The U.S. Food and Drug Administration (FDA) has denied a request from an anti-legalization group to place marijuana and its derivatives on a list of restricted substances that are not “generally recognized as safe and effective.”
The move is “not necessary for the protection of public health,” Janet Woodcock, the director of FDA’s Center for Drug Evaluation and research wrote on Monday in a letter to the group, Drug Watch International.
The organization had filed its petition requesting the cannabis crackdown in December, writing that 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.'”
The prohibitionist organization pleaded with FDA to take action 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.”
“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].”
But FDA balked, saying that while it “appreciates the safety and public health concerns that motivate” the request, the agency “already has adequate authority to remove unapproved new OTC drugs containing marijuana or THC from the market.”
“In order for FDA to take enforcement action against illegal marketing of unapproved new OTC drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC.”
While the decision by FDA not to assign so-called “negative monograph” status to marijuana and THC won’t do anything to make marijuana more available, or change its legal status—which remains prohibited under Schedule I of the Controlled Substances Act—the rejection suggests that the Trump administration is not looking for excuses to go out of its way to deal public relations blows to the cannabis industry.
In fact, despite a move by U.S Attorney General Jeff Sessions this January to rescind Obama-era protections for state marijuana laws, President Trump himself indicated last month that he supports pending congressional legislation to end federal cannabis prohibition.
Last week, the powerful U.S. Senate Appropriations Committee issued a report criticizing roadblocks to research on marijuana that are caused by its ongoing Schedule I status.
The FDA’s negative monograph list currently contains unapproved drug products such as certain daytime sedatives, aphrodisiacs and deterrents to nailbiting or thumbsucking.
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,” the agency wrote in its rejection of the Drug Watch International petition.
“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 products cannot be marketed under the FD&C Act,” the feds said. “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’ per section 201 of the FD&C Act that must be approved by FDA to be legally marketed.”
“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,” FDA’s Woodcock wrote. “[A]s discussed above, FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.”
Indeed, FDA sent a series of warning letters in November to manufacturers of products containing cannabidiol (CBD), a marijuana component that is increasingly used to treat epilepsy and other medical conditions, and which is sometimes marketed as having tumor-shrinking properties.
“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” FDA Commissioner Scott Gottlieb said in a press release at the time. “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.”
More recently, however, FDA approved a CBD pharmaceutical drug, Epidiolex, to treat severe epilepsy.
“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,” Gottlieb said in the press release announcing the move last month. “But, 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.”
For now, that Gottlieb’s FDA passed up the opportunity to add marijuana to the restrictive negative monograph list allows the cannabis industry to avoid another round of headlines about finger-wagging federal regulators calling them out.
O’Rourke And Cruz Clash On Marijuana And Drugs At Senate Debate
Candidates in one of the most contentious U.S. Senate races in the country this year clashed about the issues of marijuana legalization and drug policy reform during a debate on Friday night.
“I want to end the war on drugs and specifically want to end the prohibition on marijuana,” Democratic Congressman Beto O’Rourke said in response to an attack on his drug policy record from Republican Sen. Ted Cruz, whom he is seeking to unseat in November.
During one of the most heated exchanges of the hour-long debate, the GOP incumbent slammed O’Rourke for sponsoring an amendment as an El Paso city councilman in 2009 that called for a debate on legalizing drugs as a possible solution to violence along the Mexican border.
“I think it would be a profound mistake to legalize all narcotics and I think it would hurt the children of this country,” Cruz argued.
He also criticized a bill the Democrat filed in Congress to repeal a law that reduces highway funding for states that don’t automatically suspend drivers licenses for people convicted of drug offenses. “That’s a real mistake and it’s part of pattern,” he said.
“There’s a consistent pattern when it comes to drug use, that in almost every single instance, Congressman O’Rourke supports more of it.”
Calling the issue “personal to me,” Cruz spoke about his older sister, who died of a drug overdose.
“To be clear, I don’t want to legalize heroin and cocaine and fentanyl,” O’Rourke countered.
“What I do want to ensure is that where, in this country, most states have decided that marijuana will legal at some form—for medicinal purposes or recreational purposes or at a minimum be decriminalized—that we don’t have another veteran in this state, prescribed an opioid because the doctor at the VA would rather prescribe medicinal marijuana but is prohibited by law from doing that,” he said.
It’s time to end the war on drugs. That starts by ending the federal prohibition on marijuana.
— Beto O'Rourke (@BetoORourke) September 21, 2018
Enumerating other potential beneficiaries of cannabis reform, the Democrat also referenced an “older woman with fibromyalgia” and “an African-American man, because more likely than not, that’s who will be arrested for possession of marijuana, to rot behind bars, instead of enjoying his freedom and the opportunity to contribute to the greatness of this country.”
Cruz, who called O’Rourke, “one of the leading advocates in the country for legalizing marijuana,” said that he thinks ending cannabis prohibition “is actually a question on which I think reasonable minds can differ.”
“I’ve always had a libertarian bent myself,” he said. “I think it ought to be up to the states. I think Colorado can decide one way. I think Texas can decide another.”
But despite his support for letting states set their own cannabis laws, which he also voiced during his failed candidacy for the 2016 Republican presidential nomination, Cruz hasn’t cosponsored a single piece of legislation during his time in the Senate that would scale back federal marijuana prohibition.
Ted Cruz accidentally advocating against marijuana legalization, an incredibly popular policy in the country and in Texas…
— Texas College Dems (@CollegeDemsTX) September 21, 2018
Earlier in the debate, the two sparred over the killing this month of Botham Jean, an African-American man shot in his own apartment by a Dallas police officer, a subject about which O’Rourke recently made headlines by calling out in a fiery speech to a black church.
Photo courtesy of NBC News.
Lawmaker Pushes For Marijuana Legalization In Kenya
A Kenyan lawmaker is introducing legislation to legalize marijuana nationwide.
Member of Parliament Kenneth Okoth wrote a letter to the National Assembly speaker on Friday, requesting help to prepare the legislation so that it can be published.
The bill would decriminalize cannabis possession and use, clear criminal records of those with prior cannabis-related convictions, enact a legal and regulated commercial sales program and impose “progressive taxation measures” in order to “boost economic independence of Kenya and promote job creation.”
It's high time Kenya dealt with the question of #marijuana like we do for miraa, tobacco, and alcohol#DecriminalizeIt #LegalizeIt #RegulateIt #TaxIt #HarmReduction #PettyOffences @YoungMPsKenya @HumanRightsMPs @KEWOPA @ICJKenya @lawsocietykenya @shecyclesnbi @DavidNdii @gathara pic.twitter.com/6ISnxjt2gS
— Kenneth Okoth, MP Kibra (@okothkenneth) September 21, 2018
Currently, marijuana (or “bhang,” as it’s locally known) is illegal in Kenya—as it is in most of Africa.
Another provision of the draft legislation concerns “research and policy development.” Okoth wants the country to conduct studies on the medical, industrial, textile and recreational applications of cannabis. And that research would have a “focus on the preservation of intellectual property rights for Kenyan research and natural heritage, knowledge, and our indigenous plant assets,” according to the letter.
Kenya Gazette special issue "..Act of Parliament to decriminalize the growth and use of Marijuana.." pic.twitter.com/gXFNx8ehbC
— The African Voice (@teddyeugene) September 21, 2018
“It’s high time Kenya dealt with the question of marijuana like we do for tobacco, miraa, and alcohol,” Okoth wrote on Facebook.
“Legalize, regulate, tax. Protect children, eliminate drug cartels, reduce cost of keeping petty offenders in jail. Promote research for medical purposes and protect our indigenous knowledge and plants before foreign companies steal and patent it all.”
Okoth’s push for legalization in Kenya comes days after South Africa’s Constitutional Court ruled that individuals can grow and use marijuana for personal purposes. The court determined that prohibition violated a person’s right to privacy, effectively legalizing cannabis in the country.
It’ll take a while for Okoth’s bill to move forward. The legislation will need cabinet approval, then it must be published so that all interested parties can review the proposal before it enters into parliamentary debates. Whether Okoth’s fellow lawmakers will embrace the legislation is yet to be seen.
Photo courtesy of Wikimedia.
Governor Signs Marijuana Legalization Bill, Making History In US Territory
With a governor’s signature on Friday, the latest place to legalize marijuana in the U.S. isn’t a state. It’s the Commonwealth of the Northern Mariana Islands (CNMI)—a tiny Pacific territory with a population of just over 50,000.
Under the new law signed by Gov. Ralph Torres (R), adults over 21 years of age will be able to legally possess up to one ounce of marijuana, as well as infused products and extracts. Regulators will issue licenses for cannabis producers, testing facilities, processors, retailers, wholesalers and lounges. Home cultivation of a small number of plants will be allowed.
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Photo courtesy of Max Pixel.