On Feb. 10, 1959, the U.S. Food and Drug Administration (FDA) announced that nasal inhalers containing basic amphetamine can be sold only by prescription. Previously this product (used for relieving nasal congestion) had been sold directly to the public. Basic amphetamine has been replaced by safer, more effective prescription and over-the-counter (OTC) products for relieving nasal congestion.

The original amphetamine epidemic was generated by the pharmaceutical industry and medical profession as a byproduct of routine commercial drug development and competition. Searching for a decongestant and bronchodilator to substitute for ephedrine, in 1929, biochemist Gordon Alles discovered the physiological activity of beta-phenyl-isopropylamine (soon to be known as amphetamine). Alles published his first clinical results with the compound in 1929, began amphetamine’s clinical development in collaboration with pharmacologists and clinicians at the University of California, and received a patent on its orally active salts in 1932.

Meanwhile, possibly inspired by Alles’s work, the Philadelphia firm Smith, Kline and French (SKF) investigated the base form of amphetamine and patented it in 1933. SKF marketed it as the Benzedrine Inhaler, a capped tube containing 325 mg of oily amphetamine base and little else. For congestion, one was meant to inhale amphetamine vapor every hour as needed. Although no legal category of prescription-only drugs existed in the 1930s the Benzedrine Inhaler was advertised for over-the-counter sale upon its introduction in 1933 and 1934 and for the next 15 years. Following expiration of Alles’s patent in late 1949, consumption of pharmaceutical amphetamines in the United States surged.

During the 1950s, fierce commercial competition helped drive amphetamine consumption higher still. According to FDA manufacturer surveys, by 1962, US production reached an estimated 80000 kg of amphetamine salts, corresponding to consumption of 43 standard 10-mg doses per person per year on a total-population basis.

Evidence was also emerging around 1960 that amphetamine is truly addictive, instead of merely “habituating” like caffeine, as leading pharmacologists had asserted when the drug was first introduced. Postwar changes in thinking about addiction, promoted particularly by the World Health Organization, facilitated this new perspective on amphetamine by moving the concept away from an opiate model, defined by acute physiological withdrawal, toward a psychosocial model of “drug dependency” defined by compulsive behavior and erosion of function.