On April 27, 2020, the FDA issued a warning letter to Santiste Labs LLC for promoting its transdermal patches containing botanical oils and/or CBD with unsupported claims that they can treat coronavirus (COVID-19).
The company's Defend Patch was promoted with statements on its website such as "Santiste Labs, the science driven leader in transdermal delivery has just announced the release of the DEFEND Patch in response to the global pandemic and acute health crisis of COVID-19. The company . . . created a transdermal patch that can boost your immune system and provide antiviral support all day, using all-natural ingredients. Their patent-pending composition of botanical oils uses TD-CUBED technology to provide precise, sustained release through the skin over 3 days, " and "One of the products that offers possible resistance to the novel corona virus is a transdermal patch developed by Santiste Labs LLC . . . The patches are designed to deliver CBD, or other natural substances known to have antiviral properties . . . "
The FDA has previously stated: "There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19).
The agency instructed the companies to send an email to COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours of receipt of the warning, describing the specific steps they have taken to correct these violations.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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