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100521 1 (1977-01-13)

handle is hein.gao/gaobadxtd0001 and id is 1 raw text is: 

DOCUMENT RESUMHE


00521 - [A0590977]

Food ancl Drug Administration's iegulation of Food Additives.
January 13, 1977. 18 pp.

Testimcny before Sen. Gaylord Nelson, Chairaan, Senate Select
Committee on Small Business; by Gregory J. Ahart, Director,
Human Resources Div.

Issue Area: Consumer and Worker Protection: Standards, Laws, and
     Regulatioas Enforcement (903).
 Contact: Haman Resources Div.
 Budget Function: Health: Prevention and Control ci Health
     Problems (553).
 Organization Concerned: Canadian Health Pro-ecticn Branch; Food
     and Drug Administration; G. D. Searle and Co.; National
     Academy of Sciences; National Institutes of Pealth: National
     Cancer Inst.
 Congressional Relevance: Senate Committef on the Judiciiry:
     Administrative Practice and Procedure Subccomittee; Senate
     Committee on Labor and Public Welfare: Health Subcommittee;
     Senate Select Committee on Small Business.
 Authority: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301;
     21 U.S.C. 348). 21 C.F.R. 121.1(k).

          Reviews of color and food additives--Red No. 2,
 saccharin and aspartame--included (1) the history of FDA's
 reaulation, (2) the current status of testing, and (3) whether
 the rev.ulatory artions taken complied with the aFpropriate act.
 ed No. 2, the raze of dye generically known as amaranth which
 s ets F))A composition and purity specifications, has tuen under
 suspicicn for 15 years zs being possibly carcinogenic or toxic
 to the rprodtjctive system Under existing law, action should
 have L-cen taken I 1/' years after being placed on the
 provisionil list, but extensions were granted. Red No. 2 was
 finally oanned in January 1976. FDA limited saccharin use,
 because of initial studies indicating possible adverse effects.
 No final proof has been obtained. Aspartame, an artificial
 sweetener, never was put on the market because of outside
 objections to it and discovery of a possible carcinogen in its
 makeup, but it did cause its manufacturer's testing procedures
 to be questioned and found faulty. The initial regulation for
 marketing aspartame haE been stayed, but final resolut4'on has
 not been sade. Continued use of saccharin under the interi3 food
 additive regulation should be justified, and, if justified,
 should be used at the conventional level of 100 to i, rather
 than the present 30 to 1, with the level of toluenesulfonamide
 decreased. All agencies responsible for protecting the puhlic
 from carcinoqens should cooperate to develop a uniform policy
 for identifying and regulating carcinogenic chemicals and for
 allowing public exposure to carcinogens. FDA should he required
 to have all approved and proposed food additives tested for
carcinogenity. (SS)

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