The U.S. Food and Drug Administration (FDA) has issued its latest batch of warning letters to five companies that the agency claims are illegally selling CBD food and beverage products.
The FDA issued the warning letters to 11-11-11 Brands, Naturally Infused LLC, Newhere Inc dba CBDFX, Infusionz LLC and CBD American Shaman LLC, according to the agency’s Nov. 21 news release.
“These companies are selling CBD-containing products that people may confuse for traditional foods or beverages, which may result in unintentional consumption or overconsumption of CBD,” FDA officials said in the release. “CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.”
The five warning letters, dated Nov. 16, also outline violations related to the Federal Food, Drug, and Cosmetic (FD&C) Act, according to the release. These violations include the sale of unapproved CBD products that claim to cure, mitigate, treat or prevent diseases, as well as adding CBD to animal foods.
Officials said in the release that CBD raises safety concerns, particularly with long-term use.
“The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm,” they said. “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 FDA has requested responses from the companies that received the warning letters within 15 working days, according to the release. The responses must state how the companies will address the issues described in the letters or provide reasoning and supporting information to demonstrate why they think the products do not violate federal law.
If the companies fail to respond to the warning letters, they could face legal action, including product seizure, according to the release.
This is not the first time that the FDA has issued warning letters to businesses in the cannabis and hemp industries. The agency sent warning letters to CBD companies in March for claiming that their products could cure, treat or prevent COVID-19. The agency issued another batch of letters to delta-8 product manufacturers in May for violations of the FD&C Act, and sent another set later that month to companies selling unapproved animal drugs containing CBD.
Jonathan Havens, partner at Saul Ewing, said that historically, the FDA has been limited in its enforcement regarding CBD products and has only issued warning letters to companies that make what he calls “particularly aggressive therapeutic claims.”
However, the letters issued this month were a bit different, he said, because the warnings focused on product format.
“They specifically addressed, in a couple of the letters, beverages that FDA claimed consumers could be confused by, and it could lead consumers to ‘unintentionally’ consume CBD,” Havens said. “What FDA seems to be saying there is these look like your run-of-the-mill beverage products or food products, and consumers might consume them and not know that there’s CBD in them. And given what FDA’s said are some of the safety risks around CBD, as a protector of public health, FDA thinks that’s a problem.”
While Havens has doubts about whether consumers could actually confuse CBD-infused foods and beverages with non-infused products, he said it’s “an interesting argument” by the FDA.
“It gives a little bit of new flavor … for the FDA enforcement to say, ‘OK, we’ve told you we’re concerned about CBD before, and we’re going after these companies for aggressive claims, but now we’re also concerned about the format that these products are presented in,’” he said. “Are consumers confused, and as a result, are they unintentionally consuming CBD? In FDA’s eyes, might that be a safety risk?”
The most recent batch of warning letters also focused more on the products’ attractiveness or appeal to youth than past letters, Havens added.
“These are adult products, and the way that you market them matters,” he said. “Again, I don’t want to say to anybody that FDA hasn’t talked about youth appeal before—they’ve certainly talked about that with regard to delta-8 before and they did that again yesterday—but it really drove home the point that marketers and retailers need to think long and hard about how these products are positioned, particularly if they’re sold throughout a store or online or they’re easily accessible where someone under the age of 18 or under the age of 21 may be able to purchase them.”
In addition, the five letters issued this month discussed how the products in question were marketed as dietary supplements, which Havens said is impermissible because, from the FDA’s perspective, CBD is a drug ingredient, not a dietary ingredient.
“That’s not a new issue, but what’s interesting is, … with one of the products in particular, it was a delta-9/CBD combination product, so it contains both CBD and delta-9 THC,” he said. “And delta-9 THC is a pretty … burgeoning category within the hemp space. What was interesting to me is FDA said that it’s a problem if you say CBD is a dietary supplement, but they didn’t say anything about delta-9. … I don’t want to read too much into it, but it was an opportunity, I suppose, for FDA to say, ‘Hey, we have an issue with delta-9,’ but they didn’t say that. They only took issue with the fact that you can’t call your products a supplement if they have CBD in them.”
Meanwhile, Havens added, there are a lot of CBD supplements on the market, and the FDA has not taken enforcement action against the vast majority of them.
“They haven’t really done too much about that, so it’s not clear that they’re really that focused on it,” he said. “No one has ever received a warning letter for just selling CBD as a dietary supplement. You have to have some sort of aggravating factor, whether that’s aggressive claims, a confusing form factor [or] attractiveness to youth. The supplement issue in and of itself has not been enough to yield FDA enforcement.”
Overall, Havens said the warning letters issued last week are not groundbreaking, but they do offer different perspectives that the FDA had not yet addressed.
The CBD industry has largely done a good job of self-regulating in the absence of a federal regulatory framework, Havens added, and he doesn’t think anyone should take the latest warning letters as a sign that the industry must make any immediate changes.
“[Saul Ewing has] the privilege of working with some of the leading operators in the space,” he said. “They’ve done a really good job of operating above board and having independent third-party testing, labeling that is responsible and form factors that aren’t confusing to people. So, I would say the first thing is nobody should take this as a sign that the CBD industry has work to do. There are some players in the space that might want to look at their practices and tweak them. I think if you’re selling your products in chain retail and you’re being distributed by these national distributors, your products are already doing the right thing. What FDA tends to latch onto is the never-do-wells in the space who maybe are only selling online … and are making those aggressive claims.”
Havens said business operators thinking about getting into the CBD space shouldn’t view the warning letters as a reason to reconsider their plans, but rather as a reminder that there is a compliant way to operate in the industry.
“If you’re a retailer who’s exclusively selling CBD and the brands that you’re carrying are responsible, I would say keep doing what you’re doing,” he said. “For brands that have marketing that’s attractive to youth or that make aggressive claims or it’s kind of confusing to consumers about what the product is or is not, then I would say that you could learn from what FDA has said in these letters."