APRIL 1982 - VOLUME 3 - NUMBER 4
Wyeth and the Reagan Administration Accused of Delaying the Recall of Dangerous Baby Foods
The infant formula issue, often considered a third world concern, surfaced in the United States in early March when Wyeth Laboratories, a subsidiary of American Home Products, was forced to recall 2.8 million cans of defective infant formula.
Wyeth was slow to announce the full extent of the problem with its products and reluctant to institute a thorough recall.
"Wyeth was putting the buck ahead of the infants," said Duke Latkovic, an aide to Representative Ronald Mottl (D-Oh.), who co-sponsored a March 11 hearing on the recall.
On February 25, Wyeth received information from its research laboratories that some of its products already more than three weeks on the market were deficient in Vitamin B6 -- an essential nutrient.
For infants relying on manufactured baby food as a mainstay of their diet, this B6 defect can cause serious problems. "The clinical symptoms of concern," according to the U-.S. Food and Drug Administration's Hazards Evaluation Board, "are increased irritability, gastrointestinal upset and progressing to seizures and generalized convulsions. The severity of the convulsions. . . in a worst case analysis could be life threatening due to secondary complications."
After five days went by, in which time Wyeth confirmed the existence of the problem which was caused by human error, the company called the Food and Drug Administration (FDA) "to alert them to our findings," said Charles F. Hagan, , vice president and general counsel of American Home Products, in testimony before the House subcommittee on oversight and investigations.
The next day, March 3, the FDA and Wyeth jointly announced a recall of the company's Nursoy brand infant formula. Since February 1, approximately 571,000 cans of Nursoy lacking the nutrient B6 were distributed throughout the United States, Wyeth announced.
Wyeth did not announce, however, the existence of B6 deficiencies in a related product called SMA even though the company knew about the problems with SMA on March 1, according to Hagan's testimony.
"The company didn't want a big to-do about SMA because it's a big seller," Representative Albert Gore (D-Tn.) told Multinational Monitor, "so they piddled around for 10 days."
Unlike the Nursoy brand, the SMA products did contain some B6, but not at levels prescribed by law. "Most lots tested showed between 80 and 90% of the legal requirement for B6 content," Gore explained. "That legal requirement is based on the minimum amount needed for healthy development."
Wyeth "labels its products as having B6 content over the limit" established by the FDA, says Chris Smith, an FDA, press officer, so the defective products were also "technically misbranded."
"Wyeth's attitude was, 'well, is 80% B6 life threatening?'," Smith explains. "Our experts said yes."
Still, Wyeth put up a fight about how the product should be recalled.
Wyeth sought a "low-priority recall - basically notifying only the . wholesalers, without notifying the public," Representative Gore said, even though "two million cans of defective formula were out on the marketplace."
Under pressure from Representatives Gore and Mottl, the FDA insisted that Wyeth publicly announce the recall. "They [company officials] got their hands pushed behind their backs," says the FDA's Smith. "No comment," responded a Wyeth spokesperson to a question on whether the company fought the recall.
On March 12, Wyeth agreed to recall 2.3 million cans and bottles of SMA infant formula, which "may have' been available for sale in retail stores since February 2, 1982," a Wyeth and FDA announcement stated.
The Wyeth episode "would have been prevented," Gore stated at the Congressional hearing, if the Reagan administration had not backpedalled on implementing the Infant Formula Act, which became law on September 26, 1980.
The Commissioner of the FDA, Arthur Hull Hayes, confirmed Gore's claim. "In December 1980, three months after the Infant Formula Act was signed into law, FDA published proposed Infant Formula Quality Control Regulations," Hayes testified. "These would have required that an infant formula not be shipped by a manufacturer until it had laboratory results establishing that certain nutrients including vitamin B6, were present in the product at the required levels." Had they been approved by the Reagan Administration, said Hayes, "the proposed regulations would have, if followed by the firm, prevented this problem."
"Incredibly, the new administration has delayed the implementation of the law for 14 months so far," Gore told the subcommittee on oversight and investigations, "because of their concern that the companies might incur extra costs as a result of the new law."