The Food and Drug Administration (FDA) has sent warning letters to five companies that sell foods and beverages containing CBD—the agency’s latest stepped-up enforcement action that comes amid growing calls for a regulatory pathway for lawful marketing of the non-intoxicating cannabinoid.
FDA didn’t specify why it targeted these 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.”
“CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” FDA said.
FDA warns companies for illegally selling food and beverage products that contain #CBD. These CBD products in forms that are appealing to children, such as lollipops, gummies, and cookies, are especially concerning. https://t.co/bNVwItE3BU pic.twitter.com/pyR8GZRLbi
— FDA FOOD (Ctr for Food Safety & Applied Nutrition) (@FDAfood) November 21, 2022
There does seem to be a common thread connecting most of the businesses that received warning letters, with four of them selling CBD-infused candies or gummies, but it’s unclear why these particular companies are being singled out. Plenty of hemp businesses started marketing such products across the country after the crop and its derivatives were federally legalized under the 2018 Farm Bill.
“Today’s warning letters also outline additional violations of the [Food, Drug, and Cosmetic Act] Act, including that several of the companies are illegally selling unapproved CBD products that claim to cure, mitigate, treat or prevent various diseases, and adding CBD to animal foods, such as pet treats,” the agency said.
“The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”
Another unique aspect of the FDA action is the agency’s warning that evidence “suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.”
In its notice about the letters, FDA said that the “use of CBD raises safety concerns, especially with long-term use.”
“Scientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.”
The scope of the enforcement action is limited in this case, but industry stakeholders say that it’s part of a “pattern” within FDA that could have a chilling effect on the market.
“We have a lot of really exciting new companies out there, particularly in the beverage space, that have popular, well-accepted products that have levels of CBD that studies demonstrate are not unsafe to the public,” Jonathan Miller, general counsel for the U.S. Hemp Roundtable, told Marijuana Moment on Tuesday.
“Those companies can continue to try to operate the space, but the louder the FDA displays its antagonism, the harder it is for them to find markets,” Miller said.
— US Hemp Roundtable (@HempRoundtable) November 22, 2022
Asked for clarification on why the five companies received warning letters, an FDA spokesperson told Marijuana Moment that the action was taken because the businesses were “selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
“CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning,” the spokesperson reiterated.
In a separate blog post on FDA’s CBD policy, the agency said that food ingredients “must be shown to be safe to be lawfully added to food” and it hasn’t yet “found sufficient information showing how much CBD can be consumed, and for how long, before causing the various types of harm we’re concerned about.”
“For example, to date, we don’t know whether regular or long-term CBD consumption could negatively affect fertility,” it said. “CBD may also interact with other substances and alter their effect on the body. Studies suggest CBD may increase and/or prolong caffeine’s effects, which could be a problem for people who are sensitive to caffeine.”
FDA added that it is “holding CBD to the same standard that we would any other substance that is intentionally added to food, like sweeteners or preservatives.”
Just this week, Truss CBD USA—a joint venture of the beer giant Molson Coors and the cannabis company HEXO Corp—announced that it will be exiting the U.S. market because of the lack of federal regulatory certainty around the hemp industry.
The company said that there “remains no near-term pathway to federal legalization, leaving uncertainty in the market,” and that’s “left some chain retailers and distributors hesitant to accept CBD beverage brands, complicating distribution and making the path to profitability a challenge,” as Beverage Daily reported.
Other major companies like PepsiCo and Carl’s Jr. have dipped their toes into the hemp product market with food and beverage items containing various amounts of CBD. It’s unclear if FDA plans to expand its enforcement action in a way that would impact those product lines.
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.
FDA has been “increasing their public antagonism to CBD food and beverages,” Miller said. However, from another perspective, their focus on that specific type of cannabis marketing “might signify that they’re less antagonistic towards CBD as a dietary supplement.”
“We’re hoping that there may be some some movement in that direction,” he said. “But for this hemp industry to truly open up, we need to be able to see the cola companies and potato chip companies and candy companies follow up on their plans to add CBD to their product lines—and it’s very clear that from this FDA stance that the only way that that’s going to happen is if Congress steps in and requires the regulation of these products.”
FDA said that it is aware “that there’s great public interest in CBD products, even though CBD cannot lawfully be added to foods or dietary supplements.”
“While we continue exploring policy solutions to address the large, violative market of CBD products, we will continue to monitor the marketplace and take action, as needed, against companies that pose the greatest risk of harm to the public,” the agency said.
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 by Kimzy Nanney.