The FDA just refused to regulate CBD

Over the past few years, CBD has rocketed to the forefront of the wellness industry, touted as a magical elixir that can treat all sorts of maladies, including pain, anxiety, stress, sleep disorders, diabetes, acne, depression, and even, according to some particularly bold claims, cancer.

The limited research into the medical benefits and risks of CBD doesn’t support most of these cure-all assertions. But CBD’s rise in popularity — which began exploding in 2019 due to a confluence of consumer trends, including a boom in herbal supplements and the spread of marijuana legalization — was bolstered by the coronavirus pandemic as people sought out ways to alleviate the unique stresses of recent years. US sales reached $4.17 billion in 2022, and forecasts predicted that the market could quadruple by 2026.

Today, you can buy CBD oil, vapes, tinctures, and edibles in convenience stores, gas stations, and smoke shops from Florida to Oregon. You can shop online and order everything from CBD bath bombs to dog treats; you can drink Goop-approved CBD cocktails or nosh on infused candy and cookies. The anxiety drug du jour seems to have found its way into every kind of lifestyle and household product imaginable. Nail polish? Check. Toothpicks? Yep! You can even buy a CBD pillow and bedsheets to infuse your sleep experience with maximum chill. It’s a Wild West time if you’re a hemp entrepreneur.

But CBD, a cannabis compound also known as cannabidiol, exists in a gray area under federal law, and its exact legality has long been tricky to define. Any substance marketed as a supplement or food additive has to meet safety standards issued by the Food and Drug Administration, and that’s where things have gotten hairy for CBD manufacturers and marketers. Food and drinks that contain CBD have never actually been FDA-approved.

For years, the FDA hasn’t come down one way or another with guidance on how to regulate, label, or market CBD in supplements and food products. So store shelves proliferated with quasi-legal tinctures and gummies and beverages, all taking advantage of the FDA gray area. The FDA has warned companies selling CBD products and consumers about unproven health claims made by manufacturers, steadfastly holding that CBD doesn’t meet the definition of a dietary supplement — a position that has been challenged by the industry and consumers as demand for CBD has boomed. Without regulation, however, there’s no way for a consumer to know what, exactly, is in that CBD they bought at the gas station — or if it contains any CBD at all.

In late January, the agency finally issued a decision on CBD, and it’s a potentially damning blow to the industry. The FDA announced that it was denying three citizen petitions requesting guidance on CBD; the agency’s existing safety standards for supplements or food additives, it ruled, aren’t sufficient to regulate CBD’s use. Further, it expressed concerns that CBD products could be dangerous, especially with long-term use. Essentially, the FDA has said that CBD is a headache that it doesn’t want to deal with, so it’s kicking things over to Congress to sort out the mess.

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA principal deputy commissioner Janet Woodcock said in a statement. “[A]fter careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency said that it would work with Congress to develop a new cross-agency regulatory framework for the substance.

The past few years have been a trailblazing time for the CBD industry, with government oversight struggling to keep up with the burgeoning market. Will the FDA’s announcement force producers underground, or will the gray market continue to flourish while it awaits federal regulation?

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Why CBD regulation has been so tricky

Cannabidiol is an active ingredient found in the cannabis plant; it’s the second most abundant compound after its cousin tetrahydrocannabinol, a.k.a. THC. Unlike THC, CBD doesn’t cause the euphoric effect associated with marijuana. This is partly why it became so popular in recent years; because the compound is not considered psychoactive, cannabis-curious consumers believed they could reap health benefits from the plant without getting high.

All hemp is cannabis, but not all cannabis is hemp. When the 2018 Farm Bill legalized hemp — defined as cannabis containing less than 0.3 percent THC — and its derivatives, including CBD, entrepreneurs saw dollar signs without the legalization and regulatory hurdles facing THC.

Yet part of what’s hampered regulation of CBD is exactly what’s hampered regulation of THC: Research on cannabis compounds is nearly nonexistent in the United States since marijuana is still illegal under federal law. The Drug Enforcement Agency strictly limits marijuana cultivation for research, and the glacial pace of cannabis legalization means scientists and researchers have largely been unable to investigate the medical benefits and risks of cannabinoids, leaving agencies like the FDA with little hard data with which to make regulatory decisions.

CBD, however, has been scientifically linked to the prevention of seizures, and the FDA has approved a prescription drug called Epidiolex that contains CBD as an active ingredient. This is largely also why the agency refuses to regulate other CBD products; a provision in the FDA’s Federal Food, Drug, and Cosmetic Act states that if a substance such as THC or CBD is an active ingredient in a drug that has been approved or is being investigated in clinical trials, any other products containing that substance are excluded from the definition of a dietary supplement. Because it’s an ingredient in a drug, the FDA argues, CBD cannot be used in food and drinks. Under current regulations, it’s even off the table for dog treats.

Last August, bipartisan congressional lawmakers expressed frustration in a scathing letter to the FDA commissioner, over a bill that would have regulated hemp-derived CBD as a food additive. The lawmakers called out the agency’s brief response to their request for assistance crafting a regulatory framework as “completely insufficient.” Now that the FDA has punted oversight to Congress, the CBD industry is hopeful that change is finally underway. US Hemp Roundtable general counsel Jonathan Miller says legislation will be reintroduced in the House and Senate in the next few weeks. “We completely disagree with the FDA that they don’t have the authority to regulate CBD,” Miller told Vox. “What we do agree on is that it’s time for Congress to act.”

Miller believes the FDA’s fixation on CBD as a pharmaceutical is misguided. “We completely disagree with their assessments on CBD safety,” he says. “The FDA is focused on the side effects of CBD products that have many thousands of milligrams per serving, as opposed to all the studies we’ve provided, measuring products typically sold in stores that contain 25, 30, 50 milligrams — studies that consistently show they don’t have adverse effects.”

Over-the-counter access to hemp and CBD products is essential for people who use them as part of their wellness regimen, says Olivia Alexander, founder and CEO of the national topicals and wellness brand Kush Queen: “It’s especially necessary in states without access to adult-use cannabis and expensive medical markets.” Kush Queen provides lab results for products on its website, and Alexander counts her business among a few trusted CBD companies, including Charlotte’s Web, which is an official supplier to Major League Baseball. “But there are also tons of crazy fringe cannabinoid brands,” she says. “We need regulation.”

In 2019, the National Cannabis Industry Association (NCIA) published a white paper outlining a framework for CBD products with four lanes of regulation, with pharmaceutical drugs at one end and CBD food and dietary supplements at the other. “We need to ensure that CBD is accurately labeled and that we’re careful about health-related claims being made on the packaging,” says NCIA director of communications Bethany Moore. “It should be regulated to protect public health, but it’s a low safety risk.”

Hemp cultivators have also been hugely affected by federal inaction; some hemp advocates say the FDA has stifled the industry as the skyrocketing legal hemp supply tanked prices, leaving many farmers unable to cash in on their harvest. “There was tremendous excitement among farmers after the 2018 Farm Bill [which legalized the production and sale of hemp], and since then, because of the FDA’s lack of regulation, hemp and CBD biomass prices have crashed by more than 95 percent,” says Miller. “There’ve been a lot of bankruptcies, and many farmers have been left holding the bag.” He is hopeful that bipartisan support for hemp farmers in Congress will prevail. “Whether you’re talking about [Republican] Mitch McConnell or [Democrat] Ron Wyden — those two don’t agree on very much, but they both feel strongly about this.”

A collective shrug from the gray market

The FDA declined a request for an interview when Vox reached out to ask about what, if anything, will happen with existing products. Will they be pulled off shelves? Will the agency continue to issue warning letters to CBD businesses making health-related claims? Questions to the FDA went unanswered, but, given the speed at which federal regulators operate, the CBD gray market looks likely to keep chugging along for the time being.

As the industry waits for Congress to pick up the regulatory baton, CBD shops and e-commerce sites across the country told Vox that they’re keeping calm and carrying on. When reached by phone, employees at CBD stores weren’t even aware of the FDA’s announcement; Vox spoke with retail employees and store owners in Rhode Island, Massachusetts, New York, Kentucky, and Missouri. “I can’t say I’ve noticed anything,” said an employee at a New York outlet of CBD Kratom, a chain with more than 50 retail locations nationwide. A worker at CBD World in Warwick, Rhode Island, also said she had yet to see any change in sales or store policy.

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“This is my first time even hearing about it,” a staffer with SunMed CBD in Worcester, Massachusetts, told Vox, adding that he believes most customers don’t realize that CBD isn’t FDA-regulated. “I don’t think it’s made any kind of impact. The fact that I don’t know this information means your average person doesn’t know this information.” He said that customers who ask about CBD safety at SunMed are told to consult a physician if they have concerns about interactions with prescription drugs, and that all of their products have available lab results, including cannabinoid and terpene profiles, and information on potency, pesticides, herbicides, and heavy metals.

The owner of the SunMed CBD store, Alex Valle, was also surprised to hear about the FDA announcement. “I hadn’t heard about it, but I think [regulation] is long overdue,” he said. “I think it’s fantastic, given that cannabis has been utilized for thousands of years. I’m glad they’re capable of moving forward with this.”

While hemp and cannabis advocates hold out hope that the FDA’s decision will put pressure on Congress to regulate CBD and other cannabis products sensibly, it’s business as usual for most purveyors. “I’m just chilling until they get it together,” says Alexander, of Kush Queen. “The FDA announcement isn’t really going to affect us in any way.”

For now, consumers will have to make their own decisions on whether to use CBD products, or wait for more data and regulation.