Wiley's Proto-FDA vs. Coca-Cola

Related articles

In the early days of what would later become the Food and Drug Administration, Secretary of Agriculture James Wilson would only approve seizures of products from small manufacturers whose hygienic practices were clearly objectionable. But Harvey Washington Wiley, chief of what was then known as the U.S. Bureau of Chemistry, longed to go after "the big boys," as he liked to call them. Prominent on his wish list was the Coca-Cola Corporation.

Bureau inspectors returned from Coke's headquarters in Atlanta with tales of childhood addiction to the popular beverage. Those kids were all "doped on Coke" Wiley concluded, and he was convinced that added caffeine was the source of the problem. Wilson, however, balked at taking action because any seizure would lead to a highly publicized trial, and Coca-Cola could afford to pay whatever it might cost to defend itself.

U.S. Marshals vs. the Man with the Secret Formula

Like Wiley, Asa Candler was raised by loving parents on a productive farm and subsequently acquired a facility with chemistry. Unlike Wiley, he was a product of a war-devastated South who first sought his fortune in nearby Atlanta at the age of ten. There, he traded mink pelts for straight pins and other notions bought cheap and later sold dear in rural Georgia. Thus he discovered that good money could be made from small sales to millions of people, an important principle upon which he based his major enterprise, the Coca-Cola Corporation.

Three years after the 1906 Pure Food and Drug Act was enacted, bureau inspectors returned from Atlanta with concerns about the general public's apparent dependency on the intoxicating effects of carbonated beverages. Coca-Cola especially attracted their interest because of its domination of the industry, and Asa Candler's tenacious resistance to their inquiries. Why, they asked, was the formula kept secret? Rumors of a cocaine residual from coca leaves could not be confirmed in their Washington laboratory, but there was no argument about the beverage's certain caffeine content. Wiley was unconcerned that coffee and tea contained twice as much caffeine as Coca-Cola did. He saw a danger to society and urged seizure of the product.

His boss, Secretary of Agriculture James Wilson, was less willing to challenge a major corporation that could afford to defend itself in court. Later he relented, and on a chilly October morning in 1909, U. S. Marshals waited in a Chattanooga rail yard to intercept a shipment of Coca-Cola syrup arriving from Atlanta. The sensational trial that followed, "United States vs. forty barrels and twenty kegs of Coca-Cola," would pass through district and appellate courts before reaching the Supreme Court for a final resolution.

Demon Caffeine

The government's prosecution of the case was hindered by ambivalent language in the 1906 law. Violations required either proof of adulteration with a dangerous substance and/or a deliberate misbranding of the product. Caffeine served as Wiley's toxic adulterant. As for misbranding, he challenged the validity of the trademark name: "Where was the 'coca' and the 'cola' in Coca-Cola," he asked?

When Candler learned that federal attorneys intended to plead a case for misbranding, he could hardly believe that Wiley sought to punish his product for not containing the powerfully addictive alkaloid, cocaine. His defense strategy was twofold: caffeine was not an added substance but rather integral to the original formulation, and Coca-Cola was a universally recognized and distinctive name that fully justified its trademark. Meanwhile, he predicted accurately that the government's case for caffeine being a dangerous substance was weak. During the limited time still available before trial, Candler sought the best scientific data he could find on caffeine's human psychological effects.

Coca-Cola's attorneys found James Cattell, Columbia University's distinguished experimental psychologist, who promptly turned them down. Instead, the professor volunteered his young protege and recent doctoral recipient, Harry Hollingsworth, who warily agreed to conduct a study of caffeine but with certain conditions. Fearing that his career might be adversely influenced by the taint of corporate-funded research, he specified that he must have absolute control over the design of the study and that his findings could be published regardless of what they said. If they were favorable to Coca-Cola, the company could not refer to him by name or to his academic affiliation in any subsequent advertising. Coca-Cola not only accepted his conditions but lived up to the agreement fully.

Prior studies were limited to caffeine's influence on basic motor responses. Hollingsworth conducted thirty tests of cognitive function, including measures of perception, association, judgement, discrimination, and reaction time. He managed to avoid all of the problems experienced by Wiley and his by then notorious "Poison Squad." Subjects were recruited from graduate student ranks at Columbia. His wife, until recently a fellow graduate student, helped him conduct the experiments, which included rigid control of dietary intake and avoidance of any alcohol and caffeine beyond the limits of the study. Using a random crossover design with satisfactory intervals inserted between the test periods, subjects could serve as their own controls. Even as he was preparing his testimony in anticipation of departing for Chattanooga, Hollingsworth's wife was still collating the final data in their modest New York apartment.

The Trial

The Coca-Cola trial was as much a media event as could be generated in a southern city in 1911. Journalists from New York and Atlanta fought for space in the courtroom with Chattanooga's best trial reporters. Each day, the Chattanooga News devoted most of its front page to the trial. Attorneys for both sides had assembled an impressive assortment of expert witnesses, including scientists from distinguished universities as well as from numerous government laboratories. Selected members of the clergy were asked to speak against Coca-Cola's dangers but their largely anecdotal evidence could not withstand the withering cross-examination by the company's lawyers. Most of the government's scientists depended exclusively on laboratory data, largely based on force-feeding small animals with an exclusive diet of Coca-Cola. The jury was clearly unpersuaded by the prosecution's case.

When Professor Hollingsworth took the stand and proceeded to describe the conduct of his experiments, the courtroom fell silent and each juror listened with renewed intensity. Few people sitting in that room had ever listened to a scientist explain why the conduct of experiments on human subjects must be so carefully controlled in order to assure valid conclusions. The soft-spoken professor was rarely interrupted by either legal team. His data convincingly proved that caffeine was only a mild stimulant, one that worked quickly but was short-lived. He found no evidence of fatigue or depression for any dose used in the study. At the close of morning, he concluded that caffeine, in amounts equivalent to those found in Coca-Cola, showed no deleterious effects in mental performance. Instead, it stimulated a tolerable level of increased alertness. There was no cross-examination. The government's attorneys wanted the professor to leave the stand as quickly as possible.

Hollingsworth and his wife were later paid handsomely for their research, allowing her to complete her own graduate degree. His career was surely influenced by his receipt of corporate research funding; he became a widely recognized expert on the influence of various drugs on cognitive function. In addition, he became well known for his writing about methods for proper conduct of research on human subjects. His initial reluctance to participate in the caffeine study was transcended by the realization that experiments of the kind he wished to pursue could not be achieved without private support. He continued to solicit corporate support for much of his research. His Coca-Cola-funded study has stood the test of time and remains a classic.

A Loss for Wiley But Still a Matter for the Supreme Court

At the close of testimony in Chattanooga, it was clear to all present that the government's case could not be sustained, and that it would be legal folly to give it to a jury. There was no convincing evidence of a deleterious effect from caffeine, and without that, Coca-Cola would become the certain victor. Yet, Justice Department attorneys were troubled by the concept of a corporation hiding behind its trademark and defending every ingredient in the original formulation from the jurisdiction of a regulatory law. When Coca-Cola's attorneys filed for a directed verdict from the judge, the prosecution enthusiastically agreed. Without a jury decision, the judge's decision was subject to review in the Sixth Circuit Court of Appeals. The government intended to appeal its apparent loss. Meanwhile, Secretary Wilson manipulated Wiley into resigning as chief of the Bureau of Chemistry.

On July 13, 1914, a panel of three appellate judges sitting in Cincinnati confirmed the directed verdict in Chattanooga. Learning of their decision, Asa Candler could barely restrain himself and promptly issued a statement that his beverage had received from learned judges "an entirely clean bill of health." But neither court had said anything of the kind. The legal questions had involved only the meaning of words like "adulterant" and "misbranding." Neither jurisdiction had even deliberated on whether or not caffeine was a danger to human health. The appellate decision was not favorable to the statutory power of the food law, though, and so the Department of Justice wasted no time in taking the matter to the Supreme Court.

On February 29, 1916, attorneys representing the federal government and Coca-Cola appeared before the impaneled justices, among them Charles Evans Hughes, who would later write the opinion for a unanimous court decision. Once again, Coca-Cola's defense was based on its conviction that caffeine was not an adulterant because it was part of the original formulation. This time, the justices were not buying that argument. Hughes would later write, "If this were so, then manufacturers would be free to put arsenic into compound articles of foods made according to its initial formulation and then sell the lethal mixture under a fanciful and harmless name."

As to the accusation of misbranding, Coca-Cola stuck to its "distinctive name" theory, but the court observed that a manufacturer could designate a mixture as "Chocolate-Vanilla" even though it was destitute of either one or both ingredients, provided of course that the combined name qualified for trademark approval but no corporation could hide behind a trademark in order to avoid regulations that guaranteed public safety. Simply stated, the justices agreed that the company's entire defense was illegitimate. Published in October 1916, the Hughes opinion reversed both the Cincinnati and the Chattanooga decisions, requiring that the issue of caffeine's alleged injurious properties be remanded for retrial in district court.

A Compromise Is Forced and Coke Loses Some Zip

There would be no retrial. Asa Candler had since retired, and his son, Charles, was not only in charge but also more willing to seek compromise than his father. Department of Justice attorneys accepted Coca-Cola's offer to reduce by half the caffeine content in their beverage rather than risk another highly visible trial. Standing behind this compromise was the scientific evidence relating to caffeine's affect on cognitive function: a mild, short-lived stimulant and nothing more.

Ten years had elapsed since passage of America's first pure food and drug law. Uncertain wording of the original statute necessitated court interpretation for clarification and empowerment. A public-spirited crusader bent on assaulting a major corporation was willing to proceed even without the evidence to prove his allegation. The courtroom failed as an effective venue for resolving questions of science. After a long decade of battle, both sides were eventually willing to compromise.

Nearly a century later, our society faces analogous conflicts. Regulation is a political process that seeks avoidance of risk; innovation is a scientific process that necessarily accepts some element of risk. Government regulation inevitably places these two forces in conflict with each other. For the public interest to be served in a creative society, a satisfactory compromise must be achieved.

Jack C. Fisher, M.D., a member of the Advisory Board of ACSH, is Emeritus Professor of Surgery, UCSD, and a historian who is currently writing a book on the regulation of foods, drugs, and devices in twentieth-century America. Read his previous articles on Wiley, his "Poison Squad," and the creation of pure food and drug laws.