title: Diet pills and the cataract outbreak of 1935: reflections on the evolution of consumer protection legislation.
abstract: An outbreak of cataracts in 1935 caused by dinitrophenol (DNP), the active ingredient of popular diet pills, highlighted the inability of the U.S. Food and Drug Administration (FDA) to prevent harmful drugs from entering the marketplace. Just two years earlier, the FDA used horrific images of ocular surface injury caused by cosmetics at the World's Fair in Chicago to garner public support for legislative reform. The FDA had to walk a fine line between a public awareness campaign and lobbying Congress while lawmakers debated the need for consumer protection. The cataract outbreak of 1935 was conspicuous in the medical literature during the height of New Deal legislation, but questions persist as to how much it affected passage of the proposed Food, Drug, and Cosmetic Act (of 1938). The legislation languished in committee for years. The cataract outbreak probably had little impact on the eventual outcome, but medical opinion concerning the safety of DNP may have contributed to the voluntary withdrawal of the diet drug from the market. We review the DNP cataract outbreak and examine it in context of the challenges facing regulatory reform at that time.
authors.affiliation: Department of Ophthalmology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA; Department of Pathology and Cell Biology, Morsani College of Medicine, University of South Florida, FL, USA. Electronic address: cmargo@health.usf.edu.
authors.forename: Curtis E
authors.initials: CE
authors.lastname: Margo
authors.affiliation: Department of Ophthalmology, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Harman
mesh_terms: D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000266:history*; D002386:Cataract / Q000139:chemically induced / Q000453:epidemiology / Q000266:history*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004032:Diet; D004140:Dinitrophenols / Q000009:adverse effects / Q000266:history*; D004196:Disease Outbreaks / Q000266:history*; D049673:History, 20th Century; D006801:Humans; D007880:Legislation, Drug / Q000266:history*; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history*
chemical_list: D019440:Anti-Obesity Agents; D004140:Dinitrophenols
keywords: Food and Drug Administration; diet pill complications; dinitrophenol; drug and cosmetic act of 1938; food; secondary cataract; toxic cataract