Pioneering Consumer Advocate Gave Rise to FDA

Harvey W. Wiley, MD (1844-1930)

In the 1880s, when mislabeling, potentially toxic preservatives, and poor quality food that sickened people were common, chemist Harvey W. Wiley, MD (1844-1930), became one of the first consumer advocates for safe food.

At the time, there were few government controls, and manufacturers substituted inexpensive ingredients for those listed on the label. For example, honey was often diluted with glucose syrup.

Although pure food bills, many of which were the result of Wiley’s initiatives, had been introduced into Congress in the 1880s and 1890s, they were killed by powerful lobbies. In a grass-roots effort that would have made Ralph Nader proud, Wiley leveraged $5,000 to publicize the problems, enlisting healthy young male volunteers, known as the “poison squad,” to act as guinea pigs to test the effects of chemicals, preservatives, and adulterated foods.

Wiley believed that widely used food preservatives such as borax were a major safety issue at the turn of the century, according to an AOCS Lipid Library publication of the American Oil Chemists’ Society. He thought manufacturers should have to prove the safety of such additives and preservatives, and he asked Congress in 1899 for funds to do his own studies. Three years later, based on his results, Congress did enact new controls over imported foods.

With his poison squad, Wiley initially studied five preservatives: borax, salicylic acid, sulfuric acid, sodium benzoate, and formaldehyde. The volunteers ate food containing doses that ranged from 1/5 gram to 4 grams and recorded their own weight, temperature, and pulse before each meal. Physicians monitored the volunteers and recorded any symptoms. The volunteers also submitted daily urine and stool samples. Part of the study involved determining whether or not the preservatives were released during perspiration and respiration. The volunteers did not know which foods contained preservatives.

This unorthodox manner of testing attracted some people who mocked or tried to undermine the effort, and Wiley realized he had to be proactive in gaining public confidence in the validity of his testing. When he learned that reporters had been interviewing the chef through a basement window where the tests took place, he subsequently reported all details to the press.

When the additives made volunteers so ill from vomiting or stomachaches that they could not function, he stopped the tests. He discovered that borax, for which he reported results in 1904, was one of the least toxic preservatives, but if doses were increased, the subjects lost their appetites, felt full, and suffered stomachaches and headaches. Other preservatives showed similar results. The tests also showed that these preservatives were not excreted in feces, perspiration, or respiration, according to AOCS.

While Wiley agreed that small amounts of preservatives were harmless and could slow food spoilage, he also argued that the accumulation of additives posed a public health threat, because it was not possible to control how much a person ate over time. He was ultimately unsuccessful in fighting food preservatives, but borax, salicylic acid, formaldehyde, and copper sulfate fell out of use. AOCS notes that the poison squad paved the way for federal regulation of foods and drugs in the United States.

On June 30, 1906, Wiley’s efforts bore fruit when President Theodore Roosevelt signed the Pure Food and Drugs Act, largely written by Wiley, according to the FDA. Wiley was appointed to oversee its administration. The Pure Food and Drugs act was replaced by the Food, Drug, and Cosmetic Act of 1938.

Like Nader, who was born in Connecticut to Lebanese immigrants who ran a restaurant and bakery, Wiley also came from humble beginnings. He was born in a log cabin on a frontier farm in Kent, Ind., in 1844. During his early years, he helped with the farm, planting and harvesting crops. His father was also a local schoolteacher.