Today, Janet Woodcock, MD, FDA’s Principal Deputy Commissioner, released a statement, concluding that existing regulatory frameworks for foods and supplements are not appropriate for CBD.
Following what Woodcock called a careful review, she determined, “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.”
Loren Israelsen, President of the United Natural Products Alliance, said of course UNPA is very disappointed by FDA's continued refusal to take action on CBD. “That said, it is noteworthy the FDA has acknowledged its support for a pathway to market CBD containing dietary supplements. That is clearly progress and an important step on resolving the persistent delays that have been bad for consumers and responsible industry.”
Safety concerns
The FDA cited safety concerns, pointing to the potential for CBD to inflict harm to the liver and male reproductive system, as well as have negative interactions with certain medications. The Agency is also concerned about CBD exposure to children and pregnant women.
Woodcock chairs a working group that has examined studies related to Epidiolex, published in scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency. Despite the evidence, Woodcock said it is not apparent how CBD products could meet safety standards for dietary supplements or food additives.
Jonathan Miller, General Counsel of the US Hemp Roundtable, said his group is extremely disappointed with the announcement.
“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,” said Miller.
Sibyl Swift, PhD, Chief Science Officer, cbdMD, said the company spent in excess of $1M on its safety dossier, which included 5 OECD studies.
“Through those studies, which align with the regulatory process established for dietary supplements, we identified levels that our ingredient may be safely consumed. Our level is significantly lower than the dose supported by studies for Epidiolex. Further, our conditions of use are appropriate for dietary supplements and are not for the same conditions of use as a drug. We have successfully demonstrated that the ingredient contained in our products is safe and was more than sufficient when reviewed by other regulatory agencies. We find it hard to believe that Europe has better science or unique tools to be able to analyze this data. FDA should hold itself as a leader in safety, but instead it is happy to lag behind other countries,” Swift said.
“It seems that no level of safety evidence will be good enough for FDA. During the last four years, FDA has repeatedly disregarded evidence demonstrating safety that is relevant to CBD at the levels commonly used in supplements and continues to rely heavily on safety concerns related to high dosage Epidiolex to support the agency’s inaction. In its statement today, FDA noted that a new regulatory pathway would benefit consumers by providing clear labels, prevention of contaminants, CBD content limits, and limits on use in certain populations—all this can and should be addressed through the existing dietary supplement NDIN process once FDA creates a legal pathway for CBD in dietary supplements. CRN offered the agency a blueprint for that pathway, and it has been ignored," said the Council for Responsible Nutrition (CRN) President and CEO Steve Mister.
“We do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods”
“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 or conventional foods,” the FDA statement said. “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals."
“FDA is lying and fear mongering,” said Swift. “They have tools, and they have applied the tools before many, many times. They have tools under the labeling rules, they have tools under the rules for cGMP, and they have the most potent tools in their ability to review safety data in the new dietary ingredient notification (NDIN) process. The only issue is drug exclusion and if it did not exist they could review safety data in an NDIN submission and make a determination of safety for the stated conditions of use and label on an ingredient by ingredient basis.”
Access denied
“Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements," the FDA statement noted.
The citizen petitions were filed by the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and Natural Products Association (NPA).
Daniel Fabricant, PhD, President, and CEO of the Natural Products Association, said this move 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,” Fabricant said.
Legislative solutions to be pursued
“But it gets scarier. When you read between the lines of today’s 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,” said Fabricant.
He added that NPA will look for relief with every branch of government and will need the help of its members to “right the wrong.”
Swift added that cbdMD is considering all of its options to ensure that its customers are not denied access to safe, efficacious dietary supplements.
The FDA statement did say the agency is prepared to work with Congress on a new way forward, something Miller said he supports.
“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, bi-partisan coalition that has developed in Congress to re-introduce legislation in this new Congress in the coming days to direct 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,” Miller said.
Israelsen said he looks forward to continuing UNPA's aggressive work to seek a legislative solution that provides a clear and reasonable regulatory pathway for hemp-derived dietary supplements.
“Now that FDA has clearly stated its support for CBD containing dietary supplements, an active and constructive engagement by the agency with Congress will be essential if a solution is to be found. UNPA leadership has over 100 collective years of legislative experience working on dietary supplement policy and we will continue to work actively with key members of Congress to get to a solution this year,” Israelsen said.
“Today’s announcement and response to our petition does nothing to make consumers any safer. It is yet another example of the agency shrinking from its critical public health role in hopes that Congress will make those decisions instead," said Mister. "CRN looks forward to continuing its work with congressional lawmakers to develop a legislative solution given the absence of FDA leadership.”
Indirect consumption in animal products
The FDA statement also highlighted CBD for animals, noting that people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD.
“Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals,” the statement said.
Enforcement to continue
The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.
Background
The industry has operated in regulatory limbo since the passing of the 2018 Farm Bill legalizing the cultivation of hemp, as the FDA repeatedly calls for more research on the safety and efficacy of CBD and issues warning letters in lieu of regulatory framework.
"Since Congress enacted the 2018 Farm Bill, FDA’s inaction and indecision have frustrated consumer interest in having safe and beneficial CBD products available to them and allowed a ‘gray’ CBD marketplace to emerge without meaningful oversight. The agency’s ‘punt’ to Congress, asking it to intervene after four years, is a further disservice to consumers and responsible industry," said Mister.
With the 2023 Farm Bill approaching, lawmakers on the US House and Senate agriculture committees will draft a new federal Farm Bill that will shape a number of programs for the next five years.
Medical Marijuana, Inc.’s CEO Blake Schroeder said including some language to regulate CBD in this next Farm Bill is much needed.
“The respectable players in the industry just would like some guidance. The 2018 Farm Bill made clear that anything with less than .03% THC is completely legal for use in foods and food supplements. Well, where do those products fall–are they foods? Are they food supplements? Is there some kind of a different category? These are clearly foods or dietary supplements and just some guidance in that respect would be a great win for the industry,” Schroeder said during a recent NutraCast.
The House and Senate Agriculture Committees are accepting feedback via this online form.
Research guidance
Earlier this week, FDA published a guidance note on cannabis and cannabis-derived compounds for clinical research.
“This guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research,” FDA said. “This guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs.”
The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” provides non-binding recommendations intended for products that meet the legal definition of a drug under the Federal Food, Drug and Cosmetic Act. The FDA clarifies that “cannabis and cannabis-derived compounds that may be used in manufacturing human drugs include botanical raw materials, extracts and highly purified substances of botanical origin.”
The quality considerations: sourcing, trial and control
In the document, the FDA expands legal sourcing options for clinical research beyond the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) at the University of Mississippi – the only federally sanctioned source to date.
Now, sponsors and investigators may use other sources “if deemed to be of adequate quality by FDA when reviewed as part of an IND,” as well as NIDA-DSP for delta-9 THC over the 0.3% threshold and DEA-authorized sources for Schedule I cannabis materials for research.
It also provides a list of recommended regulatory standards and documents to ensure that sponsors consistently manufacture a quality product. As such, they should be able to “submit sufficient information to demonstrate the identity, quality, purity, and potency or strength of the investigational drug” in each phase of clinical investigation.
In considering control status, the FDA acknowledges that the 2018 Farm Bill significantly reduced the regulatory requirements for cannabis and cannabis-derived compounds but that the Control Status Act (CSA) and Drug Enforcement Agency (DEA) requirements still apply if cannabis does not meet the definition of hemp (i.e., it exceeds the threshold of .3% delta-9 THC by dry weight). This carries over to intermediates or finished products, which should base delta-9 calculations on composition of the formulation with water removed.
This story continues to develop.
Asia Sherman contributed to this report.
