The Food and Drug Administration "continually misrepresented" scientists' findings when it banned products containing cyclamates in 1969 on grounds that the artificial sweetener caused cancer in laboratory animals, a U.S. Claims Court hearing officer has ruled.
Claims Court Judge Judith Ann Yannello recommended an award of $8.2 million to California Canners and Growers Association, which had produced canned fruits and vegetables containing cyclamates under the Diet Delight brand name.
"No one had found cyclamates to be carcinogenic," Yannello said in her 45-page recommendation. "Yet the FDA continually misrepresented the input it was receiving from groups of scientists."
Scientists' studies showed that laboratory rats sometimes developed cancer when injected with huge doses of a mixture of 10 parts cyclamates to one part saccharine, the report said. But scientists did not know whether the cancer was caused by cyclamates, saccharine or a combination of the two, it added.
Nevertheless, "the FDA repeatedly reported that cyclamates had been found to have caused cancer when ingested by laboratory animals," the report said. "This was wholly inaccurate."
Yannello said the FDA ultimately was correct in recalling cyclamates from the market because they no longer could be "generally recognized as safe."
However, the agency is considering whether to lift its 15-year ban on cyclamates, said FDA spokesman Jim Greene. In 1982, the FDA's cancer assessment committee found that there was "no credible evidence showing that cyclamates cause cancer in animals," he said.
The FDA has asked the National Academy of Sciences to review the committee's findings. The academy is expected to report in March.
A spokesman for the Justice Department, which defended the government's actions, said its lawyers are "studying the opinion, and we don't have anything to say at this point."
Julian Heron, the lawyer for California Canners and Growers Association, said his clients "would be thrilled" with the hearing officer's recommendation "if they were still in business." The association went out of business at least partly as a result of a dramatic decrease in sales stemming from the ban on cyclamates, Heron said.
The suit was one of thousands filed in U.S. Claims Court against the federal government each year. In most cases, judges' decisions are final, pending appeal to the U.S. Court of Appeals.
In this case and in certain others, however, the judge acts as a "hearing officer" and makes a recommendation to Congress, though it may be reviewed first by a three-judge panel if there is an appeal. Congress then may approve the award, reject it or modify it, perhaps to include all persons or businesses affected by the government's action.
Congress did the latter several years ago after the government banned the sale of pajamas containing the fire-retarding chemical Tris, which was shown to cause cancer.
In both the Tris and cyclamate cases, the suits were presented to the Claims Court from Congress because the U.S. government claims immunity from suit in those cases.
Yannello, in her recommendation Friday, said the government has a "moral obligation" to reimburse California Canners and Growers Association for some of its losses.