FDA WARNING_LETTER - Dr. Thomas Balshi/Intilight - April 19, 2022

The FDA issued a Warning Letter to Dr. Balshi on April 13, 2022, concerning the distribution of INTILIGHT INTIMATE LIGHTENING TREATMENT, a drug product intended to bleach and/or lighten skin. The product is cited as an unapproved new drug and a misbranded drug, violating sections 505(a) and 502(ee) of the FD&C Act, respectively.

The FDA determined INTILIGHT is a drug based on its intended use as a skin bleaching product, evidenced by claims on its label and websites (intilight.com, southflderm.com), such as "Intimate Skin Lightening Treatment" and "lighten and whiten embarrassing darker or discolored areas."

As a skin bleaching drug, INTILIGHT falls under section 505G(a)(4) of the FD&C Act, which deems such products not generally recognized as safe and effective (GRASE) based on a 2006 proposed rule. Consequently, INTILIGHT is considered a new drug requiring an FDA-approved application under section 505 of the FD&C Act for marketing since September 23, 2020. No such approval exists for INTILIGHT.

The introduction of this unapproved new drug into interstate commerce violates section 301(d) of the FD&C Act. Furthermore, the product is misbranded under