RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 3 > FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

Posted 27 March 2020 | By Zachary Brennan 

FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

As there are still no approved treatments for COVID-19, the US Food and Drug Administration (FDA) this week warned Ireland-based Carahealth for offering unapproved herbal products and other products referred to as “Immune Tonic” on its website to mitigate, prevent, treat, diagnose or cure COVID-19.

The warning letter, released publicly on Friday, follows the distribution of warning letters to seven companies for making fraudulent and unsupported claims about products, including essential oils and colloidal silver, to treat COVID-19. FDA created a list of these unapproved products.

In its warning letter for Carahealth, FDA points to dubious claims on the company’s website, such as, “Constituents in herbs exhibit a diverse array of anti-viral, virostatic, immune enhancing and anti-influenza activities that may prevent and treat pandemic influenza.”

The company has 48 hours to respond to FDA via email to describe the steps it’s taking to correct these violations.

“Once you have taken corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action,” the letter says.

FDA also reiterated: “There currently are no vaccines, pills, potions, lotions, lozenges or over-the-counter
products available to treat or cure COVID-19.”

Warning Letter

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.