About FDA

Percentage of food and color additive petition reviews completed during the quarter within 360 days of filing

Dictionary: FDA has the primary legal responsibility for determining the safe use of food and color additives. Before a food additive is marketed that will have technical effect in food, there must first be a regulation issued by FDA that authorizes such use. Similarly, before a color additive is marketed for use in food, drugs, cosmetics, or in certain medical devices, FDA must issue an authorizing regulation. A company that seeks a regulation for a new use of a food or color additive must submit a petition to FDA with evidence that the substance is safe for the intended use. A substance for which the use is generally recognized by qualified experts as safe is exempt from premarket approval as a food additive. "GRAS" is an acronym for the phrase Generally Recognized As Safe. The GRAS notification program is a voluntary procedure that is operating under a proposed rule issued in 1997. FDA reviews the notice and responds to the notifier by letter. In general, FDA’s response has been in one of three categories: does not question the basis for the GRAS determination, concludes the notice does not provide a sufficient basis for a GRAS determination, or at the notifier’s request has ceased to evaluate the GRAS notice.

FDA also has responsibility for the regulation of components of food contact materials (food contact substances) under the same authority as for direct food additives. To market a new food contact substance or an existing substance for a new use, manufacturers must notify FDA 120 days prior to marketing the substance. Notifications must establish that the proposed use is safe in accordance with the same safety standard as direct food additives. In the event safety is not established, FDA may object to the notification to prevent marketing. In addition, FDA may ask for additional information based on our review or request that a notifier withdraw a deficient notification.

Increasing the efficiency of review of food and color additive petitions, GRAS notices, and notifications for food contact substances:

• Increases consumer choices for safe packaging materials, food ingredients, and color additives;
• Provides consumers and industry with additional tools to mitigate or prevent microbial contamination that may lead to food borne illness; and
• Maximizes the use of FDA resources applied to food safety and public health protection.

Information is current as of December 31, 2012.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

Number of food and color additive petitions reviews completed during the quarter within 360 days of filing

Fiscal Year - 2011

Time	Target	Number
Oct-Dec 2010	N/A	4
Jan-Mar 2011	N/A	1
Apr-Jun 2011	N/A	2
Jul-Sep 2011	N/A	3

FY 2011 Total: 10

Total number of food and color additive petitions reviews completed during the quarter

Fiscal Year - 2011

Time	Target	Number
Oct-Dec 2010	N/A	4
Jan-Mar 2011	N/A	1
Apr-Jun 2011	N/A	2
Jul-Sep 2011	N/A	3

FY 2011 Total: 10

Median number of days to complete review during the month

Fiscal Year - 2011

Time	Target	Number
Oct-Dec 2010	158	147
Jan-Mar 2011	158	115
Apr-Jun 2011	158	138
Jul-Sep 2011	158	123

FY 2011 Overall: 131