The Food and Drug Legislation of 1906

Drug Importation Act of 1848

During the early years of American independence most of the supply of medicinals other than some indigenous herbs had to be imported from Europe. Adulteration of botanical and mineral drugs, including the critical drug opium, was widespread. The effort to ensure a pure supply of drugs was one of the factors leading to establishment of the first pharmacy schools in this country in Philadelphia (1821), Boston (1823), and New York (1829). The problem of drug impurity peaked during the Mexican-American War (1846 1848), when it was perceived that adulterated drugs supplied to the Army had caused the deaths of large numbers of soldiers. A law providing for expert inspection of drugs coming into six designated ports passed Congress with ease, despite opposition from some business interests (2).

Although very successful for two years, the power of the law was soon undercut by a lack of proper enforcement at some ports, partly arising from a lack of appropriate standards and methods of analysis, but mainly owing to political interference and appointment of unqualified inspectors under the spoils system. By 1860, the law was rarely enforced. During Lincoln’s presidency, Dr. Edward R. Squibb, a physician and founder of the eponymous drug company, went to Washington to carry a strong plea for better administration of the law. He presented a letter to an assistant of Treasury Secretary Salmon P. Chase, and received a sympathetic hearing. Unfortunately, Chase appointed, as examiner for the Port of New York, a politically connected Wall Street broker whose only claim of expertise was having been a druggist some seventeen years before his appointment. The campaign of Squibb and other pharmacy and medical leaders thus came to naught (2).

“Every man did that which was right in his own eyes”

Through the 19th century the doctrine of laissez faire oversaw the regulation of both foods and drugs. The egalitarian philosophy of Jacksonian democracy undermined the authority of the schooled professional: the clergyman, the doctor, and the lawyer. There was a revolt against “heroic” treatments, such as bleeding and huge doses of mercury and cathartics, routinely employed by the mainstream physicians. State licensing laws were repealed, in the interest of “free trade” in doctoring, so that graduates of fly-by-night medical schools and even persons with no formal education could freely practice. Samuel Thomson of New England built a medical system based on American botanicals, taking as his slogan “every man his own physician.” Samuel Hahnemann’s homeopathy reached the US from Germany in 1825 and flourished here. Lay healers emphasized natural remedies, including water. Do-it-yourself medicine was encouraged by all these movements.

At the same time, patent medicines (or nostrums) appeared and were heavily advertised in newspapers and magazines. Not really patented, the composition of these products was secret. The spread of public elementary education provided an ever-increasing readership for the gory symptoms and miraculous cures featured in the advertising. The nostrums relied heavily on alcohol, opium, and cocaine as their (undeclared) active ingredients; thus, teetotalers were seduced by alcohol-induced euphoria. Acute pain was relieved by opium or cocaine, but the patient soon became addicted to his medicine (2).

In mid-nineteenth century America, adulteration of foods became a huge concern. Chocolate was occasionally mixed with wheat flour, beans, rice, almonds, or soap. Frequently, red mercuric oxide was added to enhance color and weight. Candies, including their paper wrappings, were colored with metallic dyes. Wheat flour was cheapened by adding potato starch, ground peas, or rice. Copper sulfate or alum was added to inferior flour for use in baking bread; inorganics such as chalk or plaster of Paris countered the acidity of spoiled flour and produced deceptively white bread. The watering of milk was a widespread practice.

In colonial times, various laws had been enacted to protect the food supply, but the unfettered individualism of the nineteenth century swept away these protections. One particularly outrageous result, affecting the children of New York City, was the “swill milk” scandal. The whiskey distillers hit upon an ingenious idea to enhance their profits. They established herds of dairy cows adjacent to their fermentation plants. The spent, fermented grain, was discharged, boiling hot, into troughs, as the sole food for closely-penned cows, each standing in a space of three-by-eleven square feet. Milkmen delivered this milk door-to-door in the poor sections of the city. When a cow ended its foreshortened life, its unhealthy carcass joined the meat supply in the uninspected city butcher shops.

It was estimated that in 1840, 60,000 New York families, including 25,000 children less than five years of age, were using this swill milk as a staple of their diet. Public health crusaders considered swill milk to be the leading cause of death in slum children. Investigative journalists stimulated public outrage, both in New York and throughout the country, forcing the city fathers into perfunctory action. Even when the New York situation became a sensation in Europe, the city government continued to look the other way. Finally, in 1862 the State legislature enacted a law banning swill milk (2).

A Cauldron of Conflicting Interests

In 1879, Pennsylvania Congressman Hendrick B. Wright introduced the first bill to protect the purity of food and drink drugs were not included. Wright’s bill died in committee. Until the end of the nineteenth century, every session of Congress had one or more omnibus bills (that included purity legislation) placed before it, but none passed into law.

A melange of special interests competed during these decades. The public interest clearly required federal laws to assure the purity of the food supply, and in the case of patent medicines, to let the consumer know what they contained. This immediately raised the issue of the extent of federal power. Washington cannot regulate intrastate commerce, but under the interstate commerce clause of the Constitution, articles entered into inter-state commerce may be regulated. Another concern was government intrusion into everyday private life. As one Congressman said before the House, if the Secretary of Agriculture is allowed to establish the standard for a food product, “how long will it be before he will say what kind of clothing we shall wear..., what kind of horse you shall drive...” (2). This concern is echoed even today, as some cities prohibit restaurants from using trans-fat-containing oils.

The food and patent medicine industries opposed legislation, but their front was not completely unified. Each industry welcomed laws beneficial to itself. Thus, when an outbreak of trichinosis in Europe was blamed on American pork, leading to an importation ban of American pork products, US livestock producers lobbied for inspection laws. Passed in 1890 1891, these forbade the export of unwholesome meat and required microscopic inspection of pork prior to export (2).

Among liquor manufacturers, a conflict existed between distillers and rectifiers. The former sold straight whiskey that had been aged in charred wooden barrels; the latter mixed whiskey with grain alcohol and colored it with caramel.

The distillers wanted legislation to force the rectifiers to divulge the nature of their products on the label; the rectifiers accused the distillers of selling liquor containing poisonous fusel oil a mixture of toxic three- to five-carbon alcohols produced during fermentation but removed during the aging process. Ultimately, the rectified beverages were required to be labeled as “blended” whiskeys.

The second half of the nineteenthth century saw great advances in science and technology. The science of bacteriology developed, with its promising implications for both medicine and food quality. In technology, food-canning processes were developed. It also became possible to create foods that did not exist in nature, which aroused vehement opposition, on grounds both philosophic and economic. In the 1880s, great controversy arose over two such “counterfeit” foods: glucose and oleomargarine.

Glucose, discovered in Europe and produced there by the hydrolysis of potato starch, was made in the US from corn starch. Because of its lower cost, it was used to replace sugar in jellies, baked goods, and confectionery; to adulterate honey or even to serve as a counterfeit honey. It was attacked by sugar producers as being unsafe, and proposals were made to tax it. However, chemical and physiologic investigations proved the safety of glucose (2). Today, it is an enormously versatile food ingredient, appearing on labels as “corn syrup.”

A much bigger storm was caused by oleomargarine, developed in France in the 1860s as a cheap substitute for butter, and introduced into the US in the 1870s. Oleomargarine was made mainly from beef fat, but other, less savory, scraps from meat processing were also included. US dairy farmers, envisioning ruin of the butter market, protested vehemently, while large meat packers added oleomargarine to their product lines. In 1886, Congress taxed oleomargarine, to make its price less attractive. Many state legislatures banned the sale of yellow-colored margarine; nonetheless, it remained popular. The tax was repealed in 1950 and the coloring ban in the 1960s (2, 3). Today, most margarine is made by hydrogenation of vegetable oils. This process produces trans-fats, which are another current health concern.

The Twentieth Century Dawns

The logjam was broken, and both the Pure Food and Drugs Act and the Meat Inspection Amendment were enacted in the first decade of the twentieth century. How did this happen? Business interests did not suddenly decide to put the public weal ahead of profits, nor did all members of Congress decide to snub their contributors and lobbyists. Demand for legislation arose from a diverse coalition of citizens, including women’s organizations; civic organizations; scientific, medical, and public health institutions; state food and drug officials; and journalists, businessmen and politicians (4). The demand was fueled by the public’s dismay and horror at what it learned from press expose on the conditions in the medicine and food industries. Of the many who crusaded for federal legislation, three names stand out: Dr. Harvey Washington Wiley, Samuel Hopkins Adams, and Upton Sinclair. Wiley was the chief government chemist, while Adams and Sinclair were journalists of the group then described as “muckrakers,” who now would term themselves investigative reporters.

Harvey W. Wiley and the Poison Squad

Harvey Wiley (Box 1) was appointed as Chief Chemist of the US Department of Agriculture in 1883 and became a consumer advocate and crusader for pure foods. He developed tests for food purity, demonstrating how rampant adulteration and false labeling were. Largely through his work, pure food bills were introduced in Congress during the 1880s and 1890s, but all were successfully opposed by powerful lobbies (5).

In 1902, on a budget of $5,500, Wiley organized a volunteer group of healthy young men, to test the effects of adulterated foods and of individual chemicals on themselves. With Wiley joining them at meals, these men ate foods containing measured quantities of borax, salicylic acid, formaldehyde, and other preservatives. The newspapers dubbed them the Poison Squad. Some of the men were sickened at times, but it is said that none suffered lasting health damage (6). The results were published, not in scientific journals, but in the press. Suddenly, the public was drawn into the debate about food safety. Women, the family meal preparers, banded together in Federated Women’s Clubs to support legislation. The major canners voluntarily stopped using questionable chemicals and became supporters of food safety legislation. The 1906 Act was largely written by Wiley, who has been called the “Father of the Pure Food and Drugs Act” (6).

Adams’s The Great American Fraud

In a series of magazine articles running from October 7, 1905 to February 17, 1906 in Collier’s Weekly, Samuel Hopkins Adams (Box 2) exposed the patent medicines, or “nostrums,” and their sponsors, as well as the quacks imposing on the American public. The labels of patent medicines were full of glowing statements of what they would cure, but disclosed no information whatsoever on what they contained by way of active or inactive ingredients. Adams bought bottles of some of the highly advertised medicines and had them analyzed by his former chemistry professor and by experts at a pharmaceutical laboratory. In addition to alcohol, cocaine and morphine, as mentioned above, another popular ingredient was acetanilide. At that time, organic synthesis was coming into its own in Europe. One of the first synthetics, acetanilide had analgesic and antipyretic properties. It also was quite toxic, causing methemoglobinemia. Many deaths were caused through inadvertent overdose or from hypersensitivity to the compound.

The other major evil that Hopkins attacked were the “miracle workers” and humbug “specialists” who offered to cure alcoholism, drug addiction, and other afflictions by mail or by means of some potion. An example of the miracle worker category was a self-styled wizard named Isham who came to New York and sold “California Waters of Life.” He claimed that this water, from a spring near San Diego, was the same as the water which gushed from the rock smitten by Moses (see Numbers XX, 11). It cured rheumatism, cancer, Bright’s disease, and diabetes, and for good measure, baldness as well. There were also bearded, professional types whose photographs appeared in print advertising, whose appearance presumably vouched for their expertise.

The nostrum sellers and quacks were major advertisers in newspapers and magazines, learning quickly how to capitalize on their clout. The proprietor of Hall’s Catarrh Cure, one F. J. Cheney, added a clause to his advertising contract stipulating that the contract was voided in the event of any hostile law being enacted. At a conference of the Proprietary Association of America, Mr. Cheney presented the wording of his clause, which was gratefully adopted by the other nostrum sellers and became known as the “Red Clause.”

Cheney’s clause co-opted the print media; it was now in their interest to oppose any regulatory legislation. Hopkins cited the following example of how the free press had been silenced. In March 1905, the Massachusetts legislature debated a bill providing that every patent medicine declare its contents on the label. Some twenty legislators spoke and dramatic information was released. Not one of the Boston papers reported this debate, although the business of the legislature was typically covered in detail.

Adams’s articles were collected in a book titled The Great American Fraud (7), grouped into two series called “The Nostrum Evil” and “Quacks and Quackery.” Additionally, covered were the conspiracy against freedom of the press, exemplified by the Red Clause, and the shabby treatment of letters sent to nostrum makers by customers.

In the Victorian era and early twentieth century, certain health issues, particularly those related to genital problems, were not discussed or written about openly. Many patent medicines, particularly those purporting to cure “women’s complaints,” invited their users to write in any questions or problems. They promised complete confidentiality. Women wrote, believing their questions would receive attention from qualified and sympathetic medical people. Adams discovered, however, that these confidences were replied to by form letters, and that letters were sold in bulk to brokers who resold them to augment the mailing lists of other nostrum makers or fake medicos (7).

Adams’s magazine series and his book, which was published by the American Medical Association (AMA) and snapped up by the lay public, expanded awareness of the need for legislation to control the evils he described. The pure food and drug bill was reintroduced in 1906, this time with good chances for passage (2, 7).

The Jungle

In the summer of 1904, Upton Sinclair (Box 3), a 26-year old writer and recent convert to socialism, having read newspaper accounts of a failed strike in the Chicago stockyards, became interested in the situation there. He proposed to write a novel on the subject, and sold the serial rights to Appeal to Reason, a national circulation socialist weekly published in Kansas. That autumn, having received a $500 advance, he checked into a hotel opposite the Union Stockyards, telling people that he was writing the Uncle Tom’s Cabin of the labor movement.

Sinclair spent seven weeks in what was called Packingtown, doing research for his novel. Serial installments began to appear in March 1905. His central aim was to expose the brutal working conditions in the meatpacking plants and the merciless exploitation of the workers, mainly immigrants rendered helpless by lack of education and scant knowledge of English. As a small example, one could be fired for even asking for a day off for personal need. In describing the assembly line slaughter and processing of cows and pigs, Sinclair told how flesh from tubercular cows, cholera-infected hogs, as well as floor sweepings and even rats were incorporated into breakfast sausages and pickled meats; and how chemicals were added to improve the appearance of the products.

When The Jungle appeared in book form in February 1906, both the novel and its author achieved instant fame. The revulsion of its readers was such that the sale of meat in the US dropped by 50%. Sinclair sent an advance copy to President Theodore Roosevelt and was invited to lunch at the White House. Roosevelt, as a Colonel in the Spanish-American War, had been outraged by rotten meats (“embalmed beef”) supplied to the Army, and was a staunch opponent of the Beef Trust. Roosevelt sent an investigative team to Chicago: Sinclair’s statements were found to be accurate in almost every detail. Sinclair, who was attacked both as to facts and ad hominem (e.g., that he spent more time in Chicago brothels than in the packing plants), unleashed a barrage of letters and telegrams to Congressmen and newspapers, stirring further public outrage. He also peppered the President with letters, which greatly irritated Roosevelt.

The Beef Trust’s lobbyists and supporters in Congress were thus neutralized. The Jungle is widely credited for the passage, in June 1906, of the Pure Food and Drugs Act and the equally important Meat Inspection Amendment (8–10). Ironically, Sinclair felt that he had not succeeded in his objectives. He had aimed to arouse the American public to the unjust treatment of the laboring people of Packingtown, and to promote socialism as a remedy for social injustice. Instead, the public focused its anger on the disgusting way its food was being prepared.

Passage of the Pure Food and Drugs Act and the Meat Inspection Amendment of 1906

Because of the onslaught of public opinion churned up by the work of Wiley and the writings of Adams and Sinclair, opposition to the idea of food and drug legislation was forced to retreat. The special interests concentrated instead on building loopholes into the law, in which they were to some extent successful. Following Senate passage, the House passed the bill 241-17, on June 23, 1906. The bill then went to a conference committee where the Senate version made more concessions to industry and to the constitutional conservatives, and the House conferees yielded in the interest of quick passage. In only one week the bills were reconciled, and on June 29 both Houses of Congress accepted the conference bill. On June 30th, the President signed both landmark bills into law (2).

Provisions of the 1906 Acts

The Meat Inspection Amendment was a strong and straightforward piece of legislation. Federal inspectors were to oversee all meat processed for interstate and foreign commerce, both before and after slaughter. Condemned meat was to be destroyed. Dangerous dyes, chemicals, and preservatives were banned. Sanitation and hygienic conditions in plants were established.

The Pure Food and Drugs Act reflected the assumption that if the consumer were adequately informed, he could protect himself. The Act was built around four key words: food, drug, adulteration, and misbranding. The definition of drug was so written as to include patent medicines. For foods, six major forms of adulteration were spelled out. In the case of drugs, adulteration meant deviation from accepted standards (Box 4).

Misbranding was defined as deceptive labeling. The label must state the place of manufacture of the product. It must declare and state the quantity of any alcohol, morphine, opium, cocaine, heroin, alpha- or beta-eucaine, chloroform, cannabis, chloral hydrate, or acetanilide. Another significant provision was the definition of “person” to include corporations. Two types of legal action were authorized: prosecution for a misdemeanor, punishable by fine or imprisonment, and government seizure of adulterated or misbranded product (2).

The positive effects of the 1906 legislation were soon evident. For example, on June 8, 1907 Samuel Hopkins Adams was happy to report in Collier’s that “the cocaine purveyors have largely been driven out of business” (2). Acetanilide was also removed from products, and was largely replaced by phenacetin (7). The latter analgesic was itself banned, some ninety years later, because of toxicity concerns (11).

On the other hand, there were imperfections and loopholes. One example was the “distinctive name proviso.” Foods that were otherwise illegal could be marketed if they had a distinctive name. A beautifully packaged product called BRED-SPRED was heavily advertised as a jam or jelly substitute. It contained no fruit, but was made of pectin, grass seeds [!], coal tar colors, and artificial flavors. Because neither “jam” nor “jelly” appeared on the label, BRED-SPRED was legal under the 1906 Act (6).

In human affairs, perfection is never achieved. Although the Meat Inspection Amendment did its job well, the Pure Food and Drugs Act was flawed. Over time, Congress acted to make improvements. In 1913, the Could amendment required that the contents of a food package must be shown on the outside of the package. The Distinctive Name loophole was plugged in 1938 (6). On the positive side, the 1906 Act gave rise to the Food and Drug Administration, which carries out its mission as a science-based regulatory agency. Throughout the twentieth century, further laws were enacted to address various important issues in the area of food and drugs. A century’s experience has shown that government, acting on a firm basis of science rather than politics, can effectively protect the population from the greed and guile of those who would prey upon it.