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

In Brief: Island Glow

This article was originally published in The Tan Sheet

Executive Summary

Island Glow: FDA warning letter sent to sun tanning products' maker Centre Manufacturing for misbranding. Dated Jan. 8, the letter states that the St. Paul, Minn.-based company's Island Glow and private label suntanning products are unapproved new drugs based on claims such as, "Speeds up the tanning process" with tyrosine. FDA "is not aware of any data demonstrating that tyrosine or its derivatives are effective in stimulating the production of melanin," the letter states. In addition, U.S. material time/material extent marketing data are not available on the products, and the ingredients in the items are not GRAS/E, the letter states. The products also are misbranded because the labels "fails to bear adequate directions for use for the conditions that are offered"...

You may also be interested in...



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

People In Brief

Perrigo promotes in pricing, planning

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS086667

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