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Pure Food and Drug Act

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**1. Historical Significance and Passage of the Pure Food and Drug Act:**
– The Pure Food and Drug Act of 1906 was a key Progressive Era legislation signed by President Theodore Roosevelt.
– Enforcement was assigned to the Bureau of Chemistry, later renamed the U.S. Food and Drug Administration.
– The law focused on truth in labeling, raising standards in food and drug industries.
– It defined misbranding and adulteration for the first time and prescribed penalties.
– An 1882 article in Scientific American highlighted the need for new laws on food and drugs.
– The law took 27 years to adopt, with public awareness raised by muckraking journalists.
– Dr. Harvey Washington Wiley’s hygienic table studies brought attention to food preservatives.
– The table trials, known as The Poison Squad, tested the effects of common preservatives.
– The trials led to public outcry and supported the passing of the Pure Food and Drug Act.

**2. Impact on Food and Drug Industries and Beginnings of the Food and Drug Administration:**
– The Act aimed to ban adulterated or mislabeled food and drug products in interstate commerce.
– It required active ingredients on drug labels and set purity levels for drugs.
– The law led to the creation of the Food and Drug Administration for enforcement.
– Penalties for violations were modest but included seizure and destruction of goods.
– The Act was a significant step in raising standards and protecting consumers.
– The 1906 Act led to the establishment of the Food and Drug Administration (FDA).
– The Bureau of Chemistry, a precursor to the FDA, oversaw food safety initially.
– In 1927, the Bureau transformed into the Food, Drug, and Insecticide Administration.
– The FDIA was renamed the FDA in 1930.
– The Federal Food, Drug, and Cosmetic Act of 1938 largely replaced the 1906 Act.

**3. Specific Drugs Deemed Addictive and Enforcement of Labeling:**
– The law required drug labels to list any of 10 addictive and/or dangerous ingredients.
– Alcohol, morphine, opium, and cannabis were included in the list.
– A cadre of food and drug inspectors was established for enforcement.
– Goods found in violation could be seized and destroyed at the manufacturer’s expense.
– Deficiencies in the 1906 Act led to the 1938 Federal Food, Drug, and Cosmetic Act.
– Efforts were made to ban unsafe products and later ineffective ones.
Coca-Cola faced attempts to be outlawed due to its high caffeine content.
– The Act required accurate labeling of substances like alcohol, cocaine, and heroin.
– Sale of opiate-containing patent medicines decreased by 33% post-labeling mandate.

**4. Replacement with Federal Food, Drug, and Cosmetic Act and Future Ramifications:**
– Deficiencies in the 1906 Act led to its replacement in 1938.
– The new Act became the statutory basis for regulating foods, drugs, cosmetics, etc.
– The Federal Food, Drug, and Cosmetic Act remains the foundation for FDA regulation.
– The new Act addressed gaps in the 1906 legislation and introduced new provisions.
– President Franklin Roosevelt signed the new Act into law to strengthen consumer protection.

**5. References and Sources:**
– The Pure Food and Drug Act of 1906 was pivotal in drug policy reform discussions.
– Various sources discuss the impact and enforcement of the Act.
– Studies and articles highlight the Act’s influence on labeling and consumer safety.
– The Act’s significance is acknowledged in public health and legal contexts.
– Academic papers, reports, books, and articles provide insights into the Act’s history, implications, and enforcement.

The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.

Pure Food and Drug Act
Great Seal of the United States
Acronyms (colloquial)PFDA
Enacted bythe 59th United States Congress
EffectiveJanuary 1, 1907
Public law59-384
Statutes at Large34 Stat. 768, Chapter 3915
Acts repealed
  • Pure Food and Drug Act (1906)
  • 37 U.S. Stat. 416 (1912) (Sherley Amendment)
  • 37 U.S. Stat. 732 (1913) (Gould Amendment)
  • 41 U.S. Stat. 271 (1919) (Kenyon Amendment)
  • 42 U.S. Stat. 1500 (1923)
  • 44 U.S. Stat. 976-1003 (1927)
  • 46 U.S. Stat. 1019 (1930) (McNary-Mapes Amendment)
  • 48 U.S. Stat. 1204 (1934) (21 U.S.C. §§ 1-15)
Titles amended21 U.S.C.: Food and Drugs
Legislative history
  • Introduced in the Senate as S. 88 by Weldon Heyburn (RID) on December 14, 1905
  • Passed the Senate on February 30, 1906 (63-4)
  • Passed the House on June 20, 1906 (143-72)
  • Reported by the joint conference committee on June 23, 1906; agreed to by the House on June 23, 1906 (Did not agree) and by the Senate on June 23, 1906 (241-17)
  • Signed into law by President Theodore Roosevelt on June 30, 1906
Major amendments
Food, Drug, and Cosmetic Act (1938)
Food Quality Protection Act (1996)
United States Supreme Court cases
United States v. Johnson (1911)

In the late 1800s, the quality of food in the United States decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, even formaldehyde, to keep food fresh. Simultaneously, the quality of medicine was abysmal. Quack medicine was common, and many drugs were addictive or dangerous without actually providing a curative effect. Opium and alcohol were chief ingredients, even in infant medicines. The work of muckraking journalists exposed the horrific practices of both industries and caused public outcry.

Foremost among such exposés was The Jungle by Upton Sinclair, published the same year as the act. With its graphic and revolting descriptions of unsanitary conditions and unscrupulous practices rampant in the meatpacking industry, it was an inspirational piece that kept the public's attention on the important issue of unhygienic meat processing plants. Sinclair quipped, "I aimed at the public's heart and by accident I hit it in the stomach," as outraged readers demanded and got the Pure Food and Drug Act, as well as the 1906 Federal Meat Inspection Act.

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