IVC Omega-3 Supplement With FDA Health Claim Premieres At PLMA
This article was originally published in The Tan Sheet
Executive Summary
IVC Industries is introducing a private label omega-3 supplement that will use FDA's qualified health claim addressing the association between omega-3 fatty acids and coronary heart disease.
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IVC Industries is introducing a private label omega-3 supplement that will use FDA's qualified health claim addressing the association between omega-3 fatty acids and coronary heart disease. The Freehold, N.J.-based firm introduced several vitamin/mineral combination products at the Private Label Manufacturers Association trade show in Chicago Nov. 13-14. Premium Omega-3 Complex with Fish Oil softgels contain "essential omega-3 and omega-6 fatty acids, DHA and EPA from flax and fish oil" and are indicated for heart health, labeling states. FDA approved a 78-word qualified claim for omega-3 fatty acids Oct. 31, but industry has criticized the claim as lengthy and not useful (1 (Also see "Pearson Plaintiffs Using Shortened Omega-3 Qualified Claim" - Pink Sheet, 20 Nov, 2000.)). Although IVC has not yet decided how it will word its claim, it said it most likely will follow the FDA version. As a direct result of FDA's de facto recall of PPA-containing products, IVC also has reintroduced its Calorie Burners dietary supplement in the Body Enhancers line, with new labeling highlighting the product as "PPA-free," "caffeine-free," and "all natural." "Calorie Burners is the gently stimulating, naturally effective answer to weight control to help you burn calories; the only true and healthy way to a slimmer body," labeling says. The supplement is ephedra-free and contains "a natural herbal formula that...may be helpful in burning some of the calories that could end up as fat." The primary ingredient is chromium picolinate 200 mcg; Calorie Burners also contains citrus aurantium, panax ginseng, cayenne, cinnamon and parsley powder. IVC recommends consumers take two tablets per day. Pharmaceutical Formulations, Inc. also stressed it has stopped producing PPA-containing products. The private labeler said the ingredient comprised only a small part of its overall array of generic drugs and claims it will not be negatively affected by FDA's action. PFI plans to promote its pseudoephedrine products to help retailers fill in the gaps caused by the removal of PPA products. |