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This article was originally published in The Tan Sheet

Executive Summary

Choles-Response, which labeling states "supports healthy cholesterol levels," began shipping in March to health food and GNC stores nationwide. The product comes in 30-, 60- and 90-count sizes with suggested retail prices of $12.50, $23.50 and $33.50, respectively. Consumers are recommended to take one tablet three times a day. Among its numerous ingredients, a daily dose contains 715 mg red yeast rice extract standardized to 1.4% lovastatin, 50 mg dandelion root extract, 50 mg hawthorn berry extract and 15 mg CoQ10. The product could face FDA opposition in light of the agency's stance that red yeast rice products with lovastatin are unapproved drugs, as well as FDA's structure/function claims final rule, which sets stricter limits on acceptable cholesterol reduction claims (1"The Tan Sheet" Jan. 10, p. 5)

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