As the U.S. Food and Drug Administration (FDA) continues to stall on regulating cannabidiol (CBD) as a dietary supplement, Congress is moving forward on requiring the federal agency to establish regulations.
Sens. Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., filed the Hemp Access and Consumer Safety Act on Wednesday. The legislation would create a clear pathway for CBD to be used in food, beverages and dietary supplements, opening the door for non-pharmaceutical CBD producers to market hemp-derived CBD products through additional sales channels.
Jonathan Miller, general counsel for the U.S. Hemp Roundtable (USHR), called the bill a huge win for American consumers, farmers and the hemp industry as a whole.
“Consumers will benefit from knowing that CBD products must be manufactured according to FDA-approved CBD processes,” Miller said in a USHR press release. “Struggling American farmers will benefit from a stabilized marketplace. It also will stimulate innovation and job creation in the hemp industry.”
FDA regulation to ensure consumer safety in the CBD market is necessary as demand and commercial interests in CBD products continue to grow, Scott Melville, the president and CEO of Consumer Healthcare Products Association (CHPA), said when the House version was introduced. A national trade association with headquarters in Washington, D.C., CHPA represents manufacturers and marketers of over-the-counter medicines, dietary supplements and consumer medical devices.
“The continued lack of regulatory clarity along with insufficient oversight around hemp and hemp-derived CBD has led to bad actors entering the marketplace, exposing consumers to potentially unsafe products that may lack consistency in product quality,” Melville said.
The Senate bill would amend the Federal Food, Drug and Cosmetic Act (FD&C Act), which prohibits any new dietary ingredients, food or beverage from entering the market if it has been studied or approved as a drug. A pharmaceutical version of CBD, Epidiolex, is currently approved and regulated by the FDA. The FDA has the authority to exempt items from the FD&C Act but has yet to exempt hemp-derived CBD despite congressional action to legalize its production and sale.
The Senate bill hits the nail right on the head because it aims to lift the medical exclusionary rule attached to GW Pharmaceuticals under the FD&C Act, said Kaelan Castetter, the CEO of Empire Standard, a large-scale hemp and CBD processor and manufacturer in New York. GW Pharma is the manufacturer of Epidiolex, which the FDA approved in 2018 for the treatment of seizures associated with two rare forms of epilepsy.
“The first thing that needs to happen is they need to drop the medical exclusion rule. They need to say that GW Pharmaceuticals’ medical exclusionary rule is not valid,” Castetter said. “A lot of companies have the data and the ability to go through these application processes [to market their CBD products as dietary supplements]. The thing is the FDA is just not taking them. They’re like, ‘Oh, it’s CBD? That’s GW Pharmaceuticals’ exclusionary.’”
In addition, the Senate’s Hemp Access and Consumer Safety Act prioritizes consumer safety by requiring manufacturers to comply with all existing federal regulations for products that contain CBD, and ensures that those products are properly labeled, according to a press release from Wyden.
“CBD products are legally being used and produced across the nation. Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone,” Wyden said. “It’s been more than two years since I worked with colleagues to have Congress legalize hemp and hemp-derived products. It’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”
In March 2020, the FDA embarked on a comprehensive evaluation of CBD products, requesting science-based data from industry leaders so the federal agency could explore viable and appropriate regulatory pathways for hemp-derived products outside the drug context.
In March 2021, a team of principal investigators from Validcare presented preliminary findings to the FDA’s Cannabis Product Council—after seven months of clinical research—that showed no evidence of liver disease and no increase in the prevalence of elevated liver function tests (which would indicate inflammation or damage to cells in the liver, according to Mayo Clinic) in 839 adult participants who consumed oral CBD products. Validcare is a provider of digital decentralized patient-centric clinical trials for the life science and health care supplement industry.
But principal investigators of that study said they were going to continue to analyze real-world data and add a second cohort to their study to increase statistical certainly for liver safety across diverse populations and consumers with various medical conditions.
Castetter said it’s not unusual for the FDA to request additional data and studies to be done before the agency acts.
“This is why Congress needs to act, and this is why this bill is so important, because you just need to tell the FDA what they need to do at this point,” he said. “They’re not going to do it on their own.”
Also the director of policy analysis at Castetter Cannabis Group, which offers management consulting, regulatory analysis and policy research services, Castetter played a role in shaping 2019 legislation in New York aimed at proper labeling of cannabinoid hemp products as dietary supplements. The legislation was signed in 2020 but hasn’t been implemented yet.
Castetter said if there isn’t a clear, regulatory pathway for CBD to be used in food, beverages and dietary supplements, then he believes growth in the CBD space is at its ceiling.
“Most significant retailers are not going to look at that risk profile and be comfortable with it,” Castetter said. “If you’re labeling a [CBD] product as a dietary supplement, it’s not lawful under the Food, Drug and Cosmetic Act.”
In addition to promoting market growth and consumer safety, the Senate’s Hemp Access and Consumer Safety Act honors the country’s commitment made to farmers in the 2018 Farm Bill, according to the U.S. Hemp Roundtable.
The viability of growing cannabinoid hemp collided with market saturation in 2019, leaving many industry stakeholders questioning CBD hemp’s future as a large-scale commodity in the U.S. Kyle Truesdell, a hemp farmer with operations in several western states, said in the U.S. Hemp Roundtable press release that the Senate’s bill provided him renewed optimism.
“Hemp farmers have been suffering for three years because of a lack of clarity from Washington,” Truesdell said. “This bill gives me hope that our hard work and investment will finally start to pay off.”