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Chapter 2 Outline:
2.1 Legal Roots of Consumer Protection
2.2 Federal Entities
2.3 State Entities
Introduction
The government has a strong interest in ensuring that products consumers purchase are safe for their intended use. Imagine taking a product off the shelf, unsure whether or not the product contains sharp debris or toxic chemicals, or asking yourself whether or not the product will explode at any moment.
2.1 Legal Roots of Consumer Protection
By the end of this section, you will be able to:
- Understand the need for legally enforceable standards for products
- Describe the unfortunate tragedy that led to significant changes in federal legislation with respect to cosmetic and drug safety
Before the development of consumer product safety standards based on scientific advances, numerous beauty products, for example, contained poisonous chemicals, including lead, arsenic, mercury, and even the radioactive element radium. Wallpaper, beer, wrapping paper, candles, ornaments, and even sweets all contained arsenic. These products were at their height of popularity in the late 1880s to the early 1900s, though these ads were still found in the U.S. as late as the 1920s, and finally banned from cosmetic use in 1938 with the passage of the Food, Drug, and Cosmetics Act (See Figure).
This legislation, first introduced in 1933, took 5 years to make it through Congress. Like many pieces of languishing legislation, a disaster finally spurred Congress to take action. In 1937, a reputable Tennessee drug company, S.E. Massengill, advertised a new wonder drug, Elixir Sulfanilamide, that doctors used to treat strep throat and other ailments. Sulfanilamide had been used safely in powder and pill form, until the company’s chief chemist, Harold Cole Watkins discovered that sulfanilmaide would dissolve in dyethelyne glycol, creating a mixture satisfactory in appearance, smell, and flavor. Without testing for toxicity, in early September 1937 the company sent 633 shipments of the new compound all over the country.
Without any kind of required safety or pharmaceutical testing, Watkins failed to notice that dyethelyne glycol, a chemical used as an antifreeze, is a deadly poison. Thus, S.E. Massengill sent out a toxic “remedy” marketed to contain alcohol, which it did not contain, for use to treat sore throats in children. By mid October, an FDA inspector reported that 8 children and 1 adult had died from Elixir Sulfanilamide. Warning messages and inspectors were dispatched to stop the use and collect the poison that had been distributed. Often requiring detective work to track the salesmen and the products down, federal, state, and local officials were able to recover 234 gallons and 1 pint of the 240 gallons distributed. In all, more than 100 children and adults died in 15 states.
The FDA charged S.E. Massengill with “misbranding,” due to “Elixr” implying that the product contained alcohol, when in fact it did not. If the product had been called a “solution” rath