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CRN at Odds with FDA over Combos

October 1, 2008: 05:38 PM EST
Council for Responsible Nutrition (CRN) president and CEO Steve Mister has taken Bayer’s side in a dispute with the FDA over Heart Advantage, a combination of aspirin and phytosterols that fits somewhere between an over-the-counter (OTC) medicine and a dietary supplement. The FDA has issued a warning letter stating that the entire product is a drug, maintaining that its twin claims – that aspirin keeps the blood flowing and phytosterols help to lower bad cholesterol – “may be interpreted by the consumer as medical advice”. Bayer says it stands behind both claims and that neither is intended to replace medical advice. Mister says the CRN “continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness”, and urges the FDA to help companies “maneuver the regulatory challenges”. CRN says the agency has scope under the Dietary Supplement Health and Education Act (DSHEA) and the US Food, Drug and Cosmetic Act to approve such combinations.
"Council for Responsible Nutrition says that Supplement-OTC Drug Products Play Important Role; FDA says Otherwise", Functional Ingredients, October 01, 2008, © Penton Media, Inc.
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