Captains Cloth logo

Unapproved N95 Face Masks Draw FDA Warning Letter

August 13, 2021

A Laguna Niguel, Calif.-based marketer of N95 masks drew a warning letter from the FDA for the unapproved products.

The company, Captain’s Cloth, claimed its KN95 Face Mask made by Lianyungang Manai Protective Equipment in Jiangsu, China can “prevent virus,” and it displayed the FDA’s logo on the face mask packaging in an unauthorized use.

The warning letter is among a recent spate of letters by the agency aimed at stopping the marketing of unauthorized products related to the COVID-19 pandemic.

View today's stories