Whether it’s a shot of CBD in your hot chocolate at a shop in Culver City, California or a dollop of CBD-infused whipped cream at a restaurant in Queens, New York, you can find CBD in food and beverages without looking too hard. Earlier this week, for instance, Congressman Earl Blumenauer, a Democrat from Oregon, tweeted a photo in which five smiling people, including U.S. Senator Ron Wyden, “celebrated the legalization of hemp” by toasting with a CBD chocolate hazelnut custard donut.
Cannabidiol (CBD) is one of dozens of active compounds in the cannabis plant, that, unlike tetrahydrocannabinol (THC), does not get a consumer high. In recent years, it has become increasingly ubiquitous as an additive in various products, even though it remains in murky legal waters.
This week, a bipartisan group of Congress members signed a letter to the FDA, calling on Commissioner Scott Gottlieb to “provide guidance on lawful pathways for food products containing hemp-derived CBD in interstate commerce” and indicate when public meetings will take place.
Sent from the office of Representative Chellie Pingree, a Democrat from Maine, the letter asks the FDA to respond by February 22. It also points to recently-reported crackdowns in New York, Maine, and Ohio, and says that “These actions have spurred a tremendous amount of confusion among manufacturers, hemp farmers, and consumers of these products.”
The rise of CBD in food happened first under the cover of the 2014 Farm Bill, which outlined specific provisions for the cultivation of hemp, a plant particularly abundant in CBD, and then under the Agriculture Improvement Act, commonly known as the “2018 Farm Bill.” When Congress passed that bill in December, many industry members determined that because the legislation removed hemp—Cannabis sativa L., with a THC concentration that does not exceed 0.3 percent—from the Controlled Substances Act, hemp-derived CBD products had therefore been legalized nationally.
But that was not quite the case.
If anything, as we will see, the 2018 Farm Bill—coupled with the FDA’s approval of Epidiolex, a pharmaceutical formulation of plant-derived CBD for the treatment of specific types of seizures—seems to have added a new layer to federal policy, and that new layer has trickled down to state and local agencies and shaped their CBD enforcement policies.
CBD, in essence, has become a pharmaceutical product from the FDA’s perspective, and therefore its presence in food is not currently permitted. As a result, officials across the country have cracked down on businesses, putting them on notice that enforcement is imminent—and many shopkeepers and consumers don’t understand why.
In early February, local authorities descended on businesses in New York and Ohio, forcing them to stop selling food containing CBD. As Eater first reported, in Manhattan, health department officials bagged up and “embargoed” CBD-infused chocolate chip cookies and Rice Krispies treats at Fat Cat Kitchen. The action, authorities told co-owner C.J. Holm, was due to rules prohibiting food providers from introducing additives to food and drinks. This made no sense to Holm, who, in an interview with Cannabis Wire, said that health officials had been to her restaurant twice before and made no mention of the CBD products—even though they had been openly advertised.
Meanwhile, North Carolina health authorities recently issued warning letters to businesses, ordering them to stop selling food products containing CBD. Anita MacMullan, who directs the Food and Drug Protection Division at the state’s Department of Agriculture and Consumer Services, warns in the letters: “Failure to comply could result in legal action being taken against you, including without limitation, embargo, seizure and injunction.”
Even in California, where adult use of cannabis was legalized in 2016, the Los Angeles County Department of Public Health-Environmental Health Division, which oversees eighty-five cities, plans to penalize businesses that offer CBD-infused foods come summer.
And in Maine, where adult cannabis use is also legal, the Department of Health and Human Services has also recently ordered businesses to pull CBD-infused food from shelves.
A crackdown seems to gathering momentum.
The FDA sets its limits
The same December day that President Donald Trump signed the $867 billion 2018 Farm Bill into law, FDA Commissioner Scott Gottlieb issued a statement indicating how his office would enforce the part of it related to hemp and CBD. In it, he acknowledged that hemp had been removed from the Controlled Substances Act and “will no longer be an illegal substance under federal law.” However, he added, “Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change.”
Congress, Gottlieb wrote, “explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.” In light of “growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD),” the commissioner made it a point to clarify that these products are “subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
This, he underscored, “is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.”
As part of his explanation for the need to regulate what many perceive as a harmless substance, Gottlieb said the FDA is “concerned at the number of drug claims being made about products not approved by the FDA.” In order for cannabis and cannabis-derived products to claim “that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders, and diabetes),” he made clear, they must first go through the FDA approval process.
Selling unapproved products with unsubstantiated therapeutic claims, he added, “is not only a violation of the law, but also can put patients at risk, ” as it “may keep some patients from accessing appropriate, recognized therapies.”
Gottlieb went further to discuss how the law affects interstate shipping of CBD products—basically forbidding it. While food products containing CBD are currently for sale online and being shipped nationwide, Gottlieb made it clear that “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce.” Gottlieb explained: “This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations.”
Summing up, he added: “Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”
The commissioner also highlighted pathways for companies “to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis.” He cited the June 2018 approval of Epidiolex as an example. Epidiolex is used to treat symptoms of people suffering from Lennox-Gastaut syndrome or Dravet syndrome.
State and local regulators listen to the FDA
At the state and local level, officials point to to the FDA when issuing their directives. For instance, during this year’s North American Cannabis Summit, Mark Starr, of the California Department of Public Health, said, “People have been confused in the industry about CBD. The bottom line is it can’t be added to any foods in California. And that’s not because of cannabis law, but because of FDA rules.”
Starr said these days his office was “getting even more calls about CBD from industrial hemp going into food products.” Because of the Farm Bill, he said, people think, “‘Oh, we can do this. And: No, you can’t.”
The warning letters issued by North Carolina’s division of Food and Drug Protection also mirror the FDA’s language. In them, authorities’ logic went this way:
- It is prohibited under the FD&C Act to introduce or deliver for introduction into interstate commerce any food to which has been added a substance that is an active ingredient in an approved drug product
- CBD is the active ingredient in the approved drug product Epidiolex, a drug product that has been approved under the FD&C Act
- Since CBD is the active ingredient in Epidiolex, it is currently excluded from being a dietary supplement
In an email to Cannabis Wire, Anita MacMullan, who directs the division, said that the state’s Department of Agriculture and Consumer Services “has worked closely with FDA to ensure consistency in interpretation of federal statutes and regulations.” According to MacMullan, the Department of Agriculture and Consumer Services has also discussed enforcement surrounding CBD products with the FDA and maintains contact with other state regulatory programs regarding CBD.
Lyndsay Meyer, a spokesperson at the FDA, confirmed to Cannabis Wire that the agency maintains “ongoing communication with state and local officials to answer questions about the requirements under the FD&C Act,” as well as “to better understand the landscape at the state level.”
Still, though there is evidence that the states are listening hard to the FDA, this is not uniform across the country. Amid the increased crackdowns and threats of legal action, Missouri officials made a move that appears to run counter to the FDA’s approach.
In late January, the state’s Division of Alcohol and Tobacco issued a press release in response to what it said were “numerous inquiries from Industry Members about using CBD oil products in relation to the alcohol industry.” In reply, the state determined that the passage of the Farm Bill “allows for the legalization of Hemp (where most of the CBD oil commonly comes from)” and that the state Division “has no legal authority to bar the use of CBD oil in combination with alcohol beverages as long as the oil contains no THC.”
The Missouri Division of Alcohol and Tobacco, in other words, has no problem with adding CBD to alcoholic beverages, or the selling of CBD products by liquor licensees in the state.
The road ahead
In his news release offering guidance on CBD in relation to the 2018 Farm Bill, Commissioner Gottlieb indicated that the FDA will “take enforcement action” to protect public health against companies “illegally selling cannabis and cannabis-derived products.” So far, he added, the FDA has sent warning letters. At the state level, enforcement so far has involved the embargoing of products, meaning shops are allowed to keep them so long as they do not display or continue to sell them. But in July, Los Angeles County will take a different approach. The county plans to begin citing businesses found to sell CBD-infused food products and deducting two points on their inspection reports.
Back in New York City, health officials have lifted the embargo on the CBD-infused products at Fat Cat Kitchen. But, co-owner C.J. Holm told Cannabis Wire, she is still not allowed to sell them. Instead, health officials will follow in Los Angeles County’s footsteps, with fines to food establishments that offer food or drinks containing CBD starting October 1. According to Holm, health officials also said that selling CBD products could affect an establishment’s letter grade, a system generally meant to reflect sanitary conditions.
All in all, it remains to be seen if these efforts will succeed in getting CBD-infused products off shelves and out of restaurants, or if local law enforcement even has the resources to pursue violations. The CBD trend is widespread and growing.
Meanwhile, the FDA has promised a sort of listening tour, to hear what vendors of CBD products have to say.
FDA Commissioner Gottlieb said that the agency intends to “hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products.” Part of the purpose of the meeting, he said, is to gather ideas about “the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.”
In response to a request for comment regarding the letter from Congress members, FDA press officer Michael Felberbaum told Cannabis Wire that the FDA “will respond directly to the members of Congress.”
As a member of the House Appropriations Subcommittee, Congresswoman Pingree also plans to question FDA Commissioner Gottlieb in person. He is expected to appear before the committee next week.