USA – the Food and Drug Administration (FDA), have reported that it plans to enforce regulations against the use of cannabidiol (CBD) in plant-based foods and beverages.
According to the administration, the California Department of Public Health (CDPH) issued a revised FAQ in which it prohibited the use of CBD derived from industrial hemp in food and beverage products.
CBD is a naturally occurring cannabinoid constituent of cannabis.
The revised document states that “until the FDA rules that industrial hemp-derived CBD oil and CBD product can be used as a food or California makes a determination they they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.”
Hemp-derived CBD, a non-psychoactive compound, has been a growing presence in the marketplace, generating US$190 million in sales in 2017, according to the Hemp Business Journal.
The fast-paced growth is in part due to a rising interest in natural functional foods and drinks.
However, brands attempting to break into the market must navigate a maze of federal and state regulations that govern the legal production and sale of industrial hemp-derived CBD products in the U.S.
Industrial hemp is at the center of the debate in California.
Under federal law, marijuana is a Schedule I Controlled Substance, a definition which includes all parts of the cannabis sativa plant other than the mature stalks, the ungerminated seeds, or pastes or oils extracted from those parts.
CBD is derived mainly from the flowers and leaves, which means it and any other substance derived from those parts are considered an illegal controlled substance by the U.S. Drug Enforcement Administration (DEA).
However, CBD manufacturers have cited the 2014 Farm Bill, which legalized hemp cultivated under state-sponsored pilot programs aimed at research, as legal protection.
The administration also highlighted the inherent risk for brands operating in the CBD space, in which the threat of federal action looms as a constant threat.
CBD is not defined as a dietary supplement under federal law because it has already been the subject of investigational new drug applications, a position reaffirmed by Robert Durkin, deputy director of the Office of Dietary Supplement Programs, last month.
However, Durkin also stated the agency has prioritized cracking down on products making unsubstantiated health claims on CBD products.
“This is kind of the proverbial case of you don’t have to outrun the bear, you just have to outrun the person standing next to you,” said Justin Prochnow, an attorney at Greenberg Traurig who specializes in legal and regulatory issues in the food and beverage industries.
“As long as you aren’t making crazy claims, they are most likely going to leave you alone.”
With the federal status still in flux, some states have taken action themselves. Colorado passed the Colorado Hemp Foods Bill earlier this year which created a registration system for companies to legally produce hemp and hemp-derived CBD food and beverage products in the state.
In March, Indiana, a previous flashpoint of the CBD debate, legalized hemp-derived CBD extracts that contained less than 0.3 percent THC and explicitly defined hemp-derived CBD as not a controlled substance.
However, until CBD’s status is resolved on a federal level, state laws only address one side of the issue.
The CDPH FAQ is not a legal document and it’s unclear whether it is intended as a template for enforcement or as a way to influence manufacturers with a public statement, as Prochnow suggested was possible.
“Sometimes the FDA puts stuff out there and they hope a large number of people will change their habits just based on what the FDA said they might do,” he said.
“California just put it out there that they aren’t the playground for CBD that some might have thought they were.”
As California waits for the FDA to act, Congress is proactively seeking to address the status of CBD: the Senate’s version of the Hemp Farming Act of 2018 would fully legalize industrial hemp cultivation and production of hemp-derived products including CBD.
A House version did not include this exemption, and the two bills are currently in committee.
“At some point we are going to have a real federal final decision on this, because we’re not going to be able to have it done piecemeal [by states],” Prochnow said.
“I’m still a big believer than in 2-3 years it’s going to be legal for everyone. I just don’t see how that toothpaste gets put back in the tube.”