FDA won't back down on cyclamates The Food & Drug Administration has decided not to let the artificial sweetener, cyclamate, back on the market. Citing a "host of uncertain ties about the safety of this com pound," the agency has given the sweetener's manufacturer, Abbott Laboratories, 30 days to withdraw its three-year-old request to have cy clamate, banned in 1969, approved for use as a food additive. If the re quest is not withdrawn voluntarily, FDA says it will publish a formal no tice denying the petition in the Fed eral Register. The decision apparently came as a surprise to Abbott, which says that it knows of no unresolved safety ques tions that would preclude FDA ap proval of cyclamate. Earlier this year a National Cancer Institute Advisory committee, which spent nine months studying available cyclamate data, concluded that present evidence does not establish the carcinogenicity of cyclamate (C&EN, March 15, page 6). But the committee said that it did not have enough data on cyclamate's long-term effects on humans to reach a conclusion on cyclamate's potential carcinogenicity in man. It added that the cyclamate question has pushed carcinogenicity testing to its limit and questioned whether further testing really would prove anything. Nevertheless, in a letter to Abbott, the director of FDA's division of food and color additives, Dr. Richard J. Ronk, says that although ^ata at hand do not label cyclamate as a car cinogen, the carcinogenic potential of cyclamate is unresolved and clearly additional studies are required to re solve the issue. FDA also indicated that it is concerned about test data that, it says, show that cyclamates cause reproduction defects in test animals, as well as studies in humans and animals showing that the chem ical could cause damage to chromo somes. According to Ronk, the chromo somal damage "was produced in some cases by doses not far above those likely to occur in ordinary human consumption." He adds that although "FDA has not previously asked for resolution of the mutagenic potential of a compound, it is imperative to do so in this case." FDA had considered allowing re stricted use of cyclamate as a tabletop sweetener. But Ronk says that "once cyclamates were in the home and freely available, regardless of any labeling to encourage moderate use, there would be inappropriate or ex cessive use by some individuals over 8
C&EN May 17, 1976
which there could be no meaningful control. Because of the substantial likelihood of abuse of cyclamates as a table-top sweetener, safe conditions of use of the compound could not be prescribed even if the issues of carci nogenesis and mutagenesis were re solved." Abbott says it is now determining what action to take in response to FDA's decision. Under FDA proce dures, the company can request a hearing after FDA publishes a formal denial notice. If FDA either refuses a hearing or reaffirms its decision after a hearing, the company then could take the matter to court. D
Foreign investment in U.S. is no threat Foreign portfolio investment in the U.S. is apparently stepping up, and most of the activity is in corporate stocks. Of the $86 billion of overseas capital invested in the U.S. by the end of 1975, about $37 billion, or 43%, was in the form of stocks. The balance is primarily in U.S. government secu rities (held by foreign central banks) and debt issues by corporations. This foreign participation, Gerald L. Parsky, assistant Treasury secre tary, told a Senate subcommittee, "is beneficial" and U.S. fears of take-over attempts by overseas investors are largely unfounded. Foreign investors
hold only about 5% of all publicly traded stocks. Even foreign govern ments awash with cash such as the Persian Gulf oil-producing nations tend to be conservative investors and don't seek to take over U.S. indus tries. Saudi Arabia, for example, claims it will not invest more than 5% in any one company, and currently owns no more than 1% of any com pany. Further, Parsky notes, overseas investment by oil-producing nations likely will decline as their economies are better able to absorb oil revenues. In 1975 oil producers invested about $5.7 billion in the U.S., or about 7% of total foreign investment. Parsky notes a Treasury Depart ment study that shows that nearly every country in the world (or its cit izens) owns some U.S. stocks, but only a handful account for the bulk of ownership. Switzerland, the U.K., and Canada account for nearly 60% of stock ownership. With the Nether lands and France figured in, the total approaches 75%. Along with the data presented to the subcommittee Parsky also got in a plug for the International Invest ment Survey Act of 1975 (S. 2839), which would give Treasury broad authority to collect data on interna tional investment instead of "relying on a patchwork of laws to collect data on foreign portfolio investment," some of which "are clearly lacking in some respects or ambiguous as to our authority to collect such data." Π
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Ford signs bill reinstating White House science adviser A ceremony in the White House Rose Garden last week marked the return of science to the White House. Surrounded by Congressional backers of the legislation and leaders of the scientific community, President Gerald R. Ford signed into law a bill creating a new Office of Science & Technology Policy in the executive office of the President. Behind Ford, from the left, are Vice President Nelson A. Rockefeller, Sen. Frank E. Moss (D.-Utah), Rep. Olin E. Teague (D.-Tex.), and Rep. Charles A. Mosher (R.-Ohio). Ford said he took "great pleasure" in signing a bill that "reflects a renewed recognition of the importance of scientific, engineering, and technological contributions." The director of the new office will be a member of the White House Domestic Council and an adviser to the National Security Council. The office will have a positive involvement in deliberations on federal R&D programs and will prepare five-year plans on R&D options for resolving the nation's problems.
