FDA has heart
This article was originally published in The Tan Sheet
Executive SummaryAgency concludes use of heart symbol in labeling of Rexall Sundown's CoQ-10 Ultimate softgels, Twinlab's Twinsorb CoQ10 softgels is acceptable because labeling contains "contextual statements that...establish the products are not intended to treat, prevent, mitigate, diagnose or cure heart disease." In April 23 letter to law firm Arnall Golden Gregory (Atlanta), FDA notes "if a label contains adequate context to make clear that a product" is not a disease claim, then it can be considered a structure/function claim within the scope of DSHEA. Agency's letter responds to a March 18 correspondence from AGG claiming use of the heart symbol makes products unapproved new drugs...
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