Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Structure/function notification burden queried

This article was originally published in The Tan Sheet

Executive Summary

FDA asks for dietary supplement firms' comments on the reporting burden of notifying the agency about structure/function claims. In a June 2 Federal Register 1notice, the agency estimates, based on submissions received in the past two years, that 2,200 firms will make the reports per year and each will require 0.75 hours to report the necessary information, for a total annual industry burden of 1,650 hours. The Dietary Supplement Health and Education Act requires manufacturers making structure/function claims on supplements to notify FDA of the claims within 30 days of a product reaching the market. The deadline for comments is Aug. 3, according to the notice

You may also be interested in...



Law firm asks for structure/function petition decision

The dietary supplement industry would have no reporting burden for structure/function claim notifications if FDA affirmed a citizen petition to revoke the claim notification rule, A. Wes Siegner says. The Hyman, Phelps & McNamara attorney reminded FDA in a Nov. 23 1letter that the agency has not responded to HPM's Feb. 4, 2000, petition, which asked FDA to rescind its disclaimer requirement for structure/function claims and its requirement that supplement firms notify FDA of such claims, as long as the claims are "truthful, non-misleading and derive[d] from nutritive value." Siegner's letter responds to FDA's June 2 Federal Register notice seeking comment on the burden of claim notification - estimated at 1,650 total hours annually (2"The Tan Sheet" June 8, 2009)

3D Carbon Partners With Resolution Medical To Produce More Than 1 Million Nasal Swabs A Week

Resolution Medical teamed up with Carbon to introduce more than one million 3D-printed nasal swabs a week to address the shortage for COVID-19 testing.

ACC 2020: Medtronic’s Evolut TAVR Works In Low-Risk Bicuspid Study

Early results from the Low-Risk Bicuspid study of the Evolut transcatheter aortic valve replacement system showed low rates of all-cause mortality or stroke.

Topics

UsernamePublicRestriction

Register

PS103001

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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