President Biden last Friday signed the Formula Act, a bipartisan bill that suspends tariffs on imported baby formula until the end of the year. On “The Milk of Life,” an episode of the Gastropod podcast featured on Now & Then this week, hosts Cynthia Graber and Nicola Twilley examined the history and science of formula, including focusing on efforts by congress in the late 1970s to regulate formula quality in developing nations. During the same period, legislators also worked to crack down on domestic abuses in formula production, leading to a dramatic stand-off with the powerful Syntex Corporation. 

Syntex had quite a track record. The pharmaceutical giant emerged from the research of organic chemist R.E. Marker, who in early 1944 isolated the steroidal hormone progesterone from Mexican barasco yams. In 1951, Syntex scientists expanded upon these initial discoveries to produce norethisterone, which suppressed ovulation. Over the next decade, Syntex, G.D. Searle & Co., and Johnson & Johnson pioneered the commercial birth control industry, reaping massive profits. By the early 1970s, Syntex was also a leader in the production of soy-based baby formula, offering two leading brands, Neo-Mull-Soy and Cho-Free. 

In early 1978, Sidney Saperstein, Syntex’s nutritional services chief, advocated for the removal of salt from Syntex’s baby formula, which also limited the resultant amount of the electrolyte chloride, important to the growth of small babies. 

20,000 American infants consumed the formula post-change. Syntex did not note the chloride shift on their packaging or advertising. One twistedly ironic Neo-Mull-Soy ad that ran in medical journals stated, “It’s what’s left out that’s important,” noting the formula’s absence of cow’s milk, corn, and lead, but leaving out any reference to the dearth of salt. Syntex scientists admitted that their scientists had stopped testing chloride levels shortly before the salt removal. The Food and Drug Administration (FDA) did not require the tests. 

By October 1978, parents were reporting incidences in their children of kidney problems resembling a rare disease called Bartter’s Syndrome, brought on by a blood imbalance called metabolic alkalosis.

Syntex recalled the low-chloride formulas in August 1979, spending $4 million to notify doctors and pharmacies of the change and to destroy two million cans of the formulas. The removal was slow, however, with the questionable products still on the shelves in many cities at year’s end. The Center for Disease Control reported that at least 118 babies were suffering from Bartter’s Syndrome symptoms, including blood in their urine and dangerous levels of hormones known to cause high blood pressure. Most were on the road to recovery after switching to formulas with more chloride.

Freshman Democratic Tennessee Representative Al Gore, a member of the House Committee on Interstate and Foreign Commerce’s Subcommittee on Oversight and Reform, was disturbed. His own baby had taken one of the low-chloride Syntex formulas. 

On November 1st, 1979, Gore chaired a Subcommittee hearing on Syntex’s blunder. “We are concerned here with human life at its most vulnerable stage,” Gore proclaimed during his opening statement. “We are talking about food that may be the sole source of nourishment during infancy, foods that must be safe.” 

Gore heard testimony from a Memphis pediatrician named Shane Roy, who recounted blowing the whistle on the formulas after three babies were hospitalized with Bartter’s Syndrome at his Le Bonheur Children’s Hospital. Roy’s persistent calls to Syntex, the FDA, and the CDC led directly to the recall. 

Gore also heard from Marvin and Brenda Hill, whose son Douglas was one of the three babies admitted at Le Bonheur.  Mr. Hill detailed the “mistrust” that he and his wife felt after the incident: “If you can’t trust your infant formula or baby foods, how do you have any faith in anything that you open for yourself or anybody in your family – bottle, package, can?” 

And Syntex President Paul Freiman explained that salt was cut due to a supposed attempt to make babies healthier: “In recent years, the medical profession, strongly supported by consumer groups, has taken the position that having salt in baby food is bad for children. Many companies removed salt from their products and were praised for it. In that widely prevailing climate of opinion, the salt in Neo-Mull-Soy and Cho-Free dropped.”

Gore responded with incredulity, and also attacked Freiman for his attempts to send the botched formula to babies overseas after the U.S. recall, a move Freiman said only happened with assurances from foreign governments that the formula would be used as a supplement, rather than as the central form of sustenance. Gore’s seeming shock continued: “You were going to send an English language labeled product overseas, one that had been the source of serious illness among infants here, and rely on its proper use overseas?”

By early 1980, Syntex was fighting 30 lawsuits from the parents of children who had consumed the low-chloride formulas. The Hills, for example, signed on to a $2 billion class-action claim filed in the U.S. District Court in Memphis. 

As the suits streamed in, leading government officials effectively confessed to overseeing a broken regulatory framework. “It never should have happened,” the FDA Bureau of Food’s Director Sanford Miller told the Wall Street Journal in August 1980. “We were at fault. Industry was at fault.” 

Meanwhile, Carole Laskin and Lynne Pilot, two Washington-area mothers whose babies had taken the Syntex formulas, began to lobby Congress for new regulations. The duo created Formula, an advocacy group that pooled resources with other families affected by Syntex’s mistakes and aimed to reform baby formula testing. 

Laskin explained the duo’s lobbying efforts in a 1980 Washington Post profile: “We talked on the phone 82 times a day. We’d call each other in the morning and say, ‘Who are you going to take today?’ I’d say, ‘I’ll take the FDA and the Center for Disease Control,’ and she’d say, ‘Okay, I’ll take the Hill and The National Institutes of Health.'”

The duo’s efforts paid off. On September 26th, 1980, President Carter signed the Infant Formula Act of 1980. The legislation required formula manufacturers to test for 29 crucial nutrients in their formulas and gave the FDA broad access to testing records. 

Syntex stopped selling baby formula in 1981. That same year, the Department of Justice opened a criminal investigation into Syntex’s changes to Neo-Mull-Soy and Cho-Free. Richard K. Willard, the Acting Head of the Civil Division, oversaw the effort. Willard was a passionate conservative concurrently working on drafting a controversial National Security Directive to require consistent  polygraph tests for government employees handling classified information. 

Syntex’s main defense continued to focus on the “good faith” reasons for removing salt from their formula. Syntex lawyer Richard Alstin wrote in a letter to the DOJ in March 1983 that his client “was motivated by a positive concern for the health of infants and a desire to improve the quality of the product,” declaring that the motivation for the salt removal was “a purely salutary one.” 

Willard ageed, announcing he was declining to charge Syntex in May 1984 despite intensive outcry from the FDA, whose Chief Counsel, Thomas Scarlett, had stated that there was “sufficient evidence to prosecute” Syntex and that a conviction “would stand for the proposition that carelessness is not to be tolerated.” 

Willard’s decision shocked Ohio Democratic Senator Howard Metzenbaum, an independently-wealthy airport parking lot magnate known for taking on consumer crusades and who had worked with Gore on the initial inquiries into Syntex. 

When President Reagan nominated Willard to be Assistant Attorney General in July 1985, Metzenbaum castigated the lawyer. “The societal concerns were all on the side of the infants,” Metzenbaum told the nominee. “Your societal concerns were somewhere else.” Willard was still confirmed. 

Parents think they can count on the infant-formula manufacturer and the Government to provide protection,” Metzenbaum told the press in September 1985. “But we find instance after instance in which the Government fails.” 

Only months later, however, an unexpected discovery during a lawsuit brought the case briefly back to life. Chicago lawyer John B. Hayes represented two six-year-old boys affected by the Syntex formulas. In late 1985, the Cook County Circuit Court awarded $5 million to the families of the boys and a $22 million penalty against Syntex, then one of the largest individual damages claims ever levied against a pharmaceutical company. 

After the case, Hayes circulated a long-hidden memo from a Syntex doctor, S. John Ingram, to Syntex CEO Albert Bowers. The 1980 letter was a reaction to the company’s aforementioned assertion that salt was removed from the formulas due to “prevailing” medical opinion. “Our use of this statement has bothered me for months,” Ingram wrote. “It seems unnecessarily self-serving and obfuscatory…There are thoughtful outsiders who will eventually see through it.’ 

Metzenbaum seized on the memo, which Syntex had declined to provide during the Department of Justice investigation. On December 20th, 1985, Metzenbaum wrote to Willard demanding that the probe be reopened and calling the company’s defense “a seeming falsehood.”

The Senator continued to press, introducing in April 1986 an amendment to the Infant Formula Act designed to increase the frequency and oversight of nutrient testing in formulas. Metzenbaum’s staff contended that Willard and other Reagan loyalists had intentionally avoided enforcing the Act, giving formula companies wide latitude over their quality-control systems. “They had a little different idea about government regulation and never promulgated them,” said Joel Johnson, a Metzenbaum’s aide, in October 1986. “It was basically thrown back to the manufacturers.” 

Pilot and Laskin’s advocacy group, Formula, had continued keeping tabs on children who had consumed the salt-free Syntex formulas and found that as many as 5,000 children were living with learning disabilities and other permanent development issues. “These poor kids are going to have to pay for Syntex’s mistakes for the rest of their lives,” Pilot relayed in 1986. “They are living hell because they are living with what Syntex did.”

The Syntex scandal reared its head several more times during the late 1980s. In June 1987, a National Institute of Health study published in the medical journal Pediatrics backed Formula’s findings on permanent damage from the formulas. Syntex responded by claiming that the NIH undertaking was “not a well-controlled, definitive study.” 

Courts continued to disagree. In 1989, a Florida family whose ten-year-old son had taken Neo-Mull-Soy and had developed lasting learning and coordination problems received a $1 million judgment against the company. Similar lawsuits trickled in until the late 1990s. 

The fragile dance in the Syntex saga between government regulation, infant health, and private enterprise resembles the current efforts to disseminate baby formula, even as chemical concerns have given way to worries over tariffs and the supply chain. The sensitive quest to secure a safe and accessible pathway to those who need formula, “the sole nutrient” for millions of babies across the country and throughout the world, is clearly far from over. 

For more on Metzenbaum’s regulatory battles in Washington, check out Tom Dierner’s 2008 Fighting the Unbeatable Foe: Howard Metzenbaum of Ohio

And head to the Twitter account of author and Now & Then Editorial Producer David Kurlander for supplemental archival threads on each Time Machine piece: @DavidKurlander.

To receive Time Machine articles in your inbox, sign up to receive the CAFE Brief newsletter sent every Friday.  

The Time Machine Archive  

Catch up on some recent Time Machine’s deep dives into history: