CSPI’s conclusions regarding these matters are simple, Ms. Heller said: “Consumers can’t tell one type of claim from another. Therefore, the same evidentiary and eligibility standards should apply to all categories of claims.” To those who would argue that it would be too difficult to change the standards for all claims, she insisted this was not the case. “It is not going to be burdensome at all,” she said. “There are well-established claims, like ‘calcium builds strong bones,’ that could form a category of claims to be included in a safe harbor or a positive list, as it is known in the European Union.” In addition, health claims could be rephrased as structure–function claims, provided structure–function claims meet the minimum and maximum nutrient levels currently demanded by health claims. The FDA could also consider the structure–function claims approved by the European Food Safety Authority, she added. While CSPI delivered these recommendations to the FDA in 2008 and 2009, she said, the agency has yet to take action on them. CSPI’s recommendations are consistent with the committee’s Recommendations 3 and 4, Ms. Heller noted, “because they are based on the premise that all claims should be based on stringent scientific standards and should only appear on products that are part of a healthful diet.”

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