EuroPharma Questioned on LitoZin Claims

EuroPharma Questioned on LitoZin Claims

GREEN BAY, Wis.--EuroPharma Inc. received a letter of objection from the Food and Drug Administration (FDA), after it filed notification of statements of nutritional support it planned to make for its new product, LitoZin. Among the statements were: "promotes joint health, mobility and comfort," "promotes mobility and comfort by reducing pain due to everyday activity" and "supports healthy C-reactive protein levels."

FDA (www.fda.gov) objected to the claim on reducing pain due to everyday activity, stating the claim suggests the product is intended to treat a disease, such as arthritis. It cited its final rule on structure/function claims, in which FDA concluded most claims about relieving joint pain are implied disease claims, and any claim about pain treatment or prevention is ordinarily a disease claim.