WARNING LETTER
Skin Beauty Solutions
MARCS-CMS 683006 —
July 25, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Cassandra Pryor
Recipient Title
Manager
Skin Beauty Solutions
P.O. Box 25527
Saint Paul
,
MN
55125-0527
United States
info@skinbeautysolutions.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
July 25, 2024
RE: 683006
Dear Cassandra Pryor:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https://www.skinbeautysolutions.com/ in April 2024 and has observed that your website offers numerous chemical peel drug products; including, multiple strengths of lactic acid, glycolic acid, combination glycolic and lactic acid, and salicylic acid products
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, including “LACTIC Acid Skin Chemical Peel 90%,” “GLYCOLIC ACID Skin Cosmetic Grade Peel 70%,” “Combination Peel GLYCOLIC 35% LACTIC 45%,” and “SALICYLIC ACID Skin Chemical Peel 30%” (hereinafter referred to as your “chemical peels”) for sale in the United States. 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 (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 website, your firm’s chemical peels are drugs under 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 observed on your website https://www.skinbeautysolutions.com/ that establish the intended use of these products as drugs include, but may not be limited to, the following:
LACTIC Acid Skin Chemical Peel 90%
• “lactic acid skin peel 90%
Clears Acne & Scars
Removes Dead Skin Cells”
• “Chemical peels work by loosening and gently sloughing off the damaged, unattractive skin cells. . .. Lactic Peels can also work on the deeper layers of skin to accelerate the skin’s natural production of collagen and elastin.”
GLYCOLIC ACID Skin Cosmetic Grade Peel 70%
• “glycolic acid skin peel 70%
Clears Acne & Scars
Removes Dead Skin Cells
Prevents Fine lines & Wrinkles”
Combination Peel GLYCOLIC 35% LACTIC 45%
• “combination peel
Glycolic Acid 35%
Lactic Acid 45%
Clears Acne & Scars
Removes Dead Skin Cells
Smoothes [sic] Fine lines & Wrinkles”
SALICYLIC ACID Skin Chemical Peel 30%
• “salicylic acid skin peel 30%
Removes Blackheads
Clears Acne & Scars”
• “SALICYLIC ACID SKIN CHEMICAL PEEL W/ BETA HYDROXY (BHA) BY SKIN BEAUTY SOLUTIONS – IDEAL FOR ACNE, BLACKHEADS, DERMATITIS, WHITEHEADS, CLOGGED PORES.”
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 address any 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 actions within fifteen working days, state the reason for the delay and the time within which you will do so. 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 and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
___________________
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We have observed that your website offers Lactic Acid skin peel 35%, 50%, 70%, 90% strengths, Glycolic Acid skin peel buffered and unbuffered 35%, 50%, 70% strengths, combination Glycolic Acid 35% and Lactic Acid 45% strength, and Salicylic Acid skin chemical peels 10%, 20%, and 30% strengths.
Content current as of:
07/30/2024
Regulated Product(s)
Drugs