Modernizing FDA's Supplement Industry Regulation Mapped Out In Five-Point Plan
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.
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Acting commissioner's comment on supplement industry regulation was her most definitive statement about the agency’s work in consumer health sector at CHPA's regulatory conference. Pandemic, she says, heightened consumer interest in self-care along with demand for OTC drugs and supplements.
“We would certainly want to have some enforcement and be able to utilize that enforcement,” says ODSP acting director Cara Welch. Stakeholders opposed to the change should “get comfortable with the idea of opening up DSHEA and should most certainly be part of the discussion.”
US Wellness Market In 2019: Amarin Wins, Loses On Supplements; Gottlieb Leaves With Consumer Health Flourish
Looking look back on US wellness market developments and events in 2019, HBW Insight finds a firm that doesn’t compete in the dietary supplement sector, Amarin, made a good bit of news that affected the industry during the year. We track news across the wellness space from the past year.