The U.S. Food and Drug Administration (FDA) has issued several cosmetics-related updates:

  • In January 2016, FDA published a release noting that “Warning Letters Highlight the Differences Between Cosmetics and Medical Devices.” In this statement, the agency notes that several recent warning letters – in addition to past warning letters – explain the differences in the definitions of cosmetics and medical devices. The statement notes that recent warning letters have been directed at certain devices, which have been marketed for “regrowing hair, weight reduction, spider vein removal, and dermabrasion, as well as injectable fillers and decorative lenses.”
  • In February, FDA updated its guide, “Cosmetics Compliance Program: Import and Domestic,” which sets forth guidelines for data reporting “to ensure that imported and domestic cosmetics meet regulatory requirements through inspection, sample collection and analysis.” The program emphasizes four primary areas of concern: compliance with mandatory labeling requirements; prohibited or restricted ingredients; non-certified and non-permitted color additives; and cosmetics that contain bovine-derived tissues imported from countries affected or at risk of bovine spongiform encephalopathy (BSE) outbreaks.
  • In March, FDA updated “Is It a Cosmetic, a Drug, or Both? (Or  Is It Soap?)” and “Color Additives and Cosmetics” to be available in French, Korean, Spanish, Simplified Chinese, and Traditional Chinese. The color additives guide summarizes approval, certifica- tion, identity and specifications, use and restrictions requirements. Failure to adhere to the requirements will render a cosmetic “adulterated” under the Federal Food, Drug, & Cosmetic Act.
  • On March 16, FDA updated its website to include a release regarding reactions reported by consumers who used EOS Lip Balm®. According to FDA, 58 reports were submitted between August 6, 2014, and January 28, 2016, for several EOS Lip Balm® flavors. The agency is working with EOS and its manufacturing subcontractor to address the issue.