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

NAD Recommends Ganeden Change Claims With FDA’s Label Decision Pending

This article was originally published in The Tan Sheet

Executive Summary

Ganeden Biotech should stop using certain testimonials and claims for some Digestive Advantage products, but whether it should market products in the line as "medical foods" is up to FDA to decide, according to the National Advertising Division

You may also be interested in...



Medical food warning letter

Several products marketed by Ganeden Biotech are the subject of a recent FDA warning letter because they are labeled as medical foods but do not meet the definition under federal regulations required for products carrying such a distinction, the agency says. "Your products are not medical foods because the diseases and conditions described in the product labels do not have distinct nutritional requirements established by medical evaluation and because the products do not have any unique impact on the dietary management of those diseases and conditions beyond that which could be achieved by modification of the normal diet alone," the letter says. In addition, several of the products' names and claims make them misbranded, FDA says. For example, Arthritis Advantage claims to be "clinically proven to reduce pain and increase mobility," while Digestive Advantage is "for those who suffer from chronic constipation"...

NaZura’s Lovidia Weight-Loss Supplement Strategy Focused On Brand Building

NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.

NaZura’s Lovidia Weight-Loss Supplement Strategy Focused On Brand Building

NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.

Topics

UsernamePublicRestriction

Register

ID036688

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