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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.

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

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  • Select the specific GRN number below to view additional details about any GRAS Notice.
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Records Found: 12 Page 1 of 1
(sorted Z-A)
Substance Date of closure FDA's Letter
864 Bacillus coagulans SNZ 1969 spore preparation Pending
725 Inactivated Bacillus coagulans GBI-30, 6086 Feb 12, 2018 FDA has no questions (in PDF) (52 kB)
691 Bacillus coagulans SANK 70258 spore preparation Aug 28, 2017 FDA has no questions (in PDF) (54 kB)
670 Inactivated Bacillus coagulans GBI-30, 6086 Mar 15, 2017 FDA has no questions (in PDF) (47 kB)
660 Bacillus coagulans GBI-30, 6086 spores Jan 13, 2017 FDA has no questions (in PDF) (81 kB)
601 Bacillus coagulans SBC37-01 spore preparation Apr 28, 2016 FDA has no questions
597 Bacillus coagulans SNZ1969 spore preparation Feb 29, 2016 FDA has no questions
559 Bacillus coagulans Apr 2, 2015 At the notifier's request, FDA ceased to evaluate the notice
526 Bacillus coagulans strain Unique IS2 spores preparation Mar 23, 2015 FDA has no questions
399 Preparation of Bacillus coagulans strain GBI-30, 6086 spores Jul 31, 2012 FDA has no questions
378 Cultured [dairy sources, sugars, wheat, malt, and fruit- and vegetable-based sources] fermented by [Streptococcus thermophilus, Bacillus coagulans, Lactobacillus acidophilus, Lactobacillus paracasei subsp. paracasei, Lactobacillus plantarum, Lactobacillus sakei, Lactobacillus bulgaricus and Proprionibacterium freudenreichii subsp. shermanii or mixtures of these strains] Mar 26, 2012 FDA has no questions
240 Corn, cane, or beet sugar cultured with Lactobacillus paracasei subsp. paracasei, Bacillus coagulans LA-1, or Propionibacterium freudenreichii subsp. shermanii, or mixtures of these microorganisms Oct 24, 2008 FDA has no questions

(sorted Z-A)
Substance Date of closure FDA's Letter