GRAS Path Draws Interest As New Dietary Ingredient Alternative, But Carries Challenges
This article was originally published in The Pink Sheet Daily
In the wake of FDA’s draft guidance on NDI notifications, more companies reevaluate the status of their ingredients before going to market. The GRAS for use in foods process is a clear – but rigorous – alternative pathway.
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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.
History of use, toxicology studies key