1/24/2018 Need for a New Food and Drug Law Elixir of Sulfanilamide raspberry flavored death Industry strongly objected to the 1906 1906 law lacked a mandatory premarket drug Pure Food and Drug Act testing Few purity standards were available Elixir Sulfanilamide incident in 1937 exposed this flaw Food adulteration was common Sulfanilamide is not harmful in itself Took several incidences and 100 Diethylene glycol,which was used to deaths from "elixir of sulfanilamide" prepare a new liquid form of this drug,is in 1937 to revise the 1906 Act toxic (a cough syrup) Produced by S.E.Massengill Company of Bristol,Tennessee Elixir of Sulfanilamide Elixir of Sulfanilamide raspberry flavored death raspberry flavored death 1906 law lacked a mandatory premarket 1937 letter excerpt from Dr.AS Calhoun to President Roosevelt drug testing "Nobody but Almighty God and I can know Diethylene glycol kills by causing acute what I have been through these past few kidney damage days.I have been familiar with death in the years since I received my M.D.from ·Over 100 people died Tulane University School of Medicine with The public outcry caused by this the rest of my class of 1911.Covington County has been my home.I have practiced incident and other similar disasters led here for years.Any doctor who has to the passing of the 1938 Federal practiced more than a quarter of a century Food,Drug,and Cosmetic Act has seen his share of death."1/24/2018 15 Need for a New Food and Drug Law • Industry strongly objected to the 1906 Pure Food and Drug Act - Few purity standards were available - Food adulteration was common - Took several incidences and 100 deaths from “elixir of sulfanilamide” in 1937 to revise the 1906 Act Elixir of Sulfanilamide raspberry flavored death 1906 law lacked a mandatory premarket drug testing • Elixir Sulfanilamide incident in 1937 exposed this flaw • Sulfanilamide is not harmful in itself • Diethylene glycol, which was used to prepare a new liquid form of this drug, is toxic (a cough syrup) • Produced by S.E. Massengill Company of Bristol, Tennessee Elixir of Sulfanilamide raspberry flavored death 1906 law lacked a mandatory premarket drug testing • Diethylene glycol kills by causing acute kidney damage • Over 100 people died • The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act Elixir of Sulfanilamide raspberry flavored death 1937 letter excerpt from Dr. AS Calhoun to President Roosevelt “Nobody but Almighty God and I can know what I have been through these past few days. I have been familiar with death in the years since I received my M.D. from Tulane University School of Medicine with the rest of my class of 1911. Covington County has been my home. I have practiced here for years. Any doctor who has practiced more than a quarter of a century has seen his share of death