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


Implied Disease Claims Provision Is Setback For Industry - Hutt

This article was originally published in The Tan Sheet

Executive Summary

Strict implementation and enforcement of the implied disease claims provision in FDA's structure/function claims final rule could mean "lost ground" for dietary supplement firms, eradicating gains resulting from the agency's "retreat" from the proposed "disease" definition, according to attorney Peter Barton Hutt.

You may also be interested in...

Vitamin E Health Claim Falls Short Of Significant Scientific Agreement - FDA

FDA has determined a health claim relating vitamin E to a reduced risk of heart disease does not meet the "significant scientific agreement" standard. The agency's decision is articulated in a Jan. 11 letter to the Washington, D.C. firm Emord & Associates, which submitted the claim petition on behalf of Julian Whitaker, MD, Durk Pearson, Sandy Shaw and others.

Hot Flashes, PMS Structure/Function Claims Allowed Under Final Rule

FDA will permit dietary supplement makers to make structure/function claims for "common, mild symptoms associated with normal life stages or processes." Examples of allowable claims include hot flashes associated with menopause and mild mood changes, cramps and edema related to the menstrual cycle.

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





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