Pharmaceutical

FDA warns skin care company to stop marketing products as drugs

supplements liquid flowers 315x210 FDA warns skin care company to stop marketing products as drugs The Food and Drug Administration (FDA) slapped Rebecca Sue Wachsler and the company she founded, Aegeia Skin Care LLC, with a warning letter over misleading claims made for some of the products marketed on her website www.aegeiaskincare.com. The website claims the company’s facial cleansers, toners, masks, and creams can diagnose, cure, mitigate, treat or prevent disease, which renders them unapproved drugs in the eyes of the FDA, and puts the company in violation of the Federal Food, Drug, and Cosmetic Act.

The products at issue are Aegeia Skin Care’s Purifying Facial Cleanser, Refining Facial Toner, Nourishing Clay Mask, and Silken Body Butter. The company claims that the cleanser can stimulate circulation; combat acne, rosacea and eczema; treat insomnia and anxiety; relieve burns; and protect against infections and cancer, among other claims.

For example, the description on facial cleanser with vanilla essential oil states the product can “protect the body from…infections and even some forms of cancer, such as those of prostrate, colon etc. It also helps assist the body in repairing the damages already done.”

The company claims that the kokum seed butter in its Silken Body Butter “has a remarkable ability to…heal ulcerations and fissures of lips, hands and soles of feet. It helps reduce degeneration of the skin cells.”

“Your products are not generally recognized as safe and effective for the above referenced uses,” the FDA stated in its warning letter. The agency requested that Aegeia Skin Care take prompt action to correct all violations associated with hits products.

“Failure to do so may result in enforcement action without further notice,” the letter stated. “The (Federal Food, Drug and Cosmetic) Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.”

Source: FDA Warning Letter