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


NPA expects AER cost estimates

This article was originally published in The Tan Sheet

Executive Summary

The Natural Products Association alerts dietary supplement firms to prepare to submit comments on expected estimates from FDA on manufacturers' costs to comply with adverse event report labeling requirements. The trade group says Oct. 7 a draft of a Federal Register notice the agency posted and withdrew the same day included cost estimates for compliance with FDA's December 2007 AER draft guidances. The guidances recommend that labels for supplements and OTC drugs include complete mailing addresses and statements informing consumers the information should be used for reporting AEs (1"The Tan Sheet" July 28, 2008, p. 12). NPA and other trade groups say neither requirement was in the law that made AERs mandatory and they should not be included in FDA's guidance

You may also be interested in...

FDA Estimates Dollar Costs For Adverse Event Labeling But Doubts Persist

FDA's estimate of nearly $44 million for the dietary supplement industry to revise labels to comply with the adverse event reporting law may understate the actual burden by leaving out some key costs

FDA’s AER Language Guidance Leaves Room For Interpretation – Consultants

As dietary supplement firms revise their product labels to reflect FDA's adverse event reporting draft guidance, some industry experts say acceptable changes are not as onerous as many have feared

Bragg Live Wants Consumers To Know Efficacy Differs Among Apple Cider Vinegar Formats

Bragg Live says its survey highlights misconceptions consumers have concerning health benefits and efficacy of different delivery formats of apple cider vinegar.





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