FDA WARNING_LETTER - Pan American Laboratories, LLC - November 30, 2009

The FDA issued a Warning Letter to Mr. Wingerter regarding the Neevo caplets prenatal product, marketed on http://www.neevoprenatal.com and http://www.pamlab.com. The FDA reviewed these websites in November 2009.

The primary violation is that Neevo caplets are labeled and marketed as a "medical food" but do not meet the statutory definition in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria in 21 C.F.R. 101.9(j)(8). Specifically, the product is intended for conditions (planned pregnancy, pregnancy, postpartum, lactation, MTHFR polymorphism) where distinctive nutritional requirements can be met through modification of a normal diet, contradicting 21 C.F.R. 101.9(j)(8)(ii). The FDA states that folic acid and other micronutrients for these conditions can be readily obtained from fortified foods and dietary supplements. Therefore, the product is misbranded under Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 343(a)(1)] because its label is false and misleading.

Additionally, the FDA noted that the Neevo prenatal product label appears to contain an NDC number, which is intended for drugs and should not