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AdvaMed raises concerns about final rule on "intended uses"

The FDA should scrap the "totality of the evidence" standard in the final tobacco product classification rule's definition of "intended uses" and use the approach provided in its proposed rule instead, AdvaMed wrote in a letter released by the agency last week. Because the standard "is more outcome determinative than prescriptive, manufacturers seeking to avoid potential enforcement action will have no choice but to curb important product-related communications," AdvaMed wrote.

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