HBW Insight 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

In Brief: Island Glow FDA warning letter

This article was originally published in The Rose Sheet

Executive Summary

Island Glow FDA warning letter: Sent to the sun tanning products' manufacturer 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 is not available on the products, and the ingredients in the items are not GRAS/E, the letter states. The products are also misbranded because the labels "fail to bear adequate directions for use for the conditions that are offered"...
Advertisement
Advertisement
UsernamePublicRestriction

Register

RS003732

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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