Security Theater

After Seven People Died From Poisoned Tylenol in 1982, the FDA Required Over-the-Counter Medicine to Come in Tamper-Resistant Packaging. In 1998 It Renamed the Packaging Tamper-Evident, Because It Did Not Resist Tampering.

On 29 September 1982 Mary Kellerman, a 12-year-old from Elk Grove Village outside Chicago, was given an Extra-Strength Tylenol capsule. She was dead by 7 a.m. Adam Janus, a 27-year-old postal worker, also died. His brother Stanley, 25, died the same day as Adam, and Stanley's wife, Theresa, 19, two days later. Within a few days seven people in the Chicago area, aged 12 to 35, were dead. The capsules had been filled with cyanide, and investigators concluded, in the later words of the Food and Drug Administration, that the poison had been "intentionally introduced into the capsules after they had reached the retail shelf." The FDA added a sentence that would govern the next sixteen years of regulation: "Although the product's packaging met all FDA requirements at the time, it was not designed so that tampering would leave visible evidence."

Until then, over-the-counter medicine had been sold on open shelves in bottles that anyone could unscrew and close again, on the working assumption that nobody would want to. Johnson & Johnson's McNeil Consumer Products subsidiary recalled more than 31 million bottles of Tylenol. Others took up the idea quickly. In the weeks that followed, 270 so-called copycat poisonings were referred to the FDA. An agency spokesman, Bill Grigg, told UPI in November that 36 of them showed real signs of tampering. The rest were hoaxes, or people blaming an illness on whatever they had last swallowed.

The Seals

On 5 November 1982 the FDA published a rule requiring most over-the-counter drugs to come in a "tamper-resistant" package, defined as one with "an indicator or a barrier to entry" that could reasonably be expected to give consumers visible evidence that tampering had occurred. Six days later Johnson & Johnson brought Extra-Strength Tylenol capsules back in what UPI described as a "triple-sealed safety package": glued flaps on the outer box, a tight plastic band around the neck, and a foil seal over the mouth of the bottle. A bright yellow label warned consumers not to use the capsules "if either of the two seals is broken." The third seal was the box.

By February 1983 the main complaint about the new packaging was that it worked on the customers. The Arthritis Foundation called the new Tylenol containers "extremely difficult to open even by able-bodied persons." A pharmacy official at the American Association of Retired Persons described them as all but "bulletproof." Dr. Fredrick Sherman of the Mt. Sinai School of Medicine observed: "Old people are not used to getting their Excedrin in tennis ball containers." A Johnson & Johnson spokesman replied: "Three seals are better than one seal." An FDA spokesman explained that the rule required only a "reasonable expectation" that tampering would be visible. "It doesn't say you have to do it 10 times," he said.

The Letter

Congress passed the Federal Anti-Tampering Act, signed on 13 October 1983. It made tampering with a consumer product a federal crime, and also made it a crime to knowingly communicate false information that a product had been tainted. Five days later, a federal court in Chicago entered into evidence a letter that James Lewis had sent to Johnson & Johnson in 1982. "So far, I have spent less than fifty dollars, and it takes me less than 10 minutes per bottle," it said. "If you want to stop the killing, then wire $1,000,000 to bank account number 84-49-597 at Continental Illinois Bank Chicago, Ill."

His lawyer admitted that Lewis had written the letter, but said the aim was to embarrass his wife's former boss. The account belonged to the now-defunct Lakeside Travel Agency, which had, per the defence, failed to meet its last payroll. The jury deliberated for three hours and convicted him of extortion. He received ten years. After his arrest, the Associated Press later reported, he had given investigators a detailed account of how the killer might have operated. He was never charged with the murders.

The Capsule

On 8 February 1986 Diane Elsroth, 23, of Peekskill, New York, died after taking Extra-Strength Tylenol capsules laced with cyanide. A second poisoned bottle turned up in a store in Bronxville. When her estate sued, the household that bought the bottle testified, according to the federal court, that "the flaps to the box were glued shut, the shrink seal did not appear to be disturbed, and the foil seal... had not been broken." Someone had breached all three seals, and then resealed the container and box "in such a way that the tampering was not readily detectable."

Johnson & Johnson stopped selling over-the-counter medicine in capsules and switched to tablets and "caplets," which are tablets shaped like capsules. Its chairman, James Burke, told WABC-TV: "In hindsight, which is 20-20, I wish we had never gone back to marketing these capsules." In 1988 Judge Gerhard Goettel dismissed the Elsroth suit, finding that McNeil and the A&P supermarket chain could not be held responsible for a wrong that an unknown third party had committed. In 1989 the FDA amended its rule to require at least two tamper-resistant features on capsule products, or one if the capsules themselves were sealed. The FDA would later note that all known deaths from contaminated over-the-counter drugs had involved capsules, including three in 1986, "4 years after the tamper-resistant packaging requirements were first imposed."

The Beneficiaries

In June 1986 Bruce Nickell died in Washington state after taking Extra-Strength Excedrin capsules. A few days later Sue Snow, 40, a bank manager in nearby Auburn who did not know the Nickells, died after taking the same brand. On 9 May 1988 a federal jury in Seattle convicted Bruce's widow, Stella Nickell, on five counts under the new federal anti-tampering law, in what UPI called the nation's first fatal consumer product tampering trial. Prosecutors said she wanted out of an unhappy, debt-ridden marriage and $176,000 in life insurance. The other bottles were for staging. "It was essential to make this appear the work of a random killer," said the prosecutor, Joanne Maida. Nickell had herself brought contaminated bottles to the police. She received 90 years.

In February 1991 two people in Washington state died after taking cyanide-laced Sudafed capsules. In 1993 Joseph Meling was sentenced to life without parole; prosecutors said he had wanted his wife's $700,000 life insurance and had made the poisoning look like the work of a random killer. His wife survived. Stanley McWhorter, 44, and Kathleen Daneker, 40, did not. The FDA later recorded that the Sudafed packaging met all of its tamper-resistant standards, and that "there were visible signs of tampering that were both numerous and conspicuous."

The Rename

In January 1994 the FDA proposed changing the word. "The change in terminology is intended to underscore the view that no package design is tamper-proof," it wrote, adding that the Sudafed packaging "did not prevent the 1991 tampering incidents, although it met FDA requirements and the evidence of tampering was strikingly visible." It also noted that "few new technologies have been added since 1982."

The final rule, published on 4 November 1998, required all over-the-counter hard gelatin capsules to be sealed, and replaced "tamper-resistant" with "tamper-evident" across the agency's regulatory programme. "Labeling is unacceptable if it implies that the product is tamper resistant or tamper proof," it said. The FDA explained that "the term 'tamper-resistant' does not technically mean that a product is tamper proof," but that it "can imply that it is difficult to breach an antitampering feature." The new word "appropriately shifts the emphasis from the ability of the feature itself to protect consumers to the ability of vigilant consumers to protect themselves." One comment objected that this moved the burden onto "unsuspecting sick and poor consumers." The agency disagreed, and wrote that "consumers must take some responsibility for protecting themselves." Four comments warned that sealed capsules would give consumers a false sense of security. The FDA replied that "the heightened sense of security may have some basis in fact."

James Lewis died at his home in Cambridge, Massachusetts, in July 2023, aged 76. Police said the death was "not suspicious." No one has been charged with the murders. Every bottle of over-the-counter painkillers now comes with a tamper-evident seal, which anyone can remove, and a label asking the customer to check whether someone has.

Filed from public reporting:

After Seven People Died From Poisoned Tylenol in 1982, the FDA Required Over-the-Counter Medicine to Come in Tamper-Resistant Packaging. In 1998 It Renamed the Packaging Tamper-Evident, Because It Did Not Resist Tampering.

The Seals

The Letter

The Capsule

The Beneficiaries

The Rename

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