In Vivo 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 Debuts List For Rapidly Announcing Noncompliant Ingredients In Supplements

Executive Summary

FDA announces addition of Dietary Supplement Ingredient Advisory List page to its website to identify ingredients it has preliminary determined should be used in dietary supplements. It also publishes warning letters submitted recently to firms marketing supplements containing two ingredients agency has concluded should not be used: eight were warned about using an ingredient identified as "DMHA" and three about using phenibut.

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.

FDA Prioritizes Vinpocetine Decison After Animal Study Shows 'Developmental Toxicity'

Agency announces plan in statement by two deputy commissioners warning consumers about safety concerns regarding the semi-synthetic derivative of vincamine, "specifically concerns about the use of this ingredient by women of childbearing age." Recent findings by NIH National Toxicology Program's study with rats and rabbits indicate "vinpocetine may cause a miscarriage or harm fetal development," FDA says.

NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA

FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.

Related Content

Topics

UsernamePublicRestriction

Register

RS148731

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