The Food and Drug Administration (FDA) once again rejected an attempt by a prohibitionist group to add marijuana and THC to a list of restricted over-the-counter drugs.
Drug Watch International (DWI), an anti-drug group led by a former Drug Enforcement Administration special agent, initially submitted a petition asking FDA to classify cannabis and THC as “negative monographs” in November 2017, arguing that doing so would send a message to the marijuana industry and mitigate public health risks.
A negative monograph is a classification for substances that FDA does not consider “generally recognized as safe and effective,” meaning they are illegal to market.
FDA denied that petition in July 2018 and laid out various reasons the request was unfounded. While stating that FDA appreciated the petitioners concerns about the unlawful marketing of products containing cannabis, the agency said defining marijuana and THC as negative monographs “is not necessary for the protection of public health” and that existing laws are in place to prevent such illegal marketing.
Two months later, DWI submitted a “petition for reconsideration,” stating that FDA is “not enforcing laws to halt unlawful marketing of unapproved cannabinoid medicines.” The group argued that adding the substances as negative monographs would “clarify the [legal] status of cannabinoid drugs” and emphasized that FDA has added other drugs to the restricted list “that are less dangerous than marijuana.”
In a letter dated July 18, 2019, FDA shot down the appeal and systematically rejected each of DWI’s arguments.
“We have carefully considered the Reconsideration Petition and comments submitted to the public docket for the Reconsideration Petition,” FDA wrote. “For the reasons set forth below, FDA denies your Reconsideration Petition.”
To start with, FDA explained that it is not required to consider petition appeal requests that include “new information and views,” which is exactly what DWI included in its request. The agency decided to review the appeal anyway, and it still found that the request was baseless.
“We conclude that the Reconsideration Petition does not warrant modifying or overruling the Original Petition Response,” Lowell Schiller, FDA’s principal associate commissioner for policy, wrote. “We have not found that granting the Reconsideration Petition would be in the public interest or in the interest of justice. Additionally, the relevant information and views in the administrative record were adequately considered when we denied the Original Petition.”
Here are the other reasons that FDA said it wouldn’t be accepting the petition for reconsideration:
—Citizen petitions aren’t supposed to be used to force enforcement action by FDA.
—Laws prohibiting the marketing of unapproved over-the-counter drugs are “unambiguous” and so classifying cannabis and THC as negative monographs would not, as DWI argued, clarify their legal status.
—FDA has an arsenal of communications tools to convey its concerns about the public health risks of marijuana; therefore, it disagreed that “undertaking the monograph rulemaking process is a necessary, effective, or efficient way to communicate to the public” about such risks.
—Although DWI said the inclusion of other substances that it claims are less harmful than marijuana as negative monographs demonstrated a need to add marijuana, FDA replied that inclusion on the list “does not necessarily mean that therapeutic categories and active ingredients that are not included in negative monographs pose comparatively more or less serious potential risks to the public health.”
“While we appreciate the safety and public health concerns that motivate your requests, the Reconsideration Petition does not persuade us to modify or overrule the Original Petition Response,” FDA concluded. “We have not found that granting the Reconsideration Petition would be in the public interest or in the interest of justice. Additionally, the relevant information and views in the administrative record were adequately considered when we denied the Original Petition.”
Though FDA’s response to the petition is far from an endorsement of cannabis or its derivatives, it signals that the current administration is not interested in entertaining bad faith attempts to disrupt the legal industry.
That said, the agency has made clear that it will continue to take enforcement action against marijuana and hemp companies that make unsanctioned claims about the therapeutic potential of their products. Most recently, it sent a warning letter to CBD company Curaleaf for selling “unapproved products with unsubstantiated therapeutic claims,” causing the company’s stocks to plummet.
At the same time that FDA is working to hold cannabis businesses accountable, it is also working to develop regulations for hemp-derived CBD, which was federally legalized under the 2018 Farm Bill. Earlier this month, the agency said it was speeding up its rulemaking process amid growing pressure from industry stakeholders and policymakers.
Read FDA’s full letter rejecting the further restricting of marijuana below:
Photo courtesy of Mike Latimer.