In a statement released Friday, FDA commissioner Dr Stephen Hahn and principal deputy commissioner Dr Amy Abernethy noted that while CBD is now widely available, we “still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds."
Specifically, they added: “We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products. Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health.”
‘Outstanding knowledge gaps’
Existing efforts generally “are not adequate to fill the outstanding knowledge gaps,” they claimed, noting that longitudinal studies, which provide data about the health of subjects over an extended period of time, are needed to understand long-term health effects of CBD use.
Meanwhile, they added, “observational studies that are too small or that do not include techniques to ensure data quality or methodological rigor are of limited use for public health decision making.”
Rates of CBD use, and rates of use of specific CBD products, are also poorly understood, they said: “What is the denominator of risk for adverse events in the population taking CBD? What specific populations have the highest CBD exposures and what specific products are frequently used? What other products, such as over-the-counter or prescription drugs, are used alongside CBD products? Are there risks associated with interactions between CBD products and other products, beyond those that have already been identified and communicated by the FDA?”
CRN: ‘FDA could fix this problem today’
So what does this mean for food and supplement companies, who have been operating in a kind of legal grey area for years, navigating a patchwork of different state rules, and waiting for action at a federal level from the FDA, which says ingestible CBD is not a lawful dietary ingredient (because it was first investigated as a drug), but has not pulled it from shelves, instead focusing enforcement action on companies making unsubstantiated health claims?
Steve Mister, president and CEO of Washington DC-based trade association the Council for Responsible Nutrition (CRN), said the latest statement amounted to “nothing more than an end-of-administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area.
“Today’s announcement tries to excuse the agency’s inaction by decrying a lack of data, even as FDA has blocked the New Dietary Ingredient (NDI) route for CBD supplements by declining to review them, and done little that might incentivize data to be presented or invested in research of its own.”
The FDA could “fix this problem today” by simply applying the current regulatory framework for assessing new dietary ingredients to cannabinoids such as CBD, argued Mister, who filed a citizen's petition last June urging the FDA to regulate CBD as a legal dietary supplement.
Inaction has consequences
And the longer we wait, the longer consumers are potentially at risk, and responsible players in the industry at a disadvantage, he claimed.
“Because of the FDA’s failure to act, the public continues to be exposed to possible harms by a wild-west market that continues to expand without meaningful regulatory bounds.
"And responsible manufacturers of dietary supplements containing CBD – who are dutifully abiding by those regulations, and incurring the costs of doing so – suffer as their products are sold alongside products that may or may not contain CBD, may contain THC, make illegal disease claims, or contain unsafe adulterants.”
According to the CRN's 2020 petition, the "FDA already has explicit authority to promulgate a regulation finding that dietary supplements containing CBD may be lawfully marketed under the FDCA, despite its use first as a drug. Under this path, FDA would, by regulation, remove CBD from the exception to the statutory definition of a dietary supplement that applies to certain articles that were first approved or investigated as a new drug."
After that, each unique manufacturer of a CBD-containing ingredient would then be required to file its own new dietary ingredient notification (NDIN) proving product safety; products would have to be manufactured using good manufacturing practices (GMPs) in FDA-registered facilities; firms would have to follow adverse event reporting requirements, and products would have to be labeled in compliance with FDA regulations.
Attorney: 'This announcement has the effect of resetting expectations'
So what do legal experts make of the FDA's progress report, and what does it mean for food and supplement makers?
Greg Kaufman, partner at Eversheds Sutherland, told FoodNavigator-USA: "In my view, this announcement has the effect of resetting expectations around the regulation of CBD by the FDA. While the industry may have been hopeful that the FDA would provide helpful regulatory guidance in the new year, the announcement suggests such hope may be unrealistic.
"I am also inferring from the announcement that the Draft Enforcement Guidance that the FDA submitted to OMB in July of last year in unlikely to see the light of day."
FDA’s inaction 'creates perverse incentives for actors in the marketplace'
Given the exclusionary rule, which prohibits food/supplement makers from using an ingredient that was first investigated as a drug, the FDA now “needs to prescribe limits and conditions for the inclusion of cannabidiol in dietary supplements, foods and beverages through notice and comment rulemaking,” argued Jeni Lamb Rogers, partner at PSL Law Group.
“But this will take some much-needed initiative from the FDA, which we have not seen from the agency on cannabidiol to date," she observed.
In the meantime, she said, “The FDA’s inaction creates perverse incentives for actors in the marketplace," by putting responsible players at a disadvantage because they face higher compliance costs.
"Consumers have no effective way of distinguishing between products that are produced safely and those that are not.”
'Myriad and conflicting state laws'
In the absence of federal regulations, states such as New York, Florida and Colorado, meanwhile, are coming up with their own rules on CBD, she said. "I deal with the consequences of this every day in my practice advising clients on how to label cannabidiol products. When you layer in the complexity of myriad and conflicting state laws, manufacturers trying to do the right thing have a hard time clearly communicating all the requirements to the consumers on their labels.”
She added: “I think the agency will find that if it proposes something to the industry, it will get much of the feedback that it needs regarding safety through the notice and comment process, and once a rule is finalized there will be a legal framework to enforce for the safe production of cannabidiol products as supplements and foods for the betterment of public health.”
States in unenviable position of deciding matters on a state-to-state basis
Joseph Schilleci, Jr., attorney and owner at Schilleci & Tortorici, added: "The FDA continues to state publicly that CBD based supplements are prohibited while products alleged to have CBD included are flooding the marketplace without any guidance from the federal government.
"It would be our view that this trend will continue and only get worse, leaving the States with the unenviable position of having to decide matters on a state-to-state and inconsistent basis while the FDA stands idly by....Nonetheless, it will be interesting to watch in the coming months with a new President and Congress."
Many CBD products 'did not contain the levels of CBD they claimed to contain'
In connection with several warning letters, the FDA said its tests had found multiple products currently on the market do “not contain the levels of CBD they claimed to contain.”
The first phase of the FDA’s sampling and analysis study (~200 samples) found that “fewer than half of the tested products contained CBD at concentrations within 20% of their claimed amount and some products contained the psychoactive, intoxicating cannabinoid THC.”
The second phase of the sampling plan – which has yet to be conducted - will involve a much larger sample set (1,000-3,000 products), said the agency.