Allure Imports – FDA Warning Letter, Mar 31, 2021
On April 7, 2021, the FDA and FTC issued a Warning Letter to the recipient regarding unapproved and misbranded products related to COVID-19. The FDA and FTC reviewed websites www.facedoctor.ca, www.vitalityc60.com, and www.allureimports.com, and associated social media, on February 25, 2021, and March 31, 2021.
The FDA observed that "Silver Soul Immune Support," "Silver Soul Body Spray," and "Vitality C60" were offered for sale in the U.S. and intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. These products are unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502. "Vitality C60" is also intended for COVID-19 mitigation/treatment/prevention in animals, making it an unsafe and adulterated drug under sections 512(a) and 501(a)(5) of the FD&C Act, as it lacks required approvals.
The letter cites specific claims from the websites and social media, such as "Colloidal Silver for Coronavirus" and claims that C60 "boosts dogs' immune systems" and helps "fight off this novel pathogen."
The
ID · 711d9dfb-0b0f-4e19-86ea-41914a1c552a
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.