Pink Sheet 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

Trans fat labeling

This article was originally published in The Tan Sheet

Executive Summary

FDA has added an addendum to its recent guidance on requesting an extension to use existing label stock after the trans fat labeling effective date of Jan. 1, the agency said Dec. 30. Due to the "numerous requests" from industry on the guidance and the agency's "limited resources to handle all of these pending requests prior to the Jan. 1 effective date," FDA will only consider requests postmarked as of Dec. 31. In order to be considered, the requests must be for product labels that otherwise comply with FDA labeling requirements. The product also must not contain more than 0.5 g trans fat per labeled serving. The labeling guidance was released Dec. 14 (1"The Tan Sheet" Dec. 12, 2005, In Brief)...

You may also be interested in...



Trans fat labeling

"The estimate of the amount of time needed, not exceeding 12 months, to exhaust the number of existing labels for all products identified that the firm is requesting to use," is one factor CFSAN will take into account when reviewing requests for extensions on compliance with the trans fat labeling final rule, according to a 1guidance released by the Center for Food Safety & Applied Nutrition. According to the center, the guidance will publish in an upcoming issue of the Federal Register. FDA "does not object" to the use of "alternate means of compliance" such as a sticker label declaring the amount of trans fat in a product as long as the sticker "adheres to the package under intended storage conditions," the guidance states. The final rule on trans fat labeling was released in 2003 (2"The Tan Sheet" July 14, 2003, p. 7)...

Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch

A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.

With Preservative-Free Alaway Eye Drops, Bausch Expands OTC Portfolio Of Planned Spin-Off

Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals. 

Topics

UsernamePublicRestriction

Register

SC081785

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