Table of Contents

• Foreword
• Preface
• Acknowledgments
• Chapter 1. Introduction
• Chapter 2. Early Federal Regulation of Foods and Drugs
• Regulation Prior to 1800
• The 1848 Drug Law
• The 1886 Butter Fight
• A Growing Need for Federal Regulation
• The 1903 Pure Food Law
• The Push for a 1904 Pure food Law
• Chapter 3. The Predatory Patent Medicines
• The Post Office and Patent Medicines
• Patent Medicine Manufacturers on a Roll
• Enter the Muckrakers
• Edward Bok and The Ladies’ Home Journal
• Samuel Hopkins Adams and Collier’s
• Good Housekeeping Magazine Enters the Ring
• Efforts to Fight Quackery in the Post-Depression Era
• Did Quackery Ever Die Out?
• Chapter 4. The 1906 Pure Food and Drugs Act
• The Jungle
• Laying the Groundwork for the 1906 Pure Food and Drugs Act
• The Fifty-Ninth Congress: Victory over Special Interests
• Dr. Wiley Is Hamstrung by Special Interests
• The Ill-Fated Coudrey Amendment
• The Sherley Amendment
• The 1906 Law and the 1912 Election
• The Jamaica Ginger Incident
• Harvey Washington Wiley, “Father of the Food and Drug Law”
• The FDA: A Capsule History
• Chapter 5. The Fight Against Baby Killers: The Harrison Narcotic Act of 1914
• The “Baby Killers”
• Public Outcry Becomes Overwhelming
• The 1914 Harrison Narcotic Act
• Shortcomings of the Harrison Narcotic Act
• Charles B. Towns
• Chapter 6. The 1938 Federal Food, Drug, and Cosmetic Act: Safety Required
• The Saga of the 1933 Tugwell Bill
• Copeland’s Work on the Tugwell Bill in 1934
• Copeland Tries Again in 1935
• Copeland Tries Again in 1936
• Copeland Continues in 1937
• The Plot Thickens: The Lea Bill Is Introduced in the House
• The Wheeler Bill
• Adjournment of the 1937 Congress
• The Advent of Sulfonamides
• The Elixir of Sulfanilamide Tragedy
• The 1938 Congress: Action at Last
• The 1938 Food, Drug, and Cosmetic Act Becomes a Reality
• A Novel Interpretation of the 1938 Law
• The 1938 Law and Cosmetics
• The Supreme Court Broadens the 1938 Law to Include Mailed Advertising
• FDA Confronts the Atomic Age
• Chapter 7. Differentiating Prescription Medications from Nonprescription Medications
• Early FDA Attempts to Control Nonprescription Sales of Dangerous Medications
• Pharmacists Flaunt the Law
• California Attempts to Limit Nonpharmacy Sales of Nonprescription Products
• The Durham-Humphrey Amendment
• Opposition to the Durham-Humphrey Amendment
• Who Should Be Able to Sell Nonprescription Products?
• Further Controls Urged on Barbiturates, Sleepers
• Chapter 8. The 1962 Kefauver-Harris Amendments: Proof of Effectiveness
• Trouble for the Drug Manufacturers
• Thalidomide
• Thalidomide and the Kefauver Bill
• Prescription Drug Product Review Begins
• A Nonprescription Drug Review Is Authorized
• Chapter 9. The FDA OTC Review and Rx-to-OTC Switching
• Kefauver-Harris Applied to Nonprescription Medications
• A Review of Nonprescription Products for Efficacy/Safety Begins
• The FDA Review and Rx-to-OTC Switches
• Switching via the “Switch Regulation”
• Switch Methods Related to the New Drug Application (NDA)
• Factors Considered in an Rx-to-OTC Switch Decision
• Chapter 10. Homeopathy
• The Father of Homeopathy
• The Doctrines of Homeopathy
• The Waning of Homeopathy
• Royal Copeland and Homeopathy
• FDA Enforcement in Regard to Homeopathics
• The 1994 FDA Petition and the NABP
• Homeopathic Popularity Today
• Lawsuits Challenging Homeopathy
• Whither Homeopathy?
• Chapter 11. A History of Dietary Supplement Regulation
• The Proxmire Amendment to the Food, Drug, and Cosmetic Act
• The FDA OTC Review in Relation to Vitamins and Minerals
• The Coincidental Publication Dates
• L-Tryptophan and Eosinophilia
• FDA’s Reaction to the L-Tryptophan Tragedy
• The Nutrition Labeling and Education Act
• The Dietary Supplement Act of 1992
• Enactment of the Dietary Supplement Health Education Act of 1994
• Contents of the 1994 Dietary Supplement Health and Education Act
• Post-DSHEA Dietary Supplement Regulation
• The FDA Modernization Act of 1997
• Hijinks on the Internet
• What Lies in the Future for Dietary Supplements?
• Notes
• Index