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
UsernamePublicRestriction

FDA Clear On Supplement Ingredient Petitions, But Still Fuzzy On Sec. 912

This article was originally published in The Tan Sheet

Executive Summary

FDA says current dietary supplement regulations make clear that citizen petitions can be filed to request approval of ingredients that were studied in clinical trials and were part of unsuccessful investigational new drug applications

You may also be interested in...



Ovos' Former IND Homotaurine Strikes Out As Dietary Ingredient

FDA rejects Ovos Natural Health's citizen petition to classify homotaurine as a dietary ingredient, but leaves the door open for future attempts on the pathway Ovos tried to navigate – moving a substance from failed investigational new drug to dietary supplement.

FDA Guidance Raises Prospect Of More INDs For Supplement Research

An FDA draft guidance that seeks to clarify when an investigational new drug application should be filed may add logistical knots to the process of studying foods and dietary ingredients, stakeholders say.

FDA Expands Phytosterol Heart Health Claim In Proposed Rule

FDA significantly overhauls a health claim linking phytosterols to a reduced risk of coronary heart disease, expanding the type of enriched conventional foods and forms of dietary supplements that can make the claim.

Related Content

Topics

UsernamePublicRestriction

Register

RS134943

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