3 ENTER THE FEDS

Entrenched and well-connected food industry lobbyists did not sit idly while Wiley built his case for federal intervention. The most powerful ones represented canners, who relied on preservatives, and the profitable so-called rectified whiskey trade, in which distillers added coloring and flavor agents to cheap, impure alcohol and sold it as whiskey. Wiley had made rectifiers his number one target, charging that 90 percent of the country’s whiskey was fake. Lobbyists argued that everything they added to liquor was harmless and that any federal regulation would be anti-American, decimate business, and force thousands out of work. Wiley, they argued, had no real-world experience in administering food laws and had cherry-picked evidence to draw inflammatory and misleading conclusions.1 They also contended that Congress did not intend drinks and liquor to be covered by a law addressing food.

Wiley realized that Congress was unlikely to embrace any proposal that was too hard on the rectifiers. Between half to two thirds of all federal income came from a tax on alcohol; even fake whiskey makers paid it.2

Some consumer advocates were disappointed that the federal oversight and regulatory law Wiley envisioned was almost entirely about food and failed to address the dangers of pharmaceuticals. In fact, while he had assigned a small number of researchers in his Bureau of Chemistry to collect evidence of “advertising of fraudulent [patent] remedies,” he favored excluding all patent drugs from any statute.3 The one proposal he supported was more symbolic than substantive, an ambiguous provision to more efficiently inspect the two hundred or so USP/NF drugs.4

His reluctance surprised colleagues, some of whom knew that Wiley privately condemned patent medications as “the most vicious of the whole circus of medical frauds… which preyed on incurables.”5 A few friends knew about a childhood incident that helped form Wiley’s opinion of nostrums. He fell ill with malaria when he was eleven, the result of a mosquito infestation in the southern Indiana lowlands. The Wileys were too poor to afford Abram’s Pill, a proprietary “miracle cure” that promised “instant remedy” for malaria’s high fever and bone-rattling chills. It turned out the Wileys were fortunate. Some neighbors died not from malaria but instead from Abram’s Pill. Years later Wiley discovered the cure’s main ingredient was arsenic.6

Why was he unwilling to take the lead when it came to a public health issue that matched so well with his expertise and interest in medicine and chemistry? The answer is in Wiley’s personal letters and papers: his cold political calculus was that championing drug regulation reduced the chances of convincing Congress to pass a straightforward pure food law. Wiley thought he lacked the political capital to tackle two powerful lobbies simultaneously. He feared that adding drug oversight into the mix would be too complicated and doom any proposed legislation.7

However, in 1905, the year he started dismantling the Poison Squad, Wiley abruptly reversed himself. Collier’s had begun publishing a blistering ten-part exposé of the dangers of bogus patent medications hawked as cure-all elixirs.8 The opening paragraph of the first article set the tone: “Gullible America will spend this year some seventy-five million dollars in purchasing patent medicines. In consideration of this sum it will swallow huge quantities of alcohol, an appalling amount of opiates and narcotics, a wide assortment of varied drugs ranging from powerful and dangerous heart depressants to insidious liver stimulants; and far in excess of all other ingredients, undiluted fraud.”9

The Collier’s series sparked a fury over patent drugs. It shamed the American Medical Association to stop accepting nostrum advertisements in its journal, JAMA. It had been running lucrative patent drug ads while ostensibly debating the ethics of doing so.10 In the wake of the Collier’s publication it tried playing catch-up by reprinting the investigative series as an inexpensive booklet and distributing half a million copies.11

Wiley saw an unexpected opportunity in the great hue and cry. More than a dozen pure food bills had stalled in five previous Congresses. Maybe, he calculated, if he included drugs as part of any proposed law, the outrage over nostrums might help break the political stalemate. Politicians knew the Collier’s series had struck a public nerve. Failure to act might provoke a voter backlash.12

To the distress of the nostrum makers, Wiley soon suggested the name of the proposed statute be changed from the Pure Food Act to the Pure Food and Drug Act.13

That proposal thrilled health advocates. By 1905, as Wiley drafted the bill that would be submitted to Congress, a plentiful and cheap supply of unregulated Heroin and cocaine had resulted in what he called the “tragic numbers”: an estimated addiction rate as high as 2 percent of the population, upward of 1.5 million addicts.14

In one draft of the law, Wiley defined drugs as “any substance intended to be used for the cure, mitigation, or prevention of disease.”15 That was broad enough to encompass both USP/NF and patent drugs. He also proposed that patent remedies disclose all ingredients on their labels. As for any that included cocaine or alcohol—both of which he personally thought more dangerous than Heroin or opium—they should be dispensed only with a doctor’s prescription.16

Those revisions sent a chill through the drug industry. At the turn of the century it was not a business dominated by a handful of mega-companies. Instead, there were hundreds of firms, ranging from established ones to many questionable operations that thrived selling nostrums. All disliked the idea of federal oversight. Conventional pharma firms hoped any statute might only go so far as to eliminate patent quackery. The influential Proprietary Medicine Manufacturers and Dealers Association of America, a consortium mostly of wealthy patent medicine businessmen, feared the law would target them.17 Many of them had never made a nostrum but were naturally gifted promoters who wanted no restrictions on how they marketed their products to consumers.18

One strategy to fight the proposed law was to make Wiley himself the issue, casting him as a well-intentioned chemist who had exceeded his expertise and knowledge. There was a little-known counter-narrative to Wiley’s selfless do-gooder image. The same considerable ambition that made it possible for him to attract a wide public following had spawned many bitter enemies.19 Would Congress reject his statute if he was marked as someone who had cunningly manipulated his interests in food purity only to satisfy a lust for personal fame? The Proprietary Association knew Wiley had hired press agents to bolster his reputation for tirelessly battling corrupt businessmen to expose fraudulent labeling and fake products.20 It also had uncovered evidence that he might have sometimes used his bureau’s growing influence to benefit a handful of companies he favored.21

After a heated debate, however, the Proprietary Association decided Wiley was personally off limits. There was not enough evidence to make the case against him as a power-obsessed chameleon. The consensus was that going after him was too risky.

The Proprietary Association’s final strategy was simple but inspired. Under the guise of public safety, it focused on deflecting the spotlight away from all patent drugs to only a handful of the most dangerous homemade nostrums.22 Industries that had become dependent on patent remedies for revenue liked the idea that only a few outlier drugs were the problem. Dispensing physicians and pharmacists as well as wholesale suppliers of the ingredients joined the effort. Both the National Associations of Wholesale and Retail Druggists soon came aboard.23

The biggest indirect beneficiaries were the newspapers in which patent drugmakers advertised.24 At the turn of the century, patent remedies brought in $50 million annually to more than four thousand papers.25 It was half of all the income for newspapers, money that Wiley dubbed “blood money.”26 The newspapers dispatched a small army of lobbyists with the same message to Washington: don’t damage a good industry because of the bad actions of a few. All the while, the Proprietary Association reminded congressional leaders of the federal 4 percent tax on the retail price of all patent drugs; any legislation that led to a reduction in the number of drugs sold would also reduce what had become a steady source of government revenue.27

The lobbying effort was relentless. Wiley rewrote the draft repeatedly to drum up congressional support. At times, he confided to a friend, he was so worried that lobbyists might kill the bill that he often knelt inside the closet of his office and prayed.28

Once the bill got to congressional committees, drug lobbyists redoubled their efforts. It was not long before most of the key revisions benefited the pharma industry. One amendment eliminated the requirement for prescriptions for cocaine and alcohol-based drugs.29 Another diluted the language to punish drugmakers by freeing them of any responsibility so long as they could demonstrate their promotional claims were “made in good faith.” Wiley had wanted a listing of all ingredients on every label but another change required they only had to show any of sixty “poisons.” That was weakened further to require revealing just eleven ingredients deemed addictive or dangerous, including cocaine, opiates such as morphine, opium, and Heroin, alcohol, chloroform, and cannabis.30 Even those judged “poisonous” were required only if they exceeded an arbitrary legal minimum.31 Wiley fretted that allowing those drugs to be used without notice and at any dosage threatened to “simply make the bill a joke.”32

The acrimonious debate continued for months. In early June, on the heels of the Collier’s series, Wiley got some unexpected help in persuading last-minute holdouts in Congress. A socialist weekly ran a serialization of Upton Sinclair’s novel The Jungle.33 Sinclair wrote about the plight of poor immigrant workers in the U.S. He hoped his book might spark a revolt against capitalism. “The ‘Uncle Tom’s Cabin’ of wage slavery!” wrote his friend and fellow socialist Jack London. “What ‘Uncle Tom’s Cabin’ did for black slaves, ‘The Jungle’ has a large chance to do for the wage slaves of today.”34 Sinclair’s political message was overshadowed, however, by the novel’s fifteen stomach-wrenching pages about filthy conditions in Chicago’s stockyards and meatpacking industry.35 A revolted public read of putrefied meat deliberately mislabeled and sold. Worse was the disclosure that ground meat sometimes contained poisoned rats or dismembered body parts from accidents among the assembly line workers.36 The outrage that followed that serialization compelled Congress to cobble together and approve the Meat Inspection Act. The Pure Food and Drug Act, informally known as the “Wiley Act,” passed with it.37 President Theodore Roosevelt signed both into law on June 30, 1906.38

The thrust of the new law, hailed as a milestone in consumer safety legislation, was “truth in labeling.” That seemed straightforward since food and drug companies were not previously required to list any ingredients. And the landmark legislation put in place some long-overdue and commonsense regulations against misbranded and adulterated foods and drugs.39

The widespread enthusiasm might have been tempered if it had been known how the pharma lobby had weakened the provisions that applied to the drug industry. While the Pure Food and Drug Act appeared to deliver radical reform, it lacked the substance to enforce its hyperbolic promise. There were critical exceptions to universal truth in labeling. “The bill is not as good as we should like it,” Wiley privately admitted to one colleague.40 A last-minute amendment even permitted the sales of USP/NF medications that failed to meet the quality, strength, and purity claims on their labels.41 Patent drug makers did not have to disclose any ingredients they did not tout in their marketing. The law’s most devastating omission was its failure to address the fantastic but improbable therapeutic claims of nostrums. Wiley and other consumer advocates hoped the courts might liberally interpret the law’s ban on “false labeling” to apply to unproven healing and curative claims. In United States v. Johnson in 1911, the Supreme Court dashed that by ruling that the bar on dishonest labeling did not cover therapeutic claims (the court upheld the right of a physician to sell six alcohol and herbal remedies as a cure for cancer).42 I 43

America’s most popular patented medicines made minor changes to their labels and then trumpeted their compliance with the new law. Vin Mariani, a top selling nostrum marketed for maintaining “overall good health, energy and vitality,” was typical. It was a French Bordeaux with 7.2 mg of pure cocaine per ounce. Vin Mariani, a favorite of Pope Leo XIII, claimed to have “over 7,000 written endorsements from prominent physicians in Europe and America.” In the wake of the Pure Food and Drug Act it listed cocaine on its label but made no changes about the remedy’s unproven curative powers.44 Hundreds of other nostrum makers who featured cocaine or opium as primary ingredients did the same. Some even boasted that they reduced the concentration of opiates or alcohol in their nostrums, but those cuts were mostly negligible.45 A few narrowed the breadth of what they promised. Hazeltine & Co. changed the tagline for its popular Piso’s syrup—a solution of alcohol, cannabis, and chloroform—from “Cure for Consumption” to the more generic “Remedy for Coughs and Colds.”46

Within a year of the law’s passage, most nostrum makers included on their label, “Guaranteed under the Pure Food and Drug Act.”47 They hoped the public would conclude that tagline meant the drugs were not dangerous.48

Although both the nostrum industry and traditional pharma had won many concessions in the law, it still empowered the Bureau of Chemistry with exclusive enforcement powers. Some wondered whether Wiley would push the limits of the law and tie up pharma firms in litigation. They did not know that Wiley had decided to concentrate on “battles attracting the attention of the whole nation.” He wanted to target companies with which every American was familiar. Fortunately for pharma firms, none were that prominent. Although Bayer was a household name in Germany, it had not achieved that status yet in America. As a result, Wiley showed no interest in tackling its Heroin brand. A popular drug manual published by Squibb noted in 1903 that “Heroin has lost none of its prominence” and cited a small study in which it had demonstrated “decided advantages” in treating bronchial infections and without a “tendency to form a Heroin habit.”49 (It took sixteen years before the government required a prescription for Heroin and another decade before it placed restrictions on its sale. By then the country had added an additional quarter million addicts.) Wiley did not even open an investigation when Bayer announced its discovery of a new class of drugs, barbiturates. Potent and addictive sedatives, its first product, phenobarbital, went on sale under the brand name Luminal in 1908 without prescription.50

Moody’s, the financial rating firm, reaffirmed to Wiley that he was right in judging the drug business too insignificant to generate daily headlines. When Moody’s started publishing industry analyses in the U.S. in 1909, pharmaceuticals was so small it was not listed as a separate category. It took another twenty years before Moody’s created one, ranking drug firms as the sixteenth most profitable American industry. There were hundreds of small companies vying for a piece of the nascent trade, none with more than 3 percent of the market.

Only 135 of the first 1,000 enforcement actions under the Pure Food and Drug Act were against drugmakers.51 Most involved technical labeling infractions resulting in fines of less than $50.52

Wiley did bring some landmark actions. They involved corn syrup, saccharin, benzoate of soda, aluminum baking powders, and a multiyear battle over rectified versus pure whiskey53 II 54 He declared caffeine public enemy #1 and made Coca-Cola his highest-profile target. As Wiley correctly forecast, his campaign demonizing caffeine—which he claimed was more dangerous than strychnine—galvanized public attention. It was front-page news when he charged that Coca-Cola was a public health hazard that violated the law since it did not list caffeine as an ingredient. Wiley’s “literal-mindedness about labels” was evident when he contended the company duped consumers by calling itself Coca-Cola despite having no cocaine—it had been removed entirely in 1904—and only a trace of cola.55

Wiley’s animus against caffeine was sincere. His fundamentalist Christian parents had raised him to believe it was “a devil’s stimulant.”III56 He was convinced caffeine caused mental defects and motor deficits as serious as alcohol and that it was “habit-forming and nerve-racking.” Damning caffeine as “the most common drug in the country,” he warned that “coffee drunkenness is a commoner failing than the whiskey habit.… This country is full of tea and coffee drunkards.” He warned Congress that caffeine was toxic and in public speeches sounded the alarm: “I would not give my child coffee or tea any more than I would give him poison.”57

With Wiley focused an caffeine, Congress acted on its own regard in 1909. It passed the first ever federal drug prohibition statute, the Opium Exclusion Act.58 That targeted a smokable variety of opium favored by Chinese immigrants, whom Senate majority leader Henry Cabot Lodge had described as “uncivilized elements in America.” The law did not address the opium used in patent medicines or traditional pharma drugs.59 Its unintended consequence was that Chinese criminal gangs took control of the opium trade in San Francisco’s and Los Angeles’s Chinatowns, resulting in higher prices and a jump in crime.60 Meanwhile, the American public interpreted the passivity of Harvey Wiley, who was admired for his zealous crusading, as evidence that drugs for sale had somehow passed safety and efficacy criteria under the Pure Food and Drug Act.

The Coca-Cola trial, United States v. Forty Barrels and Twenty Kegs of Coca Cola, in 1911, was the culmination of Wiley’s career.61 Prosecutors held the trial in Chattanooga, where Coca-Cola had a large bottling plant. The government’s case cast Coca-Cola as a dangerous, addictive drink. Its caffeine stimulation was so well known, testified a Department of Agriculture chemist, that many consumers called it by the nicknames “coke” or “dope.”62 (Coca-Cola did not take a trademark on Coke until 1942.) In its defense, Coca-Cola called a series of leading chemists and research scientists who contended that the government had overstated the danger of caffeine, and in any case, the amount of caffeine in the soda was only a third of what was in an equivalent cup of coffee or tea.

Three weeks into the trial, Coca-Cola made a motion to dismiss the case. It argued that since caffeine had replaced coca-leaf extract in the soda recipe a year before the enactment of the Pure Food and Drug Act, it was not an added ingredient that qualified as an “adulterant or additive.” Therefore the law did not apply. The trial judge stunned Wiley and the Justice Department by agreeing with Coca-Cola and dismissed the government’s case.63 It was a body blow the Supreme Court ultimately upheld.

Wiley’s Bureau of Chemistry had committed enormous resources to the prosecution. By casting himself as the public face of the government’s case he had put his reputation at risk. An internal federal investigation revealed that Wiley had so badly wanted to win that he had engineered an annual consulting arrangement for $1,600 with a Columbia professor who was the government’s star trial expert about the evils of caffeine. Without that deal, the professor had been reluctant to agree to testify since the government paid its experts only $9 a day. Although Wiley had broken no laws with the consulting work-around, and his bosses had approved it, it looked bad after the case had imploded.64

After twenty-nine years at the Bureau of Chemistry, the combative and toxic environment had worn Wiley down. He resigned in 1912 and accepted a job at Good Housekeeping magazine for $10,000, double his government salary. As their director of foods, sanitation, and health, he still wielded influence with his monthly column about nutrition and food safety that reached 400,000 subscribers. The magazine built a modern testing lab for Wiley and initiated the Good Housekeeping Seal of Approval for products.65

Although Wiley had justifiably earned a place in history as the father of the Pure Food and Drug Act, he had little to boast about when it came to drugs. Business boomed for the traditional USP/NF medications. Worse was that sales of nostrums soared by 60 percent in a decade, for the first time crossing $100 million annually.66 When Wiley later wrote his memoir, his failures were evident by his omissions. In 325 pages he attacked private lobbyists and government bureaucrats for diluting his landmark statute. He regaled his readers with insider details about his battles against saccharin manufacturers and whiskey rectifiers. He even re-litigated the Coca-Cola case. In Wiley’s recounting of history, he was always right but somehow the government had repeatedly failed to do what was right.67 But he never mentioned cocaine or heroin and only referred to patent drugs a single time—to claim that internal power struggles at the Bureau of Agriculture had “made it impossible to bring any cases.”68

As Wiley stepped off the national stage, there was no doubt that pharma had emerged intact from the country’s first landmark legislative effort at drug oversight. Its successful lobbying campaign had eviscerated much of the Pure Food and Drug Act. It would serve as a template for pharma battles with the government in the decades ahead.

I. Dr. A. O. Johnson of Kansas City marketed Dr. Johnson’s Mild Combination Treatment for Cancer. Every sale included a 125-page book of questionable testimonials from “cured patients.” Congress addressed this statutory shortcoming in 1912, but the drug lobby weakened the final language to ban therapeutic claims that were “false and fraudulent.” That meant enforcement actions had to establish “intent to defraud,” a standard that proved nearly impossible as drug companies claimed they believed the claims to be accurate.

II. Wiley’s Boy Scout image was sullied years later when it was disclosed that he had not only accepted favors and gifts from some food industry giants, but that they influenced his decisions about whether to bring enforcement actions. A sugar industry lobbying group employed his nephew in a sweetheart deal. He only moved against benzoate of soda after his benefactors at H. J. Heinz stopped using it; critics said he had conspired with Heinz to allow them to capture the catsup market. In one instance, he even testified in an adulterated coffee case on behalf of a businessman who had doled out favors to him and some of his family.

III. Prohibition of caffeine remains a tenet for some Christian denominations. The Mormon-owned Brigham University finally yielded in September 2017 to appeals by non-Mormon students and permitted the sale of caffeinated soda.