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

UsernamePublicRestriction

FDA Expects Safety As Ticket To Enter 'Pre-DSHEA' Dietary Ingredient List

This article was originally published in The Rose Sheet

Executive Summary

FDA agrees with public health advocates that ingredients should be on a potential list of those available when Congress passed DSHEA only after current substantiation for a reasonable expectation of safety for their intended uses.

You may also be interested in...



FDA Could Stick With Current Advice On NDI Notifications, Old Ingredient Evidence

FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam Guggenheim.For both of those developments, she says, "I'm not holding my breath."

NPA Pre-DSHEA Ingredients Book: First Chapter In FDA's Industry-Sourced Reading?

NPA published a book listing pre-DSHEA dietary ingredients and FDA is interested in reviewing the trade group's methodology for compiling the list, which could be a litmus test for how the agency will evaluate industry-produced lists of “old” ingredients.

Rose Report Podcast – September 2017

Rose Sheet’s editorial team counts down top news items in the cosmetics and dietary supplement sectors over the past month, including possible cosmetics regulatory convergence under a renegotiated NAFTA, the FTC’s first enforcement action against social media influencers, FDA movement to develop a list of “old dietary ingredients” pre-dating DSHEA, and more.

Related Content

Topics

UsernamePublicRestriction

Register

RS121232

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