FDA Prioritizes Vinpocetine Decison After Animal Study Shows 'Developmental Toxicity'
Executive Summary
Agency announces plan in statement by two deputy commissioners warning consumers about safety concerns regarding the semi-synthetic derivative of vincamine, "specifically concerns about the use of this ingredient by women of childbearing age." Recent findings by NIH National Toxicology Program's study with rats and rabbits indicate "vinpocetine may cause a miscarriage or harm fetal development," FDA says.
You may also be interested in...
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.
Trade Groups Remain Skeptical Of Consumer Reports Supplement Analysis
Consumer Reports report stating supplements are ineffectual and possibly dangerous shortchanges supplement regulations, undermines the work to enforce regulations and deceives consumers, say industry trade groups.
'Innovation' Meeting Shows FDA-Industry Gap On NDI Guidance Details Remains
Panel discussions and public comments during FDA public meeting show industry sees agency, as it stated in draft NDI notification guidances published in 2011 and 2016, is allowing little room for innovation through making new ingredients available for use in VMS products. FDA says immense growth of the VMS market since DSHEA passed shows numerous products available in US contain substances that haven't been notified to the FDA with proof showing they are dietary ingredients and are safe for use.