In Brief: Concept Chemicals warning letter
This article was originally published in The Rose Sheet
Executive Summary
Concept Chemicals warning letter: FDA tells Houston-based company June 11 that cloroxylenol-containing JOVAE Bio-Intensive Shampoo is an unapproved new drug due to label claims for "relief of dry, itchy, flaky scalp" problems caused by "dandruff, psoriasis and seborrheic dermatitis" and "antimicrobial" benefits. The claims make JOVAE subject to the 1991 final rule for dandruff products, under which cloroxylenol is not approved, FDA explains. JOVAE also is misbranded because it does not carry appropriate label warnings and directions, the agency notes. In addition, FDA states, the products are adulterated due to current Good Manufacturing Practices violations. Concept Chemicals, which distributes the shampoo to salons in Houston and surrounding areas, says it is talking to FDA and expects only minor changes in product labeling...