Omni Nutraceuticals

Inholtra Joint Pain analgesics with glucosamine and chondroitin are monograph compliant despite FDA concerns about OTC/supplement combination products, Omni says. A launch date has not been set for the line of four analgesics (aspirin, acetaminophen, ibuprofen and naproxen sodium ) and the company is still in talks with FDA regarding labeling. Omni says the products differ from other combinations because they will be labeled only with OTC indications, claims and dosing schedules approved under existing monographs, not structure/function claims. FDA recently sent letters discouraging several companies from marketing products with both OTC and supplement claims, and promised future guidance on the issue (1"The Tan Sheet" June 12, p. 3). Omni will list glucosamine and chondroitin as "inactive ingredients" on labeling but will prominently display them on packaging, relying on consumers' knowledge of the ingredients