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OGC-96-35 1 (1996-08-21)

handle is hein.gao/gaobabloh0001 and id is 1 raw text is: 




GAO            United States
               General Accounting Office
               Washington, D.C. 20548

               Office of the General Counsel




               B-273018


               August 21, 1996

               The Honorable Nancy Landon Kassebaum
               Chairman
               The Honorable Edward M. Kennedy
               Ranking Minority Member
               Committee on Labor and Human Resources
               United States Senate

               The Honorable Thomas J. Bliley, Jr.
               Chairman
               The Honorable John D. Dingell
               Ranking Minority Member
               Committee on Commerce
               House of Representatives

               Subject: Department of Health and Human Services - Food and Drug
                         Administration: Food Labeling; Nutrition Labeling, Small Business
                         Exemption

               Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on
               a major rule promulgated by Department of Health and Human Services - Food and
               Drug Administration (FDA), entitled Food Labeling; Nutrition Labeling, Small
               Business Exemption (RIN: 0910-AA19). We received the rule on August 6, 1996. It
               was published in the Federal Register as a final rule on August 7, 1996. 61 Fed.
               Reg. 40,963.

               Enclosed is our assessment of the FDA's compliance with the procedural steps
               required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule.
               Our review indicates that the FDA complied with the applicable requirements.

               The rule is in response to the Nutrition Labeling and Education Act Amendments of
               1993, Pub. L. 103-80. The Nutrition Labeling and Education Act of 1990, Pub. L. 101-
               535, established the requirement that with limited exceptions, a food, including both
               conventional foods and dietary supplements must have a label bearing certain
               nutrition labeling in order not to be considered misbranded. Among the exceptions
               to this nutrition labeling requirement was one for small business based upon the


GAO/OGC-96-35

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