In Brief: FDA warning letter
This article was originally published in The Rose Sheet
Executive Summary
FDA warning letter: Sent to St. Paul, Minn.-based private labeler Cassidy for violation of the Fair Packaging & Labeling Act for a variety of its shampoo, hair gel and hair spray formulations. FDA warns the company that use of claims such as "regenerates cells" and "regenerates hair" may "cause your products to be considered drugs." In addition, the letter notes that packaging ingredient declarations differ from production batch records, and that the label does not bear "an accurate declaration of the name of each ingredient" in the products. For example, FDA notes that ingredient declarations refer to "aqueous extract of" rather than water; color additives used in formulation are not included in ingredient declarations; and ingredient declarations do not include ingredients listed in the production batch record but do include ingredients not contained in the product formula. The letter also cites Cassidy for its use of FD&C Blue No. 2, which is not approved for use in cosmetics. Cassidy says it has removed the color additive from its formulation and is changing its labeling...