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QUANTUM DISCONTINUES PROMOTIONAL MATERIALS FOR SIX DIETARY SUPPLEMENTS

This article was originally published in The Tan Sheet

Executive Summary

QUANTUM DISCONTINUES PROMOTIONAL MATERIALS FOR SIX DIETARY SUPPLEMENTS following a July 1 warning letter from FDA. The Eugene, Ore.-based Quantum said that it plans to remove from commercial distribution all promotional materials for its Super Night Trim Capsules, Night Trim Capsules, Super Day Trim Tablets, Day Trim Tablets, Migrelief Capsules and SEE Tablets due to an FDA determination that the materials contain false or misleading therapeutic claims. For the time being, Quantum stated that it does not expect to issue revised promotional materials for the products. FDA told Quantum that promotional labeling for these products included statements that indicate the products are intended for use as drugs. However, the agency said it was "not aware of any substantial, scientific evidence that the combination of ingredients" found in the supplements to support their safe and effective use as therapeutic products. For example, FDA noted that Super Night Trim Capsule labeling carried misleading statements such as: "The all-natural nutrients in Super Night Trim act as metabolic enhancers so you can diet effectively. Ornithine and glycine may help stimulate the metabolism to burn fat." Other ingredients found in Super Night Trim Capsules, according to the warning letter, include niacinamide, vitamin B[6] and valerian root extract. Product labeling for Quantum Night Trim Capsules described the product as the "overnight reducer" and suggested that the product's "fat burning qualities help women replace soft, fat, dimpled, cellulite with leaner muscles," the warning letter says. The product also contains ornithine, glycine, niacinamide, and vitamin B[6]. In an accompanying promotional newsletter called "VitalSigns," FDA noted, Super Day Trim Tablets and Super Night Trim Capsules are said to "not merely decrease the appetite naturally, but actually help the body to function more efficiently, ridding itself of unwanted fat . . . A key effect of these technical diet products meant for nighttime use is to stimulate the release of human growth hormone, or HGH." FDA also objected to claims made in promotional materials for Day Trim Tablets, which are comprised of L-carnitine 240 mg, L- phenylalanine 60 mg, L-tyrosine 140 mg, vitamin B[6] 40 mg, vitamin C 400 mg, L-glutamaine 400 mg, glucomannan 100 mg and chromium GTF 100 mcg. "The all-natural nutrients in Day Trim help fill you up, curb your appetite, reduce your craving for sweets and burn fat," FDA quoted the materials as stating. The agency also cited unsubstantiated therapeutic claims for two non-nutritional products: Migrelief, a headache relief tablet made from feverfew extract, white willow extract and meadowsweet extract; and SEE Tablets, an eye soothing product comprised of bilberry extract, omega seed powder, beta carotene, vitamin A, vitamin C, vitamin E, citrus bioflavonoid, vitamin B[2], rutin NF, selenium, pantothenic acid, chromium and zinc. Quantum's product catalog touted Migrelief as the "British All-Natural Migraine Formula," while the SEE Tablets were promoted as being "important in preventing lipid pre-oxidation in the eye," according to the FDA warning letter.
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