Florida has become the latest state to add a controversial element to its new hemp program: hemp in food.
The state’s new hemp program, which took effect Jan. 1, 2020, now recognizes that all portions of hemp are allowed in food, including cannabidiol (CBD). It also dictates that any establishment manufacturing, processing, packing, holding, preparing or selling food with hemp extract is considered a hemp food establishment and must have a food permit. The new rules give the Florida Department of Agriculture and Consumer Services (FDACS) a hefty task—the agency is now responsible not only for enforcement, pulling samples and testing for the hemp program but also for conducting food establishment inspections.
Colorado was the first state to do recognize hemp as food back in 2018 with HB 1295. Several others have since followed suit, including Illinois, Indiana and Texas. California tried to pass a similar bill last year, which has been reintroduced in the legislature and could be approved as early as March.
The U.S. Food and Drug Administration (FDA) has said some parts of hemp are generally recognized as safe (GRAS): hulled hemp seed, hemp seed protein powder and hemp seed oil. CBD, however, is another story, and the agency has been outspoken in its stance that marketing the cannabinoid as a dietary supplement or added to food is illegal.
While not unprecedented, recognizing hemp as food does have risks, which in part stem from ambiguities within the FDA’s stance. While the FDA clearly states “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement,” much of the agency’s elaboration on that statement revolves around two key elements:
- the interstate transport of ingestibles that contain CBD.
- labeling these products with misleading or outlandish health claims.
"CBD intended for ingestion in Florida is legal and regulated by FDACS. However, FDA guidance can seem somewhat unclear and confusing," Holly Bell, the director of cannabis for FDACS, tells Hemp Grower. "According to the FDA’s website, ... 'The FDA has seen only limited data about CBD safety, and these data point to real risks that need to be considered before taking CBD for any reason.' There is a clear need for states to step up and fill in that guidance as was intended with the 2019 Farm Bill."
The FDA’s CBD crackdown to date has revolved mainly around labeling. Late last year, the agency issued warning letters to more than a dozen companies for making health claims that violate the Federal Food, Drug, and Cosmetic (FD&C) Act.
“At present, the FDA has used its resources to ensure that manufacturers and brands are not making egregious, over-the-line health claims about their CBD products,” says David Kramer, an attorney with Vicente Sederberg LLP. “Neither the FDA nor any other federal agency have formally challenged these state laws, which are clearly at odds with the FDA’s position.”
When contacted for a response to states clearing the way for CBD in food, an FDA spokesperson referred Hemp Grower to the agency’s Q&A page, which states: “When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.”
Aside from issuing warning letters, the FDA has yet to make any real legal moves against companies that have included CBD in food. Rest assured, they’re out there—companies and restaurants have added CBD to everything from coffee to cereal, and hundreds of CBD products line the shelves in supermarkets.
Lawsuits, however, have started rolling in from other sources. Elixinol, a Colorado-based hemp product manufacturer, is the most recent company facing a lawsuit, which comes from a California resident who claims she wouldn’t have bought the company’s products if she knew they were being sold illegally. That case is now moving through federal courts. Elixinol recently urged a judge to toss the case, claiming that “regulatory uncertainty” surrounding CBD didn’t make its sale illegal, according to Law360.
Elixinol’s argument is one companies may be smart to make when facing lawsuits. While judges may not outright dismiss cases, because the FDA has said it is looking to provide additional guidance on CBD in the near future, courts may be open to withholding proceedings until the agency comes forward with an updated stance.
This has already been the case for some lawsuits against CBD manufacturers. In Snyder et al v. Greens Road of Florida LLC, the plaintiff claimed the CBD manufacturer misrepresented the amount of CBD in each product. The judge concluded “there appears to be a need for consistent guidance” from the FDA regarding ingestible CBD, and the case has been delayed until those regulations are released.
The FDA has consistently said it is working on providing regulatory clarity on ingestible CBD. Though the agency has said it could take years for final regulations, its latest budget proposal for 2021 indicates cannabis is a priority. The agency recently requested $5 million to devote to regulating cannabis and hemp.
Along with that, however, may come greater resources to enforce current regulations while devising new ones.
“This new funding will enable FDA to continue regulating the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives. The initiative will support regulatory activities, including developing policy, and continue to perform its existing regulatory responsibilities including review of product applications, inspections, enforcement, and targeted research,” the FDA says in its proposal.
As the FDA seeks funding, growing pressure from states to allow CBD in ingestibles leaves some predicting the agency may have a change of heart soon.
“CBD in food is probably the most complex and confusing legal issue facing the hemp industry currently,” Jeff Greene, co-founder and director of business development for The Florida Hemp Council (FLHC), tells Hemp Grower. The nonprofit organization helps bolster the state’s hemp industry and provides regular feedback to FDACS on its regulatory efforts. “The state of Florida currently recognizes hemp as a food, while FDA regulations will not allow for CBD in food as it considers it as an ‘unapproved new drug.’ We anticipate a resolution with this conflict in the near future.”
Amy Steinfeld, a managing partner at Brownstein Hyatt Farber Schreck's Santa Barbara office and co-chair of the firm's cannabis and industrial hemp group, and Jack Ucciferri, a law clerk for the firm, predict CBD guidance from the FDA will be one of its top priorities for 2020. “To avoid a redux of the CBD regulation quagmire, the FDA will race to establish regulatory clarity for these newly commercialized cannabinoids in addition to outlining regulations for CBD,” the two recently wrote for Hemp Grower.
Pressure on the FDA is growing from federal lawmakers, as well. House Agriculture Committee Chairman Collin Peterson (D-Minn.) recently introduced federal legislation, HR 5587, that would amend the FD&C Act to permit adding CBD into foods and marketing it as a dietary supplement.
Until then, companies may still face uncertainty when adding CBD to ingestibles, but those in states that have recognized hemp as food can take comfort in knowing they have additional protection.
“Hemp has thousands and thousands of applications, but by initially classifying it as a food, Florida was probably wise in getting things started simply and efficiently for the time being,” Greene says