Repare Skincare

WARNING LETTER Repare Skincare MARCS-CMS 680247 — July 25, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Karen Martin Repare Skincare 16 Spinnaker Drive Mashpee , MA 02649-3654 United States info@repareskincare.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER July 25, 2024 Repare, LLC 177 Fairway Crossing Crossing, Glastonbury, CT 06033 RE: 680247 Dear Karen Martin: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https://repareskincare.com in March 2024 and has observed that your website offers numerous chemical peel drug products; including multiple strengths of Trichloroacetic Acid (TCA) and Glycolic Acid products 1 including “100% TCA Skin Peel” and “GLYCOLIC ACID 70%” (herein referred to as your “TCA chemical peels” and “Glycolic Acid chemical peels”) for sale in the United States. As described below, your TCA chemical peels and Glycolic Acid 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 TCA chemical peels and Glycolic Acid 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 that establish evidence of the intended use of these products as drugs include, but may not be limited to, the following (emphasis original): From the webpage https://repareskincare.com/products/tca-peel: • “Revitalizing TCA Skin Peel: Customize Your Strength from 15% to 100% - Target Wrinkles, Acne, and Imperfections . . . o TCA Skin Peel Kit Uses: Tattoo removal, warts, moles, skin tags, aging, scars” • “ Introducing RePare Skincare’s TCA Skin Peel o Renew aging skin with our DIY at-home skin peel... o Reduce fine lines and wrinkles o Stimulate collagen production o Reveal softer, more youthful skin o Visibly fade freckles, scars, and hyperpigmentation” From the webpage https://repareskincare.com: • “START REBUILDING YOUR COLLAGEN TODAY WITH A TCA PEEL!” • “ TCA & GLYCOLIC PEEL INDICATIONS : . . . o Fine lines, Wrinkles, Crepey Skin o Stimulates Collagen & Elastin o Hyper-pigmentation / Age Spots / Sun Damage o Enlarged Pores, Acne Scars & Stretch Marks o Lightens & Brightens o Actinic Keratosis o Fades Tattoos o Skin Tags” From the webpage https://repareskincare.com/products/glycolic-acid-peel: • “Versatile Glycolic Acid Peel Range 25%-70% - Professional Formula for Age-Defying Skin . . . removes the outer layer of the epidermis and dermis. Professionally formulated to reduce wrinkles, fine lines, crepey skin, acne, large pores, age spots and hyper-pigmentation. It dramatically reverses the visible signs of aging.” Your TCA chemical peels and Glycolic Acid 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 ____________________ 1 We have observed that your website offers TCA Skin Peels in 15%, 20%, 25%, 35%, 50%, and 100% strengths, and Glycolic Acid peel in 25%, 35%, and 70% strengths. Content current as of: 07/30/2024 Regulated Product(s) Drugs