The U.S. Food and Drug Administration (FDA) has issued three warning letters to companies marketing topical skin care products. According to these letters, the three companies make claims on their websites that indicate they sell products which would be classified as “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA). FDA referenced statements from the websites that establish these products are drugs according to the FDCA “because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body.” The companies that received these letters are Annmarie Gianni Skin Care, Ageless Aesthetics, Inc. and Be Green Bath and Body.
In the July 15, 2016, letter to Annmarie Gianni Skin Care, FDA provided examples of claims from three products sold on the skin-care site including Repair Serum, Anti-Aging Eye Cream and Anti-Aging Serum. Noted claims from the Repair Serum included, “Using vegan stem cells…a new way for your skin to build collagen, repair itself and prevent aging” and “Ideal for treating: Sun spots, age spots, acne scarring, Hyperpigmentation.”
The July 18, 2016, letter to Ageless Aesthetics, Inc. also identified three products with claims indicating that the products are intended for use as a drug, including Growth Factor, White Balance Click Intense Brightening Serum, and White Balance Click Oxy-R Ultra Brightening Serum.
FDA noted claims on each of the products. For Growth Factor, the agency identified two statements including, “Stimulates production of collagen and elastin (fibroblasts)” and “sh-Oligopeptide-1 (EGF): obtained by biotechnology, triple-filtered and liposome stabilized. Activates the skin receptors stimulating…skin regeneration.”
Be Green Bath and Body received a letter dated July 15, 2016, identifying four products with claims in violation of federal law, including Rose Hip Scar Oil Treatment, Evening Primrose Healing Oil, Organic Shea Butter Tin and Calendula Cream. Example statements from Rose Hip Scar Oil Treatment included, “[H]eal damaged skin from scars and burns” and “[R]educe scar tissue and stimulate the growth of new skin tissue,” as well as “’Scar Oil Treatment is beneficial for many skin conditions such as rosacea, dermatitis, eczema, acne and psoriasis.’” FDA also noted that the Rose Hip Scar Oil Treatment is intended to treat a disease or diseases that “are not amendable to self-diagnosis or treatment without the supervision of a licensed practitioner,” meaning that it is not possible to include directions for a layperson to use the oil for the intended purpose. The FDA letter said the product is thus misbranded under the FDCA, and introduction or delivery into interstate commerce of a misbranded drug also violates the act.
All three letters noted that FDA has not provided an all-inclusive list of violations nor have they listed all of the products promoted by each company’s website that may violate the FDCA. The companies were advised to review their websites and product labeling and encouraged to quickly correct all violations.