FDA Prioritizes Vinpocetine Decison After Animal Study Shows 'Developmental Toxicity'
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...
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.
FDA announces addition of Dietary Supplement Ingredient Advisory List page to its website to identify ingredients it has preliminary determined should be used in dietary supplements. It also publishes warning letters submitted recently to firms marketing supplements containing two ingredients agency has concluded should not be used: eight were warned about using an ingredient identified as "DMHA" and three about using phenibut.