Foods and Cosmetics Safety

by Food and Drug Administration (FDA)

Prompted by increasing concerns over the use of untested chemicals as food preservatives, Harvey Wiley, M.D., chief chemist of the Agriculture Department's Bureau of Chemistry, set out to investigate whether such preservatives should be used in food and which quantities were safe. Congress appropriated funds for the studies in 1902.

Wiley recruited volunteers, which the press soon dubbed the Poison Squad. The young men ate foods containing measured amounts of borax, salicylic acid, formaldehyde, and other chemical preservatives. He stopped each unconventional experiment after many of his volunteers became sick. According to anecdotal reports, none of the men was permanently harmed.

In the end, Wiley advocated that chemical preservatives should be used in food only when necessary, that the onus of safety should be on the producer of foods, and that consumers should be informed about ingredients on food labels - the basic elements of current food laws and regulations.

"The Bureau scientists watched in amazement as the public was suddenly drawn into the debates over food safety," says Suzanne White Junod, Ph.D., a historian at the Food and Drug Administration in Rockville, Md. "Wiley's studies drew widespread attention to the problem of food adulteration, and public support for passage of a federal food and drug law grew. The 'hygienic table studies,' as Wiley preferred to refer to them, were a crucial prelude to the enactment of the Food and Drugs Act of 1906."

A century later, the FDA's Center for Food Safety and Applied Nutrition still stands committed to the public, says Robert E. Brackett, Ph.D., who has served as the CFSAN's director since January 2004. "Throughout CFSAN's evolution, the dedication of the staff has remained constant, and priority-setting has always been based on doing the most good in protecting and promoting consumer health."

The CFSAN ensures the safety of about 80 percent of all food consumed in the United States, regulating everything except meat, poultry, and certain egg products, which are regulated by the U.S. Department of Agriculture. The CFSAN annually regulates 240 billion dollars' worth of domestic food; 15 billion dollars' worth of imported seafood, fresh produce, and other imported foods; and 15 billion dollars' worth of cosmetics sold across state lines. "We are proud to be a world leader in applying science-driven policies to the safety of foods and cosmetics," Brackett says.

The First Federal Food Laws

The original Pure Food and Drugs Act was passed by Congress on June 30, 1906, and signed into law by President Theodore Roosevelt. The law, which was enforced by the Agriculture Department's Bureau of Chemistry, prohibited the introduction of misbranded and adulterated foods, drinks, and drugs in interstate commerce; prohibited the addition of color additives to conceal inferiority; and prohibited the use of "poisonous" colors in confectionary.

Under the 1906 Pure Food and Drugs Act, there was no pre-market approval system for food ingredients or drugs. The government could act only after products were on the market. On the same day that the Pure Food and Drugs Act became law, the Meat Inspection Act was passed. Historians agree that this legislation was passed amid a slump in meat sales after the publication of The Jungle, by Upton Sinclair. One chapter in the book, for example, contains shocking disclosures of unsanitary conditions in meat packing plants at the turn of the last century. The Meat Inspection Act expanded federal meat regulation to provide continuous inspection of all red meats in interstate distribution.

Other federal food legislation followed. In 1907, the Agriculture Department issued Food Inspection Decision 76, which listed seven colors approved for use in food. Subsequent F.I.D.s in the early part of the 20th century established a voluntary certification program and listed new, added colors.

In 1913, the Gould Amendment, which requires that contents be plainly marked on the outside of the food package, was added to the 1906 Pure Food and Drugs Act. A pivotal ruling on the use of a substance in food came in 1914, when the government had to show a relationship between a chemical additive and the harm it allegedly caused in humans.

The first decade after passage of the act marked a period of significant growth. "Added to initial concerns about food, and in the wake of germ theory, came increasing concerns about microorganisms in foods as a cause of disease," Junod says. "Wiley began to hire expert microbiologists. They helped transform the canning industry, the egg industry, and the refrigeration industry, helping to ensure safer food for all Americans."

But the 1906 law still had serious flaws. For one, manufacturers concerned that the new standards might shut down their businesses had inserted a so-called distinctive name proviso into the law. "This proviso allowed the marketing of foods with distinctive names that would have been otherwise illegal under the 1906 act," Junod says.

For example, a product called BRED-SPRED would have been considered adulterated or misbranded under the FDA's standards because it had no fruit. "There wasn't a single strawberry in the jar," Junod says. "It was made of coal tar, artificial pectin, artificial flavors, and grass seeds. This product and other similar products were beautifully packaged, exquisitely labeled, and heavily advertised in leading women's magazines."

Jelly had always been half sugar and half fruit. But because BRED-SPRED had a distinctive name - it didn't call itself jam or jelly - manufacturers had legal protection from misbranding. "BRED-SPRED typified the kind of inferior product that began to gain a foothold in the U.S. marketplace in the 1920s," Junod says. "Consumers had no way of knowing that such products were of low quality."

Progress was made in 1924 when the Supreme Court ruled against deceptive labeling on apple cider vinegar. According to the ruling, the 1906 Pure Food and Drugs Act prohibited information on product labels that could mislead or deceive, even if the information was technically true. But it wasn't until 1938 that the FDA received authority under a new federal food and drug statute to issue food standards in "the interest of consumers."

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.