The future of saccharin as a food additive and the fate of the controversial Delaney clause are not intertwined, according to the U.S. Food and Drug Administration's chief counsel, Richard A. Merrill carefully tried to separate the issues surrounding the proposed ban of the artificial sweetner and the law that forbids use of any cancer-causing additive in the food supply during a presentation here last week.
The saccharin ban was "the right decision and would have been the right decision even without Delaney," Merrill told food editors attending the annual Food Marketing Institute. He balmed the press statement that informed the public of FDA's action on March 9, hastily framed to coincide with the Canadian announcement, for much of the ensuing confusion. But he insisted it was not, as some FDA critics have charged, a "put-up job" intended to trigger revocation or reform of the controversial clause.
"The press statement put more (emphasis) on Delaney than it should have," Merrill said. "Another over-riding standard," he explained is "that food additives must be shown to be safe." He termed "a red herring" the FDA's own statement about the amount of saccharin fed the rats used in the Canadian experiments that precipitated the ban. The dosages were more than a person would receive "from drinking 800 12-ounce diet sodas daily over a lifetime," the FDA announced.
Merrill said this illustration was borrowed from the Canadian announcement and was intended to explain "in laymen's terms" why there was no immediate ban and no recall of saccharin. Instead, he conceded, it had fueled the controversy.
He also emphasized that the ban has not taken effect. It merely has been proposed. There will be public hearings at FDA next Wednesday and Thursday and a decision is not expected before midsummer. In the meantime saccharin remains on the market. While the agency has suggested a middle ground, making saccharin an over-the-counter drug (available without prescription), it turns out there is a catch. The promoters of saccharin must first provide evidence that it indeed does what they claim it does - promotes weight loss.
"We're asking them to put up or shut up," Merrill said in response to a question. He said FDA had neither the legal option nor a mandate to find a suitable substitute before proposing the saccharin ban.
The future of the Delaney Clause is being considered by both the administration and Congress. Merrill mentioned several options under discussion, though he stressed no recommendations had been made.
Delaney itself is brief and - one of the reasons it is controversial - very much to the point. It reads: "No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animals."
Merrill suggested in narrow terms a special exception might be made for saccharin ("not probable") or there might be no change. Widening the scope, Delaney might be extended to cover more than food additives - a position supported by Sen. Gaylord Nelson (D-Wis.) or a level of acceptable risk might be established by Congress. Another possibility, one "we are not likely to warmly endorse," the counsel said, is for Congress to direct FDA to make risk/benefit judgments on an additive-by-additive basis.
He foresees Delaney as a continuing issue because with so much cancer apparently due to environmental factors "the next 10 to 15 years will be a period of taking things away from people. Cures do not appear to be around teh corner, so the choice is to reduce exposure" to cancer-causing agents. As an example he cited food packaging materials leeching into the food supply in low levels. "If it goes into the food," Merrill said, "it becomes an additive and thus it is Delaney versus the food packaging industry."
The other speakers on the panel were a leading consumer activist, Dr. Sidney Wolfe, director of the Health Research Group of Washington, and a Delaney antagonist, Elizabeth M. Whelan of the Harvard School of Public Health.
Wolfe contended Delaney should be invoked more, not less, because "eating-related cancer is up." He argued that the FDA does have discretion ("too much discretion") under the statute because it can reject an experiment or even the conclusion an experiment reaches, that few chemicals cause cancer in man, that there is no evidence that even a small amount of a proven carcinogen is safe to ingest. He defended the scientific soundness of the Canadian saccharin study and was supported by Merrill, who said FDA had been consulted by the Canadians.
Whelan attacked Delaney as "an arbitrary, inflexible statute." She faulted it for a reliance on animal tests, for insisting on "zero tolerance" when technology had reduced next-to-zero to such minute stature, for ignoring the benefit and risk concept and for being a "devisive factor in ongoing research." She told the audience "we need rational, scientifically based, politically blind decisions" on the safety of food additives.
Asked what she would substitute for Delaney, Whelan said there was no specific substitute. "Every decision must be made separately," she said.