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


FDA Narrowed "Disease" Definition Expands Structure/Function Claims

This article was originally published in The Tan Sheet

Executive Summary

Dietary supplement manufacturers will be able to make expanded structure/function claims on product labeling under an FDA final rule published in the Jan. 6 Federal Register. The rule clarifies the distinction between structure/function and disease claims by reverting to the older, narrower definition of "disease" used in the Nutrition Labeling & Education Act.

You may also be interested in...

CFSAN 10-Year Dietary Supplement Strategy Comprises Six Core Areas

The creation of an advisory committee or "standing group" on dietary supplements is one of the priorities under the FDA Center for Food Safety & Applied Nutrition's 10-year plan for supplement regulation.

Disclaimers May Be "Subterfuge" For Disease Claims, PhRMA Exec Warns

FDA should be cautious in allowing a disclaimer statement that could mislead consumers into believing dietary supplements can cure or prevent disease, a PhRMA rep maintained at FDA's Aug. 4 public meeting on the regulation of supplement structure/ function claims in Washington, D.C.

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