CES LLC Warning Letter Details

Summary

CES LLC was cited for distributing an alcohol-based hand sanitizer product packaged in 8.45-ounce bottles that resembled beverage containers, creating a misbranding violation under section 502(i) of the FD&C Act. The product's label made drug claims such as "Fights over 99% of most common germs within seconds," establishing it as a drug requiring proper OTC antiseptic labeling and appropriate packaging that would not mislead consumers. The FDA specifically warned that packaging hand sanitizer in containers resembling food and beverage containers posed safety risks to consumers, particularly regarding accidental ingestion.