Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your 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).
Passage 2your 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.
Passage 3“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.”
Passage 4“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.”
Passage 5“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”
Passage 6“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.”
Passage 7“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”
Passage 8“Why facial peel? . . . Chemical Peels also help skin disorders like acne and rosacea . . . #chemicalpeel”
Passage 9“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.”
Passage 10“[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”
Passage 11Your 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).