Christine Esposito, Managing Editor02.11.21
Clarke Pharmaceutical Manufacturing, Inc., Webster, TX, has been sent a warning letter by the FDA following a review of the company’s website in December 2020 and January 2021 in which the agency flagged select products, including a topical skin cream.
According to FDA’s letter, claims made on Clarke Pharmaceutical Manufacturing’s website establish its Natural Progesterone Skin Cream as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act because it is intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
The claims for the skin cream included:
• “Natural Progesterone cream is used in hormone replacement therapy and for treating menopausal symptoms such as hot flashes.”
• “This topical progesterone cream is also used for treating or preventing certain allergies in which hormones play a role; and for treating bloating, breast tenderness, decreased sex drive, depression, fatigue, lumpy (fibrocystic) breasts, headaches, low blood sugar, increased blood clotting, infertility, irritability, memory loss, miscarriages, brittle bones (osteoporosis), bone loss in younger women, symptoms of PMS, thyroid problems, foggy thinking, uterine cancer, uterine fibroids, water retention, weight gain, and vaginal irritation.”
A drug is misbranded under section 502(f)(1) of the Act if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. Prescription drugs, as defined in section 503(b)(1)(A) of the can only be used safely at the direction, and under the supervision, of a licensed practitioner, according to FDA.
The agency said the company’s “Natural Progesterone Skin Cream” product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Natural Progesterone Skin Cream fails to bear adequate directions for their intended use and, therefore, the products are misbranded, and the introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act.
The company was also cited for claims related to additional ingestible products.
According to FDA’s letter, claims made on Clarke Pharmaceutical Manufacturing’s website establish its Natural Progesterone Skin Cream as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act because it is intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
The claims for the skin cream included:
• “Natural Progesterone cream is used in hormone replacement therapy and for treating menopausal symptoms such as hot flashes.”
• “This topical progesterone cream is also used for treating or preventing certain allergies in which hormones play a role; and for treating bloating, breast tenderness, decreased sex drive, depression, fatigue, lumpy (fibrocystic) breasts, headaches, low blood sugar, increased blood clotting, infertility, irritability, memory loss, miscarriages, brittle bones (osteoporosis), bone loss in younger women, symptoms of PMS, thyroid problems, foggy thinking, uterine cancer, uterine fibroids, water retention, weight gain, and vaginal irritation.”
A drug is misbranded under section 502(f)(1) of the Act if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. Prescription drugs, as defined in section 503(b)(1)(A) of the can only be used safely at the direction, and under the supervision, of a licensed practitioner, according to FDA.
The agency said the company’s “Natural Progesterone Skin Cream” product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Natural Progesterone Skin Cream fails to bear adequate directions for their intended use and, therefore, the products are misbranded, and the introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act.
The company was also cited for claims related to additional ingestible products.