CES LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your Hand Sanitizer product is packaged in containers that resemble drinking water bottles customarily purchased by U.S. consumers. OTC hand sanitizer drug products packaged in containers that resemble beverage containers commonly used by adults and children may mislead consumers into believing the products are food and, thereby, increase the risk of accidental ingestion. As such, your OTC hand sanitizer, packaged in 8.45 ounce bottle containers that have a similar shape, size, and function as a plastic bottle ordinarily used to package drinking water, is misbranded under section 502(i)(1) of the FD&C Act, 21 U.S.C. 352(i)(1).