Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

WHCCAMP

This article was originally published in The Tan Sheet

Executive Summary

FDA should initiate a review process much like its ongoing OTC monograph review to evaluate botanicals and appoint a "dietary supplement ombudsman," American Herbal Products Association asserts in recent letter to White House Commission for Complementary & Alternative Medicine. AHPA maintains agency's August 2000 "Botanicals Drug Guidance" does not sufficiently address marketing botanicals with a long history of use as nonprescription drugs. WHCCAMP also should recommend FDA employ "responsible advocate" for supplement industry in its report to President. Interim report was scheduled for July 16, but has yet to be released (1"The Tan Sheet" July 9, p. 8)

You may also be interested in...



FDA supplement ombudsman

Rep. Frank Pallone (D-N.J.) urges HHS Secretary Tommy Thompson to establish a dietary supplement ombudsman position at FDA, in Feb. 21 letter. Pallone states ombudsman "would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. [He] would help address the need for centralized authority and accountability within FDA." American Herbal Products Association called for a supplement ombudsman at FDA in a 2001 letter to the White House Commission for Complementary & Alternative Medicine (1"The Tan Sheet" July 30, 2001, In Brief). Pallone's letter also calls for the release of GMPs, noting they have been delayed numerous times...

FDA supplement ombudsman

Rep. Frank Pallone (D-N.J.) urges HHS Secretary Tommy Thompson to establish a dietary supplement ombudsman position at FDA, in Feb. 21 letter. Pallone states ombudsman "would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. [He] would help address the need for centralized authority and accountability within FDA." American Herbal Products Association called for a supplement ombudsman at FDA in a 2001 letter to the White House Commission for Complementary & Alternative Medicine (1"The Tan Sheet" July 30, 2001, In Brief). Pallone's letter also calls for the release of GMPs, noting they have been delayed numerous times...

FDA supplement ombudsman

Rep. Frank Pallone (D-N.J.) urges HHS Secretary Tommy Thompson to establish a dietary supplement ombudsman position at FDA, in Feb. 21 letter. Pallone states ombudsman "would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. [He] would help address the need for centralized authority and accountability within FDA." American Herbal Products Association called for a supplement ombudsman at FDA in a 2001 letter to the White House Commission for Complementary & Alternative Medicine (1"The Tan Sheet" July 30, 2001, In Brief). Pallone's letter also calls for the release of GMPs, noting they have been delayed numerous times...

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS092862

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel