HBW Insight 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


Supplement Claim Guidance Stresses Human Studies, But Leaves Questions

This article was originally published in The Tan Sheet

Executive Summary

An FDA guidance could leave dietary supplement firms confused on what is appropriate evidence for substantiating structure/function claims

You may also be interested in...

Align Supplement Industry Regulation With DSHEA, Groups Tell FDA In 'Responsible Innovation' Comments

Targeted guidance on questions around NDINs and using import alerts to keep violative products off market are among supplement industry trade groups' suggestions for improving FDA oversight of the industry. Groups also continue asserting that the agency can strengthen its VMS product manufacturing and marketing oversight with its existing authorities.

Qualifying Language For Supplement Claims Needs Clarification – CRN

The role that qualifying language can play in dietary supplement structure/function claims is unclear in FDA's draft guidance on claim substantiation, the Council for Responsible Nutrition says in Jan. 10 comments

Supplement Substantiation Claims Guidance Aims For Clarity

FDA expects a new guidance detailing the boundaries of "competent and reliable scientific information" will enhance consumer confidence in supplement claims





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