History of Food Regulation

According to the Web Pages

www.msu.edu/course/fsc/421/Lecture%20Sked.htm

and
  www.navs.org/law/other_resources.cfm?SectionID=Law

As Existing on January 16, 2004

            In 1266 the English government prohibited the sale of corrupted wine, meat, fish, bread or water.  In 1641 some colonial laws in New England mandated fish inspection in order to improve trade relationships.  Iowa (1838), the Oregon Territory (1848), and California (1850) adopted acts directed against vendors of unwholesome provisions.  In 1889 the U.S. Secretary of agriculture called for national inspection of beef in response to some cases of European rejection of U.S. beef.  In 1906, Upton Sinclair published The Jungle, exposing unsanitary meat packing plants.  In that same year, President Roosevelt read The Jungle and called for an investigation.  Also in 1906, Congress responded with the Meat Inspection Amendment and the Food and Drug Act.

            The Food and Drug Act prohibited the manufacture, sale, or transportation of adulterated or misbranded or poisonous food, drugs or medicines and liquors.  Cocaine was controlled for the first time by this Act.  This Act was amended several times and has been superceded by the Food, Drug and Cosmetics Act of 1938.  Of the amendments to the original Act, one of the more memorable was the Butter Amendment of 1923, which was designed to protect butter from the threat of oleomargarine.  (The consumer had to mix the yellow coloration into oleomargarine on his own.)

            In 1906, enforcement of the Food and Drug Act was vested in the USDAs Bureau of Chemistry, where it remained until 1927.  This was consistent with the lobbying role played by the Bureaus Chief Chemist at that time, Dr. Harvey Wiley.  As an early crusader for consumer protection, Dr. Harvey was known for the formation of Bureau Poison Squads (one of which determined that preservatives as a group were bad) and for his general aptitude for hell-raising.  In 1927, enforcement of the Food and Drug Act was vested in a separate agency, the USDAs Food, Drug, and Insecticide Administration, where it remained until 1930.

            The agency with the name Food and Drug Administration was not formed (within the USDA) until 1930.  This agency migrated to the Federal Security Agency in 1940, to the Department of Health, Education, and Welfare in 1953 and to the Department of Health and Human Services (DHHS) in 1979.  Today, the DHHS Secretary enforces the FDCA, delegating authority to the Commissioner of the FDA except on significant public issues, on which the Secretary can act unilaterally.

            The 1906 Act considered food to be adulterated if any substance were mixed with the food so as to lower or injuriously affect its quality, if one food substance were substituted for another, if any valuable food component were extracted, if food damage were concealed, if added ingredients rendered the food injurious to health, or if the food contained diseased or unfit substances.  The 1906 Act considered food to be misbranded if imitations were offered under a different name, if the labeling was misleading, if weights and measures were not plainly and correctly stated, or if the label contained false or misleading statements about the ingredients.

            There were many problems with the 1906 Act.  The Act failed to provide clear-cut definitions and standards.  Appropriations bills to fund enforcement were not passed.  Intent to adulterate was required.  The government never won a single case prosecuted under the 1906 Act, because the defendants could plead ignorance.  Alternately, in the celebrated 1911 case of Dr. Johnsons Mild Combination Treatment for Cancer, Tumors, and Other Chronic Diseases, alleged misbranding was rejected by the U.S. Supreme Court because the 1906 Act only prohibited misleading statements about the ingredients, not about effectiveness.  Finally, attention was diverted from food and drug quality by the advent of World War I.

            Due to the defects in the 1906 Act, to the availability of new technology in the areas of food canning and chemical analysis, to increased use of cosmetics, and to preventable food tragedies, the Food, Drug, and Cosmetics Act was passed in 1938.  The most immediate cause of this Act was the sulfanilamide tragedy of 1937.  Sulfanilamide, an effective treatment for strep throat, was itself unobjectionable.  Unfortunately, the chief chemist at a manufacturing company chose a liquid matrix for the active ingredient solely on the basis of taste.  His choice, diethylene glycol, turned out to be a deadly poison, and there were 107 deaths, mostly of children.  However, the companys failure to test for safety or to list all ingredients was not a violation of the 1906 Act.

            The 1938 Act prohibits interstate traffic in all food (not just added substances) that may be injurious to health and increases labeling requirements.  Factory inspections and injunctive relief were authorized.  Food standards for identity, quality, fill, and grade were established.  Whereas the 1906 Act defines adulteration in terms of the presence of poison, the 1938 Act recognizes that

the majority of things consumed by the human family contain, under analysis, some
  kind of poison it depends on the combination and chemical relation to the body that
  determine whether or not the substance is dangerous to the human system

            Under the 1938 Act, any food containing any avoidable or added substance that is unsafe is adulterated.  Unsafe refers to poisonous or deleterious substances, except those that cannot be avoided by good manufacturing practices.  The Act authorizes the FDA to set tolerances for unavoidable contaminants.  There have been many subsequent amendments to this Act, affecting insecticides, meat and poultry, food and color additives, labeling, vitamins, minerals, supplements, saccharin, and most recently, the FDA Modernization Act of 1997.