**GAO-04-476R**                      Feb 26, 2004                  

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## Highlights

GAO reviewed the Food and Drug Administration's (FDA) new rule declaring dietary supplements containing ephedrine alkaloids adulterated because they present an unreasonable risk. GAO found that (1) the rule would declare dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use; and (2) FDA complied with applicable requirements in promulgating the rule.

## Department of Health and Human Services, Food and Drug Administration: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an    Unreasonable Risk, GAO-04-476R, February 26, 2004

B-293677February 26, 2004The Honorable Judd Gregg     Chairman     The Honorable Edward M. Kennedy     Ranking Minority Member     Committee on Health, Education, Labor, and Pensions     United States SenateThe Honorable W.J. "Billy Tauzin     Chairman     The Honorable John D. Dingell     Ranking Minority Member     Committee on Energy and Commerce     House of Representatives     Subject:Department of Health and Human Services, Food and Drug Administration: Final Rule Declaring Dietary Supplements Containing Ephedrine    Alkaloids Adulterated Because They Present an Unreasonable RiskPursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and    Human Services, Food and Drug Administration (FDA), entitled "Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk    (RIN: 0910-AA59). We received the rule on February 12, 2004. It was published in the Federal Register as a final rule on February 11, 2004. 69 Fed. Reg. 6788.     The final rule declares dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or    injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use.     Enclosed is our assessment of the FDAs 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.     If you have any questions about this report, please contact James W. Vickers, Assistant General Counsel, at (202) 512-8210.  The official responsible for GAO evaluation work relating to the    subject matter of the rule is Marjorie Kanof, Managing Director, Health Care.  Ms. Kanof can be reached at (202) 512-7101.                 signed     Kathleen E. Wannisky     Managing Associate General Counsel     Enclosurecc: Ann Stallion     Regulations Coordinator     Department of Health and       Human Services            ENCLOSURE     ANALYSIS UNDER 5 U.S.C.  801(a)(1)(B)(i)-(iv) OF A MAJOR RULE     ISSUED BY THE     DEPARTMENT OF HEALTH AND HUMAN SERVICES,     FOOD AND DRUG ADMINISTRATION     ENTITLED     "FINAL RULE DECLARING DIETARY SUPPLEMENTS     CONTAINING EPHEDRINE ALKALOIDS ADULTERATED     BECAUSE THEY PRESENT AN UNREASONABLE RISK"     (RIN: 0910-AA59)(i) Cost-benefit analysis     FDA performed a cost-benefit analysis on the final rule and estimates that the option chosen for removing the dietary supplement from the market will generate estimated benefits of between $43    million and $132 million per year.  The analysis also discusses the costs and benefits of the other options considered by FDA during the rulemaking process.(ii) Agency actions relevant to the Regulatory Flexibility Act, 5 U.S.C.  603-605, 607, and 609     FDA conducted a Final Regulatory Flexibility Analysis that found that the final rule would have a significant economic impact on a substantial number of small entities.  The analysis    discusses the various impacts on manufacturers and distributors and the options that were considered.(iii) Agency actions relevant to sections 202-205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C.  1532-1535     FDA states that the final rule does not contain either an intergovernmental or private sector mandate, as defined in title II, of more than $113 million ($100 million adjusted annually for    inflation) in any one year.(iv) Other relevant information or requirements under acts and executive orders     Administrative Procedure Act, 5 U.S.C.  551 etseq.     The final rule was issued using the notice and comment procedures found at 5 U.S.C. 553.  On June 4, 1997, FDA published a Notice of Proposed Rulemaking in the Federal Register.  62    Fed. Reg. 30678.  This proposed rule was followed by numerous other notices published in the Federal Register by FDA that withdrew portions of the 1997 proposed rule and advised of the    availability of additional information regarding the drug.  See 62 Fed. Reg. 44247 (August 20, 1997), 63 Fed. Reg. 23633 (April 29, 1998), 65 Fed. Reg. 17474 and 17509 (April 3, 2000), and    68 Fed. Reg. 10417 (March 5, 2003).  FDA received over 48,000 comments in response to the various notices and the relevant comments are discussed in the preamble to the final rule.     Paperwork Reduction Act, 44 U.S.C.  3501-3520     The final rule does not contain any information collections that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.     Statutory authorization for the rule     The final rule is promulgated pursuant to the authority contained in 21 U.S.C. 321, 342, 343, and 371.     Executive Order No. 12866     The final rule was reviewed by OMB and found to be an "economically significant regulatory action under the order.     Executive Order No. 13132 (Federalism)     FDA evaluated the final rule in accordance with the order.  It found that the rule would have a preemptive effect on state and local laws that concern ephedrine alkaloids, such as labeling    requirements, because the FDA rule prohibits the introduction into interstate commerce.  The preamble to the final rule contains the contacts that the FDA had with state and local    authorities and the comments the FDA received from state authorities.

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