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Shield Technology

This article was originally published in The Tan Sheet

Executive Summary

Company's Chimal Technology Skin Shield and StarLee Skin Shield "do not qualify for evaluation under the ongoing OTC Drug Review," are unapproved new drugs and are misbranded, FDA says in a March 16 warning letter. Labeling indicates the topical products "are intended to form an impervious 'barrier' or 'shield' on the skin," the agency says, adding the products are promoted as comparable to gloves in preventing adverse effects and diseases caused by contact with various substances, and claim to prevent contracting viral diseases such as AIDS. The Tulsa, Okla.-based firm is scheduled to meet with FDA April 18 to discuss the letter. The firm's products are sold through distributors to the medical, food and cosmetic industries

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