadmoor Resort for the 9th Annual NoCo Hemp Expo, March 29-31, 2023.
FOR IMMEDIATE RELEASE
What: 9th Annual NoCo Hemp Expo
Dates: March 29-31, 2023
Where: The Broadmoor Resort, Colorado Springs, CO
Info: www.NoCoHempExpo.com
COLORADO SPRINGS, CO – With beginnings in 2014 in Windsor, Colorado, near Fort Collins, the Northern Colorado Hemp Expo, or NoCo Hemp Expo, has grown to become an internationally recognized event. For its ninth annual iteration, on March 29-31, 2023, NoCo Hemp Expo is moving a bit south and will host the world’s most comprehensive industrial hemp conference and exposition at one of Colorado’s most historic and iconic resorts, The Broadmoor.
With roots dating back to the late 1800s and located at the foot of the Rocky Mountains, The Broadmoor in Colorado Springs features a world-class setting, 315,000 square feet of meeting and convention space, a lake, 36-hole golf course, spa, restaurants, and premium lodging. Recently remodeled, The Broadmoor has been awarded a Forbes 5-Star resort rating every year since 1960. The resort is committed to sustainability in all its operations.
Photo courtesy of The Broadmoor Resort
NoCo9’s Theme: Stewardship, Sustainability, Sovereignty
The Broadmoor’s commitment to the environment ties in well with the theme of the 9th Annual NoCo Hemp Expo: Stewardship, Sustainability, Sovereignty.
“’The Earth is what we all have in common.’ That’s what farmer-philosopher Wendell Berry said. The hemp industry, like many others, took a hit over the past few years, given the climate with Covid and oversupply of CBD biomass. However, as we move past these issues, we are optimistic about a positive rebound and upward trend, and the diversification of hemp’s usage into multiple industries as we move forward into 2023, 2024 and beyond,” said Morris Beegle, President of We Are for Better Alternatives (WAFBA) and Producer of NoCo Hemp Expo.
“We are eager for an industry reset and a much-needed gathering of hemp leaders from around the world at our next NoCo Hemp Expo. The Broadmoor is a perfect place to host an international convention, elevate the hemp conversation, and attract larger businesses and corporations that should be considering hemp as part of their overall ingredient/input material and part of their ESG program moving forward into the next decade,” Beegle added.
The World of Hemp Under One Roof
Exhibits at NoCo9 will highlight the latest innovations in hemp, including the many product uses for CBD and other cannabinoids, hemp fiber in fashion and industry, hemp building materials, hemp paper and bio-composite plastics, food, oil and animal feed from hemp seed and more. The event also features a comprehensive educational program featuring a diverse lineup of expert speakers and topic material. “NoCo Hemp Expo is the one-stop gathering place for farmers, producers, manufacturers, innovators, entrepreneurs, investors and all others involved in or interested in the business of hemp,” said Beegle.
In addition, NoCo Hemp Expo is thrilled to host its 2nd Annual WAFBA Awards of Excellence Dinner, recognizing top leaders, innovators, educators, policymakers and advocates in the field, along with other networking events throughout the week.
NoCo9’s educational program will highlight investment and finance, science, technology and innovation, industry and consumer trends, regulatory news, BIPOC and diversity in the hemp industry, advances and best practices in sustainable agriculture, and more.
Applications are open now to exhibit, sponsor and speak at the 9th Annual NoCo Hemp Expo. Visit www.NoCoHempExpo.com.
About WAFBA and Colorado Hemp Company
We Are For Better Alternatives (WAFBA) is committed to researching and developing better alternatives so that hemp can once again thrive, prosper, and help individuals and communities throughout America and around the globe. The Colorado Hemp Company, producer of the 9th Annual NoCo Hemp Expo (NoCo9), is a leading organization for the advancement and advocacy of hemp farming, processing, production, innovation, education, and legalization in the USA. The entire team is committed to researching and developing alternatives, as well as informing and bringing the industry together so that hemp and other regenerative alternatives can contribute to the growth of a more sustainable environment, a green economy, and vibrant communities.
Visit www.WAFBA.org.
Media Contacts
Steven Hoffman, Compass Natural, 303.807.1042, steve@compassnaturalmarketing.com
Morris Beegle, Colorado Hemp Company, 970.541.0448, info@nocohempexpo.com
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.”
# # #