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THE FOOD, DRUG, AND COSMETIC ACT OF 1938

A Terrible Mistake

The press widely praised sulfanilamide as a miracle medicine. But in 1937 a terrible mistake was made. The chief chemist at a small pharmaceutical plant in Bristol, Tennessee, trying to create a liquid dosage form, found that the solvent diethylene glycol would dissolve sulfanilamide. With the solvent he created a liquid form of sulfanilamide called an elixir of sulfanilamide. The chemist tested the elixir for appearance, fragrance, and flavor but neglected to consult the scientific literature or make animal tests to determine the effect on the body. Nearly two thousand pints of the liquid were made, but not one named the solvent on the label. Its presence in the elixir was toxic. The Food and Drug Administration (FDA; created in 1906 with the passage of the Pure Food and Drug Act) began hearing a rumor that deaths were occurring from some sulfa compound. By the time the investigation was over, the "elixir," according to FDA calculations, had killed some 107 people, many of them children who suffered long and painful deaths. A victim's mother wrote to President Franklin Roosevelt, telling how her little girl of six had died in agony and begging the president to support legislation to prevent other families from suffering similar tragedies. She included a picture of her daughter with the letter. The chemist who created the elixir committed suicide, and the doctor who owned the company paid a fine of $26,100, the highest ever levied under the 1906 law. An outraged public begged Congress to amend the earlier law to insure such mistakes would never again occur.

Federal Regulations

The Pure Food and Drug Act marked the beginning of federal drug regulation, but it had several loopholes. It did not require the disclosure of all contents, except for narcotics; and it did not regulate the bold claims of drug makers except in cases that were "false and fraudulent." State and federal drug officials and the AMA continued the struggle to expose quackery and to strengthen the drug laws. Although some progress was made, it took the national drug scandal over "Elixir Sulfanilamide" to bring about a major revision of the act.

A Last Measure from the New Deal

On 27 June 1938 President Roosevelt added his signature to the Food, Drug, and Cosmetic Act. It was one of the last major domestic measures to come from the New Deal. Any false and misleading statement in labels was now banned, and the government no longer needed to prove fraudulent intent in lawsuits. Labeling required warnings when medication might be hazardous. Now the names of all active ingredients were required on the label for over-the-counter remedies; and quantity and proportion had to be given for a list of potent drugs and habit-forming narcotics and hypnotic substances. New drugs could not be marketed until their manufacturers persuaded FDA officials that the drugs were safe. With their new law as a weapon, the FDA launched a full-scale campaign to make self-medication and cosmetic products safe. Its first seizure under the new law was an aniline eyelash "beautifier" that blinded the women who used it.