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

Source Naturals

This article was originally published in The Tan Sheet

Executive Summary

Choles-Response, which labeling states "supports healthy cholesterol levels," began shipping in March to health food and GNC stores nationwide. The product comes in 30-, 60- and 90-count sizes with suggested retail prices of $12.50, $23.50 and $33.50, respectively. Consumers are recommended to take one tablet three times a day. Among its numerous ingredients, a daily dose contains 715 mg red yeast rice extract standardized to 1.4% lovastatin, 50 mg dandelion root extract, 50 mg hawthorn berry extract and 15 mg CoQ10. The product could face FDA opposition in light of the agency's stance that red yeast rice products with lovastatin are unapproved drugs, as well as FDA's structure/function claims final rule, which sets stricter limits on acceptable cholesterol reduction claims (1"The Tan Sheet" Jan. 10, p. 5)

You may also be interested in...



Cholesterol Structure/Function Claim Limited To Levels In "Normal Range"

FDA's approved structure/function claim for cholesterol - "Helps to maintain cholesterol levels that are already within the normal range" - may be more restrictive than industry would have preferred by referring only to cholesterol levels considered normal.

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

In Brief

Combe sells most of its OTC brands

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS091080

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