Sativex cancer drug trial poses barrier to CBD in supplements

In reliance on a drug trial that was announced eight years ago, FDA has determined CBD cannot be marketed as a dietary supplement.

FDA could change its mind, but only if it is provided evidence that CBD was marketed as a supplement or conventional food before GW Pharmaceuticals plc announced that a clinical trial had been initiated in the United States to study Sativex, a drug that was used to treat pain in patients who suffered from advanced cancer. The drug is composed mostly of two cannabinoids: CBD and THC, the psychoactive ingredient in marijuana.

Jeff Ventura, an FDA spokesman, referenced the 2007 trial in connection with the agency’s previously announced conclusion in a marijuana Q&A that CBD products are excluded from the definition of a dietary supplement.

That is because products cannot meet the definition of a dietary supplement or conventional food if a substance is the subject of a substantial clinical investigation that has been publicized. The law carves out an exception, but only if CBD was marketed as a supplement or food before the new drug investigations were authorized, Ventura explained in an emailed statement. He said the agency has concluded the exception above doesn’t apply to CBD based on the available evidence.

CBD marketers hope to persuade FDA to reach a different conclusion.

“The industry has been marketing CBD as a dietary supplement for a number of years already and believes there is good evidence CBD does qualify as a dietary supplement," said Eric Steenstra, the president of Vote Hemp, a nonprofit organization, in a phone interview. “The industry is working on a response to FDA and hoping to convince [them] that they should change their view on that."

Michael McGuffin, the president of the American Herbal Products Association (AHPA), which has a cannabis committee, said he was not aware of any companies that had submitted information to FDA.

“AHPA is in communication with numerous … companies that currently market CBD products to support their efforts to document the earliest dates of marketing of CBD as a food or dietary supplement," McGuffin said in an emailed statement.

FDA hasn’t said whether or not it will act to pull from the market CBD products that are labeled as hemp foods or supplements. The agency said it considers many factors in determining whether to take enforcement action against a firm for violating the law, including “agency resources and the threat to the public health."

“It would be very embarrassing to the federal government to crack down on CBD-related products because CBD products aren’t harmful," said Martin Lee, director of Project CBD, a nonprofit educational service dedicated to promoting research into the medical use of CBD, in a phone interview. “It would be really bad public relations for the government to come down on this."

‘Gray area’

CBD—like the rest of the cannabis space—operates under a cloud of legal uncertainty. While a number of states have passed laws legalizing marijuana for medical and recreational uses, it remains illegal to use and possess marijuana under federal law.

In reliance on a 2004 appeals court decision that pitted the hemp industry against the Drug Enforcement Administration (DEA), the CBD industry takes the position that CBD is lawful. The DEA still considers CBD a marijuana derivative and Schedule I drug that is being illegally marketed in violation of the Controlled Substances Act (CSA) and Federal Food, Drug & Cosmetic Act.

It is little wonder nutraceutical companies regularly contact Project CBD asking for advice.

“They see it as a gray area that is confusing," Lee said. “I think the more responsible ones are waiting but it’s hard to do that when you see a lot of your competitors jumping out of the gate. You don’t want to be last."

Steenstra acknowledged, “There are some significant challenges for companies still trying to work in this space because it’s in a bit of a legal gray area right now."

Marketing gaffes

In spite of the challenges, hundreds of Internet storefronts promote CBD, and a few physical stores that are focused on CBD sales have popped up in places like Massachusetts and Florida, Lee said.

Chris Brown, press secretary with Americans for Safe Access, a medical marijuana patient advocacy group, said the way in which CBD is marketed today can be confusing to consumers.

“It’s hard to tell exactly what they [marketers] think they can do and what they are marketing sometimes," he said in a phone interview. “Sometimes it’s confusing to read as a consumer."

Lee said CBD marketers have been spreading falsehoods, namely that CBD is legal in all 50 states and that CBD oil is extracted from the hemp plant’s stalk. Cannabinoids—including CBD—are largely found in the bud, and to a lesser extent, leaves of the plant, he said.

In warning letters earlier this year to CBD marketers, FDA also referenced misrepresentations that products containing CBD can treat diseases such as cancer and schizophrenia.

Although the burgeoning industry needs to mature, advocates of CBD find it nonsensical that the substance is lumped in with marijuana since CBD typically contains very little THC, the psychoactive ingredient in weed.

Legislation to the rescue?

Lawmakers in Washington are well aware of the distinction. Brown said American for Safe Access is supporting a bill that was introduced in the Senate: the Compassionate Access, Research Expansion and Respect States (CARERS) Act. Senate Bill 683 would prevent federal prosecutors from cracking down on caregivers, doctors and patients in states where medical marijuana has been legalized. The CARERS Act also would amend the CSA to remove specific strains of CBD from the federal definition of marijuana.

Other legislation also would help remove the legal uncertainty surrounding CBD. In March, lawmakers in the House introduced the Charlotte’s Web Medical Access Act of 2015. The bill would exclude CBD from the definition of marijuana and define the term “cannabidiol-rich plant" to include a plant with a THC concentration of no more than 0.3%.

Reps. Scott Perry (R-Pennsylvania) and Bob Dold (R-Illinois) said the bill would ensure that individuals suffering from epilepsy and other seizure disorders would have access to CBD oil. Similar legislation was introduced in the Senate by Sen. Cory Gardner, a Republican from Colorado, the first state in the nation to legalize marijuana for recreational use.

“The idea that there are a lot of these patients—a lot of them children—who could benefit from CBD and don’t have access to it is really compelling," Steenstra of Vote Hemp said. “I think there’s significant momentum to see something happen this session."

Still, the marijuana bills face little chance of sailing through Congress. According to Gov.Track, a legislative tracking tool, Gardner’s Therapeutic Hemp Medical Access Act of 2015 has just a 3% chance of being enacted.

But as political pressure builds to unshackle CBD from the stigma of THC-rich marijuana, CBD may have a bright future regardless of how it is marketed. 

“There’s no question CBD is going to have a huge impact in the marketplace," Lee said, “once there’s legal clarity on the issue."