Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Neutrogena Pre-emption Defense Stands On California State Court Appeal

This article was originally published in The Tan Sheet

Executive Summary

The FDA Modernization Act promotes regulatory uniformity and pre-empts litigation seeking changes to J&J/Neutrogena sunscreen labeling claims beyond FDA requirements, a California state appellate court says. OTC drug and cosmetic firms have been less successful with pre-emption arguments in other cases.

You may also be interested in...



FDA Preemption Comment Could Sway California Against Prop 65 Warnings For Acetaminophen

 Food and drug attorneys suggest it is unlikely California will require Prop 65 warnings on OTC acetaminophen products after FDA tells the state that warnings would violate federal regulations. FDA also says sciences doesn't support a conclusion acetaminophen can cause cancer and that the warnings would confuse consumers.

Preemption Argument In Drug/Cosmetic Dispute Likely Falls Short Of Supreme Court

Federal law does not preempt Allergan's suit alleging Athena Cosmetics' RevitaLash competes unfairly against the drug firm's Latisse treatment in California, according to a Supreme Court brief filed by Solicitor General Donald Verrilli. Athena argues the absence of FDA action against its eyelash enhancers signals that its cosmetic positioning is lawful.

Another Motrin Failure-To-Warn Decision Rejects Pre-emption Defense

Massachusetts’ supreme court says no “clear evidence” showed “FDA would not have approved a warning on OTC ibuprofen labels stating that redness, rash, and blisters may lead to a life-threatening disease.” McNeil’s failed appeal of a verdict in Children’s Motrin litigation adds to rulings that reject federal pre-emption against failure-to-warn complaints.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS107837

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