# FDA WARNING_LETTER - Matte Beauty - April 30, 2024

Source: https://www.keypedia.com/records/warning_letter/matte-beauty/e57a3dd3-53ba-4e67-862d-c3316b5b5fad

> FDA WARNING_LETTER for Matte Beauty on April 30, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Matte Beauty
- Inspection Date: 2024-04-30
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On July 25, 2024, the FDA issued a Warning Letter to Mr. Palmer regarding Matte Beauty's website (https://www.mattebeauty.co/) and social media (https://www.instagram.com/mattebeauty.co/). The FDA reviewed these sites in March and April 2024 and found that Matte Beauty offers various chemical peel drug products, including "TCA 100% Skin Peel," "Lactic Acid 90%," "Salicylic Acid 80%," "Glycolic Acid 70%," and "Modified Jessner Solution Peel 14%."

These products are deemed "unapproved new drugs" under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). The FDA considers them drugs because of claims made on the websites, such as reducing scars, wrinkles, acne, stimulating collagen, treating hyperpigmentation, and controlling various skin conditions. These claims establish the products' intended use as drugs.

The FDA is concerned about public health risks, citing potential skin injuries like burns, wounds, pain, swelling, and scarring, with adverse event reports already received. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" requiring FDA approval, which they

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Company: https://www.keypedia.com/companies/matte-beauty/f407af02-4438-468f-a705-47b596c51ff1

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