Food science is always evolving, and companies continue to innovate new ingredients to make foods better – here is an overview of the US FDA GRAS process for companies looking to market novel food ingredients!
Under the US Federal Food, Drug, and Cosmetic Act (FD&C Act), any substance (or chemical, ingredient, material) that becomes part of a food or affecting characteristics of a food is defined as a “food additive” and therefore requires that substance to undergo a pre-market review by the US FDA via a “food additive petition” (or FAP) process, unless it is exempt from this definition. Exemptions include ingredients that have been determined to be Generally Recognized as Safe (GRAS), have been reviewed and permitted under a Food Contact Notification (FCN), or is a prior sanctioned ingredient.
Note that “color additives” are not defined under food additives and require a mandatory pre-market review by the FDA under the Color Additive Petition process.
In this post, we will break down the 2 pathways: FAP vs. GRAS. In both cases, a company will need to compile specific data on the ingredient, including its chemistry and identity, manufacturing details, purity, stability, the intended uses (to what specific foods will it be added) and levels (what is the maximum level that would be used), estimated consumer exposure, safety/toxicology data (comprehensive review of safety from preclinical/animal studies, clinical studies, in vitro assays), and a risk assessment (intake vs. toxicology data to support safety). The FAP also requires an assessment of any environmental impacts of the ingredient’s use, but typically, this is addressed with a simple categorical exclusion (exemption).
All data is compiled and an FAP is submitted to the Agency for review and ultimate re-writing of the Code of Federal Regulation (CFR) to allow the use of the ingredient in specific foods.
The advantages of this process are that companies can submit unpublished safety data (i.e., not published in the peer-reviewed literature) and end up with a complete FDA review that supports the safety of the ingredient (i.e., customers may see this as the highest safety review possible).
The disadvantages are that the process can take 2 to 3 years to complete (which is an eternity in the context of market innovation) and upon publication in the CFR, any company can use that approval to market their own ingredient, so long as they meet the specified requirements in the regulations.
All data is compiled into a GRAS dossier and is reviewed by a 3rd-party panel of qualified experts that sign off that the intended use of the ingredient is GRAS. All pivotal safety data (preclinical/clinical) must be published in the peer-reviewed literature before the GRAS review. Once the panel signs off, the manufacturer is legally permitted to market the ingredient. Optionally, the company may wish to submit a GRAS Notice to the FDA, which provides a detailed summary of the GRAS determination. The FDA reviews the notice and ideally makes a conclusion that it “has no questions” with the GRAS determination, which it publishes in a letter, with the full GRAS notice, in a public inventory.
The advantage of this process is that it is much more expedient as compared to the FAP – perhaps only a few months for the panel to review and sign off following compilation of the dossier. This is why the GRAS process is one used by most companies intending to market a new ingredient. As well, once the panel makes its determination, only the manufacturer can use that GRAS conclusion to market that ingredient. Once a GRAS notice is filed and published, which is sometimes a requirement of customers to see some level of FDA oversight of an ingredient they will be adding to their food products, any company could technically use the GRAS notice as evidence than an ingredient is GRAS, so long as they comply fully with the details of the notice.
One disadvantage of the GRAS process is that it can be somewhat more costly in that there are added costs in pulling together a panel of experts to compensate them for their time (which is NOT contingent on any conclusion) and drafting/publishing the manuscript(s) of the pivotal safety studies.
Generally, there might be situations that necessitate an FAP, such as if consumer exposures are particularly high, or the ingredient has a particular risk profile, but otherwise, will depend on the specific needs and strategy of the manufacturer.
Do you have questions about:
- the regulatory status of your particular ingredient?
- trying to determine the best approach between FAP vs. GRAS?
- whether you have sufficient data (safety or otherwise) to support an FAP/GRAS?
RegTox Solutions is an experienced consulting firm helping companies bring novel food ingredients to the US marketplace. If you have any questions, please reach out and we’d be happy to answer any questions!