Pure Food and Drug Movement

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PURE FOOD AND DRUG MOVEMENT

PURE FOOD AND DRUG MOVEMENT. In the late nineteenth century, a reaction—the Pure Food and Drug Movement—set in against the growing scale of industry and its increasing freedom from government control. Before the mid-nineteenth century a large proportion of goods, especially consumables, were produced within the local communities where they were used, and peddlers who carried "foreign" goods were viewed with great suspicion. The advance of wage labor and the rise of large national producers battered down such localism, but the fears and suspicions of goods made by anonymous manufacturers, in far corners of the country, and in unknown conditions, remained.

Long before an organized movement for government regulation of the purity, safety, or labeling of food and drugs took root, Congress considered the problem of consumer protection. The consumers in this case were a select group, uniformed members of the U.S. military. After learning of the appalling death rates—due to disease and inadequate medicines—suffered by the Army during the Mexican War, Congress passed the Drug Importation Act of 1848, the first federal regulation of the quality of goods to be sold in the American marketplace. Though the law governed only imported articles, it was believed at the time that the rising quality of foreign drugs would pressure domestic drug makers to improve their standards to meet the competition.

Congress's first foray into the area of consumer protection was quickly undone by importers who exploited fine loopholes and party machines that staffed customs houses with cronies rather than chemists, but an important precedent was established. The federal government had asserted that it had a right to legislate to protect the public health and welfare. This ran counter to the trend in the 1850s at the state level, where the proliferation of medical disciplines, from homeopathy to magnetic therapies to faith healing, created public pressure to relax the previously strict medical licensing laws. Accompanying this trend was the increasing marketing of "patent" medicines; these concoctions of undisclosed ingredients promised to cure virtually every human ailment and were usually highly alcoholic or laced with addictive narcotics. For most of the nineteenth century these patent or "proprietary" medicines were widely used, and few objected to them. Even the Journal of the American Medical Association carried advertisements for them until 1905.

Although some colonial governments, following British practice, regulated the size, price, and purity of bread, it was when cities grew large that a significant number of people became dependent on middlemen or distant processors for their food supply, and the first public movement calling for government regulation of food appeared. In 1858 Frank Leslie's Illustrated Newspaper exposed the conditions in commercial dairies around New York City where diseased cows were fed distillery swill and their already thin milk was diluted with water and colored with chalk. The public outcry was loud enough to push the state legislature to pass the "Swill Milk Bill" but once the goal was achieved no lasting organization interested in food safety remained.

Until the end of the century most of the pressure for increased government oversight of the nation's food and drugs came not from public-spirited organizations but from private interests. Medical colleges and associations of pharmacists lobbied for restrictions on what were essentially their competitors. Butter makers and dairy interests tried to eliminate the cheap competition of oleomargarine. Kentucky bourbon distillers tried to throttle makers of blended whiskey. Cream of Tartar fought against Alum for control of baking powder. Sugar battled glucose. Meanwhile the public consumed an increasing array of foods laced with preservatives, dyes, perfumes, and cut with lard, cheap oils, by-products, and even sand and sawdust.

A few celebrated crusaders attempted to spark the interest of the public. George Thorndike Angell, better known for his founding of the movement for the humane treatment of animals, was an early advocate of government food-purity laws. Angell's loud warnings of the danger of adulterants to the public health made headlines but also were widely disputed by scientists and experts from both within and without the government. Angell cheered on Congressman Hendrick B. Wright, who introduced a broad food-purity bill in 1879, but such attempts died in every session of Congress for the next quarter century.

No comprehensive food regulation bill passed Congress before the twentieth century, however, farming interests triumphed over oleomargarine merchants in 1886, when Congress passed a special regulatory tax on margarine. Though of minor importance at the time, this proved a landmark in establishing a federal precedent for food regulation.

The struggle over this law marked the start of the career of Harvey Washington Wiley, widely considered the prime mover of food and drug regulation. As head of the Bureau of Chemistry within the Department of Agriculture, Wiley used margarine regulation as a lever with which to pry into the quality and safety of foods in general. With his newly expanded budget, Wiley purchased state-of-the-art photomicrography equipment and launched a sixteen-year investigation into food adulterants. Wiley also helped to found the Association of Official Agricultural Chemists and to place food safety at the top of its agenda.

The First Mass Movement

A mass movement calling for food and drug regulation first appeared at the state level in the 1880s. Massachusetts, New Jersey, and New York were all pressured to create more comprehensive systems of food inspection and regulation by a coalition of medical societies, women's clubs, temperance organizations, and civic organizations. By the end of the century most states had some food and drug regulations, though few seriously attempted to enforce them.

Women, especially those organized in the Women's Christian Temperance Union, were the base of a broadening movement calling for more effective protection of consumers. These reformers were alarmed at the drug addiction, alcoholism, and even death arising from routine use of patent medicines. State laws proved especially inadequate in dealing with medicine companies located in other states. Similarly, local food laws could not regulate conditions in canning plants and slaughterhouses in faraway Chicago or Baltimore.

Momentum toward a national food and drug bill built in the 1890s. A weak meat inspection law passed Congress in 1890 largely at the behest of meat packers themselves, whose products were mostly banned in Europe on the grounds of safety. In 1892 the Senate passed the Paddock Bill, which prohibited some additives and required accurate labeling, but it failed in the House. As outright food frauds multiplied during the long economic depression, the interest of civic organizations in the issue reached its height. Federal hearings exposed the rancid "embalmed beef" served to soldiers during the Spanish-American War of 1898.

Congress acted only after tragedy struck. In late 1901 thirteen children died after being given a tainted diphtheria vaccine in St. Louis. With almost no debate the Biologics Control Act became law the following year creating a tight licensing and labeling regime for makers of medical serums and antitoxins.

That same Congress also allocated money for Wiley's Bureau of Chemistry to begin investigations into the health effects of food preservatives. Wiley, by now experienced at manipulating the press, assembled a group of volunteers who were to dine on foods with established concentrations of preservatives and whose physical characteristics were carefully measured and charted over a period of months. Reporters dubbed the group Wiley's "poison squad" and followed the human guinea pigs over the course of their long experiment. The results published in 1904 were less impressive than the prolonged headline attention given to the issue of the danger of preservatives during the experiment itself.

The forces now lobbying for food and drug regulation had increased markedly from a decade before and included the American Medical Association, the trade journal American Grocer, the newly formed National Consumers' League, a number of influential food processors such as the H. J. Heinz Company, the very influential straight bourbon interests, and a number of western Senators finding political traction in condemning "eastern manufacturers." Yet, Congress still could not pass a bill through both chambers. The scales finally tipped when investigative journalists began to expose in detail food-industry practices. Samuel Hopkins Adams, a former medical student, uncovered the manipulative trade practices of patent medicine companies in a long series that ran in Collier's. Other widely read magazines of the day, such as Ladies' Home Journal, also ran exposés of food adulteration. President Theodore Roosevelt briefly mentioned the need for food and drug regulation in his State of the Union address that opened the legislative year of 1906.

Of all the so-called "muckrakers," none had a more profound impact than Upton Sinclair. When he published The Jungle in 1906, Sinclair hoped to awaken the nation's conscience to the plight of immigrant workers. Instead his stomach-turning passages depicting the conditions in Chicago's slaughterhouses caused the public to worry about its own health. As sales of Sinclair's book mounted, the split in the Republican Party between free-market stalwarts and regulation advocates widened, and worried party leaders applied pressure on the issue. After monumental wrangling, the different versions and amendments were finally reconciled, and the Pure Food and Drug Act and the Meat Inspection Act of 1906 became law.

These laws prohibited the interstate or foreign sale of adulterated (containing poisonous or spoiled ingredients) or mislabeled (including the removal of vital food constituents) foods, drugs that did not meet medical and pharmacological standards, or remedies that did not list on their labels the quantity of dangerous narcotics they contained. Meat was subject to federal inspection and condemnation.

The new system of federal food and drug regulation took a blow from the Supreme Court in 1911 in the case of United States v. Johnson, when the Court interpreted the 1906 statute to prohibit only false or misleading statements about a product's ingredients, not its therapeutic claims. But Congress partly closed that loophole with the Sherley Amendment in 1912. The Gould Amendment, requiring accurate labeling of the weight, measure, or numerical count of food packages, passed in 1913.

But there were countercurrents as well. Wiley was forced out of his post in 1912 after his vigorous enforcement against chemical preservatives and artificial sweeteners alienated him from the very agrarian interests that had helped propel the pure food movement before. After Wiley's ouster his successors trod carefully, focusing only on the most flagrant and threatening abuses that would be universally condemned. In the 1920s efforts shifted from prosecution to attempts to cooperate with manufacturers to improve their sanitation and standards, and the Food and Drug Administration (FDA) was created.

The New Deal and the Cold War

In 1933 a New Deal brain truster, Rexford G. Tugwell, helped promote a tough new revision of the 1906 law. It languished for several years, in spite of energetic lobbying from women's organizations, until a drug catastrophe involving Elixir of Sulfanilamide in 1937 killed 107 patients. The Food, Drug, and Cosmetic Act of 1938 gave the FDA the power to establish standards backed by the power to issue injunctions. The FDA's jurisdiction was expanded to cover cosmetics and medical devices, its regulatory authority over drugs was made proactive, and it was given tough new penalties and relieved of the need to prove criminal intent in all fields. The requirement that manufacturers get the FDA's approval before marketing a new good was expanded beyond drugs to include pesticides and other food additives in the late 1950s. The 1958 Delaney proviso placed a complete ban on any product shown to cause cancer in animals—a small amendment at the time, it became increasingly important with the advancing sensitivity of laboratory assayers.

During the Cold War the broad-based consumer movement that had pushed for powerful federal regulation lost voice to business interests, and Congress allowed the FDA's budget to stagnate in the face of greater regulatory responsibilities. This drift was quickly reversed when an approval review for a new tranquilizer for pregnant mothers, already in use in Europe, stretched out long enough to see the beginning of a wave of birth defects caused by the drug. Congress wasted no time in again expanding the FDA's oversight powers, requiring in 1962 that drug makers prove not only the safety but also the effectiveness of their products.

President John F. Kennedy proclaimed a "bill of consumer rights" in 1962, but it was the rise of a new consumer rights movement, now conscious of dangers from poorly designed products and led by Ralph Nader, that provided a new momentum for the expansion of regulation. Special protections were extended to children's products and fair labeling provisions were made to apply to all products in interstate commerce in 1966.

In spite of a generally conservative and antiregulation environment since the 1980s, the strength of consumer consciousness has remained strong and Congress has been wary of deregulating the food or drug industries. However, with new challenges to the existing regulatory regime from diseases such as AIDS, bioengineered foods, new factory technologies in the meat and poultry industries, food irradiation, and even potential terrorist attacks upon the safety of the food system, this issue returned to the forefront of public policy at the beginning of the twenty-first century.