Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is announcing the availability of certain documents to update the administrative docket of the proposed rule on dietary supplements containing ephedrine alkaloids. This action is being taken to ensure that interested persons are aware of the updated information. Elsewhere in this issue of the Federal Register, FDA is withdrawing certain provisions of the proposed rule on dietary supplements containing ephedrine alkaloids, and establishing a new docket that will contain new adverse event reports and related information concerning these products.
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 [Docket No. 95N-0304] ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of certain documents to update the administrative docket of the proposed rule on dietary supplements containing ephedrine alkaloids. This action is being taken to ensure that interested persons are aware of the updated information. Elsewhere in this issue of the Federal Register , FDA is withdrawing certain provisions of the proposed rule on dietary supplements containing ephedrine alkaloids, and establishing a new docket that will contain new adverse event reports and related information concerning these products. FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for Food Safety and Applied Nutrition (HFS-7), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20852, 301-827-6733. SUPPLEMENTARY INFORMATION: I. Background (Proposed Rule) In the Federal Register of June 4, 1997 ( 62 FR 30678 ), FDA published a proposed rule on dietary supplements containing ephedrine alkaloids (the “ephedrine alkaloids proposal”). That proposal would have established a finding that a dietary supplement is adulterated if it contains 8 milligrams or more of ephedrine alkaloids per single serving, required that the labels of products that contain ephedrine alkaloids state, “Don't use this product for more than 7 days,” required certain warning statements, and affected…
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; 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: 65 FR 17509
