Food Master Files
Is there guidance on what information must be in a Food Master File?
As background information, Food Master Files (FMF) are a means to submit information that one company may consider to be confidential—such as the manufacturing process for a food contact substance (FCS) or list of impurities in the FCS—directly to the U.S. Food and Drug Administration (FDA) to support FDA’s review of a Food Contact Notification (FCN) filed by another company. Importantly, however, while a Food Master File is generally used for the purpose of furnishing confidential information directly to FDA, there is no presumption of confidentiality of the information included in an FMF. That is, once an FCN becomes effective, all information contained in an FMF that support the safety and functionality of the FCS (absent extraordinary circumstances) would be available for public disclosure, unless an exemption applies. In this regard, confidential commercial or business information and trade secrets are exempt from disclosure under 21 C.F.R. 20.61 of FDA’s regulations.
In response to your question, FDA does not have any specific requirements regarding what information must be provided in an FMF. FDA also does not provide guidance regarding the appropriate maintenance of FMFs. However, in the FCN final letter issued by FDA to the Notifier, the Agency states that the Notifier "should inform the Agency of any modification to the FCS, the limitations/specifications given in the notification, or of any alteration in the manufacturing process that would result in a change in the impurities or impurity level in the FCS.” In other words, where information such as the FCS manufacturing process is provided to FDA by a third party in an FMF that is separate from the FCN itself, FDA expects the notifier to make appropriate arrangements with its supplier(s) to ensure that any such changes to a supplier’s product that may be described in an FMF are communicated to FDA on a timely basis so that the Agency can assess the impact of such change(s) on the effectiveness of the FCN.
For more information on FMFs, see the section titled, “Form 3480, Form 3479, and Food Master Files,” in the Packaginglaw.com article, Frequently Asked Questions on Food Contact Notifications.