Flood of products containing marijuana extract puts FDA in a bind
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Flood of products containing marijuana extract puts FDA in a bind

Even by the superhyped standard of internet cures, the marijuana and hemp extract cannabidiol is unique, touted as everything from a hair conditioner to a sleep aid and a way to help manage diabetes and fight cancer.

The CBD boom is also giving regulators fits, blurring the line between a drug and a dietarysupplement and testing how much the government can police health claims.

The product derived from the plant — which is not the component of marijuana that give the “high” — has been popping up online and in retailer’s shelves in the form of lattes, shampoos, ointments and drops since the 2018 farm bill legalized hemp under certain conditions and allowed CBD items to be shipped interstate with restrictions. CVS Health is starting to sell items at more than 800 stores as part of a distribution arrangement.

That’s left regulators scrambling to keep up. Minutes after the farm bill was signed in December, the FDA asserted that it could police the market because it had already approved a CBD-based medicine — and could subject other products to the same strict standards.

Pro-hemp lawmakers in Congress are demanding to know more about what the agency has in store. “This has just created a problem that we didn’t need to have,” Rep. Chellie Pingree (D-Maine) told POLITICO. “That they could have left the products that were generally recognized as safe alone.”

Instead, Pingree says, growers and manufacturers are left in confusion while states have interpreted the FDA’s statement a range of ways. “You just can’t leave them all in limbo midstream.”

But what might have been an FDA attempt to hit the pause button while it sorts through the regulatory haze has not slowed an explosion of openly marketed CBD products.

“Some mistakenly took the farm bill as carte blanche,” Cowen analyst Eric Assaraf said.

We’re reporting on the growing popularity of medical marijuana and CBD, despite the relatively little scientific evidence for different ailments. If you currently use medical marijuana/CBD, or if you’re a health care professional who has recommended them to your patients, we want to hear from you.

The FDA last year approved its first CBD-based drug, Epidiolex, as a treatment for a form of epilepsy. That therapy went through the strict product reviews reserved for prescription drugs — the same regime that FDA in December said it could order for other CBD treatments. Dietary supplements face far looser regulatory controls.

Where CBD products fall in the spectrum is the challenge facing the FDA and the rapidly growing new market.

Nearly everyone agrees that forcing every CBD product off the shelves and into the arduous drug review process won’t work. There are already thousands of oils and edibles being sold, said Marc Scheineson, an FDA-focused partner at the law firm Alston & Bird and a former associate commissioner of the agency, and many are striving to comply with the FDA’s regulatory standards for marketing dietary supplements. Pulling the products would also set FDA up for a clash with Congress, which clearly intended broader uses for hemp and its derivatives.

Several of those lawmakers have already called on the agency to clarify its stance. Oregon’s Democratic senators, Ron Wyden and Jeff Merkley, who wrote the hemp provision in the farm bill, asked the FDA in January to clarify under what circumstances it would regulate interstate CBD sales. Pingree, joined by Reps. Mark Pocan (D-Wis.) and Barbara Lee (D-Calif.), pressed departing FDA Commissioner Scott Gottlieb on the issue during a February appropriations hearing.

But clear standards could take years to materialize. The agency for now is taking a whack-a-mole approach toward the most questionable medical claims, cracking down on individual manufacturers that say their CBD products “kill cancer cells,” provide “an attractive alternative” to Alzheimer’s disease treatments or help control blood sugar in diabetics.

“The market has overwhelmed the agency’s limited enforcement resources here,” said Scheineson. It’s spread far past CBD makers that may have been spooked by the FDA’s December warning shot, he added, noting manufacturers don’t even need to make the medical claims themselves to get business.

“CBD has captured the public imagination,” Scheineson said.

There are currently thousands of “hemp oil” listings on Amazon, purporting to help with everything from pain relief to stress. Far riskier, doing a Google search for “CBD for cancer” produces a sidebar of ads for oils that consumers can buy online. One of the top hits search of “CBD for diabetes” is a website that says it is “nothing short of phenomenal” at treating the disease.

“A lot is going wrong now,” said Peter Pitts, another former associate FDA commissioner and co-founder of the Center for Medicine in the Public Interest, a libertarian-funded medical research nonprofit.

The question is where the FDA should devote its energy as the products and claims pile up. Coming down on specific manufacturers “doesn’t solve the problem, it simply allows the FDA to flex its muscle,” Pitts said.

Gottlieb, who’s leaving the agency in two weeks, has steered clear of committing to a specific path for CBD, saying the agency is assembling a high-level advisory group and planning a public meeting in April to air some of the biggest regulatory questions. He also laid out one potential option: to consign products with high-doses or pure CBD to the drug approval process and allow lower-dose items to be treated as dietary supplements that can bought off the shelf. Regulators still would have to decide on a cutoff point that, in Gottlieb’s own words, would preserve the incentive to research CBD as a drug.

While it’s extremely rare for there to be both medicines and dietary supplement with the same ingredients, there is one recent precedent — the FDA last year approved a fish oil-based medicine. But in that case, fish oil supplements had been on retail shelves for years. CBD, in contrast, was just recently made legal.

Beyond such basic questions, CBD regulation is riddled with other dilemmas. For example, the government needs to parse what kind of CBD can be used. Hemp and its derivatives are now legal; marijuana, essentially the same plant but with psychoactive ingredients, is a controlled substance — but CBD is found in both. CBD can also be derived from a plant or synthesized in a lab, as biotechs in Israel, the U.K. and Canada are exploring.

“One source of frustration for states, for growers, for manufactures, is this all kind of stems from the hysteria around hemp,” Pingree said. “It gets caught up in the marijuana debate.”

Incentives for pharmaceutical companies to study and develop new medical uses for the product could diminish if it’s sold on store shelves in high-dose forms. But in the meantime, there is still very limited research on how and why CBD works for different conditions, making it hard to back up internet marketing claims with anything but anecdotal evidence.

Beyond the recently approved epilepsy drug, no pharmaceutical companies have publicly stated whether they have submitted CBD-based medicines for FDA review, though several others are in early stages of development. And of 44 NIH-funded CBD studies in the past year, a lion’s share are housed in the National Institute for Drug Abuse, which is largely focused on potential drug misuse and harm, not health benefits.

Gottlieb has already warned that sorting out all the questions could take years. And the departing commissioner, known for being a skilled communicator and well-liked on both sides of Congress, won’t be there to shepherd CBD regulations through the rule-making process or potential clashes with Congress.

CBD advocates are not optimistic, particularly because Gottlieb’s successor, acting FDA Commissioner Ned Sharpless, won’t have an open-ended mandate. Sharpless, a cancer researcher, also comes from the drug side and is less well-versed on dietary supplements or food regulation — like many commissioners before him — said Jessica Wasserman, a partner at Greenspoon Marder representing CBD companies. “How Gottlieb briefs him up on CBD will be key.”

An acting commissioner isn’t going to strike out on their own initiatives but will manage what is currently happening, said Pitts. Where CBD falls on Sharpless’ radar “depends on the priorities and the new commissioner’s stomach for battle.”

Pingree told POLITICO that she is scheduling a meeting with Gottlieb before he leaves in the hopes that he will lay out some clarity, because “once he’s gone, we have to start over with bringing someone else up to speed.”

In the meantime, many CBD manufacturers are treading cautiously. States like New York and Maine have already ordered some CBD edibles and infused drinks off the shelves, while Texas law enforcement have raided CBD retailers, saying they are illegally selling marijuana products.

“FDA should not waste its resources trying to put the CBD toothpaste back in the tube. Nor should FDA leave CBD unregulated,” said Wasserman, who is pushing for the agency to issue a formal statement of no enforcement — a move that the industry feels could calm state actions — as it works out a national framework.

But CBD manufacturers, who have largely operated in the shadows before the farm bill, will ultimately have to come around to working with the FDA, said Scheineson. “They can’t have the laissez-faire market they have now where it’s being put in everything included food.”

“There are a lot of policymakers looking at this now, and it’s inevitable that the government will not keep its hand off of this for much longer,” he said.

(Rights of the text go to 420intel.com. Image is from shutterstock)

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