FDA WARNING_LETTER - Ultimark Products - April 19, 2022

The FDA issued a Warning Letter to Mr. Zuckerberg on April 13, 2022, concerning the distribution of PORCELANA DAY SKIN LIGHTENING CREAM. The product is cited as an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA determined PORCELANA DAY SKIN LIGHTENING CREAM is a drug intended for skin bleaching, based on claims on its label and website (Porcelana.com), such as "SKIN LIGHTENING CREAM," "FADES DARK SPOTS," and containing "Hydroquinone U.S.P. 2%." As a skin bleaching drug, it falls under section 505G(a)(4) of the FD&C Act, which deems such products not generally recognized as safe and effective (GRASE) per a 2006 proposed rule.

Consequently, the product is considered a new drug requiring an approved new drug application under section 505 of the FD&C Act, effective September 23, 2020. No such application exists for PORCELANA DAY SKIN LIGHTENING CREAM, violating section 505(a) and 301(d) of the FD&C Act. Furthermore, it is misbranded under section 502(ee) and 301(a) of the FD&C Act because it lacks an approved application and does