Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

United States. Congress. Senate. Committee on Government Operations

Date:: 1963

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

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istration—errors that may have caused most serious harm to human health, or brought death to citizens, whom the Government has not even warned of the undesirability of consuming foods containing coal-tar dyes. (Who needs jelly, candies, and cakes colored with strictly synthetic coal-tar-derived dye ials, anyway? Baie one boos ret ways in which the activities of the Food and Drug Ad- ministration should be corrected and strengthened to make the agency a more effective guardian of the public welfare. The difficulties and dangers from a consumer’s standpoint would at least be mitigated to some extent if the Food and Drug officials would adopt a policy of issuing complete, timely, clear, and straightforward public statements on what they find, and if they would readily grant the possibility of error, and the im- portance of continuous and intensive research. The list of chemical substances that may contaminate foods or be added to them continues to grow rapidly ; 2 to 8 thousand are now employed. The most vital need is to move speedily toward drastically shrinking this huge number, so that the problem of deter- mining the safety of additives and controlling their use may be reduced to pro- portions which researchers may hope to deal with successfully. THE MYSTERY OF THE BUTYLATED TwINns ™4 CONSUMERS’ RESEARCH TRIED TO FIND OUT ABOUT THE SAFETY OF TWO WIDELY USED CHEMICAL ADDITIVES FOR USE IN FOOD, BUT FOUND FEW SOURCES OF INFORMATION. IN THIS FIELD, THERE’S A STARTLING BARRIER OF GOVERNMENTAL SECRECY The names of two fat preservatives which are used in a very large number and variety of grocery items stand out in every study of food package labels by Consumers’ Research. We are safe in saying that a typical homemaker of today buying a week’s supply of packaged groceries would be very likely to include some products that contain butylated hydroxytoluene or butylated hydroxyanisole. Indeed, both are present in some food products, including cer- tain packaged raisins and breakfast foods. Of the two butylated fat preservers, BHA (butylated hydroxyanisole) has apparently been more popular among researchers. Two citizens who asked what tests had been made to determine the safety of these ubiquitous chemicals were given identical lists of references by a Government agency (see repro- duced letter), and only one item, the first, turned out-to be about BHT (butylated hydroxytoluene) ; the long chemical name given in the title of that paper is a synonym for BHT. All the remaining papers listed are about BHA. In a near-by university library, we had no difficulty obtaining the cited issue of Agricultural and Food Chemistry and the two listed issues of Bio- chemical Journal. Interestingly enough, each of the three scientific papers in these journals gave in its list of references the “Summary of Toxicity Studies on Butylated Hydroxyanisole,” third item in the F. & D. Administration’s list. Nonetheless the library could not supply that publication. We wrote to the American Meat Institute Foundation, listed in the reference as its publisher. Back promptly came the reply: * * * sorry * * * but no copies of [this] AMIF publication are available for distribution.” A “PUBLICATION” THAT WAS NOT PUBLISHED Puzzled that a large library and now apparently even the publisher could not supply this item, we asked for more information: Just what was the “Summary,” a book, pamphlet—possibly part of some larger publication? The “Summary,” cited as a reference source in at least 3 learned papers, actually, according to the Meat Institute Foundation, ‘was not published”! “It was,” they said, “information submitted to the Bureau of Meat Inspec- tion of the U.S. Department of Agriculture at the time butylated hydroxyanisole as an antioxidant for food fats was under consideration by the U.S. Depart- ment of Agriculture.” Told of the difficulties in obtaining the “Summary,” the Food and Drug Administration was of little help. Said the agency, “we are sorry that this

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