Here we are, nearly five years after the 2018 Farm Bill was passed, still dealing with uncertainty over the status of cannabidiol (CBD). In January, the U.S. Food and Drug Administration (FDA) concluded that there needs to be a a new regulatory pathway for CBD that balances consumers’ desire for access to CBD products with regulatory oversight to manage risks.
Industry reaction to FDA’s position was strong. “FDA continues its long exercise of kicking the can down the road while ignoring the realities of the current marketplace and offering little to show for its purported four-year review of a dietary supplement CBD regulatory pathway,” said Council for Responsible Nutrition (CRN) President and CEO Steve Mister. “FDA has had ample time to consider scientific evidence and develop a regulatory pathway for CBD within the existing legal 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.”
Daniel Fabricant, Ph.D., NPA President and CEO, said, “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 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.”
A key reason FDA cited for its decision: “The use of CBD raises various safety concerns, especially with long-term use,” said FDA’s Janet Woodcock, M.D., Principal Deputy Commissioner - Office of the Commissioner, in a statement. “Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”
In April, science seemed to bolster FDA’s concerns. The Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN) review of the oral toxicity of CBD stated: “The toxicological profile of CBD raises safety concerns, especially for long term consumption by the general population.”
Is the caution valid? Dr. Fabricant said of the review: “Using drug standards to conduct a ‘supplement study’ is at the very least disingenuous and at the worst very harmful for the foundering and rudderless regulatory process on CBD. Instead of using actual dietary supplement data and research like the data we supplied to the agency in our , the FDA instead chose to use drug data to draw conclusions that are three times the dose of the CBD drug Epidiolex. This is extremely troubling, confusing, and sets us back even further on one of our top priorities for the past several years, which is meaningful progress on a regulatory path for something that’s ubiquitous in the market.”
CRN, in a letter to FDA, stated: “The review article ignores the body of evidence on the safety of CBD-containing hemp extracts that have been developed for dietary supplement use…Industry stakeholders have responded to FDA’s call for scientific evidence on the safety of CBD by investing in research on their ingredients, which encompass a range of CBD-containing hemp extracts, as well as CBD isolate. This research, conducted in accordance with regulatory test guidelines, provides evidence to support the safe use of various CBD-containing ingredients for their intended uses. The studies have been published in peer-reviewed literature, submitted to the public docket that FDA opened to facilitate submission of CBD data, or shared directly with the Agency. CRN is directly aware of numerous companies that have met with the Agency and shared unpublished data in their possession that support CBD’s safety at levels relevant to the products they would market as dietary supplements. FDA has received some of these lengthy dossiers in connection with particular New Dietary Ingredient notifications, on which it has objected on drug preclusion grounds. The Agency has placed undue weight on the Epidiolex dataset and trivialized evidence that examines lower dosages, and that pattern continues with the recently published article.” While FDA is still determining how to proceed, CRN said it is in favor of states developing their own legislation to fill the regulatory void.
On the state level, NPA expressed “grave concerns” on Colorado Senate Bill 23-271, on the regulation of compounds related to cannabinoids. Dr. Fabricant, in a letter to Senate President Steve Fenberg, stated: “FDA has wasted considerable time claiming confusion on CBD when the pathway is for them to write a proposed rule, or in the interim, exercise a policy of enforcement discretion via guidance or interim final rule, which they could establish a process of reviewing any CBD product via NDI notification and establishing a daily upper limit, which would ensure consumers that FDA is fulfilling their mandate as a science-based agency to review new items in the diet. While we understand the intent of the legislation, the fact remains that ... the legislation in its current form is at odds with federal law. We strongly urge the legislature to oppose the bill in its current form.”
In May, FDA’s Intergovernmental Affairs Staff held a stakeholder call to offer information on FDA’s conclusion that a new regulatory pathway is needed. Dr. Fabricant discussed this on NPA blog and asked: “In this announcement, the priority is on state/local government officials as more important ‘stakeholders’ than, you know, farmers, manufacturers, retailers, and Americans who want their tax dollars spent on strategies and real action under current laws. Hence, they know what they can use now so that some government officials can take credit for a ‘new pathway.’ The road works, but if the government doesn’t take it, why the need to build a new one?”
Throughout all of this, brands are offering consumers the products they seek. For insights from companies trying to make their way in the CBD space, see Spotlight on Phytocannabinoids.