Recalls & Warnings
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Posted July 10, 2020
Seller of Hand Sanitizer "Alternative" Warned for Coronavirus Claims
On July 7, 2020, the FDA issued a warning letter to Ionogen, LLC for selling products with unsupported claims that they can treat coronavirus (COVID-19).
The agency emphasized that there are currently no approved treatments for the virus and 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 product Ionopure Skin & Hands was promoted as a "safe and effective alternative to traditional hand sanitizers" with statements such as "The World Health Organization has stated that any chlorine-based solution of at least 500 ppm FAC will kill COVID-19. Ionopure Skin & Hands... meet[s] this standard."
The FDA 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.
See Related Warnings:
Sellers of Essential Oils, Hand Sanitizers and More Warned for Coronavirus Claims
Seller of "COVID Supplement Protection Pack" Warned for Coronavirus Claims
Seller of Chinese Herbal Medicines Warned for Coronavirus Claims
"Anti-Viral" Supplement Recalled for Unsupported Coronavirus Claims
North Isle Wellness Center Warned for Coronavirus Claims
Seller of CBD Tinctures and "Immune Boost Packs" Warned for Coronavirus Claims
KBMO Diagnostics Warned for Unapproved COVID-19 Test
For more information, use the link below.
The agency emphasized that there are currently no approved treatments for the virus and 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 product Ionopure Skin & Hands was promoted as a "safe and effective alternative to traditional hand sanitizers" with statements such as "The World Health Organization has stated that any chlorine-based solution of at least 500 ppm FAC will kill COVID-19. Ionopure Skin & Hands... meet[s] this standard."
The FDA 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.
See Related Warnings:
Sellers of Essential Oils, Hand Sanitizers and More Warned for Coronavirus Claims
Seller of "COVID Supplement Protection Pack" Warned for Coronavirus Claims
Seller of Chinese Herbal Medicines Warned for Coronavirus Claims
"Anti-Viral" Supplement Recalled for Unsupported Coronavirus Claims
North Isle Wellness Center Warned for Coronavirus Claims
Seller of CBD Tinctures and "Immune Boost Packs" Warned for Coronavirus Claims
KBMO Diagnostics Warned for Unapproved COVID-19 Test
For more information, use the link below.