Wine, Cheese and a Dash of Poison in the Forehead: Exploring the Evolution of the Injectable Filler Industry and the Consequent Implications for Regulatory Action

Abstract

Abstract: Although the American pursuit of youth and beauty has long influenced female consumers, the recent introduction of injectable fillers has overwhelmed the country's current capacity to regulate. Millions of American women annually receive a plethora of injections; some approved, some off-label, and others wholly unapproved. This paper examines the new challenges the Food and Drug Administration must confront as consumer obsession skyrockets, and manufacturers and physicians engage in questionable activity to meet the rising demand. The public’s increasingly casual attitude toward FDA approval of cosmetic uses has endangered an industry enamored, at all costs, with the pursuit of wrinkle-free, ageless beauty. This danger is compounded by the Internet's creation of unprecedented marketing channels for manufacturers to inundate consumers with misleading information and sidestep FDA prohibitions. Through case studies of the four injectable fillers Botox, silicone, Radiesse and ArteFill, this paper addresses the obstacles the FDA must confront to adjust to a changing frontier.