Allimax Us

Warning LetterOpen

Bobbi Walton Allimax Us 500 W Superior St Unit 2205/#2205 Chicago , IL 60654-8150 United States bwalton@allimax.usIssued Jan 12, 2021Center for Food Safety and Applied Nutrition (CFSAN)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: Allimax Us
Location: Bobbi Walton Allimax Us 500 W Superior St Unit 2205/#2205 Chicago , IL 60654-8150 United States bwalton@allimax.us
FEI Number: N/A
Country: United States
Issue Date: January 12, 2021
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Drugs
Status: Open

Summary

Allimax Us was warned for selling unapproved allicin-based capsules, creams, gels, sprays, and liquids through its website and social media platforms with claims that these products could mitigate, prevent, treat, diagnose, or cure COVID-19. The products violated the Federal Food, Drug, and Cosmetic Act by being marketed as unapproved new drugs (section 505(a)) and misbranded drugs (section 502). The FDA took enforcement action during the declared public health emergency and national emergency related to COVID-19, prioritizing removal of unauthorized products making disease claims from the marketplace.