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U.S. Department of Health and Human Services

GRAS Notices

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The inventory of GRAS notices provides information about GRAS notices filed since 1998, when FDA received its first GRAS notice. As of October 17, 2016, the GRAS final rule (81 FR 54960; August 17, 2016) requires a specific format for a GRAS notice. Prior to that date, FDA processed GRAS notices under the framework of the GRAS proposed rule (62 FR 18938; April 17, 1997). Notices received prior to the effective date of the GRAS final rule provide examples for potential notifiers for the types of information that may support a GRAS conclusion. In the inventory, notices follow the requirements for the format and content of a GRAS notice as of the effective date of the GRAS final rule.

The inventory notes what type of response letter the FDA sent in response to the notice. Notifiers often resubmit notices that FDA previously ceased to evaluate at the notifier’s request, and resubmitted notices commonly receive a letter indicating FDA has no questions, after addressing deficiencies. In the inventory, entries for notices that were later resubmitted link to the newer entry in the final column. Newer entries for notices that were resubmitted include a link to the previous submission below the substance name.

Some GRNs that FDA previously ceased to evaluate at the notifier’s request were later resubmitted as a food additive petition. For each of these cases, the GRN detail page links to the food additive petition.

After issuing a response letter, we may issue a subsequent letter as circumstances warrant. The issue dates of any subsequent letters are listed under the column, "Date of add’l correspondence.”

We will update this information approximately monthly. More information about this inventory is available on the GRAS Notice Inventory Introduction page.


Search and display hints:

  • Select the specific GRN number below to view additional details about any GRAS Notice.
  • To sort by a specific field, click on the column header for that field.
  • To browse the records, use the Show All, First/Previous/Next/Last, and Jump To options at the bottom of the data table.
  • To search for a specific substance/term, enter the term in the Search box and select Show Items to display only those records that contain the selected term. (The search results also includes terms not shown on this page, but included in the full record on the detail page.)
  • The search results will return hits of records containing words that include the search term. For example, a search for the color red will return results that include terms such as reduce, ingredient, and cultured. To limit results to only the searched term, place a space before and after the word in the basic search or in the advanced search “this exact phrase” field.
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Records Found: 13 Page 1 of 1
GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter Date of add'l correspondence Resubmitted as GRN No.
  669
Cows milk-derived lactoferrin Mar 9, 2017 FDA has no questions (in PDF) (168 kB)
  612
Fractionated whey protein isolate containing cows milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2 May 19, 2016 At the notifier's request, FDA ceased to evaluate this notice
  611
Fractionated whey protein isolate containing cows milk derived lactoferrin, lactoperoxidase, and transforming growth factor β2 Apr 15, 2016 At the notifier's request, FDA ceased to evaluate this notice
  465
Cow's milk-derived lactoferrin Feb 18, 2014 FDA has no questions
  464
Cow's milk-derived lactoferrin Feb 18, 2014 FDA has no questions
  423
Cow's milk-derived lactoferrin May 2, 2012 At the notifier's request, FDA ceased to evaluate this notice
  235
Human lactoferrin purified from rice Mar 12, 2010 At the notifier's request, FDA ceased to evaluate this notice
  189
Lactoferrin (human) purified from bovine milk Dec 10, 2009 At the notifier's request, FDA ceased to evaluate this notice
  162
Lactoferrin (human) purified from rice Nov 16, 2006 At the notifier's request, FDA ceased to evaluate this notice
  130
Bovine milk-derived lactoferrin Aug 21, 2003 FDA has no questions May 27, 2004
  77
Milk-derived lactoferrin
   (Resubmission of GRN 42)
Aug 14, 2001 FDA has no questions
  67
Milk-derived lactoferrin Oct 23, 2001 FDA has no questions
  42
Milk-derived lactoferrin Mar 26, 2001 Notice does not provide a basis for a GRAS determination Apr 23, 2001
  77

GRN No.
(sorted Z-A)
Substance Date of closure FDA's Letter Date of add'l correspondence Resubmitted as GRN No.
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