HBW Insight 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


FDA Seeks $17.7m In User Fees For Mandatory Cosmetic Registration

This article was originally published in The Rose Sheet

Executive Summary

Again in its budget justification, FDA signals that a Mandatory Cosmetic Registration Program does not come cheap. Legislation would be needed to implement the program, as well as the industry user fees required to support it, but only one cosmetics safety bill currently in play includes a user-fee mechanism to fund proposed facility and product registration with the agency.

You may also be interested in...

User Fees Could Chafe Cosmetics In OTC Monograph Reform Proposal

Products marketed for cosmetic use but formulated with drugs are regulated as topical drugs and would be subject to potential OTC user fees, although the products have little similarity with oral or nasal delivery nonprescription drugs also available under FDA's monograph system, consultant David Steinberg says.

Cosmetics Reform Bill Relaunches In Senate, Sending Stakeholders To Familiar Corners

The Personal Care Products Safety Act introduced in the Senate May 11, and the Cosmetic Modernization Amendments Act that launched in the House earlier this year, closely mirror versions that divided big and small business in the last Congress. So while the US political environment may be dramatically changed, the legislative situation for stakeholders seeking updated cosmetics regulations, at the moment, is not.

Fourth Time’s A Charm? President’s FY 2016 Budget Includes Cosmetic Fees

Continuing what has become a familiar refrain, the Obama administration’s fiscal 2016 budget request for FDA includes cosmetics user fees, marking the fourth consecutive year that such a system has been proposed. Legislation would need to be introduced – and passed – in order to establish cosmetics user fees.


Latest Headlines
See All



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