TBT BSN | Notification

Notification Detail :: G/TBT/N/USA/36

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Dietary Supplements Containing Ephedrine Alkaloids;  Reopening of the Comment Period (4 pages, in English)

Objective

Product Covered

Dietary Supplements (ICS 71)

Document Notification

Link to ePing

HSCODE

71 - NATURAL OR CULTURED PEARLS, PRECIOUS OR SEMI-PRECIOUS STONES, PRECIOUS METALS, METALS CLAD WITH PRECIOUS METAL, AND ARTICLES THEREOF; IMITATION JEWELLERY; COIN

ICSCODE

71 - CHEMICAL TECHNOLOGY

Keywords

Food standards

Specific Regions

Description

The Food and Drug Administration (FDA) is reopening the comment period for a proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids” that published in the Federal Register of 4 June 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.”

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/USA/36

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