The U.S. Food & Drug Administration, or the FDA, denied a request by Drug Watch International to place cannabis and its derivatives on a restricted list of substances not “generally recognized as safe and effective.” In a letter sent to the group on Monday, director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, said the move is “not necessary for the protection of public health.”
The organization, which is very anti-legalization, filed its request back in December already, writing that approving the move would “send an industry-wide warning to the estimated 33,000 marijuana businesses in the U.S., many of which are making unsupported medical claims for marijuana and THC drug products sold as ‘medical marijuana.’”
In its petition, the group pleaded with the FDA to take measures that would “reduce or end the ability of over-the-counter sellers of these drugs to assert and advertise unsupported medical claims for their products.” Although that may sound a reasonable request, the trouble is that, as scientists continue to study the plant, research is proving most of these claims true, with evidence actually supporting them.
The petition stated that, “It would immediately make such claims unlawful and subject the sponsors to regulatory action, including injunctive seizure of mislabeled and misbranded drugs, as well as other potential sanctions permitted under the Food, Drug and Cosmetic Act.” However, the FDA balked at the idea and ultimately rejected it.
In its letter to the group, the FDA said that while it “appreciates the safety and public health concerns that motivate” the plea, the agency “already has adequate authority to remove unapproved new over-the-counter drugs containing marijuana or THC from the market.” This much is true. The agency has full authority to remove any products it deems harmful or falsely misleading.
The agency explained, “In order for FDA to take enforcement action against illegal marketing of unapproved new over-the-counter drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC.” There appears to be some federal reluctance here to smear the reputation of cannabis.
The FDA’s decision not to assign a “negative monograph” status to weed and THC will not make pot more available or change its legal status from an illegal drug under the Controlled Substances Act. The agency’s refusal indicates that Trump’s administration may not be too willing to go out of its way or to find excuses to tarnish the cannabis industry with a public relations nightmare.
In fact, despite attempts by U.S. Attorney General Jeff Sessions back in January to rescind Obama-era protections for legal states against federal persecution, President Trump seems supportive of ending federal prohibition. The U.S. Senate Appropriations Committee criticized the difficulty of research due to the continued Schedule I status of marijuana in a report last week.
Currently, the FDA’s list of negative monographs includes unapproved drug products, such as deterrents to thumb sucking and nail-biting, aphrodisiacs, and certain daytime sedatives. In its letter rejecting the petition by Drug Watch International, the FDA wrote that the list is “not intended to be comprehensive lists of all classes of OTC products, active ingredients, or conditions of use that cannot be marketed without FDA approval.”
It went on to say, “While you suggest that a negative monograph would reduce or end the unlawful marketing of unapproved new OTC drugs containing marijuana or THC, existing law makes very clear that such unapproved product cannot be marketed under the FD&C Act.” The FDA reiterates its existing authority to deal with such issues.
The agency further wrote that, “FDA has not determined that any OTC drug products containing marijuana or THC are generally recognized as safe and effective for their intended indications. Therefore, these products are ‘new drugs’ as per section 201 of the FD&C Act that require approval by the FDA for legal marketing.”
The letter continued, “That the agency has not promulgated a negative monograph specific to marijuana or THC does not absolve a drug manufacturer or marketer from its responsibility to obtain an approved NDA or ANDA if one is required by law. It is the responsibility of companies marketing drug products in the United States to ensure that their products are safe and effective and marketed in compliance with the law.”
Woodcock also wrote that, “As discussed above, the FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.” In November last year, the FDA did indeed send a series of warning letters to manufacturers of cannabidiol, or CBD products.
CBD is a cannabinoid in marijuana increasingly used to treat epilepsy and many other medical issues, and which marketers even claim has tumor-shrinking capabilities. In a press release at that time, FDA Commissioner, Scott Gottlieb, said, “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors.”
The release also stated, “We do not let companies’ market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer, and we are not going to look the other way on enforcing these principles when it comes to marijuana-containing products.” Indeed, it is incredibly unethical to make unfounded claims of cures to gravely ill people.
Gottlieb said, “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit, they may steer patients away from products that have proven, anti-tumor effects that could extend lives.” However, the FDA recently approved Epidiolex, a CBD pharmaceutical drug that treats severe epilepsy.
In the press release last month announcing this decision, Gottlieb stated that, “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development.”
“But,” he said, “At the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
Now that the FDA missed the opportunity to add cannabis to the heavily restrictive list of negative monographs, the cannabis industry can heave a sigh of relief that it is avoiding yet another round of unwanted headlines about federal regulators wagging their fingers and calling them out. With so much evidence about its medical uses emerging almost daily, adding it would be unethical anyway.