Dispensaries aren’t the only ones involved with CBD-based products. This past week, CVS and Walgreens announced that they would carry CBD-infused products, making them available at the local corner rather than a medical cannabis facility.
This has prompted major discussion and the FDA is getting involved to un-blur the line.
The following is a re-post of an article written by Sarah Owermohle for Politico
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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 hempunder 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.
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.
This article was first published on https://www.cannabisimp.com.