The Pew Charitable Trusts Anna Buck, a barista, holds a cup of CBD-infused cold brew at Blue Sparrow Coffee in Denver. Federal regulators say businesses that add cannabidiol to food are essentially adding prescription drugs into the food supply.

WHEAT RIDGE, Colo. — At Joshua Hudson’s smoothie shop, a bohemian outpost called Twisted Smoothie in a small strip mall here, customers can add a 15 mg or 30 mg shot of cannabidiol, or CBD, to their blended drinks for a few extra dollars.

They also can get a mini-lecture from Hudson on the virtues of the cannabis extract, found in both hemp and marijuana, which he and other fans claim can ease a range of health problems without making users high.

“It makes everybody better,” said Hudson from behind the counter. He takes CBD before important meetings and first dates to calm his nerves, he said. “I tell people, ‘CBD — it’s a natural Tylenol and Xanax mixed together.’”

Despite limited research on the compound’s health benefits, hemp CBD has become a nationwide health food craze. Stressed-out people flock to cafes and restaurants that sell CBD cocktails and cookies, doughnuts and dog treats. Martha Stewart is advising a cannabis company on a line of CBD products for humans and pets.

Congress recently primed the market for more growth when it legalized hemp farming and sales nationwide.

But the U.S. Food and Drug Administration says businesses such as Hudson’s cafe are unlawfully introducing drugs into the food supply.

The Federal Food, Drug and Cosmetic Act, first passed in 1938, makes it illegal to sell an active ingredient either in dietary supplements or in foods that will be sold across state lines. The FDA has approved a CBD-based drug, Epidiolex, for treating epileptic seizures and is evaluating other drugs that use the compound as an active ingredient.

Nonetheless, the FDA’s outgoing commissioner, Scott Gottlieb, last month told Congress that the agency might eventually allow sales of foods infused by diluted forms of the compound.

The solution could be a long time coming. “This is not a straightforward process,” Gottlieb told a House appropriations subcommittee. The FDA will start holding public hearings about CBD in April.

The Pew Charitable Trusts A rack of doughnuts for sale, including a sold-out tray for CBD doughnuts, at Glazed & Confuzed in Aurora, Colorado. Restaurants, cafes and food manufacturers nationwide are cashing in on the cannabidiol food trend.

Meanwhile, state and city lawmakers are making their own rules. A 2018 Colorado law contradicts federal rules, saying all parts of hemp plants can be added to food for sale. Regulators in California, Maine and New York City have sided with the FDA and banned adding CBD to food.

Many states don’t allow hemp CBD to be sold to the public at all, whether as an oil, pills or mixed into smoothies. Ohio’s medical cannabis law, for instance, includes hemp-derived CBD in its definition of marijuana, which means it can only be bought with a doctor’s permission.

Hemp industry lobbyists are pushing lawmakers in more than a dozen states to approve bills that would expand hemp farming and access to CBD products. And Gottlieb’s public statements have given many business owners confidence that the federal government — and states — eventually will allow CBD-infused food.

“I think the FDA has — I think they have every intention of embracing the industry,” said Andrew Aamot, president and CEO of Sträva Craft Coffee, a Denver-based coffee roaster that sells CBD-infused beans. “But it’s just gone so far so fast that they’re trying to catch up.”

CBD’s growing market

When Hudson began offering CBD foods here in Wheat Ridge in 2016, he had to explain to almost every customer that CBD, unlike the better-known cannabis compound tetrahydrocannabinol, or THC, is not psychoactive.

He’s had to do less explaining recently, he said, as the extract has become more popular. “People are adding CBD to everything.”

The Hemp Business Journal, an online publication that tracks the U.S. hemp industry, estimates that the market for hemp CBD products will grow from $390 million in 2018 to $1.3 billion by 2022.

A growing share of hemp CBD harvests is ending up in food, said Jonathan Miller, general counsel for the U.S. Hemp Roundtable, a Lexington, Kentucky-based coalition of hemp companies. “Right now, it’s definitely the hottest and likely the most popular use of hemp extracts.”

Hemp oil’s grassy flavor is something of an acquired taste. But food manufacturers and chefs have found ways to make it more palatable. The company that supplies Hudson’s shop with CBD dissolves the extract into flavorless oil akin to coconut oil, for instance. “I love the flavor, don’t get me wrong,” he said of hemp oil, “but 99 percent of people don’t.”

Offering CBD has been good for Hudson’s Twisted Smoothie Co. Customers who add a $5 serving of the compound to their drinks can almost double the cost of their order.

At Blue Sparrow Coffee in Denver’s hip RiNo neighborhood, baristas serve up nitro cold brew coffee made from CBD-infused beans. It tastes like, well, coffee. Anna Buck, a barista, said the brew is popular with customers who get jittery after drinking caffeine. “It’s a good way to get over the over-caffeinated buzz that coffee can give you.”

The beans at Blue Sparrow are roasted by Sträva in Denver. In recent years, CBD beans have become the lion’s share of Sträva’s business, owner Aamot said. “It’s where the growth is happening; it’s where the interest and excitement comes from.”

Sträva’s biggest customers aren’t hipsters, Aamot said — they’re older coffee drinkers who find the CBD version eases their aches and pains. He sometimes gets thank-you notes from people with disabilities, he said.

“Having a great cup of coffee that they can make fresh in the morning and that helps them get up and get about is really something astonishing,” he said.

Science behind CBD’s benefits?

Yet CBD’s health benefits remain unclear. Studies have shown CBD to be effective as an epilepsy drug, and clinical trials in the United States are exploring whether the extract could help treat anxiety, post-traumatic stress disorder, Parkinson’s disease tremors and chronic pain. But scientists generally say more research is needed.

And some products aren’t all they seem. A 2017 University of Pennsylvania study found that nearly 70 percent of CBD products sold online either contain more or less of the compound than their labels say. The FDA has sent companies numerous warning letters for making health claims without federal approval, such as that CBD can treat cancer.

Companies that put CBD in food and drink also are operating in a legal gray area.

Businesses may be willing to sell CBD despite the legal risk because the 2018 farm bill made it clear hemp isn’t marijuana, said Daniel Shortt, a Seattle-based attorney at Harris Bricken who specializes in cannabis law.

“The stakes are not as high now,” he said, as there’s less risk of the U.S. Drug Enforcement Administration getting involved.

Colorado regulators decided they had the authority to allow CBD-infused food when the 2014 farm bill let states set up hemp research programs, said Jeff Lawrence, a division director at the Colorado Department of Public Health and Environment.

The FDA hasn’t cracked down on companies for adding the cannabis compound to food, Lawrence added. “While they say it’s not allowed, they haven’t taken action.”

Asked if the FDA has pursued any enforcement actions against CBD food products, agency press officer Michael Felberbaum declined to comment in detail, but provided an email with a hyperlink to warning letters the agency has sent to companies for marketing CBD products as health treatments without federal approval.

Colorado companies that make hemp ingredients must get a food manufacturing license from the state and run tests to make sure they don’t exceed legal THC limits.

CBD food ban

Other states have banned CBD food products, citing the FDA’s position.

California public health regulators published guidelines last summer that said the state won’t consider CBD to be an approved food additive or dietary supplement until federal or state officials say otherwise. State lawmakers are considering a bill that would explicitly allow CBD-infused food.

In New York, state agriculture regulators allow businesses to sell CBD as a dietary supplement — which means products must meet certain manufacturing standards — but ban using it in food.

The New York City health department last month announced that it was prohibiting bars and restaurants from serving CBD-infused food and would begin fining establishments for doing so this fall.

“We were really frustrated,” said Andrew Rigie, executive director of the New York Hospitality Alliance. His organization, which advocates for hotels, restaurants and other businesses, had been asking the agency for guidance on CBD but never expected an embargo and fines, he said.

Businesses are preparing to end sales of a popular product. “We had been serving CBD-infused coffee and lemonades and teas and cocktails, and it was very much embraced by our customers,” said Ron Silver, founder and owner of Bubby’s, a brunch spot with two locations in the city.

In Texas, it’s illegal to sell CBD over the counter, though many businesses do it anyway, said Shannon Edmonds, director of governmental relations for the Texas District & County Attorneys Association. Under a 2015 state law, low-THC, high-CBD cannabis — including hemp — can be sold only to epilepsy patients.

But misinformation is widespread, Edmonds said. “Here at the state D.A.’s association, I get spam emails trying to sell me CBD oil and telling me it’s legal, when I know that it’s not. So I can see how people who maybe don’t do their research could be confused.”

The legislature is considering at least eight hemp bills this session, including several that would allow the sale of CBD-infused food, drink and cosmetics.

Some state leaders worry CBD might harm consumers. Alabama regulators have warned that some companies are selling synthetic CBD, a substance that can be poisonous and sickened 52 people in Utah a few years ago.

“Products labeled as CBD oil and/or other CBD-related products might contain any number of substances,” Alabama’s state health officer, Scott Harris, said in a statement last month. “There is no assurance they are safe to consume.”

Miller, of the U.S. Hemp Roundtable, said he’s confident that state and federal law will come to embrace CBD. “The good thing is, we know we’re going to win — that CBD is too big to fail,” he said, adding that the FDA clearly wants to find a solution. “It’s just that while we’re in this waiting period, it’s a source of stress.”