Secretary of Health, Education and Welfare Joseph A. Califano Jr. has ordered a top-level review to determine whether the department should recommend a change in the law that led to the announced ban on saccharin.
The furor over the ban, effectively probably in July, of the only dietary sugar substitute still on the market moved to the Capitol yesterday as a House Health subcommittee held hearings on the situation. Reactions of members differed but a majority seemed to feel that the law as it stands is too rigid.
Present law - known as the Delaney clause, a 1958 amendment to the Food and Drug Act - required that a food additive be banned if "appropriate" tests show it causes cancer in animals or humans. The Food and Drug Administration announced the ban two weeks ago because Canadian tests showed it caused cancer in rats when given in does equal to 800 bottles of diet drink a day.
Rep. Barbara A. Mikulski (D-Md.: called the tests with such massive dosage "ridiculous" and said anyone drinking even a small part of this amount "would die of gas before they would die of cancer." Rep. James H. Scheuer (D-N.Y.) said it made no sense to permit the sale of cigarettes, which tests have linked to lung cancer, but ban the sale of saccharin, which has not caused a known case of cancer in humans in nearly a century of use.
Acting FDS commissioner Sherwin Gardner said the Canadian tests on two generations of rats "demonstrated beyond serious question" that saccharin causes malignant bladder tumors in rats. Under the Delaney clause, the FDA had no choice but to ban the sweetener used by millions of diabetics and weight-watchers, he said. He added:
"We have no evidence that individuals exposed to saccharin for long periods are more likely to get cancer than individuals who are not exposed."
Gardner expressed no opinion on whether the Delaney claused should be amended to give the FDA more felxibility as many members of Congress have urged. He said Califano has requested the incoming assistant secretary of health and head of the FDA to undertake a thorough review.
A number of bills have been introduced that would permit the FDA to weigh benefits versus risks in deciding whether a substance should be banned from the market.
Gardner told the subcommittee there was a "very good possibility" that the FDA would have banned saccharin even without the requirement of the Delaney clause. "My guess is," he said, that FDA scientists would have found the Canandian tests so persuasive they would have recommended a ban under the FDA's general powers to protect the public from adulterated food and drugs.
But when Scheuer asked how the FDA "can tell us that after 80 years it is not safe when taken in normal dosages," Gardner replied:
"We really don't know one way or the other."
Rep. Henry A. Waxman (D-Calif.) said the FDa's credibility is at stake because the government has more reason to believe cigarettes cause cancer than does saccharin, but permits sale of the first and bans the latter. Gardner's response was that the FDS has no jurisdiction over tobacco.
Rep. Richard L. Ottinger (D.-N.Y.) congratulated the FDS for its action. He said the Delaney clause has protected society and that "the focus should be on dangers." Rep. Andrew Maguire (D-N.J.) said there needs to be a shift from reliance on cancer cure to prevention. Congress should exercise great care in changing the Delaney amendment, he said.
Dr. Guy R. Newell, acting director of the National Cancer Institute, expressed doubt that saccharin causes cancer in humans.
"Based on human data we do not believe saccharin is a potent carcinogen for humans, if it is one at all," Newell told the subcommittee.
The nation has 30,000 new cases of bladder cancer a year, Newell said, and it's statistically possible that up to 700 of them may be caused by saccharin. But, he said, "we have no evidence that this has in fact occured."
The hearings, which continue today, were held as an exercise in congressional oversight. Chairman Paul G. Rogers (D-Fla.) said that if the subcommittee feels legislation should be considered new hearings would be held on legislative proposals.