When Congress legalized hemp in 2018, cannabidiol, or CBD, became widely available in a range of consumer products and formulations, including topicals, food, beverages, and inhalants. Today these products are available throughout the U.S. in brick-and-mortar stores and online. Unlike tetrahydrocannabinol (THC), the cannabis component that creates a euphoric “high,” purified CBD is not psychoactive, nor is it addictive.
While CBD products have been touted for addressing numerous health issues, there are significant safety concerns associated with many of them. CBD consumer products do not fit neatly into any of the current frameworks for regulating foods, dietary supplements, tobacco products, and over-the-counter drugs. As such, the CBD consumer product market is largely unregulated. Consumers have no way to be sure that the product they buy contains the ingredients listed on the label, and that it does not contain intoxicants or contaminants.
The Promise and Challenges of CBD
Proponents of CBD say it offers a variety of health benefits, from reducing anxiety to lowering blood pressure and preventing diabetes. In 2018, the FDA approved the first CBD drug, Epidiolex®, for the treatment of seizures associated with two rare, severe forms of epilepsy. An FDA press release states that Epidiolex provides “a significant and needed improvement in the therapeutic approach to caring for people with this condition.”
Epidiolex is produced in a controlled setting to ensure consistent content, purity, and potency. The drug is subject to the same rigorous safety testing that any FDA-approved medication undergoes and is available only by prescription from a health care provider. This is not the case for consumer CBD products.
An advisory from the Substance Abuse and Mental Health Services Administration (SAMHSA) warns that CBD consumer products may not be properly labeled, may contain psychoactive THC or chemical contaminants, and may cause unintended drug interactions. In addition, there’s limited evidence to support the safety of CBD products other than Epidiolex, which is approved only for certain patients and has a substantial list of side effects. According to the FDA, research suggests long-term CBD use may be associated with liver toxicity and damage to men’s reproductive systems. It is also unclear whether CBD is safe for children and pregnant women. A study from Roswell Park Comprehensive Cancer Center in Buffalo, New York, found that vaping (inhaling) CBD leads to more severe lung damage than vaping nicotine.
A Hybrid Approach to Regulation
For these reasons, the FDA has determined that CBD consumer products cannot meet the current safety standards for foods and dietary supplements. The agency has asked Congress to authorize a regulatory framework that provides consumers with access to CBD products while adequately protecting the public’s health and safety. Congress took an important step in July when a bipartisan, bicameral group of lawmakers issued a Request for Information regarding the regulation of CBD products, but it’s not the first time the federal government has sought public input for this purpose. Health policy organizations including Aimed Alliance have been urging the federal government to regulate CBD consumer products since 2019. We have not seen meaningful progress yet.
CBD consumer product regulation should incorporate elements from the rules currently in place for foods, dietary supplements, tobacco products, and over-the-counter drugs. Congress should authorize the FDA to require CBD manufacturers to:
Implement product purity standards, including limits on fertilizer, lead, mold, and other impurities.
Follow manufacturing practices like those used in producing foods to prevent contamination.
Submit a premarket notification to the FDA 75 days before marketing a CBD consumer product. This requirement should include providing adequate, credible evidence that the product is safe under the conditions of its intended use.
Set per-serving limits on amounts of CBD, THC, and other psychoactive cannabinoids, similar to the FDA’s proposal to limit nicotine in cigarettes and other tobacco products.
Limit the total amount of each cannabinoid per package to prevent exposure to unsafe amounts of CBD, THC, or other psychoactive cannabinoids by ingesting multiple servings.
Ensure labeling accuracy by limiting variances between labeled content and actual product content.
Without sufficient resources and capacity to regulate the safety of consumer products containing CBD, the FDA will be unable to satisfy the requirements of a new law, thereby maintaining the current state of inadequate regulation and enforcement. Therefore, Congress must first make certain that the FDA has adequate resources and capacity to establish and enforce compliance with new regulations.
Ultimately, a new federal law should ensure that consumers have access to CBD products while protecting public health and safety. A new regulatory framework that accomplishes these goals must be a priority for Congress.
For more information, please read the following Aimed Alliance fact sheets:
Be sure to check out our episode with Aimed Alliance managing counsel Michael C. Barnes.
This article was sponsored by Aimed Alliance.
About the Author
Michael C. Barnes is the managing attorney for Sequel Health Law. He serves as counsel to Aimed Alliance, a not-for-profit health policy organization. Barnes counsels boards and management teams of public and private companies on business strategy, law, legislation, and regulation to advance market entry and expansion, revenue, and social responsibility objectives.
His practice centers heavily on health and drug law and policy with an emphasis on opioid and other controlled medications, cannabinoids, substance use disorders, and pain management. Barnes is also Chairman of the Center for U.S. Policy, a not-for-profit organization advancing solutions to the nation’s drug poisoning crisis.
About Aimed Alliance
Aimed Alliance is a 501(c)(3) not-for-profit health policy organization. The mission of Aimed Alliance is to protect and enhance the rights of healthcare consumers and providers. For more information and the latest news follow: aimedalliance.org