FDA warns prenatal product marketer
This article was originally published in The Tan Sheet
Executive Summary
Pan American Labs' Neevo caplets prenatal product is misbranded as a "medical food" because it does not meet the statutory definition of such under FDA's Orphan Drug Act, FDA says in a Nov. 20 warning letter to firm President Eric M. Wingerter. Following a review of Neevo Web sites, which state the product is a medical food for women who are pregnant, planning to become pregnant or who are postpartum, the agency said that the caplets do not meet the definition because the nutritional requirements they provide can be met through a modified normal diet alone - unlike products defined as medical foods