Varigard, LLC
FDA issued a warning letter to Varigard, LLC (Foley, AL) on December 29, 2021, citing its alcohol-based hand sanitizer products as unapproved new drugs marketed in violation of the FD&C Act. The company's product labels and websites made claims that the products kill and prevent COVID-19 (including specific variants), provide two hours of protection against deadly pathogens, and are flame retardant — claims that go beyond permitted OTC monograph conditions and are false or misleading. FDA also found misbranding violations including unauthorized use of the FDA logo suggesting agency approval. The letter demanded corrective action within 48 hours and warned that failure to comply could result in seizure and injunction.
Flagged claims (11)
Independent labs confirm Varigard hand sanitizer traps and kills SARS-CoV-2 (actual COVID-19), Staph, MRSA, E. coli, Pneumonia and other common, deadly viruses for two hours after each application.
Synergy Laboratories verified that Varigard is now effective against the B117 UK strain of SARS-CoV-2 (COVID-19) after it was identified in Mobile, Alabama. This is another major step in the world's fight against COVID-19…
We have now successfully tested against the original SARS-CoV-2 strain and also the B117 Uk Strain with incredible results. We are also the only hand sanitizer that has put our products through human trials to endure [sic] it's the safest product on the market.
Instead of relying on alcohol alone, our products use patented organic polymers designed to prevent germs from spreading through contact long after application.
Varigard…2 Hours of protection per use…Proven to kill actual COVID-19 (SARS-CoV-2)
LAB TESTS PROVE VARIGARD TRAPS AND KILLS COVID-19
Varigard's proprietary ingredients make it flame retardant and combustion resistant even under significant temperatures. Even if you were able to ignite our Varigard hand sanitizer, it would self-extinguish within a few seconds.
Varigard™ Formulas Provide the Longest Lasting Personal and Surface Protection Against Deadly Pathogens including COVID-19.
Varigard traps and kills SARS-CoV-2 (COVID-19) and a host of other dangerous pathogens for more than 2 hours after application….
Varigard Technologies Proven to Prevent the Tactile Spread of SARS-CoV-2, B.1.617.2 – DELTA Variant
FDA" logo is displayed on the products' labels, above the term, "REGISTERED," which creates the impression that the drugs are approved or legally marketable
Required actions (3)
Within 48 hours, please send an email to [email protected] describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
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 or other conditions.
Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most functional medicine sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker