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"...