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.