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

Source: https://www.keypedia.com/records/warning_letter/dr-thomas-balshiintilight/286bd059-16c6-480c-a8bc-e53921ed044f

> FDA WARNING_LETTER for Dr. Thomas Balshi/Intilight on April 19, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dr. Thomas Balshi/Intilight
- Inspection Date: 2022-04-19
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/dr-thomas-balshiintilight/85e389af-95d4-45d2-8f3c-91d1e4a8b7aa

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c