New saccharin-cancer tie hardens FDA stance - C&EN Global

Interestingly though, the same study shows that in women saccharin does not increase the risk of bladder cancer (C&EN, June 27, page 6). The complete ...
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C&EN July 4, 1977

New saccharin-cancer tie hardens FDA stance Once again a Congressional committee met to hear yet another chapter in the continuing saga of saccharin. This time it took place back where it all started in the House Commerce Committee's health subcommittee chaired by Rep. Paul G. Rogers (D.-Fla.). The issue that occupied much of the subcommittee's time at last week's oneday hearing was a still-unpublished epidemiological study conducted in Canada that shows saccharin use increases the risk of bladder cancer in men about 60% compared with nonusers. Interestingly though, the same study shows that in women saccharin does not increase the risk of bladder cancer (C&EN, June 27, page 6). The complete study will be published in the Federal Register on July 5. Food & Drug Administration commissioner Donald Kennedy told the subcommittee that "the new and direct evidence of human risk from saccharin suggested by the Canadian study, however, raises serious questions about the wisdom of our present proposal to consider the continued approval of saccharin for drug use." In April FDA announced that it would ban saccharin from food and drink, but allow the artificial sweetener to k continue to be sold as an over-the-counter drug. The agency based its decision on the results of another Canadian study that showed a statistically significant increase of bladder cancer in rats and their offspring when fed saccharin as 5% of their diets for two years. FDA's announcement led to a storm of protest from consumers, and it triggered numerous pieces of legislation in Congress to block the FDA proposal. The bill most likely to succeed (H.R. 5799) was introduced by chairman Rogers with the support of his counterpart in the Senate, Massachusetts Democrat Edward M. Kennedy. Both Sen. Kennedy and Rep. Rogers seem undaunted by the recent revelations from Canada. If enacted (a near certainty) the legislation would put off for 18 months any FDA action on saccharin, and it would commission the Institute of Medicine of the National Academy of Sciences to look into some of the basic scientific issues surrounding the saccharin controversy. FDA's Kennedy, though, still resists Congressional intrusion and declares that "I am troubled by the precedent" that the Rogers bill would set for other compounds that the agency may have to act against in the future. The commissioner notes that in light of the new human findings about saccharin, the agency will delay for two more months its proposed ban. But he cautioned the subcommittee: "Our purpose in extending the comment period should not be misinterpreted as weakening of our decision to remove saccharin from the food supply. Our only purpose is to examine, in light of the important new findings, whether saccharin should remain available for any purpose." D

Federal Alert— new regulations This listing covers noteworthy regulations appearing in the Federal Register from June 2 through June 24. Page numbers refer to those issues. PROPOSED Drug Enforcement Administration—Proposes rule change to protect confidentiality of researchers and research subjects engaged in drug studies with controlled substances; comments by July 18 (June 21, page 31450). Environmental Protection Agency—Proposes more stringent emission standards for new and existing ethylene dichloride, vinyl chloride, and polyvinyl chloride plants; comments by Aug. 1 (June 2, page 28154). Proposes regulations that prescribe how applicants for FIFRA registrations and reregistrations should submit data to support applications; comments by Aug. 19 (June 20, page 31284). FINAL Consumer Product Safety Commission— Adopts interim rules of practice for adjudicative proceeding under the Consumer Product Safety Act and the Federal Flammable Fabrics Act designed to speed proceedings; comments by July 21 (June 21, page 31431). Environmental Protection Agency—Adds benzene to list of hazardous air pollutants; effective immediately (June 8, page 29332). Allocates $1 billion to states and District of Columbia to carry out Federal Water Pollution Control Act; effective June 3 (June 9, page 29481). Federal Power Commission—Changes accounting and rate treatment rules for R&D expenditures; effective June 3 (June 13, page 30150). Food & Drug Administration—Revises antibiotic drug regulations' method of determining pH of products; effective July 11 (June 10, page 29857). Lists carmine as safe for use in coloring of cosmetics; comments by July 26 (June 24, page 32228). NOTICES Food & Drug Administration—Announces availability to manufacturers of food additive questionnaire for survey of food ingredients generally recognized as safe to be conducted by National Academy of Sciences (June 17, page 30894). Announces meeting on toxic substances to be held Aug. 23-24 in Jefferson, Ark.; oral presentations should be submitted by Aug. 20 (June 24, page 32319). National Institute for Occupational Safety & Health—Will begin national competition for training project grants for limited number of Occupational Safety & Health Centers; applications must be submitted by July 8 (June 15, page 30542).