On January 20, 2015, the U.S. Food and Drug Administration (FDA) added another company, Chaga Mountain, Inc., to its list of warning letters that address drug claims made for products marketed as cosmetics. According to FDA, “a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body is classified as a drug” under the Food, Drug, and Cosmetic Act (FD&C Act). After reviewing Chaga Mountain’s website, FDA found that certain claims made about some of the company’s products caused the products to be regulated as drugs. For example, the company claimed that using its “Chaga Skin Cream and Lip Balm with natural ingredients including natural Essential oils” could repair cells, treat arthritis and prostate problems, prevent side effects of cancer drugs, and more.
Because Chaga Mountain’s products are not generally recognized as safe and effective for their promoted uses, FDA considers the products to be new drugs. The company did not obtain FDA approval before distributing the products in the US, therefore they are considered to be unapproved new drugs. Distributing unapproved new drugs in the U.S. is a violation of the FD&C Act.
FDA’s list of warning letters currently contains 27 companies, including some largely known cosmetic companies such as Avon and Lancôme USA. Most of the warning letters address topical skin care preparations.
Registrar Corp is an FDA compliance firm that assists cosmetic companies with U.S. FDA labeling requirements. FDA considers promotional material and a company’s website as part of a product’s labeling. Registrar Corp’s Label and Ingredient Review Specialists review cosmetic labels, including the promotional labeling, to help ensure they are compliant with FDA regulations and do not contain claims that could cause the cosmetic to be regulated as a drug.
For questions about FDA regulations for cosmetic companies or how Registrar Corp can assist, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day through Registrar Corp’s Live Help service.