A story on infant formula in yesterday's Washington Post reported incorrectly that two children whose parents are suing the Food and Drug Administration are taking defective formula. They are not.
Consumer groups and parents sued the Food and Drug Administration yesterday, claiming that the FDA has gutted infant formula regulations because of pressure from industry.
The consumer groups cited an FDA memo unearthed by the House subcommittee on oversight and investigations in which an FDA attorney said the regulations have been so altered as to be "hardly recognizable" and that if a well-put-together court challenge of the regulations were made, "the [FDA] agency would probably lose."
Three consumer groups and the parents of two children who took defective infant formula claimed in a suit filed in U.S. District Court that the FDA's infant formula regulations, which went into effect in July, fail to carry out the mandate of a 1980 law.
In that law, Congress required that strict infant formula quality regulations be written to prevent accidents like those occurring in 1952, 1979, and 1980 when vitamin-deficient formula was sold. In two of the incidents hundreds of children may have suffered serious injuries, including convulsions and retarded neurological development, according to the consumer groups.
Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, one of the plaintiff groups, said that "vague general guidelines" were substituted for specific regulations "so industry can call the shots."
An FDA spokesman yesterday acknowledged that the quality control regulations were extensively rewritten to accommodate industry complaints.
Robert Gelardi, a spokesman for the formula industry's trade association, the Infant Formula Council, said the regulations as they now stand "are real regulations" that do require rigorous testing of each batch of infant formula before it is sold, to be sure it contains all the required vitamins and minerals.
He said the old form of the regulations required unnecessarily elaborate procedures and would have forced manufacturers to throw away at least 4 percent of all infant formula because of "silly" and purely statistical requirements.
The memo displayed by the consumer groups today said:
* The proposed regulation "basically reflects the modifications proposed by the industry." Later, FDA attorney Jeff Gibbs adds that the redrafted regulation "incorporates most changes desired by the industry . . . . It seems very unlikely that any industry group will complain about the current draft . . . ."
* "Substituting general standards for specific rules has so altered the proposed regulation that the two drafts cannot be meaningfully compared section by section."
An FDA spokesman confirmed the existence of the memo, and said the regulation was changed in favor of industry because "basically the Bureau of Foods wrote the original regulation without an intimate knowledge of that particular industry. So the regulations were changed drastically from the original."
Three examples of things no longer required by the regulations, the court papers said, are specific details about what records must be kept, testing for nutrients added in "premixes" bought from a supplier, and testing for nutrients during manufacture in addition to the still-required sampling of batches after manufacture.
In addition to the Nader group, the suit was filed by Formula, a parents' group, the Consumer Federation of America, and the parents of 11-month-old Brendan Finucane of Silver Spring, and 2-month-old Olivia Klose of Washington, both of whom have been on infant formula.