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A kinder, gentler FDA?

FDA needs to revise its constricted approval process to provide "an efficient, effective and timely process for dealing with health claims for foods and beverages," GMA told the agency in comments on the FDA Modernization Act of 1997, adding that the First Amendment prohibits FDA from acting as a "national censor." Both GMA and NFPA urged the agency to be more flexible in accepting authoritative statements to support health claims by a wider group of "federal scientific bodies." Currently, only two groups can make authoritative statements: a federal government scientific body with responsibility for public health protection or research directly related to nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences and its subdivisions.
FILED IN:  Applications  > Healthcare  > Pharmaceutical

NFPA believes FDA should also accept the word of other governmental and non-governmental scientific bodies such as: USDA and its agencies; National Institutes of Health Centers and its subdivisions; CDCP subdivisions; Office of the Surgeon General; the Defense Department and the individual military services; the Veterans Administration; and Office of Alternative Medicine; and the Office of Dietary Supplements. Non-governmental bodies would include organizations like the National Science Foundation and the Life Sciences Research Office when they are working under contract to a federal scientific body with public health responsibility. GMA noted that both Congress and the courts support greater flexibility by FDA in its approval of health claims even if the evidence is not yet definitive.

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