The FDA Is About to Deal With CBD—and Wants to Hear From You

by: Ben Adlin | on April 3, 2019 | No Comments

Cannabidiol, or CBD, has become wildly popular in recent years—and widely available, both online and in stores across the country. But despite the belief by some that the 2018 farm bill broadly legalized the cannabinoid, the truth is that federal agencies are still scrambling to determine their next steps.

Want a say in the process? Now’s your chance.

The US Food and Drug Administration oversees the nation’s food, pharmaceutical drugs, and cosmetics—three categories of products that have recently been overwhelmed by CBD and various claims about its benefits. As the FDA begins to craft regulations around CBD and infused products, the agency is asking for public comment on how to proceed.

“While the use of cannabis and cannabis-derived products, including hemp and hemp-derived products, has increased dramatically in recent years, questions remain regarding the safety considerations raised by the widespread use of these products,” wrote Lowell Schiller, the FDA’s acting associate commissioner for policy, in a Federal Register filing published Tuesday. “These questions could impact the approaches we consider taking in regulating the development and marketing of products.”

Ahead of a public hearing on CBD scheduled for May 31 near Washington, DC, the agency is asking for public comment on three specific aspects of CBD and infused products: health and safety risks; manufacturing and product quality; and marketing, labeling, and sales.

Thoughts on CBD Regulation? File a Comment With the FDA

More information is available on the federal government’s Regulations.gov website (click here to go directly to the comment form). Written comments can be sent to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Requests to speak or make a presentation at the May 31 hearing must be received by May 10, while written or electronically filed comments can be filed until much later: July 2.

Outlook: Uncertain

It’s hard to gauge how the FDA might proceed with regulating CBD. On one hand, the agency has been far more responsive to scientific evidence around cannabinoids than the US Drug Enforcement Administration. Late last year, FDA officials wrote to their counterparts at the DEA explaining that “CBD and its salts … do not have a significant potential for abuse and could be removed from the [Controlled Substances Act].” Meanwhile, the DEA has repeatedly insisted that any CBD product other than the pharmaceutical drug Epidiolex remains a Schedule I controlled substance.

But while the FDA seems more sympathetic to CBD, the agency is also trying to rein in an industry that has exploded in recent years. Hundreds of startups have exploited the legal uncertainty around CBD by insisting that cannabidiol products are already “legal in all 50 states” and promising relief for all types of ailments, whether backed by evidence or not.

“There’s too much money to be made for problems not to come up.”

Justin Polkis, Virginia Commonwealth University

That does not sit well with FDA officials. Earlier this week they took action, sending warning letters to three CBD companies—Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain—that agency officials say were making false claims about the use of CBD to treat diseases such as cancer and Alzheimer’s disease.

“According to their advertisements, the products can effectively treat diseases, including cancer, Alzheimer’s disease, fibromyalgia, and ‘neuropsychiatric disorders,’” the FDA and FTC said in a joint statement.

“We’ve seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things,” FDA Commissioner Dr. Scott Gottlieb said in the statement. (Gottlieb, who has pressed his agency to take action on CBD, is scheduled to step down from his post later this month.)

After last year’s passage of the farm bill, the FDA issued a statement saying that CBD in food products is prohibited under the federal Food, Drug, and Cosmetic Act. As a result, national drug store chains such as CVS have begun to carry CBD products, but only in non-edible form.

In the Federal Register post about the upcoming hearing, the FDA also raised concerns about the possibility of liver damage as the result of taking high doses of CBD (20 millilgrams of CBD per kilogram of body weight per day, or about 1,360 mg for a 150-lb. person). It says the risk was determined as part of the FDA approval process for Epidiolex, a purified form of CBD approved last year to treat certain forms of epilepsy.

“This is a potentially serious risk that can be managed when the product is taken under medical supervision in accordance with the FDA approved labeling for the product, but it is less clear how this risk might be managed if this substance is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling,” the Federal Register filing says.

For reference, acetaminophen—a popular pain reliever and fever reducer found in over-the-counter drugs such as Tylenol and Nyquil—is a leading cause of acute liver failure across much of the globe. “Harmless at low doses, acetaminophen has direct hepatotoxic potential when taken as an overdose and can cause acute liver injury and death from acute liver failure,” according to the National Institutes of Health.

The current unregulated nature of CBD has also raised concerns among consumers and outside observers for other reasons. Among them, a study last year by researchers at Virginia Commonwealth University (VCU) found unlabeled contaminants in a number of products sold by Diamond CBD, a retailer owned by PotNetwork Holdings. The unexpected chemicals included dextromethorphan (DXM)—a well-known cough medicine with a history of recreational abuse and health dangers—and 5F-ADB, one of a growing group of synthetic cannabinoids often known as K2 or Spice.

“Somebody needs to step in and regulate this stuff,” Justin Polkis, the lead author of the VCU study told Leafly last year. “There’s too much money to be made for problems not to come up.”

Diamond CEO Kevin Hagen told Leafly at the time that he welcomed regulation.

“All companies make big claims about their products,” Hagen said. “It’s the FDA’s job to ask for [better] labeling.”

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