After several years of deliberation, hearings, and evidence gathering, the Food and Drug Administration (FDA) released its latest position on whether it will provide oversight for the manufacture and sale of products containing cannabidiol (CBD) on January 26, 2023.
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In this post, we’ll dive into the FDA’s decision to not restrict CBD sales while calling for new regulations to ensure the quality and safety of CBD products available on the market. We’ll also discuss the legal history behind the agency’s decision, as well as its implications for consumers and the industry.
Breaking down the FDA’s position on CBD requires a bit of nuance, but the two most important things to know about the January 26 decision are:
“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” FDA Deputy Commissioner Dr. Janet Woodcock says in a statement.
“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.”
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” she adds.
Before establishing that regulatory pathway, however, the agency has said it will need further evidence regarding the potential negative effects of CBD, and especially in relation to use of the cannabinoid over a long period of time.
It will also need assistance and input from Congress. The FDA “all but explicitly” asked the legislative body to step in, according to attorneys Howard Sklamberg and Elizabeth Trentacost of Arnold & Porter.
“Ultimately, FDA’s stance leaves Congress in the driver’s seat when it comes to establishing a regulatory path forward for CBD,” the attorneys conclude.
Though the agency was initially founded with the mission of overseeing and enforcing consumer protection laws regarding food, the 1938 Food, Drug, and Cosmetic Act (FD&C Act) brought drugs and medicines under the purview of the FDA.
Later changes to the agency’s responsibilities expanded its authority to include dietary supplements, though it can’t approve these products “for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public,” according to the FDA website.
The agency does not consider CBD (or its psychoactive cousin, THC) to fall under the definition for supplements under the FD&C Act. Products containing CBD are viewed the same way.
Despite the hesitancy voiced in the January 26 announcement, the FDA has already dipped its toe into regulating CBD as a drug with the approval of CBD-based anti-seizure medication Epidiolex in June 2015.
What makes Epidiolex different from run-of-the-mill consumer CBD products was the agency’s decision that the evidence supporting the specific use of Epidiolex for its intended purpose — treating two rare and severe forms of epilepsy — was sufficient enough to approve the individual product, according to a statement from then-FDA Commissioner Dr. Scott Gottlieb.
What ultimately lies at stake for consumers is a lack of control over what is in their CBD. Studies of CBD products, their efficacy, and their purity have shown that many readily available CBD products do not necessarily contain the dose or purity that they claim.
For example, a study from 2022 that reviewed a sample of 80 hemp-derived CBD products available to consumers through online or brick-and-mortar retail in the United States found that just under half of those products contained at least 10% more or 10% less CBD than the product packaging indicated.
“Consumers and practitioners should remain cautious of unregulated and often-mislabeled CBD products due to the risks of taking too much CBD (e.g., drug-drug interactions, liver enzyme elevations, increased side effects) and the consequences of taking too little (e.g., no clinical benefits due to underdosing),” the study’s authors conclude.
Based on the study above, as well as comments from academics and legal experts, regulation will be key to reducing issues with dose and purity while protecting consumers.
“Much is at stake in getting CBD’s safety profile defined for consumers, clinicians, manufacturers, and others,” writes Rosalie Liccardo Pacula, a professor of health policy, economics, and the law at the University of Southern California.
“Undefined and unregulated, CBD will continue to pose unnecessary risks and never reach its potential as a legitimate health supplement. Congress should find the funds to unlock the mysteries of CBD and give the FDA the political cover it needs to ensure the U.S. has a safe and useful CBD marketplace.”
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Some industry representatives reacted to the FDA’s decision with disappointment.
“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,” Jonathan Miller, General Counsel of the U.S. Hemp Roundtable, said in a statement.
“We therefore see no need for FDA to go through the lengthy, burdensome exercise of establishing a new regulatory pathway for CBD, or other hemp-derived cannabinoids,” he adds.
Until regulation has been introduced, the industry will have to continue to “live with the murky status quo,” according to attorney Doug R. Sargent of Greenspoon Marder.
In terms of enforcement and compliance, that status quo means CBD industry players should continue to assume the FDA will crack down on a subset of companies with products the agency believes are improperly marketed or making unsubstantiated medical claims or being advertised to children.
“Stakeholders should keep a close eye on the legislative process and consider lobbying efforts where appropriate,” a team of attorneys from Eversheds Sutherland advise, adding that companies should take extra care when marketing their products to avoid provoking the FDA.
Despite the FDA’s reluctance to establish a regulatory framework for CBD, CBD derived from hemp plants has been federally legal since 2018 thanks to the Agricultural Improvement Act, sometimes referred to as the 2018 Farm Bill.
Some politicians have already voiced support for attaching nationwide cannabis or hemp regulation to the 2018 bill’s upcoming replacement, with MJ Biz Daily reporting that Representative Earl Blumenauer of Oregon has stated that the new bill “absolutely poses a path forward” for general cannabis reform at the federal level.
While the government mulls over its legislative and regulatory options, researchers must continue to pave the road towards CBD regulation with new evidence regarding the safety and efficacy of the cannabinoid, states USC’s Pacula.
“Additional research on the benefits and risks of CBD is imperative,” she states. “Without new authority that ultimately would allow safe cannabidiol-based products access to the market, the FDA has the unmanageable task of controlling what can only be described as a wild west of unsubstantiated claims.”
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