In Memoriam: Dale Kamibayashi, May 4, 1951 – Nov. 4, 2023
This article first appeared in Presence Marketing’s November 2023 newsletter.
By Steven Hoffman
Longtime natural products industry veteran and former Presence Marketing team member Dale Kenji Kamibayashi passed away on Nov. 4, 2023, at age 72. A beloved husband, father and family man, Dale was a valued community member, a friend to all, and a highly respected and admired colleague to many in the natural and organic products industry. Dale was an important member of our community and will be deeply missed.
From his roots in the late 1970s as the co-owner with his wife, Lisa, of a small natural foods retail store in the mountain town of Nederland, just west of Boulder, to serving as manager and purchasing director for the iconic Alfalfa’s Market, plus leadership roles in Cascadian Farm, Ceres, Rapunzel Organics and other leading companies, Dale was a strong advocate for healthy lifestyles. In 2019, Naturally Boulder honored Dale with the “Industry Leader/Community Champion” award for his vast contributions to the natural products industry and Boulder community.
Steven Hoffman (left) and Dale Kamibayashi.
Read on, below, for some shared memories of Dale Kamibayashi from some industry members and colleagues who knew and loved him best. To read more tributes and to share your memories of Dale, visit Dale’s memorial web page here, and please consider donating to his family’s GoFundMe page.
Lani Kamibayashi (Dale’s daughter, on behalf of the Kamibayashi family)
Our father was the hardest worker I knew, and our family grew up and lived for my dad’s passion. My brother Kenji and I grew up in Alfalfa’s Market; we ran around that store like we owned it. I loved it — I have so many great childhood memories of that store and the people who worked with my parents. Dad instilled our love of food and healthier eating styles that remain with us today. I am so proud of what he did and accomplished within the industry and am so fortunate to be his daughter. My family is overwhelmed with the support and generosity from all. Dale (Dad) was a remarkable leader, husband, and father for us and it’s just not going to be the same without him. We would be forever grateful if you ever had the chance to meet or know our father to keep a memory in your heart, thank you.
Chris Lobo, EVP, Presence Marketing
I worked at Alfalfa’s in the early ‘90s, mostly while I was completing grad school at the University of Colorado. During my time at Alfalfa’s, I worked in the Grocery Department and Dale K. was the Store Manager. For a time, I worked the opening shift, which meant assuring shelves were stocked and faced, and topping off the bulk bins – all before the doors opened.
That is also the period I met Michelle, my wife, who started as a cashier and also was on the opening shift. During the days Michelle and I dated, I would be in the back of the store trying to sweep up about a hundred different beans and grains that had spilled, before the “opening bell.” Michelle would often sneak back and we would quickly make out (I have no idea how dated that term is, but that is how we started a handful of mornings).
One particular morning the GM at that time, who was an uptight sort, caught us and threatened a write up. Well…that write up never came my way. I have no paper trail of who intervened, but it had to have been Dale, who was on site that day and who smilingly turned a blind eye many times to our very human practice.
I honored, respected, and cared a great deal for Dale K. as a colleague…but much more as a warm and wonderful human. RIP Dale.
Mark Retzloff, Co-Founder and Former CEO and Chair, Alfalfa’s Market and Horizon Organic Dairy, and Co-Founder of Greenmont Capital Partners
Like so many, I am shocked and grieving Dale’s passing. Dale was a brother, best friend, confidant, partner, and an example to me. I am heartbroken, as is my wife, Terry. However, I want to ensure we honor Dale appropriately. We must all remember and appreciate Dale’s legacy of treating everyone with respect, kindness, and always giving his full attention. His style of leadership should continue to be an inspiration to us all.
I have been fortunate to have known Dale for 43 years. I hired Dale in 1982 to manage our first Alfalfa’s Market store in Boulder. Dale was quickly beloved by all Alfalfa’s employees and hundreds in the community. A hallmark of Dale’s was how well-liked he was in the natural and organic movement and industry as well as on a local, state and national level.
In 2019 when Dale received Naturally Boulder’s “Industry Leader/Community Champion” award, Joan Boykin had this to say about her old friend and coworker: “Dale is a prince among men, a person of inestimable value to the community. He is known for his fair, diplomatic, understated, and generous leadership style and admired by all who know him.”
The last two times I saw Dale was at my 75th birthday in September and at our Naturally Boulder Legacy gathering. He was so Dale – that generous smile, that immediate warmth, and that always caring communication. Dale was a gem and his many life lessons will now shine through the hundreds he has touched.
I write this tribute from Kauai where I am grieving big time. I took a long walk on the beach to consider what is really important in life. Ultimately, we are all just grains of sand, and we each count ourselves tremendously grateful for friends like Dale in our lives. Too briefly, but beautifully gracing our lives.
While many of us will be absorbing this profound loss to our community, I implore each of us to send love and support to Dale’s wife, Lisa, and his children Lani and Kenji. Please consider supporting Dale’s family through their GoFundMe.
Joan Boykin, President, Boykin Consulting, Former Executive Director, The Organic Center, and Former Director of Marketing for Alfalfa’s Market, Celestial Seasonings, New Hope Network and Fresh Produce Sportswear
Dale was a consummate professional, an expert in retail operations and merchandising, and with a keen eye and mind for marketing, too. Yet, as I reflect on Dale’s contributions to the industry, it wasn’t so much about all he did, but about the manner in which he did it. He was calm and unruffled in every imaginable situation — always finding solutions to vexing problems — and I never heard a harsh word from him. I’ll remember him always for his kindness and warmth and will miss him dearly, as will countless others in our community.
Lyle Davis and Sylvia Tawse, Veterans of Alfalfa’s Market and Founders of the Fresh Ideas Group and Pastures of Plenty
When asked to describe Dale K. (everyone called him that!), Lyle Davis, who worked with Dale for nearly 18 years, said, “Sweet and steady – that was Dale I never once saw him angry or agitated.” Sylvia R. Tawse, who also worked with Dale at Alfalfa’s Markets and remained friends beyond the Alfalfa’s era, remembered working as a Marketing Manager at the Boulder store and being overwhelmed with local nonprofit requests for donations. She went to Dale to seek solutions to a tidal wave of requests. “I’ll always remember Dale’s calm and wise response. He said, ‘We just always find a way to say yes to our community.’ This lesson in generosity and inclusion has inspired and guided my decisions for three+ decades.”
Sylvia also remembers working on a ‘Healthy Choices’ newsletter story with Dale to share his family’s New Year’s recipes and traditions. Dale teared up respectfully when unveiling his grandparents’ story – a challenging time when they were interned up near Fort Collins. The recipe? A most generous New Year’s Eve soup with generous and warming ingredients. Just like Dale.
The last time Sylvia saw Dale K. was at a Naturally Boulder gathering in early October. She is forever thankful to have seen him with his iconic warm smile, and to have a big bear hug with him. All of the Alfalfa’s family and our natural and organic products industry benefitted from Dale K., and we still do. His legacy of managing through calm kindness lives on.
John Hay, Co-Founder, Celestial Seasonings
Having worked with Dale on and off over the past 40 years, I can truly say he was a very special human being. He knew all about the natural and organic food industry and had key relationships with most all of the folks in that world. Dale was a people person, and his positive and gracious personality was his greatest strength. He genuinely cared about your product, your business, but most of all about you, and that is why he was so successful throughout his long career.
Blair Kellison, Former CEO, Traditional Medicinals*
The natural foods industry’s culture of kindness and respect was set early in its inception by exceptional individuals like Dale. He embodies everything about the culture that makes our industry so special. He had a way of making each of us feel we were his favorite. I am lucky to be one of those people. The enduring nature of the HNF industry’s culture is the greatest testament to Dale’s memory. Godspeed Dale.
Bill Capsalis, Natural Products Industry Veteran and Former Executive Director, Naturally Boulder
Dale K. was a friend of mine … actually he was a friend to everyone he met. I had the pleasure of knowing him for more than 20 years as a member of the Naturally Boulder community. He would always make time for me or any of the new brands I was helping (including one I was running) to review the products and provide feedback and support. He never turned anyone away from his door while at Alfalfa’s and later at Presence Marketing. He was always kind and positive every time we saw each other. A few years back we recognized Dale with Naturally Boulder’s Community Hero Award, which was well deserved. He will be missed by so many people here and across the industry.
Debbie Wildrick, President, Frey Farms, Former Strategic Advisor, Beyond Brands, and Former CEO, BAZI Inc.*
To Dale’s family, I was deeply saddened to read today about Dale’s passing. My deepest condolences. Dale worked for me for several months when we were building a source water from Brazil. I was just speaking to my business partner the other day (just a couple of weeks ago). And, he said, “Do you remember when we all in Naples for a meeting and went to have sushi and Dale taught us how to properly eat with chopsticks?” I later moved to Denver and saw Dale often at events, especially Naturally Boulder. A very wonderful man.
JJ Rademaekers, Founder, Cocomels*
Dale was such an amazing introduction to this industry for me. When I started Cocomels at the Farmers Market, Dale was the first local buyer to express interest. Not only did he bring Cocomels into the store but he offered his time and insights so that I could understand what I was getting into and how to do it. After that, we’d meet occasionally and I’d ask a barrage of questions and he’d always give me his attention and time. He became a friend and ally in the industry and I always enjoyed bumping into him at events or shows. I’m so sorry to hear of his passing. He was a great guy who really showed interest and support for me and my journey. I will always be appreciative. Much love to his family and friends.
Steve Ehli, Natural Products Industry Veteran and Former Team Member, Presence Marketing
I met Dale in the late ‘70s and we stayed in touch through the decades. I was so pleased we got to spend several years working for the same company at Presence Marketing until I retired at the end of 2021. A kind soul and a consummate professional who dedicated his life’s work in service to grow our industry. Dale will be missed by many. The world needs more like him! My thoughts and prayers are with his family.
Kelly Shea, CEO, Shea & Associates, Former SVP of Government & Corporate Affairs, Charlotte’s Web and White Wave Foods, and Former VP of Sustainability, Sales & Trade Relations for Danone
I often saw Dale outside of his day job. His passion for “giving back” was legendary. His decade-plus volunteering on the Organic Trade Association’s annual campaign, and his passion for Boulder’s Community Food share showed Dale’s big-hearted spirit of charity. What a man! The world was better for Dale Kamibayashi in it. I went to university in Japan and spoke a little Japanese. I shared with Dale that I thought his last name must mean “bridge of God.” I imagine him walking that now.
Steve Terre, Natural Industry Veteran and Former VP of Sales, Traditional Medicinals
Sayonara Dale-San
We mourn the premature departure of a beautiful human being
His countenance
Was calmness
His bearing beneficent
His mode passionate and considerate
His smile luminous
His greeting warm and generous of spirit
Godspeed my brother on your next journey
You will be sorely missed
Too soon gone!!!
* Source: Dignity Memorial. Read more shared memories of Dale Kamibayashi by his family, colleagues, friends and community at Dignity Memorial.
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
NoCo9 Joins the Big Leagues With Keynote Speakers From Major League Baseball and Charlotte's Web
FOR IMMEDIATE RELEASE
MLB executives Jon Coyles & Uzma Rawn will join Jared Stanley of Charlotte’s Web on March 29 in a panel discussion led by NoCo9 producer Morris Beegle at the upcoming 9th Annual NoCo Hemp Expo
What: 9th Annual NoCo Hemp Expo
When: March 29-31, 2023
Where: The Broadmoor Resort, Colorado Springs, CO
Info: https://www.nocohempexpo.com/
Register for NoCo9 early bird tickets: https://www.nocohempexpo.com/ticket-sales
Loveland, CO (February 21, 2023) – The hemp industry is about to “play ball” at the upcoming 9th Annual NoCo Hemp Expo at the historic Broadmoor Resort & Convention Center in Colorado Springs, March 29-31, 2023.
Leading off this year’s most anticipated gathering of hemp industry leaders will be a special keynote conversation featuring Charlotte’s Web Co-Founder and Chief Operating Officer Jared Stanley, along with two senior representatives from Major League Baseball (MLB): Jon Coyles, Vice President of Drug, Health & Safety Programs, and Uzma Rawn, Senior Vice President of Global Corporate Partnerships.
Morris Beegle, Producer of NoCo Hemp Expo and Publisher of Let’s Talk Hemp, will lead the panel discussion, held as part of NoCo9’s Advocacy & Policy Conference on Wednesday, March 29, 11:45 am - 12:30 pm MST, the opening day of NoCo Hemp Expo – and the day before “Opening Day” of MLB’s 2023 season on March 30.
Major League Baseball became the first major professional sports league to enter into a sponsorship agreement with a CBD company when it announced the partnership with Charlotte’s Web in October 2022. The intimate discussion will dive into this groundbreaking partnership, what it means for Charlotte’s Web, and how having athletes lead the way will further educate the public about the vast potential of CBD as a natural wellness option.
'A Historic Milestone for the Sports and the CBD Industry'
“The MLB and Charlotte’s Web partnership is a historic milestone for sports and the CBD industry. The physical demands and strain on an athlete’s body are a century-old problem, and we’re here to help them address recovery in a new way. And when all else is stripped away, the mental state of an athlete is what distinguishes the greats. We know that hemp-derived CBD can provide natural solutions for top tier athletes—in both mind and body—as well as support the everyday lives of fans. As more and more athletes advocate for the benefits of CBD, MLB stands as a thought leader in advocating for player options,” said Jared Stanley, Co-Founder and COO, Charlotte's Web.
“As we enter our first full season working with Charlotte’s Web, we’re really excited to see this partnership come to life,” said Uzma Rawn, MLB Senior Vice President, Global Partnerships.
In a release on MLB.com, the league described the deal as “an exclusive multi-year partnership formed with the goal of increasing visibility of CBD for baseball players and fans.”
Charlotte’s Web has released a new CBD tincture product called Charlotte’s Web SPORT – Daily Edge that features the MLB logo. The product was developed to meet MLB’s “scientific benchmarks and no-banned substances policy,” MLB’s statement said.
“Charlotte’s Web showed a real commitment to health, wellness and science by working through the NSF Certified for Sport process before partnering with us at MLB,” said Jon Coyles, MLB Vice President, Drug, Health & Safety Programs. “This is an important, valuable conversation to have in the sports and wellness space, so I’m looking forward to our discussion.”
“I am thrilled that we will be showcasing this historic partnership and look forward to discussing its impact,” said Morris Beegle, Co-Founder and Producer of NoCo Hemp Expo, who will interview the panelists.
Experience Hemp Expo Hall – The World of Hemp Under One Roof
In addition to three days of comprehensive education, keynote presentations, workshops and seminars, NoCo9 will feature the Experience Hemp Expo Hall in The Broadmoor’s new, state-of-the-art exhibition facilities. Featuring a world of hemp and business opportunities, NoCo9 attendees can sample wares, learn about products and businesses, hold meetings and visit an expo hall full of exhibitors. The Experience Hemp Expo Hall also will feature specialized zones, including:
Divita Hemp Block Demo Zone & Solution Circle – Visit the Divita Hemp Block Demo Zone & Solution Circle – a special educational zone on the trade show floor for solo presentations, panels, demos and workshops from experts and specialists innovating with hemp across all industries, from textiles to medicinal applications, to using hemp in artisan craft production, as well as in building and construction.
Schedule at a Glance
- Advocacy & Policy Conference, Wednesday, March 29
- Lake Terrace Welcome Party & WAFBA Awards of Excellence, Wednesday, March 29
- Business & Investment Conference, Thursday, March 30
- 2nd Annual NoCo Hemp Pitch, Thursday, March 30
- Agriculture & Academia Conference, Friday, March 31
- Experience Hemp Expo Hall, Thursday and Friday, March 30-31
- Garden of the Hemp Gods – NoCo9 After Party featuring Erica Brown Blues with the Lionel Young Band, Friday, March 31
The Broadmoor Offers Special NoCo Hemp Expo Rates
NoCo Hemp Expo will take place March 29-31, 2023, at one of Colorado’s most historic 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, state-of-the-art meeting and convention space, a lake, walking paths, 36-hole golf course, spa, restaurants and lodging at a special rate for NoCo Hemp Expo attendees. Recently remodeled, The Broadmoor is committed to sustainability and has been awarded a Forbes Five-Star resort rating every year since 1960.
First Citizens Bank, EarthX, Patagonia Lead 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 to bring focus to areas where hemp can make a difference in sustainability and improving the environment.”
Exhibit and Sponsor
For more information on sponsorship and exhibiting, please visit https://www.nocohempexpo.com/sponsors-and-exhibitors-request/
Register Here for NoCo9
Visit https://www.nocohempexpo.com/ticket-sales/
About NoCo Hemp Expo
For nearly 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.
The 9th Annual NoCo Hemp Expo 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
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.”
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