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.
Oregon Officials Explain How Decriminalized Drugs And Legal Psilocybin Therapy Would Impact The State
Oregon officials finalized a series of analyses this week on separate ballot measures to legalize psilocybin mushrooms for therapeutic use and decriminalize drugs while investing in substance misuse treatment.
The Oregon Criminal Justice Commission determined that the decriminalization initiative would reduce felony and misdemeanor convictions for drug possession by 91 percent, and that reduction would be “substantial for all racial groups, ranging from 82.9% for Asian Oregonians to approximately 94% for Native American and Black Oregonians.”
Overall, the policy change would result in a 95 percent drop in racial disparities for possession arrests, the panel projects.
“The CJC estimates that IP 44 will likely lead to significant reductions in racial/ethnic disparities in both convictions and arrests.”
The conviction estimate was included in the panel’s draft analysis first released last month, but the final version was expanded to include the arrest data as well. The new document also notes that “disparities can exist at different stages of the criminal justice process, including inequities in police stops, jail bookings, bail, pretrial detention, prosecutorial decisions, and others”—a point that activists hoped the panel would include.
That said, the commission noted it “lacks sufficient or appropriate data in each of these areas and therefore cannot provide estimates for these other stages.”
The new report, published on Wednesday, cites research indicating that the resulting “drop in convictions will result in fewer collateral consequences stemming from criminal justice system involvement, which include difficulties in finding employment, loss of access to student loans for education, difficulties in obtaining housing, restrictions on professional licensing, and others.”
The decriminalization proposal was the first ballot initiative in the state’s history to receive a report on the racial justice implications of its provisions under a little-utilized procedure where lawmakers can request such an analysis.
This information will be included in a voter pamphlet as a factual statement from the secretary of state’s office.
“Our current drug laws can ruin lives based on a single mistake, sticking you with a lifelong criminal record that prevents you from getting jobs, housing and more,” Bobby Byrd, an organizer with the More Treatment, A Better Oregon campaign, said in a press release.
Both the psilocybin therapy and drug decriminalization measures also received final explanatory statements and fiscal impact statements this week.
For the therapeutic psilocybin legalization initiative, the Financial Estimate Committee said that it projects the measure will have an impact of $5.4 million from the general fund during the two-year development period. After the program is established, it will cost $3.1 million annually, “which will be covered by the fees and tax funds for the administration and enforcement of the Act.”
The explanatory statement says the measure “directs the Oregon Health Authority to regulate the manufacture, delivery, purchase, and consumption of psilocybin, a psychoactive component found in certain mushrooms, at licensed psilocybin service centers” and that a “person would be allowed to purchase, possess, consume, and experience the effects of psilocybin only at a licensed psilocybin service center during a psilocybin administration session with a licensed psilocybin service facilitator.”
It also describes an initial two-year development period during which officials will research and make recommendations on “the safety and efficacy of using psilocybin to treat mental health conditions,” after which time the new law will allow “a client who is at least 21 years of age to purchase, possess, consume, and experience the effects of psilocybin at a licensed psilocybin service center during a psilocybin administration session with a licensed psilocybin service facilitator.”
Sam Chapman, campaign manager for the psilocybin initiative, told Marijuana Moment that the group is “satisfied with the explanatory statement and believe it captures the thoughtful approach we took that led to psilocybin therapy being on the ballot this November.”
“Specifically, we were happy to see the regulations and safeguards that are built into the measure highlighted in the explanatory statement,” he said. “We also believe that the fiscal committee saw and respected our approach to keep the psilocybin therapy program revenue neutral once up and running.”
The drug possession decriminalization measure is expected to cost $57 million annually, according to state officials, but it will be covered by marijuana tax revenue, which is “estimated at $61.1 million in 2019-21 and $182.4 million in 2021-23” and would therefore be “sufficient to meet this requirement.” Cannabis revenue to cities and counties would be reduced under the measure.
The reform would also save money through reduced drug enforcement. “These savings are estimated at $0.3 million in 2019-21 and $24.5 million in 2021-23,” the analysis says. “This will reduce revenue transferred from the Department of Corrections for local government community corrections by $0.3 million in 2019-21 and $24.5 million in 2021-23. The savings are expected to increase beyond the 2021-23 biennium.”
The initiative “mandates the establishment of at least one addiction recovery center in each existing coordinated care organization service area in the state,” the separate explanatory statement says, and describes how they would be funded with marijuana tax revenue.
“The measure eliminates criminal penalties for possession of specified quantities of controlled substances by adults and juveniles,” it says. “Instead, possession of these specified quantities of controlled substances becomes a non-criminal Class E violation for which the maximum punishment is a $100 fine or completion of a health assessment with an addiction treatment professional.”
Here’s a status update on other 2020 drug policy reform campaigns across the country:
A measure to effectively decriminalize a wide range of psychedelics has officially qualified for the November ballot in Washington, D.C.
Montana activists said last month that county officials have already certified that they collected enough signatures to place two marijuana legalization measure on the state ballot, though the secretary of state’s office has yet to make that official.
In Arizona, the organizers of a legalization effort turned in 420,000 signatures to qualify for the ballot last month.
Organizers in Nebraska last month submitted 182,000 signatures in an attempt to put a medical marijuana measure on November’s ballot.
Idaho activists behind a medical marijuana legalization initiative were hoping to get a second wind after a federal judge said recently that the state must make accommodations for a separate ballot campaign due to signature gathering complications caused by the coronavirus pandemic. But following a recent U.S. Supreme Court ruling against the other group, hopes are dashed.
Prior to the COVID-19 outbreak and stay-at-home mandates, separate measures to legalize marijuana for medical and recreational purposes qualified for South Dakota’s November ballot.
The New Jersey legislature approved putting a cannabis legalization referendum before voters as well.
And in Mississippi, activists gathered enough signatures to qualify a medical cannabis legalization initiative for the ballot—though lawmakers also approved a competing (and from advocates’ standpoint, less desirable) medical marijuana proposal that will appear alongside the campaign-backed initiative.
A campaign to legalize cannabis in Missouri officially gave up its effort for 2020 due to signature collection being virtually impossible in the face of social distancing measures.
North Dakota marijuana legalization activists are shifting focus and will seek qualification for the 2022 ballot.
Washington State activists had planned to pursue a drug decriminalization and treatment measure through the ballot, but citing concerns about the COVID-19 outbreak, they announced last month that they will be targeting the legislature instead.
Read the full state analysis of the Oregon drug decriminalization and psilocybin therapy measures below:
Top White House Official Blasts Marijuana Banking Provisions In Democrats’ Coronavirus Bill
Vice President Mike Pence’s top staffer on Thursday joined the chorus of Republicans criticizing House Democrats for including marijuana banking provisions to the chamber’s latest coronavirus relief bill.
Marc Short, who is Pence’s chief of staff and previously served as director of legislative affairs for the White House, discussed the COVID-19 legislation during an interview with Fox Business, and he described the Democratic proposal as a “liberal wish list” with “all sorts of things totally unrelated to coronavirus.”
“In one instance they have provided guarantees for banking access for marijuana growers,” Short said. “That has absolutely nothing to do with coronavirus.”
He’s referring to language that was inserted from the Secure and Fair Enforcement (SAFE) Banking Act to protect financial institutions that service state-legal cannabis businesses from being penalized by federal regulators.
Numerous Republicans—including Senate Majority Leader Mitch McConnell (R-KY)—have been critical of the provision, arguing that it is not germane to the issue at hand.
Democrats, for their part, have made the case that granting cannabis businesses with access to the banking system would mitigate the spread of the virus by allowing customers to use electronic payments rather than exchange cash. They also say it could provide an infusion of dollars into the financial system that’s especially needed amid the economic downturn caused by the pandemic.
Rep. Tulsi Gabbard (D-HI) told Marijuana Moment in an interview this week that she agrees with her colleagues that the marijuana banking provision is relevant to COVID-19 bill.
“By continuing to disallow anyone associated with these industries that states have deemed legal is further perpetuating serious problems and uncertainty during a time when, frankly, we need as much certainty as we can get,” she said.
While the Senate did not include the banking language as part of their COVID-19 bill, there’s still House-passed standalone legislation that could be acted upon.
The SAFE Banking Act has been sitting in the Senate Banking Committee for months as lawmakers negotiate over the finer points of the proposal.
Last month, a bipartisan coalition of state treasurers sent a letter to congressional leaders, asking that they include marijuana banking protections in the next piece of coronavirus relief legislation.
In May, a bipartisan coalition of 34 state attorneys general similarly wrote to Congress to urge the passage of COVD-19 legislation containing cannabis banking provisions.
USDA Approves Hemp Plan For Maryland And One More Indian Tribe
The U.S. Department of Agriculture (USDA) approved hemp regulatory plans for Maryland and the Lower Sioux Indian Community on Thursday.
With this latest development, the total number of approved plans across states, territories and tribes is 55.
“USDA continues to receive and review hemp production plans from states and Indian tribes,” the agency said in a notice.
While the agency released an interim final rule for a domestic hemp production program last year, industry stakeholders and lawmakers have expressed concerns about certain policies it views as excessively restrictive.
USDA announced in February that it will temporarily lift two provisions that the industry viewed as problematic. Those policies primarily concern testing and disposal requirements. The department declined to revise the THC limit, however, arguing that it’s a statutory matter that can’t be dealt with administratively.
Last week, two senators representing Oregon sent a letter to the head of USDA, expressing concern that testing requirements that were temporarily lifted will be reinstated in the agency’s final rule. They made a series of requests for policy changes.
Agriculture Secretary Sonny Perdue has said on several occasions that the Drug Enforcement Administration influenced certain rules, adding that the narcotics agency wasn’t pleased with the overall legalization of hemp.
State agriculture departments and a hemp industry association also wrote to Congress and USDA this week, seeking an extension of the 2014 Farm Bill pilot program for hemp to give states more time to develop regulatory plans to submit to the agency.
Meanwhile, the Food and Drug Administration (FDA) is still in the process of developing regulations for CBD. It sent an update on its progress to Congress in March, explaining that the agency is actively exploring pathways to allow for the marketing of the cannabis compound as a dietary supplement and is developing enforcement discretion guidance.
An FDA public comment period was reopened indefinitely for individuals to submit feedback on CBD regulations.
Last month, the White House finalized a review of FDA CBD and cannabis research protocols, but it’s unclear when or if the document will be released to the public.
Also last month, FDA submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
Amid the coronavirus pandemic, hemp industry associations pushed for farmers to be able to access to certain COVID-19 relief loans—a request that Congress granted in the most recent round of coronavirus legislation.
However, USDA has previously said that hemp farmers are specifically ineligible for its Coronavirus Food Assistance Program. While the department initially said it would not reevaluate the crop’s eligibility based on new evidence, it removed that language shortly after Marijuana Moment reported on the exclusion.
Two members of Congress representing New York also wrote a letter to Perdue in June, asking that the agency extend access to that program to hemp farmers.
Hemp farmers approved to produce the crop do stand to benefit from other federal loan programs, however. The department recently released guidelines for processing loans for the industry.
Photo courtesy of Pixabay.