Public Health

New Hope and Disputes
by Food and Drug Administration (FDA)

(Page 3 of 6)

The year 1905 was one of crisis and change. By that time, national congresses on food and drugs had been held for five years running, and one bill after another was pressed in Congress, but House Republican leaders killed every measure without consideration. In 1905, a barrage of magazine articles appeared detailing the horrors of the American food and drug trades, from the alcohol-laden restoratives for adults to the deadly opiate-laced syrups for children, from the drug makers' bribes to newspapers not to cover the stories to the phony testimonials used to advertise products.

The final straw came with a novel, The Jungle, by Upton Sinclair. He had worked in the meat-packing industry to research the book, and intended to write a novel that would expose the awful life under "wage slavery." But in the book, he also spent a few pages describing the conditions in which meat was prepared for market: workers sick with tuberculosis spat on the floor and then dragged carcasses across it; meat rotting in storage rooms and carcasses covered with rat droppings were then made into sausage, detritus and all. The book sickened readers and became an instant best seller.

Roosevelt was outraged, doubting that anything like the conditions described could be real. He sent a team of investigators on a secret mission to Chicago to make an unannounced inspection in the meat yards. Company spies soon discovered the mission and had two weeks to clean and whitewash the plants. It wasn't enough. The investigators still found conditions revolting, the practices awful, and they even witnessed one carcass fall from the process line into a latrine. It was quickly hauled out, put back on the line, uncleaned, and sent to storage with the other meat.

Within weeks of the publication of The Jungle, meat sales dropped by half across the United States. "I aimed at the public's heart," Sinclair said, "and by accident, I hit it in the stomach." Meat companies were frightened, and ready for some rules to govern the trade, but leaders in Congress still refused to pass a bill. Women's organizations from around the country and the American Medical Association (AMA) threatened everything including a march on the offices of the congressional leaders if no action was taken this year. A watered-down version of a bill was finally released, but Roosevelt read it and found it worse than the status quo. He had held back releasing the report of his meat plant investigators, but now he turned it over to the newspapers. It verified in fact the conditions described in Sinclair's fiction, and it secured the passage of the nation's first broad food and drug acts. They were signed in June 1906.

New Laws Bring Hope, Disputes

The laws set new standards. For meat, they established inspection and approval before marketing to ensure safety. For drugs, the law did not go as far, but at least set into law the principle that the labels of medicines must be truthful and not misleading. It didn't require listing ingredients, but if they were listed, they had to be correct. The only requirement was listing poisons and dangerous ingredients such as cocaine, opium, alcohol, morphine, and chloroform. One loophole was the vagueness about cures. If a medicine claimed to cure cancer, was that misleading? The courts of the time said any claim was fine if the manufacturer believed it; evidence was not required. The understanding of what "scientific evidence" might be and what experimental trials could show remained weak for decades more.

Wiley was already the head of the new regulatory agency designated to carry out the laws and he served from passage of the law in 1906, to his resignation in protest in 1912 over what he called its lax enforcement by his superiors.

Congratulations were printed across the country on editorial pages; the people's movement for pure food and drugs had won a great victory against the bad businesses; and the future was assured. "The purity and honesty," wrote the enthusiastic editorialists at The New York Times, "of the food and medicines of the people are guaranteed." It was believed that the quacks would be put out of business and the honesty in business would rise to the center of the food and drug trades.

It did not happen. Wiley had hoped that the passage of a law, after more than three decades of voluntary failure by professions and businesses, would give the FDA the influence needed to support the honest merchants and take the miscreants to court. But the wording of the law was simply too weak.

An important case on quack remedies that Wiley chose to pursue in court was one that seemed straightforward enough. The remedy, called, weirdly enough, Cuforhedake Branefude, was sold as a "brain tonic." It contained healthy doses of alcohol, caffeine, and a lethal pain reliever called acetanilide. In one of the magazine series before the law was enacted, this pain reliever was featured together with 22 deaths the writer had found linked to it; the AMA and the chemists at the Agriculture Department had evidence of a far greater number of fatalities. The label on the Branefude packages said the medicine was "a most wonderful, certain and harmless relief" and that it had "no ... poisonous ingredients of any kind."

Simple enough: the ingredients were not harmless, and the only thing that might be called food for the brain in it was alcohol. A jury found the maker guilty. Then, the problem with the law became clear. The maker of the remedy was fined the maximum amount under the law, $700. As Wiley told reporters after the trial, the maker "had made two million on the product ... and was [still] $1,999,300 ahead." The maker didn't even bother to file an appeal; he simply changed the label and carried on selling the product for years.

There was a steady beat of disputes over the law and its meaning, with the nadir coming in the U.S. Supreme Court's ruling that said anyone with a cancer remedy that they personally believed in was entitled to sell it, regardless of medical opinion or scientific evidence.

The fundamental problems of hazardous food and drugs had not been addressed directly.

About the Author

www.fda.gov
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.