Omni Nutraceuticals
This article was originally published in The Tan Sheet
Executive Summary
Los Angeles-based marketer plans January 2001 rollout of Inholtra line extension Total Joint Health with willow bark "natural pain reliever." A 90-tablet size of Total Joint Health primarily will sell in health food stores, according to Omni. The glucosamine/chondroitin "Bone & Joint Support" line currently includes SulfaMax Natural MSM Formula, InholtraNow Natural Pain Cream and Natural Pain Formula. Future Inholtra line extensions containing analgesics covered by OTC monographs also are in the pipeline, although FDA has expressed concerns regarding drug/supplement combination products (1"The Tan Sheet" July 10, In Brief)
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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
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