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U.S. Department of Health and Human Services

About FDA

Percentage of GRAS notice reviews completed during the quarter within 180 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, 2013.

Fiscal Year - 2012

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TimeTargetPercentage
Oct-Dec 201150%73%
Jan-Mar 201250%77%
Apr-Jun 201250%45%
Jul-Sep 201250%45%

FY 2012 Overall: 61%

Number of GRAS notice reviews completed during the quarter within 180 days of filing

Fiscal Year - 2012
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TimeTargetNumber
Oct-Dec 2011N/A8
Jan-Mar 2012N/A10
Apr-Jun 2012N/A5
Jul-Sep 2012N/A5

FY 2012 Total: 28

Total number of GRAS notice reviews completed during the quarter

Fiscal Year - 2012
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TimeTargetNumber
Oct-Dec 2011N/A11
Jan-Mar 2012N/A13
Apr-Jun 2012N/A11
Jul-Sep 2012N/A11

FY 2012 Total: 46

Median number of days to complete review during the quarter

Fiscal Year - 2012
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TimeTargetNumber
Oct-Dec 2011180178
Jan-Mar 2012180176
Apr-Jun 2012180224
Jul-Sep 2012180191

FY 2012 Total: 185

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.