The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have taken enforcement action against a former NFL player’s CBD company over unsubstantiated claims that its products can be used to cure or prevent coronavirus.
The agencies sent a warning letter demanding that Kyle Turley’s NeuroXPF business cease making the claims, remove them from any marketing material and advise FDA on steps taken to correct the issue within 48 hours. Failure to comply can result in “legal action, including, without limitation, seizure and injunction,” the letter states.
The enforcement action came one day after Turley told Marijuana Moment in an interview that he would actually welcome federal moves against his company and use it as a public relations opportunity to expose the government for suppressing the “truth” about the medical potential of cannabis. He shared a screenshot of the letter on Tuesday and said “WE DID IT!!!!”
WE DID IT!!!! 🙌🇺🇸 pic.twitter.com/wiRaK9Ojcu
— KT (@KyleTurley) March 31, 2020
In the letter, officials from FDA and FTC said the agencies have “determined that your website offers cannabidiol (CBD) products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” Because the products are not authorized for such use, this marketing is in violation of both FDA and FTC regulations.
“FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” the agencies wrote. “As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.”
The officials provided examples of recent advertising where NeuroXPF CBD products were presented as immune boosters that consumers could use to “take advantage of its potential to help prepare your body to fight a coronavirus infection.”
“Crush Corona! Your best defense against the COVID-19 blitz starts with a strong immune system,” one ad states.
The gist of Turley’s logic is that because cannabinoids like CBD interact with the endocannabinoid system, which plays a role in regulating the immune system, taking CBD products can prevent and treat COVID-19. He’s received ample pushback from legalization advocates and prohibitionists alike, who say peddling these claims without clinical evidence to back them up is irresponsible and dangerous to patients.
He said in a message to Marijuana Moment on Wednesday that people in the cannabis industry who’ve criticized his CBD claims are “imposters” who “continue to showcase how the industry itself is driving its own prohibition.”
“This was a clear targeted attack on an American citizen for exercising free speech, this had nothing to do with my CBD company and the FDA is clearly not just doing their job,” he said. “I will continue to flush this corrupt system and those complicit in my efforts to free this plant. When Schedule 1 is dropped from cannabis the FDA will swiftly acknowledge the multitude of cures within God’s healing plant, from the multitude of studies these cowards wish to oppress.”
FDA made clear that, as of now, the coronavirus is not clinically proven to be among those conditions that cannabis can cure.
“You should take immediate action to correct the violations cited in this letter,” the agency said. “The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA’s implementing regulations.”
“We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to [email protected] describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.”
For the time being, NeuroXPF will be listed on an FDA page that lists companies that have received warning letters for the unsanctioned sale of COVID-related products. The page will be updated to reflect compliance after the business takes corrective action.
The government letter goes on to say that it is unlawful “to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”
“For COVID-19, no such study is currently known to exist for the products identified above,” it states. “Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims.”
In addition to potential enforcement action from FDA, Turley could also face “legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers” from FTC if his company fails to comply with the letter.
Turley shared with Marijuana Moment a copy of a letter the company is sending to FDA in response to the warning. It states that NeuroXPF has removed written and visual marketing as part of their “Crush Corona” campaign from the site and social media accounts.
“We fully respect the efforts of the FDA and FTC to protect consumers against companies making fraudulent claims that their products are intended to or in any way ‘mitigate, prevent, treat, diagnose or cure COVID-19 in people,'” it continues. “We also know that the FDA has not approved a vaccine or any other product to mitigate, prevent, treat, diagnose or cure this deadly virus.”
However, they disputed the idea that the company has misbranded their products or claimed that they can cure the coronavirus.
The letter goes on to say “we realize that there may be significant differences between what we believe and understand, and the FDA’s official guidelines for educating consumers about CBD and marketing CBD” and “Neuro XPF always strives to abide by all government guidelines and regulations throughout the conduct of our business.”
“Therefore, in order to prevent any future violations of FDA and FTC guidelines and regulations, we ask you provide definitive clarification of exactly what we can and cannot say with respect to educating consumers about CBD, as well as marketing and promoting the potential benefits of CBD,” it says. “We believe CBD can strengthen the immune system. And, during this unprecedented crisis, we believe Americans need all the help they can get.”
Nevertheless, based on a tweet he sent out after receiving the notice, it does not appear that he’s tempered his personal claims about the therapeutic potential of cannabis.
— KT (@KyleTurley) April 1, 2020
“The [FDA] will one day acknowledge the power of cannabis and its ability to prevent & cure COVID19 and every other disease,” he claimed.
This story has been updated to include NeuroXPF’s response to FDA’s warning.
Photo courtesy of Chris Wallis // Side Pocket Images.
Congressman Files New Marijuana Banking Reform Amendment To Large-Scale House Bill
The House sponsor of a bill to protect banks that work with state-legal marijuana businesses announced on Friday that he is seeking to attach an amendment containing the reform to a broader bill dealing with research and innovation in the tech and manufacturing sectors.
Rep. Ed Perlmutter (D-CO), sponsor of the Secure and Fair Enforcement (SAFE) Banking Act, has expressed interest in finding another vehicle to pursue his proposal after it was stripped from a separate defense bill late last year. The congressman’s legislation has cleared the House in five forms at this point, only to stall in the Senate.
His latest attempt to get the reform enacted is by filing an amendment with the SAFE Banking language to the America COMPETES Act, which does not deal specifically with cannabis issues as drafted but was introduced in the House this week.
“Cannabis-related businesses—big and small—and their employees are in desperate need of access to the banking system and access to capital in order to operate in an efficient, safe manner and compete in the growing global cannabis marketplace,” Perlmutter, who is retiring from Congress after this session and committed to passing his bill first, said in a press release.
I have filed #SAFEBanking as an amendment to #AmericaCOMPETES b/c cannabis-related businesses – big and small – are in desperate need of access to capital & the banking system in order to operate in an efficient, safe manner & compete in the growing global cannabis marketplace.
— Rep. Ed Perlmutter (@RepPerlmutter) January 28, 2022
“The SAFE Banking Act is the best opportunity to enact some type of federal cannabis reform this year and will serve as the first of many steps to help ensure cannabis businesses are treated the same as any other legal, legitimate business,” he said. “I will continue to pursue every possible avenue to get SAFE Banking over the finish line and signed into law.”
It remains to be seen whether the America COMPETES Act will serve as a more effective vehicle for the cannabis banking bill than the National Defense Authorization Act (NDAA), where the language was successfully attached on the House side but later removed amid bicameral negotiations. Perlmutter said at the time that Senate leadership, which is working on comprehensive legalization legislation, was to blame for the decision to remove his amendment from the proposal.
The new SAFE Banking Act amendment will still need to be made in order by the House Rules Committee in order to be formally be considered on the House floor when the body takes up the research and innovation package. The deadline to file amendments was Friday, and the panel is set to take them up starting on Tuesday.
Even some Republicans are scratching their heads about how Democrats have so far failed to pass the modest banking reform with majorities in both chambers and control of the White House. For example, Rep. Rand Paul (R-KY) criticized his Democratic colleagues over the issue last month.
In the interim, federal financial regulator Rodney Hood—a board member and former chairman of the federal National Credit Union Administration (NCUA)—recently said that marijuana legalization is not a question of “if” but “when,” and he’s again offering advice on how to navigate the federal-state conflict that has left many banks reluctant to work with cannabis businesses.
Ohio Lawmakers Will Be Forced To Consider Marijuana Legalization As State Validates Activist Signatures
Ohio activists have collected enough signatures to force the legislature to take up the issue of marijuana legalization, the secretary of state’s office confirmed on Friday.
This comes about two weeks after the Coalition to Regulate Marijuana Like Alcohol (CTRMLA) submitted a final round of signatures for the measure. The petitions’ formal validation triggers the legislative review of legalization, but it does not require lawmakers to enact the reform.
The legislature now has four months to consider the campaign’s cannabis reform proposal. Lawmakers can adopt the measure, reject it or pass an amended version. If they do not pass the measure, organizers can then collect an additional 132,887 valid signatures from registered voters to place the issue on the ballot in November.
CTRMLA previously submitted petitions for the initiative but the state said they were short some 13,000 signatures, requiring activists to go back and make up the difference.
“We are ready and eager to work with Ohio legislators over the next four months to legalize the adult use of marijuana in Ohio,” CTRMLA spokesman Tom Haren said in a press release. “We are also fully prepared to collect additional signatures and take this issue directly to voters on November 8, 2022, if legislators fail to act.”
The measure that lawmakers will be required to consider would legalize possession of up to 2.5 ounces of cannabis for adults 21 and older, and they could also have up to 15 grams of marijuana concentrates. Individuals could grow up to six plants for personal use, with a maximum 12 plants per household.
A 10 percent sales tax would be imposed on cannabis sales, with revenue being divided up to support social equity and jobs programs (36 percent), localities that allow adult-use marijuana enterprises to operate in their area (36 percent), education and substance misuse programs (25 percent) and administrative costs of implementing the system (three percent).
A Division of Cannabis Control would be established under the state Department of Commerce. It would have authority to “license, regulate, investigate, and penalize adult use cannabis operators, adult use testing laboratories, and individuals required to be licensed.”
The measure gives current medical cannabis businesses a head start in the recreational market. Regulators would need to begin issuing adult-use licenses to qualified applicants who operate existing medical operations within nine months of enactment.
The division would also be required to issue 40 recreational cultivator licenses and 50 adult-use retailer licenses “with a preference to applications who are participants under the cannabis social equity and jobs program.” And it would authorize regulators to issue additional licenses for the recreational market two years after the first operator is approved.
Individual municipalities would be able to opt out of allowing new recreational cannabis companies from opening in their area, but they could not block existing medical marijuana firms even if they want to add co-located adult-use operations. Employers could also maintain policies prohibiting workers from consuming cannabis for adult use.
Further, regulators would be required to “enter into an agreement with the Department of Mental Health and Addiction Services” to provide “cannabis addiction services,” which would involve “education and treatment for individuals with addiction issues related to cannabis or other controlled substances including opioids.”
With respect to social equity, some advocate are concerned about the lack of specific language on automatic expungements to clear the records of people with convictions for offenses that would be made legal under the legislation. That said, it does include a provision requiring regulators to “study and fund” criminal justice reform initiatives including expungements.
Ohio voters rejected a 2015 legalization initiative that faced criticism from many reform advocates because of an oligopolistic model that would’ve granted exclusive control over cannabis production to the very funders who paid to put the measure on the ballot.
Activists suspended a campaign to place another measure on the 2020 ballot due to the coronavirus pandemic.
Aside from the new voter initiative, state lawmakers from both parties are separately working to advance marijuana reform.
A legalization bill that was the first of its kind to be introduced in the Ohio legislature last year would legalize the possession, sale and cultivation of cannabis by adults. It’s being championed by Reps. Casey Weinstein (D) and Terrence Upchurch (D).
A pair of Ohio Republican lawmakers similarly filed a bill to legalize marijuana in the state in December. Reps. Jamie Callender (R) and Ron Ferguson (R) first announced their plan to push the legislative reform proposal in October and circulated a co-sponsorship memo to build support for the measure.
There are also additional local reform efforts underway in Ohio for 2022.
After voters in seven cities approved ballot measures to decriminalize marijuana possession during last November’s election—which builds on a slew of previous local reforms in the state—campaigns are now looking to enact decriminalization in Marietta, Rushville, Rutland, Shawnee, McArthur and Laurelville.
Ohio marijuana activists already successfully proved that they turned in enough valid signatures to put a local decriminalization initiative before Kent voters after having missed the 2021 ballot due to a verification error on the part of county officials. That measure is now expected to go before voters this November.
Top Federal Drug Official Says Marijuana Use ‘Stable’ Among Youth At Prohibitionist-Hosted Panel Sponsored By D.A.R.E.
A top federal drug official participated in a panel hosted by a prohibitionist group and sponsored by D.A.R.E.—and she again reiterated that data shows youth marijuana use has remained stable “despite the legalization in many states.”
While National Institute on Drug Abuse (NIDA) Director Nora Volkow expressed concerns about certain cannabis trends related to potency, commercialization and use by pregnant women, she affirmed that surveys funded by her own federal agency have demonstrated that adolescent marijuana use is “stable,” despite repeated arguments from prohibitionists that legalization would lead more young people to experiment with cannabis.
The event was hosted by Smart Approaches to Marijuana (SAM), an anti-legalization group. SAM President Kevin Sabet and the organization’s co-founder former Rep. Patrick Kennedy (D-RI) led the discussion.
“The higher the content of THC, the greater the likelihood that you will become addicted to the drug… The content of THC has gone up at least 4-fold.”
– Dr. Nora Volkow, M.D., Director of the National Institute on Drug Abuse (NIDA)
— SAM (@learnaboutsam) January 28, 2022
Sabet said that data on youth use has showed varying results in states that have legalized cannabis and asked Volkow to weigh in on the issue. She replied that federal data “have not been able to see large differences in terms of prevalence” of cannabis consumption among young people in legal and non-legal states.
The official made similar comments in an interview with Marijuana Moment late last year.
That said, Volkow said that they have seen some differences when it comes to consumption rates among adolescents for edible cannabis products.
“But the effects are not large, and one of the things that also certainly surprised me [is] the rate overall, the prevalence rates of marijuana use among teenagers, have been stable despite the legalization in many states,” she said, adding that there are some concerns about increased frequency of use and limitations in data collection with respect to dosages being taken.
Volkow also commented on a recent federally funded survey that found illicit drug use by young people has taken a significant plunge in the last year, though she largely attributed that to the reduced social interaction resulting from COVID-19 policies across the country.
“Interestingly what we’ve observed during the COVID pandemic is, across schools in the United States, the prevalence of drug use has gone down,” she said, “which likely very much reflects the fact that kids don’t have the opportunity to interact with others, and drug taking at that stage is a peer pressure behavior.”
The official also briefly addressed the fact that she feels criminalizing people over drugs in the first place is the wrong policy approach—a point she’s made repeatedly in interviews and blog posts.
She said that “criminalization has created a system for that allows a structural racism to be implemented, you can control people, and that’s a horrible policy. This criminalization actually opens up our eyes that well, yes, we need to change that.”
However, she said that “liberalizing and making the drugs widely available, with no counter messaging,” is not the alternative she would recommend.
“We need to provide them [addicts] with treatment, so just to say ok we are going to liberalize everything… and not support treatment for those people under those conditions, I actually think it is quite irresponsible.”
– Dr. Nora Volkow, M.D., Director of NIDA
— SAM (@learnaboutsam) January 28, 2022
While the SAM-hosted event did not touch specifically on psychedelics policy, Volkow has also recently discussed that issues, especially as data has shown an increase in use of the substances among adults.
She said people are going to keep using substances such as psilocybin—especially as the reform movement expands and there’s increased attention being drawn to the potential therapeutic benefits—and so researchers and regulators will need to keep up.
Volkow also mentioned that NIDA is “pleased” the Drug Enforcement Administration recently announced plans to significantly increase the quota of certain psychedelic drugs to be produced for use in research.
Photo courtesy of Philip Steffan.