PHILADELPHIA — Step away from those gummy bears. Surrender the smoothie. Put down that ice cream and that hot sauce.
Under federal law, if those products contain CBD, they’re illegal.
CBD, or cannabidiol, is derived from cannabis. It is a non-intoxicating compound reputed to have several health benefits. And this year, CBD’s popularity has exploded.
It’s added to skin creams, oils, and dietary supplements. Soon, those products will be for sale at CVS, the largest drug store chain in the U.S. Anecdotal accounts have claimed CBD to be somewhat effective as an anti-psychotic, a calming agent, and a pain reliever.
CBD is also being added to foods. It’s in the kombucha called Cannabliss at Weavers Way co-ops in Philadelphia. It’s in the muffins, coffee and lollipops at the Hip Hemp Cafe. Rocky’s Hot Sauce, produced in Oreland, Pennsylvania, purports to pack 100 milligrams into tiny bottles of their fiery elixir. Restaurants structure entire menus around it as an ingredient.
Though regulators are turning a blind eye now, it may become a source of serious agita for vendors who lace their edibles and drinks with it.
The U.S. Food and Drug Administration absolutely prohibits the addition of CBD to prepared foods. That’s despite language in the 2018 Farm Bill that loosened restrictions on the interstate commerce of hemp — cannabis that has less than 0.3 percent of THC — and its derivatives such as CBD. Even advocates and researchers advise caution before consuming it.
If you’re confused, join the club.
The federal stance has triggered crackdowns by a number of states and municipalities. The New York City Health Department sent letters last month warning that after October 1, violators will face fines, “embargoes” and a slashing their all-important health letter grades. Los Angeles will soon start penalizing companies who have “adulterated” foods with CBD (though a law pending in the California legislature could permit sales statewide). States banning CBD in food include Ohio, Maine, North Carolina, and South Carolina.
State regulators in Pennsylvania and New Jersey see wiggle room in the law and are taking a laissez-faire approach, declining to take action until the FDA gives more guidance.
But major retailers such as Whole Foods are exercising caution. “Whole Foods Market will not sell products containing CBD (cannabidiol) until all issues regarding the regulatory status are completely resolved to our satisfaction,” a spokeswoman said.
So how did this happen?
Until last year, there was a federal ban on CBD. Not that the FDA enforced it. Beyond firing off a few letters ordering manufacturers to stop making unproven health claims, the FDA made no efforts to stop commerce. After all, CBD never killed anyone.
Because CBD is extracted from cannabis, it long has been considered a Schedule 1 substance, along with all other forms of the marijuana plant and its derivatives. But because CBD doesn’t get anyone high, it existed in a gray area. CBD oils and tinctures quietly were sold at health food stores and head shops.
Last summer, the FDA approved a highly-purified form of CBD as a treatment for some rare forms of childhood epilepsy. The CBD drug, Epidiolex by GW Pharmaceuticals, may cost uninsured patients up to $32,500 a year. The FDA’s ruling initially was cheered by activists and advocates who assumed that all forms of CBD would now be legal. Not so.
“Once CBD was approved as a drug, it became prohibited to be included in a food or a nutraceutical supplement,” said Joe Reardon, assistant commissioner for consumer safety for the North Carolina Department of Agriculture. “You can’t add a drug to a food.”
Before FDA Commissioner Scott Gottlieb abruptly resigned earlier this month, he told Congress the agency would hold listening sessions to discuss hemp and its derivatives. A public meeting is scheduled in April to explore how CBD could be sold legally in food beverages and supplements.
The FDA can listen. But even they are bound by law.
The drug exclusion rule prevents any active substance in a pharmaceutical from being added to a food, points out Erica Lietzan, an associate professor at the University of Missouri School of Law.
“It’s not even ambiguous under the federal Food Drug and Cosmetic Act,” said Lietzan, who has written extensively about the legality of CBD. “It’s not controversial and not something that can be debated. The law isn’t gray at all.”
The FDA, however, could just ignore CBD. “I think that’s what they’ve been doing,” she said. “You look around and there’s CBD everywhere.” True that. The agency can also choose to selectively enforce the statute. “There are plenty of examples of them doing that. For instance, you can bring a month supply of an unapproved drug into the country for personal use,” she said. “But (selling food with CBD) is risky. The FDA could decide to make an example out of someone.”
Given the FDA’s priorities, enforcement of the statute is likely to remain sporadic. And for most merchants, the rewards for selling the products outweigh the risk.
That’s because there’s something magical that happens when a few drops of CBD are added to food. The price of a fruit smoothie increases by $2.95. The cost of a can CBD-infused sparkling water can soar to $3.99, $8.99, or more. A CBD lollipop will run you $5.
The wholesale price of a few milligrams of bulk CBD isolate is rarely more than a few pennies.
“CBD is creating a lot of head scratching,” said attorney William Roark, who co-chairs the Pennsylvania Bar Association’s Committee on Cannabis and Hemp. “But it’s also creating a huge industry.”
Analysts at Cowen Investment Management “conservatively” expect CBD products to reach $16 billion in sales in the U.S. by 2025. Cowen estimated the CBD market launched in 2014 with a few million in sales. Four years later, in 2018, CBD generated revenues of between $600 million and $2 billion. Some analysts believe the CBD industry could overtake a legal recreational marijuana market.
Consumers should think twice before taking the substance, whether it’s in food or as a nutritional supplement, said researchers and advocates.
“We don’t yet know if it’s safe to add cannabinoids to food and at what amounts,” said Marcel Bonn-Miller, a scientist who investigates cannabinoids at the University of Pennsylvania. “We need proper studies to determine what amounts of each cannabinoid, or cannabinoid combination, is safe in foods. The good thing is that there are guidelines from the FDA and companies are working to figure out the answers. “
Without regulation, consumers have no idea if what they’re paying for is pure, potent, is free of toxic substances, or even contains the compound.
“It’s a pity that the regulatory agencies aren’t doing their job,” said Martin A. Lee, the author of “Smoke Signals: A Social History of Marijuana — Medical, Recreational and Scientific” and the director of the California-based Project CBD, a nonprofit advocacy group promoting research into the substance.
“The idea of putting CBD in coffee or water or cupcakes is more a marketing gimmick. It’s not an effective form of therapy,” said Lee. “People are reaching for it because it’s a fad.”
Lee warns that CBD can interact with prescription drugs, at turns either magnifying or diminishing their effects. People with compromised immune systems, he said, should not use CBD without being assured that the product isn’t tainted. “CBD is intrinsically safe,” Lee said. “If you’re using THC or CBD for cancer, you may be able to reduce the dose of chemo. But if you don’t adjust the level of chemo, it could build up to toxic levels.”
CBD may also reduce blood pressure and, because it’s an astringent, cause some users to become dehydrated. “These are serious issues,” Lee said. “We’re not hearing about this stuff.”