At the same time that the Food and Drug Administration (FDA) is working to create a regulatory framework for hemp-derived CBD, it’s also cracking down on companies that are in its view irresponsibly marketing CBD products and making unsanctioned claims about their medical benefits.
FDA announced on Tuesday that it and the Federal Trade Commission sent warning letters to three such companies last month: PotNetwork Holdings in Florida, Nutra Pure in Washington state and Advanced Spine and Pain in New Jersey. The letters were sent “in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites,” FDA Commissioner Scott Gottlieb said in a press release.
In a Twitter thread, the commissioner added that he was “concerned to hear recently that several national pharmacy chains and other major retailers have begun to sell or will soon begin to sell” CBD products and that the agency will “be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.”
CVS and Walgreens both recently announced they will begin selling CBD-infused products.
We’ll be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.
— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019
In the press release about the warning letters his agency has already sent to CBD companies, Gottlieb asserted that they used their websites to “make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”
At the same time, the warning letters announced today make clear that #FDA has and will continue to monitor the marketplace and use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk
— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019
FDA is hustling to provide manufacturers guidelines on marketing cannabidiol following the federal legalization of hemp last last year, but the process is complicated by the fact that CBD is the active ingredient in an FDA-approved drug, Epidiolex, and remains the subject of intensive clinical testing. Gottlieb has indicated that it will take years to develop a regulatory plan for CBD without further congressional action.
In the meantime, companies that continue to choose to engage in CBD commerce should be wary about making health claims about their products. The commissioner said FDA has “limited resources” for enforcement operations, but it would take action against companies that make “over-the-line” statements.
In the press announcement, FDA listed some of the unauthorized claims that the three companies made. For example, the products were touted as being able to treat cervical cancer, Alzheimer’s disease and substance use disorder.
“I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” Gottlieb said. “The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today.”
“Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk,” he said. “These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
Questions about what constitutes an unauthorized claim that would put a company at risk of enforcement action will likely come up at the agency’s just-announced public hearing CBD issues on May 31. Stakeholders are invited to submit information about the public safety impacts of CBD and how to manufacture and market products that contain the cannabis compound.
This piece was updated to include Gottlieb’s tweets about national pharmacy chains.
Photo courtesy of Nicholas C. Morton.
California Governor Signs Marijuana Tax Fairness Bill But Vetoes Cannabis In Hospitals
California Gov. Gavin Newsom (D) announced on Saturday that he signed several marijuana-related bills into law—including one that will let legal businesses take advantage of more tax deductions—but also vetoed another measure that would have allowed some patients to use medical cannabis in health care facilities.
Under a section of current federal law known as 280E, marijuana growers, processors and sellers are unable to deduct expenses from their taxes that businesses in any other sector would be able to write off. Until now, California policy simply mirrored the federal approach.
(Marijuana Moment’s editor provides some content to Forbes via a temporary exclusive publishing license arrangement.)
Photo courtesy of Carlos Gracia.
Former Congressman Who Fought Marijuana Legalization Joins Cannabis Company Board
A former GOP congressman with a long track record of opposing marijuana legalization efforts is now cashing in on the legal cannabis industry.
FSD Pharma, a Canadian company that is a licensed producer of “pharmaceutical grade cannabis” through its subsidiary FV Pharma and researches cannabinoid-based therapies, announced on Friday that former Rep. Steve Buyer (R-IN) joined its board of directors. Missing from the press release is mention of his legislative history that includes repeated actions to oppose federal protections for state-level marijuana reforms.
From 1998 to 2000, Buyer cosponsored two resolutions and one bill aimed at condemning legalization and upholding federal prohibition. His opposition extended to limited medical cannabis reforms, too, voting five times from 2003 to 2007 against an amendment to protect state laws and the patients and providers complying with them from federal prosecution.
One of the anti-marijuana resolutions he signed onto passed the House but did not advance in the Senate. As introduced, it characterized cannabis as “both dangerous and addictive” and stated that “Congress is unequivocally opposed to legalizing marijuana for medicinal use, and urges the defeat of State initiatives that would seek to legalize marijuana for medicinal use.”
The version that passed, which Buyer voted for, expressed concerns that “ambiguous cultural messages about marijuana use are contributing to a growing acceptance of marijuana use among children and teenagers” and noting that federal authorities can enforce prohibition “through seizure and other civil action, as well as through criminal penalties.”
The separate bill he cosponsored sought to declare state laws that allow cannabis use as “null and void.”
“[I]t is the intent of the Congress to supersede any and all laws of the States and units of local government insofar as they may now or hereafter effectively permit or purport to authorize the use, growing, manufacture, distribution, or importation by an individual or group of marijuana or any controlled substance which differs from the provisions of the Controlled Substances Act and the Controlled Substances Import and Export Act or regulations issued pursuant thereto,” it read.
It’s not quite clear what changed for Buyer, but his appointment to the board of a major marijuana company that has benefitted from the successful reform movement he opposed is sure to raise questions.
In response to Marijuana Moment’s query about what accounted for the former congressman’s evolution on the issue, FSD Pharma President Zeeshan Saeed simply replied, “3M options as all other Directors and $40k cash comp.”
Hours later, Saeed clarified that he intended to send that reply to another journalist.
Raza Bokhari, executive co-chairman and CEO of FSD Pharma, said in a subsequent email that he’s known Buyer for years and believes that while he “remains opposed to recreational use of cannabis,” he “has come to recognize the potential of cannabinoid molecule in drug development targeting auto-immune diseases, especially the role of synthetic cannabinoids and other cannabinoids targeting the endocannibinoid system of the human body.”
The former congressman has been on “a very personal journey, with his wife being plagued with an auto-immune disease that has no cure and others in her family also that suffer from auto-immune diseases,” Bokhari said.
He added that Buyer has personally invested a quarter of a million dollars in the company and compared him to former House Speaker John Boehner (R-OH), who also joined the marijuana industry after opposing cannabis reform while serving in Congress.
In a press release announcing the appointment, Buyer said the “opportunity to participate in FSD’s growth at this stage is exciting” and that he’s “attracted by FSD’s medical research to tame and define the unknown by challenging the edges of medical science to provide relief to people suffering from fibromyalgia and other serious illnesses.”
In welcoming Steve Buyer to the FSD Pharma Board of Directors and announcing a share consolidation, the Company has made an immense positive stride forward https://t.co/aAP9cM2kAi
— FSD Pharma (@FsdPharma) October 11, 2019
One industry that the former congressman’s actions did assist while in office and later went on to work for as a lobbyist is Big Tobacco. Buyer raised eyebrows in 2009 when he opposed legislation to regulate the tobacco industry and argued in a House floor speech that a person is just as likely to experience the health consequences of cigarettes if they were to smoke dried lettuce or grass. He insisted that it’s “smoke that kills, not the nicotine.”
Shortly after retiring, Buyer joined tobacco company Reynolds American as a lobbyist and paid consultant.
There have been several reports that noted Buyer’s decision not to run for reelection in 2010 came amid controversy over a foundation he founded. The Frontier Foundation was supposed to provide educational funding for students, but while it raked in tens of thousands from pharmaceutical interests such as Ely Lilly and PhRMA over a three-year period, it reportedly hadn’t distributed a single scholarship.
His retirement came months after USA Today and the Indianapolis Star reported on the foundation’s activities.
But now, Buyer is entering the cannabis space, and the company described his experience in the pharmaceutical industry and Congress as an asset.
“In welcoming Steve Buyer to the FSD Pharma Board of Directors and announcing a share consolidation, the Company has made an immense positive stride forward” FSD Pharma CEO Raza Bokhari said. “Steve’s addition has further strengthened the independence and profile of the FSD Pharma Board of Directors; his broad leadership experience and pharmaceutical industry relationships will help enhance our visibility, especially among U.S. Institutional investors and on U.S. Capitol Hill.”
Buyer also previously served as a special assistant U.S. attorney and an Indiana deputy attorney general.
This story has been updated to include additional comment from FSD Pharma’s CEO.
Photo courtesy of Philip Steffan.
Inventors File Patent Application For Scratch-And-Sniff Marijuana Packages
Scratch-and-sniff marijuana packaging could be coming to a dispensary near you.
An application for a patent on the cannabis container concept was published by the U.S. Patent and Trademark Office on Thursday. In order to comply with state regulations while at the same time ensuring consumers know what they’re buying, the inventors are pitching a secure package that uses non-THC volatiles to produce the scent of the product when a sticker on the exterior is scratched.
The applicants recognized in their filing that there’s an existing patent application for scratch-and-sniff stickers that are meant to identify the flavor of coffee, but argued their idea is distinct because the other application produced the scent of coffee after it’s brewed whereas this sticker would smell like cannabis in its unsmoked form.
“A major hurdle to the purchase of Cannabis is the secure packaging laws of various states,” the application states. “Packaging can often prevent a purchaser from observing certain characteristics of the Cannabis, such as its scent.”
In a summary of the proposal, the applicants said the “general purpose of the present invention is to provide a Cannabis package and method of selection that includes all the advantages of the secure packaging, and overcomes the drawbacks inherent therein.”
Another advantage of the proposed packaging is to help patients identify medicinal properties of different marijuana varieties, or assess quality, without having to open the product, the applicants, Random Vaughn and Jonathan Tanzer of Olympia, Washington, argued. They said that scent is is important in “selecting Cannabis for medical reasons such as seizures, headaches, or insomnia.”
The application lists two iterations of the concept. The main one would involve a sticker that would be infused with the scent of cannabis. Terpenes, which are non-intoxicating compounds in the plant that give cannabis its smell and taste, would be used to produce the scent.
For the other, the scent wouldn’t correspond with the actual small of the marijuana itself, but instead various flavor notes, which are sometimes used in cannabis marketing to describe the product’s qualities similar to what’s often done with wine. The applicants listed a diverse list of potential smells, including freshly cut grass, bread, vanilla, bacon, fish and chips, a Christmas tree, cinnamon, after shave, shampoo, the seaside, furniture polish and a Sunday roast.