Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is reopening for 30 days the comment period for a proposed rule entitled "Dietary Supplements Containing Ephedrine Alkaloids" that published in the Federal Register of June 4, 1997 (62 FR 30678) (the June 1997 proposal). In that document, FDA proposed a number of requirements relating to dietary supplements containing ephedrine alkaloids, including a requirement for a warning statement on the product label. Since publication of the June 1997 proposal, new scientific evidence has come to light concerning health risks associated with the use of dietary supplements containing ephedrine alkaloids. FDA is reopening the comment period to receive comment on this new evidence, as well as on the warning statement it is now considering for dietary supplements containing ephedrine alkaloids. FDA also intends to consider, to the extent possible, whether in light of current information FDA should determine that dietary supplements containing ephedrine alkaloids present a "significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use."
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] RIN 0910-AC51 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; reopening of the comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening for 30 days the comment period for a proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids” that published in the Federal Register of June 4, 1997 ( 62 FR 30678 ) (the June 1997 proposal). In that document, FDA proposed a number of requirements relating to dietary supplements containing ephedrine alkaloids, including a requirement for a warning statement on the product label. Since publication of the June 1997 proposal, new scientific evidence has come to light concerning health risks associated with the use of dietary supplements containing ephedrine alkaloids. FDA is reopening the comment period to receive comment on this new evidence, as well as on the warning statement it is now considering for dietary supplements containing ephedrine alkaloids. FDA also intends to consider, to the extent possible, whether in light of current information FDA should determine that dietary supplements containing ephedrine alkaloids present a “significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.” DATES: S…
Other Federal Register documents from the same docket.
Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period; Correction
Dietary Supplements Containing Ephedrine Alkaloids; Administrative Docket Update; Availability
Dietary Supplements Containing Ephedrine Alkaloids; Withdrawal in Part
Dietary Supplements Containing Ephedrine Alkaloids; Reopening of Comment Period
Dietary Supplements Containing Ephedrine Alkaloids; Notification of Intent to Reopen Comment Period
Citation: 68 FR 10417
