Hobe Labs
This article was originally published in The Tan Sheet
Executive Summary
Company is making packaging changes to satisfy FDA concerns raised in an Aug. 18 warning letter that Hobe's Col-S-Rol, Lapacho and Psoria-Gard Skin Treatment System Steps 1, 2 and 3 contain "therapeutic claims which cause the products to be drugs." The claims objected to include: "High blood pressure, caused in part by fatty arterial deposits" for Col-S-Rol, "Antibiotic properties" for Lapacho, and "Emulsifies sebum and helps remove scales" for Psoria-Gard. Products also are misbranded because they do not bear adequate directions, and Psoria-Gard does not comply with the final monograph for dandruff, seborrheic dermatitis and psoriasis products, FDA notes