Monday, November 20, 2006


by David Bearman, MD for ABC-CLIO

The modern era of the Food and Drug Administration (FDA) dates to 1906 with the passage of the Federal Food and Drug Act (aka the Wiley Act). The FDA's predecessor was the Division of Chemistry under the U.S. Department of Agriculture. The division studied the adulteration and misbranding of food and drugs. In the 19th century, states exercised the principal control over domestically produced and distributed food and drugs. Control were inconsistent from state to state. Division of Chemistry chief Harvey Washington Wiley helped spur public indignation about possibly dangerous and impure ingredients through a ten-part study, Foods and Food Adulterants, published between 1887 and 1902.

This indignation over food and drugs was fanned by muckraking journalists and writers such as Samuel Hopkins Adams and Upton Sinclair, who exposed in vivid detail the hazards of human consumption of patent medicine and food. The nauseating condition of the meat-packing industry that Upton Sinclair captured in his famous novel The Jungle was the final precipitating force behind both a meat inspection law and a comprehensive food and drug law.

The Pure Food and Drug Act was the most successful drug law at curbing drug use ever passed at the federal level. Regulation of product labeling was the basis of this law. Drugs were defined in accord with the standards of strength, quality, and purity in the official drug guides United States Pharmacopoeia and the National Formulary. Any specific variations from the standards had to be plainly stated on the label. As a result there was a sharp decrease in the sales of patent medicine containing alcohol, opiates, and cocaine. Cannabis remained in patent medicines.

The 1938 Food Cosmetic and Drug Act remains a cornerstone of drug legislation. It requires FDA approval of new drugs for safety. Soon after the 1938 Act, the FDA began to identify drugs that they found were not safe for use directly by the patient, but would require a prescription from a physician. From the 1940s to the 1960s, the FDA focused more regulatory effort on the abuse of amphetamines and barbiturates than all other drugs. In the early 1960’s a new law was passed, the Kefauver-Harris Amendments in response to a medication, Thalidomide, that had resulted in fetal deformity when given to pregnant women. The new law prompted by the thalidomide tragedy mandated that both efficacy and safety be proven before a drug could be marketed.

In the case of cannabis, the FDA has been very restrictive in allowing studies to be done to determine the medical efficacy of cannabis. They have blocked almost all studies on medical benefits, instead favoring studies on adverse effects. In April of 2006, the FDA issued a statement without reference to any research or studies, stating that smoked marijuana had no known medicinal use. This was promptly criticized by Dr. John Benson, an author of the government ordered1999 Institute of Medicine Report (IOM) report on marijuana. This report had stated that smoked marijuana did have medicinal utility. Scientists at the Center for Medical Cannabis Research at the University of California were also highly critical of the FDA statement.

The FDA has moved considerably from its initial focus on proper labeling and control of adulterants in food and safe manufacture of pharmaceuticals. It has been criticized for has moving away from it's beginning as a science-based bureau to being a political arm of the current administration, which some see as too harsh on medical marijuana and other potentially beneficial therapies. The FDA’s position on the morning-after pill, stem cell research, and medicinal cannabis have been soundly criticized by the medical community as well as advocacy groups.