Page:United States Statutes at Large Volume 106 Part 5.djvu/864

 106 STAT. 4502 PUBLIC LAW 102-571—OCT. 29, 1992 may, earlier than December 15, 1993, approve claims made with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances that are claims described in clauses (vi) and (x) of section 3(b)(l)(A) of the Nutrition Labeling and Education Act of 1990 (21 U.S.C. 343 note). 21 USC 343 SEC. 203. UNITED STATES RECOMMENDED DAILY ALLOWANCES. Notwithstanding any other provision of Federal law, no regulations that require the use of, or are based upon, recommended daily allowances of vitamins or minerals may be promulgated before November 8, 1993 (other than regulations establishing the United States recommended daily allowances specified at section 101.9(c)(7)(iv) of title 21, Code of Federal Regulations, as in effect on October 6, 1992, or regulations under section 403(r)(l)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(l)(A)) that are based on such recommended daily allowances). SEC. 204. ENFORCEMENT REPORT. (a) CONTENTS.—The Secretary of Health and Human Services shall prepare a report containing a statement of the enforcement priorities and practices of the Food and Drug Administration under section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances. (b) REPORT.— Not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services shall submit the report described in subsection (a) to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate. 21 USC 393 SEC. 205. MANAGEMENT AdTVITIES STUDY. (a) STUDY. — The Comptroller General shall conduct a study of the management of activities of the Food and Drug Administration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances. (b) CONTENTS.—In conducting the study, the Comptroller General shall examine, with respect to such activities— (1) the means by which the Food and Drug Administration makes a determination that a substance poses a risk to public health and safety that justifies the expenditure of resources by the agency; (2) the means by which the Food and Drug Administration makes a determination that a substance is adulterated, misbranded, or improperly manufactured; (3) the means by which the Food and Drug Administration makes a determination relating to the quantitative management of the agency response to specific issues, in order to adjust the efforts of the agency to be commensurate with the severity of the problem addressed by the agency; (4) the approach by which the Food and Drug Administration determines the adequacy of proof related to the risk posed by, or the safety of, a substance, and the adequacy of such approach; and (5) the relationship between— (A)(i) the number of hours devoted by Food and Drug Administration personnel, and the expertise of such personnel, in conducting such activities; (ii) the cost of conducting such activities; and

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