Chapter 3: Drug Products and Their Regulations

Drug regulations are passed mainly for what is perceived to be the public good, but there is a great deal of debate about exactly what the public good is.   Issues of fact, morality, health, personal choice, and social order can become intertwined and sometimes confused; drug laws have often been passed in response to particular social crises.

Current drug laws trace back to two pieces of legislation from the early 1900s that were developed to regulate undesirable behaviors.  Issues leading to legislation were concerns about the habit of opium smoking brought to the U.S. by Chinese workers, fears that cocaine use was linked to crime, and concerns about patent medicines that made false therapeutic claims or contained habit-forming drugs

The first piece of legislation was the 1906 Pure Food and Drugs Act, which required accurate labeling and listing of ingredients.  It was later amended to require testing for safety and effectiveness.  Pharmaceuticals must be pure, safe, and effective; and it may take more than 10 years and $800 million to complete research and development and to get approval from the FDA for marketing. Dietary supplements, on the other hand, are regulated more like food.  Their labels must be accurate and they can't make unsubstantiated direct health claims, but they can make general health claims and they can be marketed without first proving safety.

The second piece of legislation was the Harrison Act of 1914, which was a tax law that regulated the sale of opiates and cocaine.  After 1919, it was expanded to prohibit providing drugs to dependent users.  As drugs became scarcer and their prices rose on the illicit market, the illicit market grew.  Harsher penalties and increased enforcement efforts, which were the primary strategies of the commissioner of narcotics, failed to reverse the trend.  Marijuana was added to the list of controlled drugs in 1937, and in 1965, amphetamines, barbiturates, and hallucinogens were also brought under federal control.

The Controlled Substances Act of 1970 replaced or updated all previous laws and provided for direct federal regulation of drugs rather than using the pretense of taxing their sale.  Controlled substances are placed on one of five schedules, depending on factors such as their medical uses and dependence potential. Amendments in 1988 were aimed at increasing pressure on users as well as on criminal organizations.  In some cases, federal and state laws differ, but federal law overrides state law.

Federal support for drug screening began in the military and has since spread to other federal agencies, nonfederal transportation workers, and many private employers.  Current federal enforcement efforts involve thousands of federal employees and include activities in other countries, along our borders, and within the United States.  Federal, state, and local enforcement limits the supply of drugs and keeps their prices high, but the high prices attract more smugglers and dealers. It will never be possible to eliminate illicit drugs.