Overview of FDA GRAS Notice in 2024

In the wave of globalization in the food industry, innovation and safety are inseparable. An increasing number of companies are actively pursuing the US FDA Generally recognized as safe (GRAS) notice for new food ingredients. Unlike self-GRAS, the FDA GRAS requires the formation of GRAS evaluation materials, and when GRAS materials are submitted to the FDA, the FDA issues the inventory notices on its official website and periodically updates the information. The latest update to this inventory was on January 7, 2025.

CIRS Group has conducted a detailed statistical analysis and summary of substances submitted for FDA GRAS in 2024, aiming to provide clients with valuable insights.

1. Summary of the FDA GRAS notice in 2024

From 2024 until January 7, 2025, 13 substances received the letter stating “the FDA has no questions” (including two submitted in 2024 and 11 submitted before 2024). There are currently 55 substances that were submitted in 2024 and are still pending. Additionally, seven ceased to be evaluated (three were resubmitted).

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Figure 1. Overview of GRAS notifications in 2024

2. Substances notified in 2024 (based on approval dates): 13 substances

In 2024, 13 substances were notified, including five microorganism-related substances, three sugar substitute ingredients, two dairy products, two proteins, and one 1-methylcyclopropene compound.

Compared to 2023, there has been a declining trend in the number of substances obtaining GRAS notifications (details can be seen in the article Surge in Applications: Overview of FDA GRAS Notifications from 2021 to 2023).

CIRS speculates that, on the one hand, the increasing number of FDA GRAS submissions in recent years has impacted the review speed. On the other hand, the FDA has been imposing stricter review requirements for submitted substances. For example, many new substances produced using synthetic biology technologies now require more detailed and comprehensive documentation.

Table 1. Substances obtained the FDA GRAS notice in 2024

No.	GRN No.	Substance	Notified date	Enterprise
1	1057	D-psicose	2024/1/25	Tate & Lyle (Britain)
2	1125	Pea protein fermented by shiitake mycelia	2024/3/27	MycoTechnology, inc. (US)
3	1127	Lactiplantibacillus plantarum ATCC-202195	2024/2/1	Danisco USA, Inc. (US)
4	1132	Hydrolyzed poultry protein	2024/1/29	Norilia AS (Norway)
5	1134	Bacteriophage preparation specific to Salmonella Enteritidis	2024/2/8	Qingdao Phagepharm Biotech Co., Ltd. (China)
6	1137	Protein-sucrose	2024/1/19	Incredo Ltd. (Israel)
7	1142	Brazzein	2024/3/11	Oobli, Inc. (US)
8	1143	Bacillus subtilis NRRL 68053	2024/1/19	Microbial Discovery Group (US)
9	1146	Nuclease enzyme preparation produced by Bacillus amyloliquefaciens expressing the gene encoding a nuclease from Serratia marcescens	2024/6/12	c-LEcta GmbH (Germany)
10	1155	1-methylcyclopropene	2024/4/23	Fresh Inset S.A. (Poland)
11	1158	Lactiplantibacillus plantarum DSM 34613	2024/5/8	Scott Laboratories, Inc. (US)
12	1172	Liquid milk, either whole or nonfat, combined with lactose and water	2024/5/20	Synlait Milk Limited (New Zealand)
13	1179	Liquid whole cow milk	2024/9/24	Crossway Foods, Ltd. (Ireland)

3. Substances still pending in 2024

In 2024, 57 substances were submitted for FDA GRAS notification, of which two have been notified while 55 are still pending. Notably, due to the surge in submissions, the FDA has extended the time required to archive newly submitted dossiers (assigning GRN numbers). As a result, many products submitted in 2024 have not yet been archived or, if archived, have not been updated on the official website.

14 substances submitted in 2024 by Chinese companies are currently pending. Among them, seven are alternative sweeteners (four steviol glycosides, two D-psicose, and one brazzein preparation), one hydroxytyrosol, one algal oil, one fungal oil, one inositol, one ergothioneine, one microorganism-related product, and one human milk oligosaccharides (HMOs).

Table 2. Substances submitted by Chinese companies still pending (based on publicly available information)

No.	GRN No.	Substance	Enterprise
1	1178	Rebaudioside I obtained by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni (rebaudioside I)	Sichuan Ingia Biosynthetic Co., Ltd
2	1182	Hydroxytyrosol	Hangzhou Viablife Biotech Co, Ltd.
3	1184	Rebaudioside M from a modified strain of Escherichia coli BL21 (DE3)	Sichuan Ingia Biosynthetic Co., Ltd.
4	1185	Algal oil (≥35% docosahexaenoic acid) from Schizochytrium sp. FJRK-SCH3	Runke Bioengineering (Fujian) Co., Ltd.
5	1186	Fungal oil (≥38% arachidonic acid (ARA)) from Mortierella alpina FJRK-MA01	Runke Bioengineering (Fujian) Co., Ltd.
6	1188	D-psicose	Shandong Starlight So True Biological Technology Co., Ltd
7	1191	Ergothioneine produced by Escherichia coli BL-21 (DE3) expressing ergothioneine synthases from Schizosaccharomyces pombe	Shanghai EGT Synbio Group Co., LTD
8	1193	D-psicose	Sichuan Ingia Biosynthetic Co., Ltd.
9	1198	Inositol	Sichuan Bohaoda Biological Technology Co., Ltd.
10	1203	Rebaudioside M2 obtained by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni	Guilin Layn Natural Ingredients Corp.
11	1204	Lacticaseibacillus casei Zhang	Beijing Scitop Bio-tech Co., LTD
12	1206	Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni	Adorvia Biotechnology Co., Ltd.
13	1207	Brazzein preparation produced by Aspergillus oryzae 90402 expressing a gene encoding for brazzein from Pentadiplandra brazzeana	Nanjing Bestzyme Bio-Engineering Co. Ltd.
14	1208	Lacto-N-triose II	Shandong Henglu Biotechnology Co., Ltd.

4. Popular GRAS substances in 2024

In 2024, a wide variety of products have been submitted for the FDA GRAS notification, with microbial-related products being particularly popular. Sugar substitutes such as steviol glycosides, brazzein, D-psicose, and monocin preparations, as well as nutritional substances like HMOs and dairy products, continue to be in high demand for submission.

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Figure 2 Proportion of product categories submitted for the FDA GRAS notice in 2024

Table 3. Details of popular substances in 2024

Category	Substances	Number of notified	Number of pending notice	Total
microbial-related products	Enzyme preparations	1	8	9
	Lactiplantibacillus plantarum	2	2	4
	Bacteriophage preparations	1	2	3
	Bacillus subtilis	1	1	2
	Saccharomyces cerevisiae	0	1	1
	Lacticaseibacillus casei	0	1	1
	Total	5	15	20
steviol glycosides	D-psicose	1	2	3
	Brazzein preparation	1	2	3
	Rebaudioside M	0	2	2
	Protein-sucrose	1	0	1
	Rebaudioside M2	0	1	1
	Rebaudioside I	0	1	1
	Monocin preparation	0	1	1
	Cellobiose	0	1	1
	Total	3	10	13
dairy products	Whole dry sheep milk	0	2	2
	Liquid milk, including whole and skim milk, mixed with lactose and water	1	0	1
	Liquid whole cow milk	1	0	1
	Liquid whole goat milk	0	1	1
	Total	2	3	5
HMOs	6'-SL	0	1	1
	LNT	0	1	1
	LNnT	0	1	1
	Total	0	3	3
Others	Spore preparation	0	3	3
	Algal oil	0	3	3
	Pea protein	1	0	1
	Hydrolyzed poultry protein	1	0	1
	1-Methylcyclopropene complex	1	0	1
	Saxifrage powder	0	1	1
	Resistant dextrin	0	1	1
	Polypeptides	0	1	1
	Ovotransferrin	0	1	1
	Inositol	0	1	1
	Rhamnogalacturonan	0	1	1
	β-Lactoglobulin	0	1	1
	Goat lactose	0	1	1
	Goat whey	0	1	1
	Fungal oil	0	1	1
	Ergothioneine	0	1	1
	Recombinant bovine lactoferrin isolate	0	1	1
	Protein preparation	0	1	1
	Hydroxytyrosol	0	1	1
	Galacto-oligosaccharides	0	1	1
	Chemically synthesized pediocin PA-1 analog	0	1	1
	(R)-1,3-Butanediol	0	1	1
	Protein Hydrolysate	0	1	1
	Total	3	24	27

5. Summary

In 2024, the FDA GRAS notice reflects the food industry’s pursuit of both innovation and safety. Although the number of notified substances has declined, the submission activity remains high. Chinese companies are significantly increasing their participation in the fields of functional ingredients and biosynthetic substances.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

*Data Source: The inventory of GRAS notices and the latest released accepted GRAS dossiers (updated as of 2025/01/07).

*Note: Because the FDA doesn’t disclose dossier acceptance dates, the statistics for substances currently pending are primarily based on the submission dates recorded in the released dossiers.

The statistics are based on the published dossiers with GRN No., and are for reference only.

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