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, B-293677, February 26, 2004
B-293677, Feb 26, 2004
This is our report on a major rule promulgated by the Department of Health and Human Services. It was published in the Federal Register as a final rule on February 11. Or if no conditions of use are suggested or recommended in labeling. 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. If you have any questions about this report. The official responsible for GAO evaluation work relating to the subject matter of the rule is Marjorie Kanof. 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.