FDA Warns Oral Care Co. for COVID-19 Claims

The US Food & Drug Administration has sent a letter to Pro Breath MD, LLC, dba Dentist Select and OraCare, Bridgeport, WV, for selling products that mitigate, prevent, treat or cure COVID-19.  The letter came after FDA and the Federal Trade Commission (FTC) reviewed www.oracareproducts.com and www.dentistselect.net on October 2, 2020, and November 10, 2020, respectively.  
 
The FDA said it observed that the firm offers “OraCare Health Rinse” and “OraCare Operatory Pre-Rinsing Set” products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19, and based on its review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. Furthermore, these products are misbranded drugs under section 502 of the FD&C Act.
 
The agencies have taken issue with the following on the company’s webpage titled “Human Coronavirus Testing – ORACARE”:  
• “New Study: “OraCare Rinse found greater than 99.99% effective against human coronavirus with no toxic effects on tissue.”
• “Activated chloride dioxide (ClO2) has the ability not only to kill viruses, but new study confirms it also kills human coronavirus.” 
• “Study Highlight #1: OraCare kills 99.99% of human coronavirus in as little as 1 minute.”
• “Effectiveness against viruses: OraCare eliminated greater than 99.99% of the Human Covid 229E virus at 1, 5, 15 and 60 minutes exposure times with 99.99% effectiveness at each exposure.” 
• “OraCare PreRinse: Not only can OraCare help improve your patient’s oral health it can protect you as a dental professional. This study confirms OraCare’s ability to kill human coronavirus as good if not better than all other rinses and with no cell toxicity even with a 60 minute exposure time.” 

It also found issues with the company’s webpage titled “Pre-Rinsing – ORACARE” which provided the following statement: “But as we have learned through the COVID-19 pandemic, viruses need to be more of a focal point.  The pandemic also raised awareness that we as dental professionals are at a higher risk for exposure to viruses.  OraCare is the BEST product for pre-rinsing because OraCare’s active ingredient chlorine dioxide (ClO2) kills bacteria, viruses, fungi, and breaks up biofilm through the process of oxidation . . .  It is safe and effective.  Dental professionals choose activated chlorine dioxide as their pre-rinse, as many are incorporating it into their daily routine of personal protective measures . . .  Not only can OraCare help improve oral health it can protect you as a dental professional.” 
 
The full letter can be found here.