What Should I know about the FDA GRAS Database & Notice

What Should I know about the FDA GRAS Database & Notice

FDA GRAS Notice | FDA GRAS Database Unlocked


Like most food businesses, you probably spend a lot of time thinking about what’s in your food and how to ensure it’s safe. One of the ways you can do this is by checking the FDA GRAS (Generally Recognized as Safe) database.

This database is a compilation of food substances/ingredients that are safe for human consumption. This means that when you see a food listed on the FDA GRAS Database, the Food and Drug Administration has determined that the food is generally considered safe for human consumption.

We will walk you through the process of accessing the FDA GRAS Database and show you some of the food substances that are currently listed.

What is an FDA GRAS Notice?

The FDA GRAS Notice is a formal notification from the FDA declaring that a food or food substance/ingredient is generally recognized as safe. The database of FDA GRAS Database can be accessed online here.

This database can be useful for scientists and researchers who are interested in determining if a particular food substance is safe to use in a food product or recipe during product development stages. It can also be used by manufacturers to determine which additives may be safely included in their products.

GRAS Notification Process:

The Food and Drug Administration (FDA) notifies the public of a food substance that has been determined to be Generally Recognized As Safe (GRAS). The GRAS notification dossier process follows a specific, standardized template that is published on the FDA’s website.

Food manufacturers must submit an application containing information about the food substance, as well as evidence that it is safe for use. Manufacturers can also request emergency approval if the substance is new and has not been previously tested by the FDA. After reviewing the application, the FDA will either issue a GRAS notification or determine that further safety testing is necessary.

If the substance is already listed in the FDA’s GRAS database, manufacturers do not need to submit an application or provide additional evidence. However, they must still follow all other applicable regulations when using this substance in food products.

FDA GRAS lists essential oils:

The FDA has updated its website to include a list of essential oils that are GRAS (Generally Recognized as Safe) according to the FDA. The essential oils on the list have been deemed safe by the FDA and they do not believe there to be any harmful effects associated with using these essential oils.

Some of the essential oils that are on the GRAS list are lavender, peppermint, thyme, rosemary, and chamomile. It is important to remember that these essential oils are only considered safe if used by the instructions on the bottle or package. If you are pregnant or breastfeeding, it is always best to speak with your doctor before using any type of essential oil.


Until recently, the identities of many food additives were a closely guarded trade secret. But with the passage of the Food Quality Protection Act (FQPA) in 1996, this policy changed. Now all food additives must be listed in the Federal Register and be subject to public review and comment. This open process allows consumers and other interested parties to learn about potential hazards and health concerns associated with these ingredients.

Foods that contain GRAS substances are not required to disclose their contents, but they are still subject to regulatory scrutiny. In March of this year, FDA released its GRAS Notice database, which provides detailed information on more than 1,500 GRAS substances currently used in foods. This expansive database will help ensure that foods containing these ingredients are safely consumed by Americans.

The release of this database is an important step in ensuring that Americans have access to safe and healthy foods. By publicly disclosing the ingredients used in American food products, FDA is ensuring that consumers can make informed choices about what they eat.

Navigating the GRAS Notice process for new food products:

If you’re a food product developer, you may have heard of the GRAS notice process. This process is used to determine whether a substance is Generally Recognized As Safe (GRAS) for use in food. However, the process can be complex and overwhelming for those who are new to it. In this guide, we’ll break down the steps of the GRAS notice process and provide helpful tips for success.

  • Understand the basics of GRAS

Before diving into the GRAS notice process, it’s important to understand the basics of what it means for a substance to be Generally Recognized As Safe. According to the FDA, a substance is considered GRAS if it is generally recognized by qualified experts as safe for its intended use in food. This determination is based on scientific evidence and the substance’s history of safe use in food. It’s important to note that GRAS status is not a formal FDA approval, but rather a determination made by the food industry.

  • Conduct a thorough safety assessment

The first step in navigating the GRAS notice process is to conduct a thorough safety assessment of the substance in question. This assessment should include a review of all available scientific literature and data on the substance, as well as any relevant safety studies or toxicology reports. It’s important to consider all potential routes of exposure to the substance, including ingestion, inhalation, and skin contact. Additionally, any potential risks to vulnerable populations, such as children or pregnant women, should be carefully evaluated. A comprehensive safety assessment will help ensure that the substance is safe for its intended use in food and will increase the likelihood of a successful GRAS notice submission.

  • Prepare and submit your GRAS notice

Once you have completed your safety assessment and are confident that your substance is safe for its intended use in food, it’s time to prepare and submit your GRAS notice to the FDA. The notice should include a detailed description of the substance, its intended use in food, and the basis for its safety. It should also include a summary of the safety assessment and any supporting data or literature. It’s important to follow the FDA’s guidance on formatting and content requirements for GRAS notices to ensure that your submission is complete and meets all necessary criteria. Once your notice is submitted, the FDA will review it and provide feedback or request additional information as needed. With careful preparation and attention to detail, you can increase your chances of a successful GRAS notice submission and bring your new food product to market.

  • Work with the FDA to address any concerns or questions

During the GRAS notice process, the FDA may have questions or concerns about your submission. It’s important to work with them to address these issues and provide any additional information they may need. This can include providing more data or literature to support the safety of your substance, r addressing any potential risks or uncertainties. By working collaboratively with the FDA, you can ensure that your submission meets all necessary criteria and increase your chances of a successful outcome. Remember, the ultimate goal is to bring a safe and innovative new food product to market, and working with the FDA is an important part of that process.

  • Keep up with ongoing monitoring and reporting requirements

Once your substance has been deemed GRAS, it’s important to continue monitoring its safety and any potential risks. This includes ongoing testing and research, as well as reporting any adverse events or concerns to the FDA. It’s also important to keep up with any changes in regulations or guidelines related to your substance or the food industry as a whole. By staying informed and proactive, you can ensure the continued safety and success of your new food product.

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