The U.S. Food and Drug Administration (FDA) is looking for Congress to take charge in regulating cannabinoid (CBD) products after concluding the agency’s existing authority over food additives and supplements does not provide all the necessary tools for managing the risks of CBD. The news comes nearly five years after the FDA announced it would begin looking into developing guidance on cannabinoid use.
Additionally, the FDA denied three citizen petitions today that requested CBD be regulated as a dietary supplement. That decision came from findings of the FDA’s CBD working group which examined studies on Epidiolex, a CBD-based drug, and concluded that the risks of CBD do not align with the existing safety parameters for dietary supplements or food additives. The agency is asking for additional data and more studies.
“For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” said Janet Woodcock, the FDA’s Principal Deputy Commissioner, in a statement. “Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”
What happens next?
In lieu of taking the lead itself, the FDA is asking for Congress’ help to develop a new regulatory body that can serve as a gatekeeper for legal CBD. Whether that body resides within the existing structure of the FDA remains to be seen, but the agency was clear on its position that these products need to be regulated so that consumer demands can be met and the emerging industry can grow within a federally-set framework.
The agency believes the new body will need to have the authority to effectively regulate labeling of CBD products, prevent contaminants, institute CBD content limits and wield the power to put minimum purchase age limits in place. Access and oversight plans for CBD products and for how consumption of CBD by animals could potentially impact and infiltrate the human food system will also be developed through this proposed regulatory path.
The news comes days after the federal agency released industry guidance for the development of cannabis-based drugs, including specific processes and factors for scientists to consider when working with hemp and marijuana ingredients. As CBD products continue to be sold in the market, the FDA said it will continue monitoring how those products are marketed, sold and take appropriate action when necessary in accordance with state regulators.
“We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities,” the agency said in a statement. “The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”
Looking forward, Congress has quite a regulatory task in front of them. While the legislative branch could grant the FDA the ability to generate a new CBD regulatory body on its own, the agency’s broader human food regulatory functions have also come under recent scrutiny.
The release of the Reagan Udall Foundation report analyzed the function of the FDA’s human food program and recommended that an internal structural overhaul may be necessary for the agency to be able to effectively regulate the food, a change that would likely require congressional approval. This means that while the FDA may need congressional help to create a body for CBD oversight, it may at the same time be seeking permission to adapt its own structure.
What will the impact be on CPG?
This move means that CBD food and beverage brands essentially will keep on doing what they have been: waiting a bit longer before they can begin selling products at major retail chains. Many retailers have stated they will not merchandise ingestible CBD products until federal guidance is published since the ingredient remains unregulated and illegal to include in food and beverage products. For now, most brands are limited to online direct-to-consumer platforms and independent retail outlets but are optimistic about the impact of today’s announcement.
According to John Simmons, co-founder of CBD beverage brand Weller, his team has been incorporating the suggested risk management tools relative to CBD labeling, contaminants and content limits for several years to ensure the products are ready to go into major retailers when federal regulatory guidance is released. He explained many of these measures are table-stakes for early-CBD adopting retailers like Wegmans and Sprouts.
Relaxation beverage brand Recess also believes the overall industry is steadily progressing along its path to retail. The company, which recently expanded its CBD-free Mood line due to increasing consumer demand, has previously said that line has helped the company secure and maintain key retail placements as it awaits federal CBD guidance.
“We are encouraged by FDA’s announcement to work with Congress to establish a workable regulatory framework for CBD at the federal level,” said Ben Witte, founder and CEO of Recess. “We look forward to maintaining a constructive dialogue with policymakers to ensure that regulations are established that protect consumers and establish clear rules for suppliers, brands and retailers to operate within.”
Jonathan Eppers, founder of CBD beverage brand Vybes, said he doesn’t believe much will change for the CBD industry in the short term following today’s announcement. He said VYBES continues to see strong demand, highlighting that the category is likely growing slower due to the lack of federal regulation preventing it from entering major retailers, but believes overall, CBD is on an upward track.
“I’m encouraged that FDA is asking Congress, who has been pro-CBD for years, to write laws that regulate CBD,” said Eppers in an email. “CBD regulations are one of the only bipartisan issues both Republicans and Democrats agree on, so maybe we’ll get something sooner than we all think.”
Simmons believes regulation could come as early as mid-summer and expects that CBD regulation will be added to the 2023 Farm Bill.
“The timing of this statement from the FDA gives legislators the opportunity to ensure the missing pieces from the 2018 Farm Bill can be properly added to the new version,” said Simmons. “That’s probably the smoothest legislative pathway, since Congress has been unable to pass independently introduced CBD legislation in years past.”