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


Cascara sagrada

This article was originally published in The Tan Sheet

Executive Summary

FDA should maintain inclusion of cascara sagrada bark in OTC laxatives monograph for adult use, while "use by children at the current recommended dose should be reconsidered" based on toxicity studies on emodin, The Toxicology Group says. In a report submitted to FDA by AHPA Dec. 19, NSF subsidiary presents safety conclusions for cascara based upon National Toxicology Program reports on toxicity of phenolphthalein, a Category II ingredient, and emodin, a constituent of cascara. "The structure of phenolphthalein and those of cascara sagrada's constituents are significantly dissimilar so that there is little reason to think that toxicity concerns for phenolphthalein should be extrapolated for cascara sagrada preparations," NSF division says. AHPA's submission is part of its citizen petition requesting FDA reconsider Category II designation for cascara (1"The Tan Sheet" Nov. 4, 2002, In Brief)...

You may also be interested in...

Cascara sagrada laxatives

AHPA "intends to submit a review document within the next several weeks that will evaluate the relevance" of published data pertaining to "the potential mutagenicity, genotoxicity and carcinogenicity of cascara sagrada ingredients," trade association tells FDA. In Oct. 28 submission, AHPA includes "eight summaries of literature searches conducted over the past several months" on cascara sagrada bark that were "not previously considered" by FDA's OTC Drug Products staff or agency's advisory review panel on OTC laxatives. Group is seeking a stay of Nov. 5 effective date of final rule classifying cascara sagrada, aloe as Category II laxative ingredients (1"The Tan Sheet" June 17, 2002, p. 7)...

Health And Wellness Trademark Review 2 March, 2021

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

In Order Shutting Down New York Supplement Firm, Federal Judge Also Criticizes FDA’s Calculations

Judge ordering permanent injunction against Confidence USA on a complaint filed in 2019 questioned FDA's calculations for requiring the firm to recall and destroy all products it had distributed since February 2018.





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