FDA WARNING_LETTER - Allimax Us - December 15, 2020

On January 12, 2021, the FDA and FTC issued a Warning Letter to Allimax.us regarding unapproved and misbranded products related to COVID-19. The agencies reviewed Allimax.us's website and social media on November 17 and December 15, 2020, observing the sale of allicin capsules, creams, gels, sprays, and liquid products marketed to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). The letter cites specific claims from Allimax.us's website and social media, such as "Allicin and the Corona Virus," "Using Allimax liquid in your eyes or Alliderm gel and Allimax Rescue Spray in your mouth can also keep sickness at bay," and images depicting Allimax as a shield against COVID-19.

Allimax.us must immediately cease selling these unapproved products and respond within 48 hours via email to COVID-19-Task-Force-CFSAN@fda.hhs.gov and COVID-19-Task-Force-CDER@fda.hhs.gov, detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and