Washington’s CBD dilemma: Dude, where’s my regulatory framework? – STAT

WASHINGTON — Online reviews proclaim CBD a “life changer,” “the best thing ever,” and “truly incredible.” It’s a $390 million industry, expected to grow to at least $1.3 billion by 2022. Montel Williams has his own designer line of CBD products; so do Tommy Chong and Mike Tyson.

Despite the rave reviews, CBD is giving Washington a major headache. The Food and Drug Administration has different rules for regulating medicines and dietary supplements like vitamins — and it isn’t perfectly clear yet which category CBD, or cannabidiol, an extract of cannabis used as a home remedy for everything from anxiety to back pain, falls into. Congress, too, has struggled. Lawmakers passed a bill last year that officially legalized hemp, the plant from which CBD is extracted, but left the FDA with little guidance on how to regulate CBD.

This isn’t the typical regulatory morass story, either. The FDA is often criticized for a “slow and burdensome approval process” that keeps promising cures from patients in need, but when it comes to CBD, lawmakers, consumer advocates, and even CBD manufacturers are unified: They want more regulation, and fast.


“I fear that the FDA is behind the eight ball on this one,” said Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest and a former FDA official. “The FDA needs to take a leadership position as quickly as possible to make sure that the wild west of CBD doesn’t harm the public health.”

You wouldn’t know it from their widespread availability on the internet, in health food shops, and increasingly in major retailers, but CBD dietary supplements are technically illegal.

The questionable legality of CBD actually has little to do with the legality of marijuana. A large portion of CBD is made from hemp, which Congress legalized in 2018.

The problem, instead, is that drug makers’ decision to test whether CBD would make a good prescription drug has left the FDA in a bind: Current law says any substance being studied as a drug also can’t be regulated as a food or supplement. And since several drug companies have been eyeing CBD for use as a medication — the FDA even approved one CBD-based drug, Epidiolex, to treat two rare forms of epilepsy last June — now, CBD can’t legally be used in dietary supplements.

It’s a rule that makes some sense. “You don’t want a drug ingredient to show up in your Cheerios,” Jonathan Havens, a partner at Saul Ewing Arnstein & Lehr and who represents CBD companies, said.

Lawyers, however, maintain the law is less clear for CBD products marketed as hemp extract, because hemp has been in the food supply long before drug makers started doing CBD clinical trials.

But for now, the FDA has taken a laissez faire approach to all the supplements and food products on the market. Though CBD is in everything from dietary supplements and makeup to lattes and dog food, the FDA only goes after the worst actors, those that make unsubstantiated claims that their products can cure serious diseases like cancer, for example.

Then-FDA Commissioner Scott Gottlieb went before the Senate in March and described FDA’s approach as “enforcement discretion,” although FDA spokesman Michael Felberbaum insisted Thursday that “the agency does not have a policy of enforcement discretion with respect to any of these products.”

The FDA’s light touch is getting more noticeable as the CBD industry balloons. According to the market research firm New Frontier Analytics, the hemp-based CBD market grew fivefold from 2014 to 2018 alone. Other firms estimate even higher growth.

Myaderm CBD
Cannabidiol pain cream products in a pharmacy in Remington, Virginia. Kristoffer Tripplaar/Sipa via AP

“If you told me in August of 2018 what would be happening in the spring of 2019 in this sphere, I wouldn’t have believed you. And yet here we are,” David Spangler, senior vice president of policy and general counsel of the Consumer Healthcare Products Association, a dietary supplement trade group, told STAT.

Just this year, the agency sent warnings to three CBD manufacturers, Nutra Pure LLC, Advanced Spine and Pain LLC, and PotNetwork Holdings. All of the companies had claimed CBD could treat conditions ranging from psychosis to depression.

But the government’s struggle to settle on a clear CBD policy is confusing more than just the drug and supplement makers. It’s also causing an internal rift in the FDA itself, according to one former senior FDA official. Gottlieb pushed the government to find a way to regulate CBD supplements, while others in the agency wanted to crack down more heavily on the burgeoning industry.

The former staffer maintained that the government is still struggling to chart a path forward, and described the issue as a “bumblebee at a memorial day bbq.”

“Everyone wants to ignore it and just hopes it doesn’t land on them and sting them,” the former staffer wrote in a text message. “But it’s out there buzzzzzzzzing around.”

Now, the FDA is considering whether it can write a new regulation that would carve CBD out of the existing law.

The agency has set up a CBD working group headed by the agency’s principal deputy commissioner, Dr. Amy Abernethy, and the agency’s principal associate commissioner for policy, Lowell Schiller. The group will be tasked with answering that question. And that same question is sure to loom large at the agency’s May 31 public meeting on CBD — the first of its kind.

“A key of goal of our upcoming hearing and associated public docket is to identify and collate all available data to help us answer these questions in order to make sure that the American public is protected – including to the extent CBD is being introduced into our food supply or other common consumer products,” FDA’s Felberbaum said.

It’s entirely new territory for the government.

“We’ve never done this before,” Gottlieb said in March.

And Gottlieb has warned that the FDA’s process could take longer than three years — a lengthy timeline for an industry that has already seen such rapid growth.

In the meantime, he’s pushed Congress to step in and solve the problem more quickly.

“The most efficient way to get to a pathway would be through legislation,” Gottleib said in March. “Probably that would just be legislation that would specifically address CBD.”

CBD makers insist they are ready to embrace more government regulation.

“In the end we just want to be treated like any other product that you buy at the store, whether it’s vitamin D or melatonin,” Jonathan Miller, an attorney at the law firm Frost Brown Todd LLC and the general counsel of the Hemp Roundtable, a trade association that includes multiple CBD makers, told STAT.

Off The Charts CBD Market
Buds of chocolate by Chronic Candy are displayed at the Big Industry Show at the Los Angeles Convention Center. From skin-care lotions to bottled water, cannabis companies are rolling out a growing array of consumer products infused CBD. Richard Vogel/AP

CBD makers themselves acknowledge the wide variation in the quality of products currently on the market. Some of them say stricter regulations will help consumers trust the industry — and help weed out bad actors.

“There [are] 2,900-plus different CBD brands out there, some of them may be made in a garage … where there’s no consumer safeguards put in place,” Tim Gordon, chief science officer for the CBD company Functional Remedies, told STAT. (Gordon added that he runs his company “like the FDA is with us everyday” and complies with existing regulations pertaining to dietary supplements.)

It’s a point that’s been echoed by consumer groups, who fear consumers could be duped, or even harmed, by underregulated CBD supplements.

“Right now the CBD marketplace is a wild west of unsubstantiated claims and potentially adulterated products. It’s long past time for the FDA to step in and use its existing authorities to start to clean up the market,” said Dr. Peter Lurie, president of the Center for Science in the Public Interest, and former associate commissioner for public health strategy and analysis at the FDA.

Traditional supplement makers, too, want more regulation of CBD — albeit for different reasons. Supplement trade associations — like the National Products Association — say the government is creating an unfair playing field, letting CBD makers get away with infractions that would never fly in their industry.

“FDA needs to get in the game,” said the agency’s former director of dietary supplement programs, Daniel Fabricant, who now serves as the CEO of the Natural Products Association. “They’ve completely abandoned their job in terms of regulating the marketplace.”

NPA wrote to the FDA in October 2018 urging the agency to crack down on CBD producers via “blitz type enforcement actions,” audits of CBD makers, and outreach to states urging them to crack down on shipping of CBD across state lines.

At the same time, the supplement industry sees a potential business opportunity in CBD, so long as they can get some clarity from FDA.

Now everyone hopes the FDA can move before something goes terribly wrong.

“We want them to hurry up,” the Hemp Roundtable’s Miller said. “The worst thing that can happen to us is somebody makes [CBD] in their bathtub and a kid dies.”

Source: https://www.statnews.com/2019/05/17/washington-fda-regulate-cbd-dilemma/