FDA WARNING_LETTER - Genesis Partnership Company SA - January 18, 2022

The FDA issued a Warning Letter to Mr. Elmar Giovanni Cardona Quintana regarding the firm's Bathletix HAND SANITIZER, marketed with Major League Baseball and National Basketball Association team logos. The product, an alcohol-based OTC hand sanitizer, was introduced into U.S. interstate commerce in June 2020 in 8-ounce bottles.

The FDA determined Bathletix HAND SANITIZER is misbranded under section 502(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(i), making its introduction into interstate commerce prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The misbranding violation stems from the product's packaging. The 8-ounce bottles resemble drinking water bottles customarily purchased by U.S. consumers. This packaging is misleading, as it may cause consumers to mistake the hand sanitizer for a beverage, increasing the risk of accidental ingestion, which the FDA has previously warned against.

The letter requires the firm to notify the FDA in writing within 15 working days of receipt, detailing specific steps taken to address the violations, prevent recurrence, and provide supporting documentation. Failure to adequately address the matter may result in legal action, including seizure and injunction.