By Steven Hoffman
For many in the CBD industry, it was a blow but not completely unexpected when, on Jan. 26, 2023, Janet Woodcock, M.D., principal deputy commissioner of the U.S. Food and Drug Administration, released an official FDA statement on CBD regulation that stated the following:
“Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.”
In addition, the FDA announced it denied three citizen petitions from the Consumer Health Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) that requested the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The FDA’s full statement can be read here.
Members of the hemp and CBD industry replied to Let’s Talk Hemp’s request for comments with a range of opinions and perspectives on the FDA’s decision. Read on to see how the industry responded.
Jonathan Miller, General Counsel, U.S. Hemp Roundtable
We were extremely disappointed with the FDA’s announcement concerning the regulation of CBD. When it comes to the safety of CBD, the FDA gets it wrong. Contrary to the FDA’s continued assertions regarding the safety of CBD, there is clear, established evidence of safety over the years. CBD products have been sold at retail for nearly a decade with no significant safety issues. The Roundtable recently met with the FDA and shared a broad range of safety studies showing that standard CBD serving sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly larger doses that are not commonly found in CBD products sold at retail.
We therefore see no need for the FDA to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD, or other hemp-derived cannabinoids. This action would be unprecedented and is unnecessary given the existing dietary supplement and food pathways provided under the federal Food, Drug, and Cosmetic Act, which include robust, comprehensive requirements aimed at ensuring the safety and quality of products, in addition to extensive FDA regulations covering the manufacturing, labeling, and marketing of products. […]
However, there is one area in which we are in strong agreement with the FDA: As we have advocated for years, a legislative solution is necessary to allow the marketing of hemp-derived cannabinoids, including CBD as dietary supplements and foods. We look forward to working with the large, bipartisan coalition that has developed in Congress to reintroduce legislation in this new Congress in the coming days to direct the FDA to utilize the existing regulatory pathways for CBD and other hemp-derived cannabinoids, one that ensures the safety and quality of products. We also remain willing to work with the FDA to ensure that hemp-derived cannabinoids like CBD are safe and adequately regulated.”
Read the U.S. Hemp Roundtable’s full statement here.
Geoff Whaling, Chair, National Hemp Association
The reality is, the statement is consistent with what the FDA has been saying, to us, since GW Pharma submitted its NDA – that there was no current policy that would allow the FDA to approve CBD as a dietary supplement once they had an application toward approving a pharmaceutical drug with the same ingredient. Only Congress could legislatively fix this. And, I might add, this is consistent with NHA’s messaging for the last five years, messaging that came directly from our meeting with senior FDA officials in 2018, prior to the passage of the 2018 Farm Bill.
NHA is working on fixes that not only will address FDA on animal feed and cannabinoids, [but] we will be doing so while at the same time addressing similarly important issues for the hemp industry – access to capital from the private sector and research. We hope that others in the industry will join us with messaging and our collective asks as we enter 2023 Farm Bill negotiations and educational efforts with this new Congress.
Patrick Atagi, President & CEO, National Industrial Hemp Council
The National Industrial Hemp Council is disappointed in FDA’s conclusion that THC and CBD products are excluded from the dietary supplement definition. We believe this could have been done through Generally Recognized As Safe (GRAS) under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, and New Dietary Ingredient (NDI), which we believe hemp is “reasonably” expected to be safe.
In federal regulations, under sections 201(s) GRAS, and FDA’s implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive. There is sufficient evidence and research to show hemp to be reasonably safe.
Michael McGuffin, President, American Herbal Products Association
It’s extremely disappointing that it has taken FDA this long to come to the equally disappointing conclusion that kicks the can down the road and passes the buck to Congress.
The law clearly provides an opportunity for FDA to grant an exception to the prior drug exclusion for cannabis-derived ingredients, including hemp and CBD. As we have expressed for nearly half a decade, AHPA wants to see FDA use that authority to have CBD come to market as any other dietary supplement would. We believe CBD should be regulated like any other herbal constituent – including being subject to such regulatory requirements as good manufacturing practices (GMP), facility registration and serious adverse event reporting.
Further, as we have stated previously, we would prefer to see CBD regulations issued as an interim final rule rather than a proposed rule that would delay a final action even further. Our call for this prompter regulatory approach is based in our concern that American consumers today can only access hemp/CBD products that are not being subject to active regulatory enforcement by FDA.
Todd Runestad, Content Director, Natural Products Insider
The FDA cited studies that call into question CBD’s safety. I’d like to see those studies. Toxicity studies are, by design, created to find how much of some agent can be taken before signs of toxicity are discovered. They could do the same thing with water — take enough and your brain can swell, and you can pass out and die. It’s incredible that regulatory bodies the world over have been able to figure out upper intake levels for hemp CBD — e.g., in the U.K. it’s 70mg/day — but the FDA can’t seem to figure it out. We all know why — because the FDA is a wholly owned subsidiary of Big Pharma.
John W. Roulac, Founder of Nutiva, Executive Producer, Kiss the Ground
After a four-year process, the FDA continues to block issuing reasonable CBD regulations. Yet it’s not surprising given the lack of science-based rulemaking at the FDA. Americans deserve better and Congress must act to resolve this.
Daniel Fabricant, Ph.D., President & CEO, Natural Products Association
Just months after FDA rejected NPA’s extraordinary Citizens Petition on a CBD regulatory path and the submission of new scientific data from CBDMD for FDA examination, the agency today claimed it does not have appropriate authority to regulate the popular and widely used ingredient that continues to proliferate in markets across the country.
This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed it was capable of during the pandemic. After more than a decade of promises, hearings, data sharing, market proliferation and states filling the regulatory vacuum, the FDA’s Dietary Supplement Division claims it cannot do what Congress authorized, which is to regulate dietary supplements under the law.
But it gets scarier. When you read between the lines of the FDA statement, the agency appears to be saying that it would prefer to defy and attack DSHEA and develop different regulatory paths for ingredients at its own discretion. That could include requiring premarket approval, unnecessary testing or who knows what. That is an especially dangerous precedent not only for CBD but for the entire natural products industry and ingredients like hemp that clearly fall under the agency’s jurisdiction. We couldn’t be more disappointed and will look for relief with every branch of government and will need the help of our members to right the wrong.
Moves like this on CBD, coupled with FDA’s actions on NAC and NMN, make it clear that the stance by our principal regulator is that they want to stymie innovation in the food/dietary supplement space. State governments and foreign governments have moved ahead on CBD and other cannabinoids to ensure that the public has basic information from their regulator such as how much to use daily. This is the whole point of a public health agency, to balance protection with promotion of public health.
Read NPA’s statement here.
Robert Hoban, Co-Chair, Cannabis Industry Group, Clark Hill
The FDA’s announcement comes as no surprise. As a legal practitioner who is intimately familiar with the Food, Drug, and Cosmetic Act, I have stated for years that the FDA regulations do not currently (nor plainly) support the addition of CBD (or other novel cannabinoids) for commercial sale and distribution. And, frankly, this is consistent with what the FDA has been saying in its warning letters and policies for years now – CBD cannot be a nutritional ingredient or supplement. None of this is a surprise, nor should it be.
But two former FDA commissioners, Hahn and Gottlieb, had previously indicated that the FDA would indeed carve some sort of pathway for CBD since the compound (CBD) is so widely used and distributed. This tended to mislead the CBD producers/industry that an approved FDA pathway was clear or imminent; it was neither. Moreover, the FDA has concerns about long-term safety of these products because there is no such data.
Under any circumstance, the FDA announcement correctly indicates that it cannot, under existing rules and laws, simply add a new ingredient to the ranks of FDA-approved compounds, considering it is recently/newly introduced into the chain of commerce, and this compound has not been run through all appropriate approval/safety channels. Moreover, there is a disconnect with many industry producers who continue to suggest efficacy associated with their products – also impermissible without substantial interface, approval/recognition (and time) with/by the FDA. And so, the FDA has looked at these producers with much apprehension.
In sum, this is not news. While there are ways that the FDA could have adopted favorable policy interpretations associated with CBD to allow for its use, this was never likely because of the dearth of long-term safety data, because of the fact that FDA personnel tend not to make disruptive decisions on their own, and because there exists a regulatory conflict between drug formulations (current and newly advanced) containing CBD and other hemp derivatives intended to be used as a food or supplement ingredient.
Thus, the FDA has asked for help from Congress. For those that consider this a “punt” by the FDA, I would suggest that it was going to be a punt all along.
Asa Waldstein, Principal, Supplement Advisory Group
Proving ingredient safety and providing usage warnings to those who are pregnant, nursing, children or taking medications are core principles of dietary supplements. I find it surprising these examples were cited by FDA as the rationale for denying the citizen petitions.
What should reputable CBD companies do now? I suggest acting like you want to be regulated, including investing in product safety data, supplement GMP practices, DHSEA-compliant marketing and labeling essential items such as common allergens and adverse event reporting contact information.
Sean Murphy, Founder, Hemp Business Journal & Kompassion
Parents with sick children like me who know the difference between full-spectrum organic hemp products and isolate CBD (Epidiolex) are in awe how controlled and corrupted the FDA has become by pharmaceutical companies like Pfizer, Moderna and Jazz. CBD as a dietary supplement is competition to the pharmaceutical industry. This is a sad day for sick children, palliative parents like me and health freedom in America. Or, to shorten it … FDA is a captured government agency by the pharmaceutical industry.
Chris Boucher, CEO, Juicetiva and Farmtiva
The FDA’s recent action is another train wreck for American hemp farmers, a blow to the health and wellness industry, and another miss for corporations looking to generate additional revenue in what could be a billion-dollar market.
How can the FDA determine that a vaccine is safe for 300 million Americans … in six months? But it can’t — or won’t — establish that a natural agricultural food commodity — that was once this country’s most important crop, that you could pay your taxes with for 200 years and that humans have been consuming for over 10,000 years — is still not safe as a food.
After eight years — the fact that the FDA still can’t determine if cannabidiol is safe, especially when there is no record of death or hospitalization from CBD — it couldn’t indicate more clearly that the payer risk drug system, which they oversee, is the corrupt influence we have always believed it to be.
Annie Rouse, COO, OP Innovates
It’s disappointing that after all these years the FDA passes the responsibility back to Congress for rulemaking. Their delay allows bad actors to continue to market and sell products in an industry we are working to legitimize. And it continues to create ongoing concerns within the gray market of artificial cannabinoids, which is not in the best interest of consumer protection.
While CBD may be viewed as a supplement to many, I understand their hesitancy and desire to have cannabinoids or hemp and cannabis as a whole regulated separate of food and supplements. Cannabis, inclusive of hemp, is one of the most complex plants on earth and elucidating its intricacies has only just started. While many of the quality control standards can build off of food and supplement standards, there are other nuances under the processes and products that need particular attention, especially with the recent rise in artificial cannabinoids. It deserves its own standards, but those will take considerable time to develop. By then we’ll be talking about cannabis as a whole, not just hemp.
Joy Beckerman, Principal, Hemp Ace International
The overtly transparent nature of FDA’s “desperately seeking harm” missive as it relates to CBD is simply striking. While this announcement repeats broad-brush concerns previously put forth by the agency, FDA continues to fail to provide a detailed explanation as to how and why the robust existing regulatory pathways are inadequate for CBD. FDA’s contumacious denial of numerous comprehensive safety studies and data, along with its irrational reliance on studies performed with extraordinarily high doses of CBD isolate on subjects with existing liver damage, have become laughable, as has FDA’s fearmongering around sexual organs and interactions with medications. Both the FDA and the National Institutes of Health Office of Dietary Supplements for some years now — with various updates — maintain consumer education web pages specifically devoted to awareness around potentially harmful interactions of dietary supplements with medications.
Having said this, as it relates to the creation of cannabis drugs — which regulatory framework is separate and distinct — it is becoming a well-accepted reality that indeed a new regulatory framework will need to be created for whole plant and whole fungi medicine. The current drug approval pathways have been developed for highly refined plant components as opposed to the whole plant.
Courtney Moran, Chief Legislative Strategist, Agricultural Hemp Solutions
The statement comes as no surprise, as the industry has been asking both FDA and Congress to develop a regulatory pathway for CBD and hemp-derived products for years. With the 118th Congress beginning its work, it’s helpful to have this in black and white from FDA, with the affirmative statement they are looking “forward to working with Congress to develop a cross-agency strategy” for regulation. We have seen several pieces of federal legislation introduced in previous Congresses to address this issue, with no movement. We hope this statement from FDA shines a light on the need to create a federal regulatory program for CBD as well as other hemp-derived ingredients and products now.
With the lack of federal oversight to date, states have taken the lead in establishing regulatory frameworks for hemp-derived end products, focusing on providing for consumer safety through a variety of mechanisms, such as requiring testing, specific labeling, age limits and setting concentration limits for products. However, the patchwork of continually changing state regulations makes it challenging for businesses to comply with, creates a gap in enforcement and further causes consumer confusion. The industry looks forward to broader collaboration with FDA and will continue to advocate for sound federal guidelines that protect consumers while providing opportunities for hemp businesses.
This is a pivotal time for our industry. We are eager to see this Congress address several outstanding issues: the regulation of CBD and hemp derivatives, protecting work-in-progress hemp, addressing the THC limit, creating grain and fiber industrial hemp exemptions, and facilitating approval of hemp ingredients in animal feed.
Rod Kight, Attorney, Kight Law Office
Although disappointing, the FDA’s press release stating that existing pathways are not appropriate for CBD is not surprising. The FDA has “punted” on this issue several times in the past and this most recent decision clearly demonstrates the FDA’s intention to wait for Congress to act, rather than to step in and regulate CBD and other hemp compounds. Given that Congress will likely pass a new Farm Bill this year, the FDA may get its wish. In the meantime, we can expect more of the same inaction by the FDA. Since CBD was first commercialized in the wake of the 2014 Farm Bill, the FDA has stood on the sidelines and allowed an entire food and dietary supplement industry to emerge without any clear guidance and with minimal oversight. The hemp industry and the consumers who use its products deserve better and we hope that Congress will enact sensible laws that force the FDA to regulate CBD and other hemp compounds.
Charlotte’s Web, in a Statement to Investors
Charlotte’s Web is encouraged that the administration has agreed that it is necessary for Congress to act for the regulation of hemp-derived cannabidiol (CBD). The FDA position has taken four years to come together, while the CBD industry has matured without a clear regulatory pathway for CBD products that are already available for sale in all 50 states and consumed safely by millions of Americans. This includes professional athletes, veterans and everyday wellness seekers. The company looks forward to continuing its work in Washington, D.C., to forward this process.
The company also agrees with the FDA on the importance of testing to ensure the quality and safety of CBD products and has already provided studies to support this position. As the CBD pioneer and market leader, Charlotte’s Web has engaged in safety studies and compiled toxicology data, including liver safety. These studies have been conducted under an Institutional Review Board and Good Laboratory Practices, following guidelines of the Organization for Economic Co-operation and Development (OECD). They have been subjected to an unbiased peer review and published in journals and have been vetted and accepted for indexing in the PubMed central database. These studies support the efforts of a legislative regulatory framework.
During this four-year period of regulatory absence, Charlotte’s Web has set the standard in responsible self-regulation in product manufacturing, safety and labeling. In addition to safety and toxicology studies, the company utilizes cGMP-compliant manufacturing facilities, seed-to-shelf testing and certificate of analysis (COA) transparency for all products. Recently, Charlotte’s Web became the first and only broad-spectrum CBD hemp extract to be NSF Certified for Sport®, the gold standard to ensure safe and consistent products for professional athletes and consumers alike.
Read Charlotte’s Web’s full statement here.
Morris Beegle, President & Publisher, Let’s Talk Hemp, NoCo Hemp Expo
As a leading trade show organizer and hemp media publisher who has worked with thousands of industry stakeholders and companies over the last decade, all who have felt the effects of unclear regulations in the space, the recent FDA decision on CBD doesn’t surprise me.
That said, it is certainly disappointing, and it makes me mad reading the announcement and the reasoning provided by Principal Deputy Commissioner Janet Woodcock. It’s clear the FDA has had the lawful ability to make an exception to the prior drug exclusion for cannabis-derived ingredients, including hemp and CBD. AHPA and others in the natural products and hemp space have provided extensive insight on this fact along with the safety of CBD and other hemp-derived ingredients for years now. The FDA, taking over four years from the passing of the 2018 Farm Bill to come to the conclusion to pass the buck back to Congress (which itself has proven ineffective and unable to pass rational policy regarding hemp and cannabis), is another obstruction in the long-documented history of the FDA fighting against plant-based ingredients and supplements.
Hemp CBD is just another herb/botanical with a high-safety/low-adverse reaction profile and should be regulated as such. The pathway already exists. The FDA’s actions, and lack of action, have cost the hemp industry billions of dollars in lost investment, lost R&D, lost infrastructure and lost revenue across the entire hemp value chain. It’s also put a lot of companies out of business and cost tens of thousands of jobs all across the country.
Now that we have this long-awaited revelation from the FDA to work with Congress and create a new regulatory pathway for hemp-derived cannabinoid products — which are currently available all over the United States in retail stores and on the internet — it’s time for those in the hemp and natural products space to focus on working together with a unified voice and to create a regulatory channel with policymakers that protects and benefits both consumers and the industry as a whole.
The post Hemp and CBD Industry Responds to FDA’s Announcement on CBD first appeared on Let’s Talk Hemp.