January 28, 2014
Increase in Enforcement Actions against Medical Foods; FDA Sends Two Warning Letters
By Riëtte van Laack –
On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease,” whereas NVN Therapeutics markets GlucoreinTM PCOS as a medical food for the “dietary management of Polycystic Ovarian Syndrome ("PCOS") by reducing the incidence of metabolic syndrome and insulin resistance.” FDA alleges that these products are misbranded as medical foods because, according to FDA, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for PCOS.
continue to read here
On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease,” whereas NVN Therapeutics markets GlucoreinTM PCOS as a medical food for the “dietary management of Polycystic Ovarian Syndrome ("PCOS") by reducing the incidence of metabolic syndrome and insulin resistance.” FDA alleges that these products are misbranded as medical foods because, according to FDA, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease and for PCOS.
continue to read here
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