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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.

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