FDA Issues Warning Letter to Companies Claiming CBD, Other Products Can Cure COVID-19

Warning letters requested that companies immediately stop selling these unapproved products and said consumers concerned about COVID-19 should talk to their health care provider.

The FDA has issued several warning letters regarding unapproved and misbranded products claiming to prevent or cure coronavirus disease 2019 (COVID-19), including a warning letter to Avazo-Healthcare, LLC, for selling misleading COVID-19 test kits and CBD products claiming to mitigate, prevent, treat, diagnose, or cure the disease.1

According to the letter to Avazo-Healthcare, the company sells 2 COVID-19 antigen test kit products, both of which are advertised as rapid tests. These are considered devices under the Federal Food, Drug, and Cosmetic Act and thus need marketing approval, clearance, and authorization from the FDA. In addition, the letter said the company did not apply for commercial distribution or interstate commerce.1

Avazo-Healthcare’s website included a page stating that Israeli researchers have used antiviral agents found in cannabis terpenes to slow the spread of COVID-19 and added that other investigators have been researching the use of CBD in the pandemic.1 The FDA letter listed these pages and said they misleadingly represent the company’s products as safe and effective for the treatment or prevention of COVID-19.1

Notably, 2 of the test kits advertised on Avazo-Healthcare’s website specify that they have FDA emergency use authorizations, although the FDA letter said that these authorizations limit distribution and use of those products to “authorized laboratories” and not for sale directly to consumers. In its response to the letter, the FDA requests that Avazo-Healthcare specify measures taken to ensure that these products are only sold to authorized laboratories.1

The letter requested that the company immediately stop selling these test kits and unapproved products, adding that consumers concerned about COVID-19 should talk to their health care provider. Avazo-Healthcare was asked to send an email within 48 hours specifying the specific steps taken to correct the violations, including an explanation of steps taken to prevent future issues.1

In addition, the FDA sent recent letters to companies Red Moon Herbs and Sage Woman Herbs, Ltd regarding unapproved COVID-19 products. According to their letter, Red Moon Herbs has been offering products including American Ginseng Elixir, ashwagandha, dandelion, elderberry, Mushroom Elixir, and Wild Cherry Bark Syrup on its website, claiming that the products can mitigate, prevent, treat, diagnose, or cure COVID-19.2

On the website’s COVID-19 resource page, Red Moon Herbs discusses immunomodulating herbs, antiviral herbs, respiratory herbs, and others, saying that these herbs have been researched and included in COVID-19 literature. The company also advertised its products as COVID-19 remedies on social media, according to the FDA letter.2

Similarly, Sage Woman Herbs received a letter regarding its selling of products such as Golden Mushroom Blend, Super Elderberry Syrup, Respiratory Tonic, and others. According to the letter, the company’s website also includes misleading statements, including “No kids have died from the Corona virus [sic].”3

Both companies were told to respond via email within 48 hours, describing specific steps taken to correct the violations.2,3

REFERENCE

  • Warning Letter to Avazo-Healthcare LLC; November 30, 2020. FDA; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/avazo-healthcare-llc-610282-11302020?utm_medium=email&utm_source=govdelivery. Accessed December 2, 2020.
  • Warning Letter to Red Moon Herbs; November 18, 2020. FDA; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/red-moon-herbs-607640-11182020?utm_medium=email&utm_source=govdelivery. Accessed December 2, 2020.
  • Sage Woman Herbs, Ltd. Dba Sage Consulting & Apothecary; November 10, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sage-woman-herbs-ltd-dba-sage-consulting-apothecary-608906-11102020?utm_medium=email&utm_source=govdelivery. Accessed December 2, 2020.