Reviewed and Approved by Tim Lombardo, Senior Director, Food Consulting Services, EAS Consulting Group (A Certified Group Company)
One trend in the food and beverage industry is to use novel substances such as botanical ingredients or extracts in beverages and conventional foods in response to consumer demand for healthier options.
These novel ingredients, however, may be unapproved food additives, while other substances, long used in our food supply, are being integrated into new products or used in quantities exceeding traditional levels.
This ongoing innovation raises questions about the legitimacy and safety of these new applications. As these changes unfold, the critical role of the U.S. Food and Drug Administration's “Generally Recognized as Safe (GRAS)” designation becomes ever more pertinent in ensuring both regulatory compliance and product quality.
This guide aims to help food and beverage manufacturers understand the importance of GRAS, the process of obtaining GRAS certification, and how to ensure your products meet the necessary GRAS standards.
Before exploring the intricate regulatory framework of the GRAS process, let’s answer the question, What is GRAS?
GRAS means "Generally Recognized as Safe". It pertains to the safety of ingredients used in foods and beverages. According to 21 Code of Federal Regulations, ingredients that meet minimum safety requirements, as long as they’re consumed under the same conditions as during the assessment, are deemed GRAS.
It’s important to understand that GRAS is not indicative of premarket review and approval by FDA. Instead, it signifies that an ingredient has undergone scientific safety evaluations of the same caliber as required to obtain approval of food additives.
GRAS status can be determined through two main paths:
Historically, companies could self-determine GRAS by assembling expert panels and conducting comprehensive safety reviews, allowing them to market their products without formal FDA involvement.
However, after safety concerns arose in the 1960s, the FDA initiated a review process, leading to the creation of a GRAS notification procedure in 1997. This allows companies to voluntarily notify the FDA of their GRAS determination, where the FDA evaluates the claim but does not formally approve or deny it.
The Ensuring Safe and Toxic-Free Foods Act of 2023, currently before the U.S. Congress, would end the ability of companies to self-determine the safety of new ingredients, substantially changing the GRAS certification process.
Food safety professionals should keep a close eye on the bill to ensure you're ready to comply should the GRAS process change.
So, what happens if an ingredient or other substance is not deemed Generally Recognized as Safe (GRAS) by qualified experts for its intended use and does not qualify for other exemptions?
In this case, the ingredient may not be used in the food supply.
This is a vital point because any unapproved food ingredients used in a food or beverage render the product adulterated under the Food, Drug & Cosmetic Act, making it illegal to import or market in the United States.
In a similar vein, when designing a new food or beverage product, it is important to know which ingredients are not considered GRAS.
FDA publishes a list of substances prohibited from use in human food and beverages in 21 CFR 189 based on a determination that they present a potential risk to the public health or have not been shown by adequate scientific data to be safe.
This list is a good place to start when researching and developing a potential formulation.
Manufacturers are often faced with the question: How do I know if my new ingredient is Generally Recognized as Safe (GRAS)?
The FDA requires rigorous safety assessments for new ingredients before they can be added to foods and beverages. If your ingredient doesn't fit in the allowable GRAS lists provided by the FDA (shown below), it is your responsibility to conduct your own GRAS assessment (more on that later).
The FDA maintains the following GRAS lists of ingredients that are considered Generally Recognized as Safe:
These lists aren't all-inclusive. Some ingredients used in the food supply before 1958 are grandfathered into a GRAS designation, and others may have undergone GRAS safety studies that haven't been submitted to the FDA.
The lists are dynamic, with new GRAS and food/color additive designations added, and prohibited ingredients updated, based on new safety data.
Make sure to consult these lists frequently. In addition, be sure to understand another important category of ingredients that merit further discussion: food additives.
Food additives undergo a different evaluation process called a Food Additive Petition (FAP).
Color Additives, which are substances capable (alone or through reactions with other substances) of imparting color, are required to undergo still a different approval process, a Color Additive Petition (CAP). (Find out more about Color Additive Petitions here.)
It is important to note that GRAS is not an option for food colors.
The key difference between GRAS and a Food Additive Petition lies in the level of scrutiny and required evidence. GRAS relies on historical common use or expert consensus, while Food Additive Petitions require a more rigorous and extensive scientific evaluation.
Manufacturers must submit formal FAP requests to FDA seeking approval for the new food additive or for a new use of an existing additive. This petition must provide comprehensive data and scientific evidence demonstrating the safety of the additive under the intended conditions of use. The FDA evaluates the petition and conducts a thorough review of the safety data before granting approval.
FDA publishes a list of allowable food/color additives and their limitations of use in 21 CFR 172.
As a food or beverage manufacturer, cross-referencing these lists provides insight into the ingredients your formulation can contain – and those it can’t. If any of the ingredients don’t fit in the allowable lists, and you still want to bring your product to market, it is your responsibility to conduct your own GRAS assessment.
Conducting a Generally Recognized as Safe (GRAS) assessment for an ingredient in your food or beverage product can be a complex process, involving several key steps.
The time it takes can vary greatly depending on the nature of the ingredient, its intended use, and the amount of data available. However, it generally takes between 6-18 months to complete a thorough GRAS assessment.
Another helpful tool is the FDA's database of GRAS notices. It contains information about every GRAS notice filed since 1998.
Remember, the GRAS process is about ensuring safety. If the substance does not meet the criteria for GRAS status, another option may be FDA's food additive petition process, which involves additional steps and may take even more time. Our regulatory arm, EAS Consulting Group, a Certified Group company, can help walk you through the GRAS determination process.
Similarly, completing a Food Additive Petition for an ingredient in your food or beverage product is an intricate process that typically takes between 2-5 years from petition submission to final ruling. EAS Consulting Group can provide expert guidance for your Food Additive Petition.
Understanding and complying with the FDA's GRAS and Food Additive Petition processes are essential for food and beverage manufacturers. Ensuring your ingredients meet these stringent safety standards is vital for regulatory compliance, product quality, and above all, consumer trust. With the right knowledge and expert guidance, navigating these complex regulations can become a smooth journey to market.
Remember, if you need help with the GRAS or Food Additive Petition processes, contact our regulatory arm, EAS Consulting Group. Let them put their years of experience to work for your company.