The Food and Drug Administration (FDA) is looking to collect additional data to fill in gaps in evidence about the safety of cannabis-derived products, while at the same time touting recent action it took to help a state agency crack down on a company selling delta-8 THC gummies that regulators say are linked to “serious adverse events.”
FDA has faced significant criticism in recent years over the lack of regulations allowing for the marketing of hemp-derived cannabinoids like CBD in the food supply or as dietary supplements. The agency has maintained that it needs to gather more data, and possibly receive some legislative support from Congress, while simultaneously taking limited enforcement action against certain businesses that sell cannabis products derived from hemp.
As part of its data collection effort, FDA posted a sources sought notice this month, soliciting information about “the availability and capability of qualified small business sources” to carry out research about “product problems (e.g., quality concerns), adverse events, and misinformation sources based on real world data (RWD) to help fill knowledge gaps” with respect to cannabinoid products.
The agency said that, since hemp and its derivatives were legalized under the 2018 Farm Bill, “both the availability of and demand for [cannabis-derived products] have surged, prompting the FDA’s Cannabis Product Committee (CPC) to identify critical needs to address the Agency’s evidence gaps in the Cannabis-Derived Products Data Acceleration Plan (DAP).”
The notice outlines data priorities for potential facilities capable of helping to fill those evidence gaps.
For example, FDA wants information about “new and emerging risks, and safety signals identified in online data sources” such as the dark web, as well as analysis on that collected data and “information on the current scientific literature.”
Additionally, the agency said it’s looking to see what businesses are capable of developing “reports on findings…including summaries, manuscripts, and presentations/webinars synthesizing the considered data, with clearance obtained through FDA management for sharing with diverse stakeholders.”
Theoretically, this is the type of information that FDA could use to develop regulations for cannabis product marketing—but in the meantime, it’s been taking enforcement action against certain hemp businesses selling items with questionable packaging or content. That’s mostly involved sending warning letters to select companies, but it also recently tipped off Minnesota regulators about a product line that it received consumer complaints about.
The information that FDA sent to the Minnesota Board of Pharmacy led to a lawsuit against the delta-8 THC company Northland Vapor, which is accused of violating the state’s unique THC edibles law that was enacted this year.
“We’re working together with our state partners to protect the public from harmful products,” FDA Principal Deputy Commissioner Janet Woodcock said in a press release from the Minnesota board.
ALERT: FDA recently forwarded a complaint re: a serious adverse event associated w/Wonky Confection’s Death by Gummy Bears delta-8 THC product to the MN Board of Pharmacy, resulting in a state action against this firm. LEARN MORE: https://t.co/TYA5qQaKW6 pic.twitter.com/38nlJfh2jQ
— FDA_ORA (@FDA_ORA) December 5, 2022
The joint investigation by FDA and the Board of Pharmacy started in early November, and more than 140,000 packages of delta-8 THC gummies, as well as about 2,300 bottles of THC syrup were confiscated. The products allegedly contained significantly more THC per serving than is permitted under the state’s cannabis law.
Further, regulators said the products were packaged in a way that could appeal to children and that the company failed to provide the state with required product testing results.
— FDA_ORA (@FDA_ORA) December 5, 2022
“To protect the public, the Board of Pharmacy embargoed this noncompliant product and is seeking an order from the court to destroy the noncompliant product as well as an order from the court to prevent Northland Vapor from manufacturing and selling edible cannabinoid products that violate state law. It is estimated the retail value of these embargoed products exceeds $7 million,” the board said. “The FDA inspection is ongoing.”
The federal-state enforcement operation launched several months after FDA partnered with Hawaii law enforcement in a “unique” surveillance operation that led to the arrests of two people associated with a cannabis business who were suspected of violating state drug laws.
Also, last month, FDA sent warning letters to five companies that sell foods and beverages containing CBD.
The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
Bipartisan lawmakers have repeatedly pressed FDA to create that marketing pathway for CBD in the food supply and as dietary supplements.
Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf in September, demanding answers over the continued lack of regulations for CBD for those purposes.
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.
After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said
At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”
Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. But the agency has largely limited its regulatory enforcement authority to sending warning letters to certain CBD businesses and denying cannabinoid marketing applications.
In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unsanctioned claims about the medical benefits of CBD products they’ve marketed for animals.
FDA also warned consumers about marijuana-infused copycat food products that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.
The agency separately issued its first set of warnings to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.
It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.
In May, a top Republican on a key congressional committee also called on leadership to schedule a hearing to hold FDA accountable for its lack of action to set regulations for CBD and delta-8 THC products.
Photo courtesy of Kimberly Lawson.