Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that it is withdrawing certain provisions of a proposed rule that published in the Federal Register of June 4, 1997 (62 FR 30678), relating to dietary supplements containing ephedrine alkaloids. FDA is taking this action because of concerns regarding the agency's basis for proposing a certain dietary ingredient level and a duration of use limit for these products. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of new adverse event reports and related information associated with these products and its plans to participate in a public forum to discuss this new information at some future date. In addition, FDA is announcing elsewhere in this issue of the Federal Register the availability of additional documentation associated with certain adverse events referenced in the 1997 proposed rule.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 111 [Docket No. 95N-0304] AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; withdrawal in part. SUMMARY: The Food and Drug Administration (FDA) is announcing that it is withdrawing certain provisions of a proposed rule that published in the Federal Register of June 4, 1997 ( 62 FR 30678 ), relating to dietary supplements containing ephedrine alkaloids. FDA is taking this action because of concerns regarding the agency's basis for proposing a certain dietary ingredient level and a duration of use limit for these products. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of new adverse event reports and related information associated with these products and its plans to participate in a public forum to discuss this new information at some future date. In addition, FDA is announcing elsewhere in this issue of the Federal Register the availability of additional documentation associated with certain adverse events referenced in the 1997 proposed rule. DATES: The proposed rule that published on June 4, 1997 ( 62 FR 30678 ) is withdrawn in part for § 111.100(a), (b), (c), (e), and (f) as of April 3, 2000. ADDRESSES: Copies of the proposed rule and related comments are available for public examination in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORM…
Other Federal Register documents from the same docket.
Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period; Correction
Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period
Dietary Supplements Containing Ephedrine Alkaloids; Administrative Docket Update; Availability
Dietary Supplements Containing Ephedrine Alkaloids; Reopening of Comment Period
Dietary Supplements Containing Ephedrine Alkaloids; Notification of Intent to Reopen Comment Period
Citation: 65 FR 17474
