WARNING LETTER
Matte Beauty
MARCS-CMS 679463 —
July 25, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Terry Palmer
Recipient Title
CEO
Matte Beauty
4495 Furking Lane
Destin
,
FL
32541
United States
info@mattebeauty.co
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 25, 2024
RE: 679463
Dear Mr. Palmer:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.mattebeauty.co/ in March and April 2024 and has observed that your website offers numerous chemical peel drug products
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, including “TCA 100% Skin Peel,” “Lactic Acid 90%,” “Salicylic Acid 80%,” “Glycolic Acid 70%,” and “Modified Jessner Solution Peel 14%,” (hereinafter referred to as your “chemical peels”) for sale in the United States. We have also reviewed your social media website at https://www.instagram.com/mattebeauty.co, which directs consumers to your above-mentioned website to purchase your products. As described below, your chemical peels are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a) and 331(d).
The Agency is concerned about potent chemical peel products that are available to be purchased and used by consumers. Such products pose a public health risk because they can cause skin injuries such as burns on the area of application, wounds, pain, swelling, and scarring. FDA has received adverse event reports of injuries involving use of such products, some of which required emergency room care, specialty care from a dermatologist, and/or surgical intervention.
Unapproved New Drugs
Based on a review of your websites, your firm’s chemical peels are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples of claims
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observed on your websites for your chemical peels that establish the intended use of these products as drugs include, but may not be limited to, the following:
From the product pages for your “Trichloroacetic Acid (TCA) Skin Peels” on your website
https://www.mattebeauty.co/tca:
• “KEY BENEFITS AND INGREDIENTS . . .
o [R]educe scars, wrinkles, fine lines, acne & reverse the visible signs of aging.
o Stimulates development of new collagen and elastin fibroblasts
o Reduces sebaceous follicle blockage, unclogs pores, and kills bacteria responsible for acne . . .
o
TCA (Trichloroacetic Acid)
- a powerful exfoliating agent works by removing the outer damaged layers of the skin in the epidermal and dermal regions.”
From the product pages for your “Lactic Acid Skin Peels” on your website https://www.mattebeauty.co/lactic-acid:
• “KEY BENEFITS AND INGREDIENTS
o [E]ffectively lighten pigmentation . . .
o Promotes stimulation of collagen”
• “
LACTIC ACID
- is specifically used to treat hyperpigmentation, age spots, and other factors that contribute to a dull and uneven complexion.”
From the product pages for your “Salicylic Acid Skin Peels” on your website
https://www.mattebeauty.co/salicylic-acid:
• “KEY BENEFITS AND INGREDIENTS . . .
o Fights acne
o Fades Acne Scars & Blemishes
o Opens Clogged Pores
o Controls all types of acne”
• “TREAT MULTIPLE SKIN CONDITIONS! Salicylic Acid Peel will reduce acne inflammation and scars, sun damage, blemishes, blackheads, whiteheads, acne, psoriasis”
From the product pages for your “Glycolic Acid Skin Peels” on your website https://www.mattebeauty.co/shop:
• “KEY BENEFITS AND INGREDIENTS
o Stimulates collagen production
o Increasing cell regeneration”
• “Encourages increased cell turnover”
• “Reduces active acne and acne marks”
• “Professional Strength for Wrinkles, Fine Lines and Sun Damage. 70% . . . is recommended for the neck, for sun damage, stretch marks, acne, scars, hyper-pigmentation, ingrown hairs.”
From the product pages for your “Jessner Skin Peels” on your website https://www.mattebeauty.co/jessner-peel:
• “KEY BENEFITS AND INGREDIENTS
o Reduces hyperpigmentation”
• “[L]ighten areas of skin discoloration”
• “
SALICYLIC ACID 14%
- salicylic acid peels . . . loosen blackheads . . . and even discoloration”
• “
TCA 14%
- . . . Reduction of acne, clogged pores, scars, wrinkles, and fine lines. Increase in collagen and elastin production.”
• “
LACTIC ACID 14%
- treats hyperpigmentation, age spots”
From your Instagram social media website https://www.instagram.com/mattebeauty.co:
• August 29, 2023 posting:
o “Why facial peel? . . . Chemical Peels also help skin disorders like acne and rosacea . . . #chemicalpeel”
• June 30, 2023 posting:
o “A chemical peel is a skin-resurfacing procedure . . . A light (superficial) chemical peel removes the outer layer of skin (epidermis). It’s used to treat fine wrinkles, acne, uneven skin tone and dryness . . . A medium chemical peel removes skin cells from the epidermis and from portions of the upper part of your middle layer of skin (dermis). It’s used to treat wrinkles, acne scars and uneven skin tone.”
• March 20, 2022 posting:
o “[A]cids lift away dead cells . . . As the topmost layer is shed, signals are sent to the living cells below to multiply and move up, to increase collagen production, to make more hyaluronic acid”
Your chemical peels are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
______________________
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We observed that your website offers Trichloroacetic Acid (TCA) Skin Peels in 10%, 12.5%, 15%, 20%, 25%, 30%, 50%, and 100% strengths; Lactic Acid Skin Peels in 30%, 50%, and 90% strengths; Salicylic Acid Skin Peels in 5%, 20%, 30%, 50%, and 80% strengths; Glycolic Acid Skin Peels in 30%, 35%, 50%, and 70% strengths; and three variations of Jessner Skin Peels. The three Jessner chemical peel products offered on your website at https://www.mattebeauty.co/jessner-peel consist of concentrations of multiple acids. The “Modified Jessner 14%” consists of 14% salicylic, TCA, and lactic acids; “Jessner Solution w/Resorcinol 14%” consists of 14% resorcinol and salicylic and lactic acids; and “Modified Jessner Solution Peel 14%” consists of 14% salicylic, TCA, and lactic acids. Additional products with various acid concentrations are available for purchase on your website.
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Claims were found on the product pages of variations of TCA, Lactic Acid, Salicylic Acid, Glycolic Acid, and Jessner skin peels offered on your website.
Content current as of:
07/30/2024
Regulated Product(s)
Drugs