Citizen Petition Requests FDA’s Confirmation that Prescription Prenatal Vitamins are GRAS/E

December 20, 2009

By Riëtte van Laack

Earlier this month, a citizen petition was submitted to FDA requesting that the Agency issue an order confirming that prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins and minerals, and used to reduce the risk of neural tube defects in infants, are Generally Recognized as Safe and Effective (“GRAS/E”) prescription drugs and are not new drugs.

The 51-page Petition describes the (at times confusing) history of folic acid regulation in the United States and the numerous occasions that FDA has recognized that prenatal folic acid-containing vitamin products are safe and effective.  Petitioner also references data that have been published in scientific literature as evidence that there can be no question that qualified experts consider folic acid-containing products as safe and effective.  This evidence combined with the long history of safe and effective use confirms that, prescription prenatal vitamins that include folic acid are GRAS/E. 

It is not clear what caused the Petitioner to submit this Petition at this time.  As Petitioner acknowledges, FDA, on various occasions and in different contexts, has affirmed that folic acid-containing products are safe and effective.  Thus far, FDA has not taken action against the marketing of these products as unapproved prescription drug products and Petitioner does not suggest that FDA intends to change its position regarding the marketing of these products. 

Petitioner’s request presumes that prescription vitamin products containing 1 mg or more folic acid are drug products and does not consider the possibility that they may also be legal prescription dietary supplements and/or medical foods, in which case no action by FDA would be required.  Nonetheless, were FDA to grant the petition, that would likley make it easier to obtain reimbursement for these products.

The lack of a stated reason for action by FDA combined with the absence of safety concerns associated with FDA’s current policy regarding prenatal vitamins are likely to result in FDA considering this Petition a low priority.

Categories: Drug Development