FDA recently issued a warning letter to Moy-Fincher Medical Group for promoting its DNA Eye Renewal product for conditions that cause it to fall under the ‘drug’ category. Some of the claims highlighted by FDA include: "helps stimulate collagen production for added strength to the dermal matrix," "control inflammation," "inhibit muscle fibers from contracting" and "mimic the activity of the youth hormone thymopoietin." FDA noted that the product is not generally recognized as safe and effective for these uses, and therefore, it is considered a new drug.
FDA issued the warning after a review of the company’s website in December 2014. According to FDA’s letter, claims on the website indicate the eye renewal product is intended to affect the structure or function of the human body, rendering it a drug under section 201(g)(l)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)].
Examples of these claims on the website include:
"Beta Glucan: Helps stimulate collagen production for added strength to the dermal matrix ... "
"Willowherb ... control inflammation."
"Spanish Lavender ... inhibit muscle fibers from contracting ... "
"Matrixyl3000 ... stimulating the production of collagen, elastic, and hyaluronic acid and decreasing cell damage caused by glycation and inflammation."
"Tetrapeptide ... mimic the activity of the youth hormone thymopoietin ... reinforcing the cutaneous immune defenses in the skin ... stimulate the growth of new cells in the epidermis."
Companies offering cosmeceuticals and beauty products should stay on high alert when it comes to making claims about their products. For tips on making appropriate and legal marketing claims, visit INSIDER’s structure/function topic page.