The Advent of Food and Drug Regulation : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

The men, of course, knew they were eating potential poisons. They didn't know, however, which foods contained the substances. At first borax was added to butter, to which the men developed a sudden distaste. Wiley then tried it in milk, meat, and coffee. Evidently, as the men determined which food contained the substances, they began eating less of it and eventually avoided that food altogether. Therefore, early on in the trials, Wiley decided he would no longer hide the preservatives and began putting them inside gelatin capsules instead. Previous tests showed that when taken in the middle of a meal, the capsules would quickly dissolve into digesting food, and in the case of borax, without discomfort. For the remainder of the five years, capsules were used for the study.

As daring as it was to submit to such testing in the first place, the men — who responded to Wiley's appeal to promote scientific knowledge while getting free meals — agreed to do so for at least six months. They also agreed to not hold the government responsible for any illness or injury that might result. The meals, which were prepared from high-quality ingredients by a certified Civil Service Commission chef, represented but a small reward for the hardships borne by the volunteers, including the possibility of long-term harm.

Bad Publicity for a Good Cause

Overnight, the Poison Squad became a national sensation. Wiley worried, however, that humorous banter about the squad would discredit the seriousness of his scientific project. But he also knew the importance of winning over the public — not only for the policy he was beginning to envision on chemicals in foods, but also for the progress of the pending federal food and drug law, then under debate in Congress.

After learning that reporters had taken to interviewing the Poison Squad's chef through a basement window, Wiley bowed to the inevitable interest and took reporters into his confidence. He reported to newspapers every detail of the experiment and its effects on the men, and also had the nerve to join the group for most of his own meals.

Wiley stopped the experiments only when the chemicals made several of the diners so sick that they couldn't function — nausea, vomiting, stomachaches, and the inability to perform work of any kind. By this time, though, stories of the men's indigestion had run rampant and were being followed by fascinated readers all over the United States. The table trials even made the minstrel shows. In the end, the publicity helped Wiley gain a Congressional hearing, as well as support for his contention that chemical preservatives had no place in food.

The Science Behind Food Additive Regulation

Wiley's findings on borax were not impressive. The results reported in 1904 showed that borax was one of the least toxic of the preservatives studied. More impressive, however, were the symptoms reported in the individual case histories as dosages of borax and other preservatives were increased: diminished appetite, feelings of fullness and discomfort in the stomach, dull and persistent headache, and in some instances, abdominal pain.

The amounts of preservatives eliminated in feces were found to be insignificant. The amount recovered from perspiration was not enough for a quantitative determination by the methods used back then. The respiration study came back without significant results.

For the sake of the food industry, which wielded a powerful influence over lawmakers, Wiley eventually admitted that very small amounts of preservatives might be harmless, and might even protect consumers from more serious dangers of food spoilage. But he argued that the accumulation of such additives was a danger to public health since he couldn't determine, much less control, quantities of a given substance that a person might ingest over time. Wiley was convinced that any kind of regulation would have to treat all preservatives alike — ruling out discrimination between food chemicals according to their risks and benefits.

Wiley didn't win all of his fights, and not many federal court cases were aimed directly at the chemicals fed to the Poison Squad. But four of the preservatives tasted by the Squad are long gone from the food additive market — borax, salicylic acid, formaldehyde, and copper sulfate. In the end, the Poison Squad, and all that they ate, helped pave the way for federal regulation of foods and drugs in the United States — the Pure Food and Drug Act of 1906, also called the "Wiley Act" and later its successor, the 1938 Federal Food, Drug, and Cosmetic Act.

Although Wiley's dining experiment was quite politicized, highly controversial, and remains scientifically contentious today, his efforts led to the scientific regulation of food additives, with rational limitations. The result? Preservatives found safe could be legally added to foods, but not to cover up the use of ingredients unfit for human consumption.

As scientists learn more about the action of certain chemicals in our bodies, the FDA can use this information to re-evaluate further uses of preservatives.

Although no formal long-term follow-up was done on members of the Poison Squad, anecdotal reports indicate that none were harmed. According to William O. Robinson of Falls Church, Va., the human guinea pigs suffered no permanent illness or injury. Robinson, a member of the Poison Squad, was 94 years old when he died in 1979.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.