Natural Products Insider is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

CBD claims for web.jpg

CBD companies in FDA crosshairs with new round of warning letters

With cases of COVID-19 still on the rise across the globe, U.S. regulatory agencies respond to false product claims by hemp-derived product marketers, many surrounding immunity boosting.

Three CBD companies were specifically targeted by FDA last week when the federal regulatory agency sent warning letters in response to alleged claims made and connected to the COVID-19 global outbreak.

“Can CBD help with Corona Virus? Possibly!” reported a March 9 Facebook post from the Laguna Beach, California-based CBD Online Store.

“Is CBD An Anti-Viral Agent For Coronavirus, Influenza, MERS, and SARS?” wondered a blog post on the website for Indigo Naturals on Feb. 12.

“Don’t Fear the #CoronaVirus FIGHT it with us!” and “Cannabis Indica speeds up Recovery from Coronavirus,” claimed Algoma, Wisconsin-based Native Roots Hemp, in separate posts online from March 20 and March 12, respectively.

FDA warned all three companies with letters stating the agency has observed each is selling CBD products in the U.S. that “are intended to mitigate, prevent, treat, diagnose, or cure COVID-19,” referring to the health claims.

“Based on our review, these products are unapproved new drugs sold in violation of … the Federal Food, Drug, and Cosmetic [FD&C] Act,” FDA wrote, demanding corrective action within 48 hours of the letters’ receipt.

As of today, both the CBD Online Store and Native Roots Hemp had taken corrective action to remove the online content that FDA deemed ran crosswise in terms of claims related to COVID-19, according to FDA’s online resource that tracks warning letters and corrective action.

Indigo Naturals—which the FDA lists as being U.S.-based, as opposed to providing specific headquarters information—had not taken proper corrective action, as of today, according to the FDA tracking database.

A spokesman for Indigo Naturals said that the company received a follow-up request from the FDA after initially making the requested changes within 24 hours.

“Our article is investigating NIH studies on CBD’s effect on immune response to infection (not specific to Covid19 since there isn’t research there).  We asked for specific guidance so [we] can fully comply,” he wrote in an email.

On its website, Indigo Naturals says they are based in California’s Carmel Valley and are owned by Sharon Gray and Andrea Goodacre Jarvis.

While the FDA said this week that Indigo Naturals had not properly corrected its website regarding COVID-19 claims, the company has added a disclaimer on pages that discuss the global virus outbreak.

“First, an important point. The FDA has not approved or tested CBD for coronavirus or Covid19. We're only going to look at pathways affected by CBD on immune response to viral infection in research only,” the pages now say.

FDA cited very specific language used by Indigo Naturals on their website connected to the disease.

“CBD administration at the time of viral infection exerts long-lasting effects, ameliorating motor deficits in the chronic phase of the disease in conjunction with reduced microglial activation and pro-inflammatory cytokine production … CBD will boost two of the T-cells powerful weapons (interferon and IL2) WHEN T cell function is LACKING. When T cell activity is too strong, it will actually suppress that activity … Levels of T cells in the lungs are important for the new coronaviruses,” a post at Indigo Naturals read.

The CBD-focused letters follow FDA’s issuance of a similar warning letter to Las Vegas-based CBD marketer NeuroXPF, a company founded by former NFL lineman Kyle Turley. The company urged potential customers to “Crush Corona!” as part of their sales pitch. Despite officially complying with FDA, Turley continued to press the idea that CBD and cannabis can dent the viral disease.

“The @US_FDA will one day acknowledge the power of cannabis and its ability to prevent & cure COVID19 and every other disease,” Turley tweeted March 31, the day FDA issued the NeuroXPF warning letter.

As of today, FDA has issued 31 warning letters related to COVID-19 claims, according to the agency’s site at FDA.gov, with 10 companies failing to make proper corrective action following issuance of the letters.

Hide comments
account-default-image

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish