FDA Asks Whether Supplement Industry Has Outgrown Regulatory Framework
Commissioner Gottlieb appointed working group at FDA to evaluate agency's existing structure and strategies for oversight of supplement sector. Group's findings will determine extent of potential changes in regulatory authorities agency will ask members of Congress to establish through legislation. Action plan expected in early 2019.
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Commissioner Scott Gottlieb announces FDA's plan for policy changes to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years." Plan includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing NDI notifications guidance and fostering submissions of the notifications.
Products marketed for sexual enhancement or weight loss remain the most common types that contain undeclared drug ingredients,but drugs are showing up less in a third type that had been frequently found with drugs, bodybuilding supplements, says study in Journal of the American Medical Association. Researchers analyzing FDA database of tainted products marketed as supplements, say the trend didn't slow as FDA increased its GMP inspections and issued numerous warning letters.
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