Regulatory News In Brief
This article was originally published in The Tan Sheet
Executive Summary
FDA fires warning shot on Breathable Foods’ “inhalable caffeine”; agency guidance advises against phthalate excipients in drugs; pandemic adverse event reporting guidance finalized; Globe All Wellness recall of tainted supplements is insufficient; more Regulatory News In Brief.
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Relaxation Potion Warning: Wake Up Call About FDA Beverage Guidance
FDA warning letter on Dewmar’s Lean Slow Motion…Potion line is the first addressing differences between products marketed as conventional beverages and as liquid supplements since a final guidance in January. Attorney Justin Prochnow says the warning could signal an FDA crackdown on melatonin in conventional beverages.
Relaxation Potion Warning: Wake Up Call About FDA Beverage Guidance
FDA warning letter on Dewmar’s Lean Slow Motion…Potion line is the first addressing differences between products marketed as conventional beverages and as liquid supplements since a final guidance in January. Attorney Justin Prochnow says the warning could signal an FDA crackdown on melatonin in conventional beverages.
In Brief
Jury orders McNeil to pay $63M in TEN suit; Marshals seize Globe All Wellness products; USP forms supplement adulteration panel; FDA warnings for GMPs flow; Hurricane Sandy impact knocks GNC revenue; Icahn takes Herbalife stake; U.K. shuts down melatonin ad.