The 1982 poisonings and the rule behind tamper-evident packaging

On September 30, 1982, FDA was told that several people in the Chicago area had died of cyanide poisoning after taking extra-strength acetaminophen capsules bought over the counter. By October 1, the toll was seven. Local authorities had tested capsules from the victims' bottles and found lethal amounts of potassium cyanide, FDA recounted in the Federal Register of November 5, 1982¹, starting on page 50442.

That notice was a final rule, published 36 days after the first report. It required tamper-resistant packaging for nearly every over-the-counter drug sold in the United States. Congress followed in October 1983 with the Federal Anti-Tampering Act², which made tampering with consumer products a federal crime.

Shrink bands around bottle caps and printed foil seals under them trace back to those weeks, on store-brand and name-brand medicines alike. This history uses FDA's own rulemaking record to show what investigators concluded, what the 1982 rule required, how later capsule poisonings forced two revisions, and what the regulation at 21 CFR 211.132⁷ says now.

What investigators concluded

Capsules linked to the seven deaths had been made at two plants, one in Pennsylvania and one in Texas. FDA inspected both and concluded the cyanide had not been added at either. Its reasoning, laid out in the 1982 rule's preamble¹, rested on the pattern. The capsules were made at three different times in two widely separated plants, yet were bought within a short period in one area. One victim's bottle held capsules of two strengths, and only the extra-strength ones contained cyanide. Some capsules showed visible signs of tampering, and FDA lab tests found that gelatin begins to break down six to seven days after contact with cyanide, a change seen in capsules from a store and from victims' bottles.

FDA and other agencies tested 1.7 million capsules and investigated about 270 reports of death or illness possibly tied to the product. No capsules outside the Chicago area were found to contain cyanide. The agency's working theory was that someone bought the capsules, laced them, returned them to their boxes and placed the boxes back on store shelves.

Their packaging had made that easy. The capsules came in plastic snap-top bottles with cotton in the neck, inside cardboard cartons. "Although packaged in compliance with current FDA requirements, neither the bottles nor the cartons were sealed," the preamble¹ says.

Governments moved quickly. Cook County, Illinois, approved an ordinance on October 4, 1982, requiring over-the-counter drugs to be sold only in sealed containers, and Chicago proposed a similar one two days later. The Secretary of Health and Human Services asked FDA to draft a national rule, and a House health subcommittee held a hearing on October 15. In the rule¹, FDA argued that conflicting local packaging laws could disrupt distribution and raise costs, and that a single federal standard would "obviate the need for State and local laws."

What the 1982 rule required

As issued, the 1982 rule¹ covered all over-the-counter human drugs except dermatological products, toothpastes and insulin, plus liquid oral hygiene cosmetics and vaginal products. It defined a tamper-resistant package as one with "an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." Barriers made of easily obtained materials such as plain tape or clear plastic had to carry a distinctive design or logo, and each package had to carry a label statement describing the feature. FDA listed 11 packaging systems it considered capable of meeting the standard.

• Film wrappers with a distinctive design
• Blister or strip packs, the format described in our piece on unit-dose and blister packaging
• Bubble packs on a display card
• Shrink seals and bands
• Foil, paper or plastic pouches
• Bottle seals under the cap
• Tape seals over carton flaps or caps
• Breakable caps
• Sealed tubes
• Sealed cartons
• Aerosol containers

FDA was blunt about the limits. "The agency stresses that tamper-proof packaging is not possible," the preamble says, and it warned that FDA would treat any label claiming a package was tamper-proof as false and misleading. Packaging requirements took effect for most products on February 7, 1983, with tablets, suppositories and all labeling requirements following on May 5, 1983. FDA estimated the rule would affect about 2 billion retail packages a year, at a recurring cost of $20 million to $40 million if features averaged 1 to 2 cents a package.

The 1983 federal crime

Public Law 98-127, the Federal Anti-Tampering Act, was signed on October 13, 1983, and added section 1365 to the federal criminal code. As enacted, it set these maximum penalties, according to the statute as published².

Congress also gave FDA authority to investigate violations involving the products it regulates. The current text of 18 U.S.C. 1365³ keeps the prison terms but replaces the fixed dollar caps with fines "under this title." FDA's history of food and drug law⁴ lists the 1982 packaging rule and the 1983 act together as one milestone.

Capsules, twice more

Even with sealed boxes, two-piece hard gelatin capsules "remained vulnerable to tampering," FDA wrote in a later rule⁶, and three deaths in 1986 were associated with that dosage form. In response, a February 2, 1989, final rule⁵ required over-the-counter products in two-piece hard gelatin capsules to use at least two tamper-resistant packaging features, or one if the capsules themselves were sealed, for example with a gelatin band. It took effect a year later.

In February 1991, two more people died after taking cyanide-contaminated decongestant capsules whose package met FDA's standards. There were visible signs of tampering "that were both numerous and conspicuous," FDA said in its November 4, 1998, final rule⁶. That rule required every over-the-counter two-piece hard gelatin capsule to be sealed, with compliance due by November 4, 1999. It also changed the term "tamper-resistant" to "tamper-evident" in labeling by November 6, 2000, because the new words emphasize consumer awareness "rather than implying that a particular package is difficult to breach or is tamper-proof." Labels now had to name every feature used, including any capsule seal.

What the rule says now

Today section 211.132⁷ sits inside FDA's good manufacturing practice regulations. Any over-the-counter drug for retail sale, except a dermatological, dentifrice, insulin or lozenge product, that is not in a tamper-evident package or not properly labeled is adulterated, misbranded, or both. The package must be "distinctive by design" or use an identifying characteristic such as a pattern, name, logo or picture. The label statement must be placed so it is "unaffected if the tamper-evident feature of the package is breached or missing." Firms can seek an exemption only through a citizen petition. The rule applies whether a product is marketed under an approved application or under the OTC monograph system. A separate paragraph keeps the child-resistant "special packaging" required under the Poison Prevention Packaging Act of 1970. The most recent change came in a 2024 medical gas rule⁸, effective December 18, 2025, which revised the labeling paragraph's list of exceptions.

Packaging failures still show up in FDA's recall records, but rarely. GxRadar searched openFDA's drug enforcement data⁹ through October 28, 2026, and found 13 recall records whose stated reason uses the word "tamper," out of 18,076 records since 2012. Nine were Class II and four Class III. None was Class I. Most described a missing, loose or broken seal or band, and none reported deliberate contamination. Recall counts by year and class are on our recalls page, and the other required panels on an over-the-counter package are covered in our guide to the Drug Facts label.