Understanding How the FDA Regulates Food Additives
and GRAS Ingredients
The Federal Food, Drug, and Cosmetic Act defines different types of food ingredients based on how they are
intended to be used and the FDA’s authorities related to them. Working within these authorities, the FDA
administers separate programs for using ingredients that are food additives and are generally recognised as safe
(GRAS).
Ingredients that are Food Additives
Some ingredients are food additives. A food additive is defined in the Federal Food, Drug, and Cosmetic Act as
any substance the intended use of which results or may reasonably be expected to result – directly or indirectly –
in it becoming a component or otherwise affecting the characteristics of any food.
The following are not included in the definition of a food additive:
Ingredients that are generally recognized as safe (GRAS).
Prior-sanctioned substances are authorized for use by the FDA or the U.S. Department of Agriculture before
the 1958 Food Additives Amendment. Examples include sodium nitrite and potassium nitrite, which are used to
preserve luncheon meats.
Colour and pesticides where other legal pre-market approval requirements apply.
Dietary ingredients in dietary supplements.
The following information on this page is about direct food additives.
Direct food additives are added to a food for a specific purpose. For example, xanthan gum—used in salad
dressings, chocolate milk, bakery fillings, puddings, and other foods—is a direct additive used to add texture.
Most direct additives are identified on food ingredient labels.
Under the Federal Food, Drug, and Cosmetic Act, the FDA must authorize a food additive before it can be used
in food on the market. A manufacturer or other sponsor must first seek approval from the FDA by submitting
a food additive petition to market a new direct food additive or before using a direct food additive different from
the FDA's approval. During the review process, the FDA consults with the U.S. Department of Agriculture for
food additives proposed for use in meat and poultry products.
Food additive petitions must provide evidence that the substance is safe for its intended use, including the foods
it will be used in and the intended levels of use. The FDA has guidance documents on its website,
including Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives, that assist
manufacturers with submitting a petition.
The FDA publishes a notice of the petitions under FDA review in the public Federal Register. The FDA evaluates
the petition and other available data and information to determine if the data demonstrate that the food additive
is safe under the proposed conditions of use. The safety of food additives must be supported by science that
reflects its use and meets the FDA’s safety standard – a reasonable certainty of no harm.
When evaluating the safety of an ingredient submitted in a food additive petition, the FDA considers:
• What is the food ingredient?
• How will the food ingredients be made?
• How much of the ingredients will be in food?
• What types of foods will the ingredient be used in?
• How much of the food ingredient will consumers eat?
• How does the body metabolize food ingredients (absorption, digestion, metabolism, and excretion)?
• What are the results of relevant scientific studies on the ingredient's safety?
The FDA determines an Acceptable Daily Intake or the amount of a substance considered safe to consume
daily for a person’s lifetime. This level includes a safety margin that includes factors accounting for potential
uncertainties in the data and known variability within the population and vulnerable populations, such as
pregnant people and children. We also consider expected exposure for consumers who eat the average amount
of foods containing the food additive and for consumers who consume much more than the average amount.
These approaches ensure that the consumption of an additive from an approved use is much lower than
expected to have any adverse effect.
Ingredients that are Generally Recognized as Safe (GRAS)
The definition of food additive in the Federal Food, Drug, and Cosmetic Act includes a provision for using
ingredients that are Generally Recognized as Safe (GRAS). As such, these ingredients do not require pre-market
review by the FDA. For an ingredient to be considered GRAS, all data necessary to establish safety must be
publicly available and qualified experts must generally recognize its safe use. In addition, GRAS users must meet
the same safety standards as food additives, have a reasonable certainty of no harm under the conditions of their
intended use, and have the same quantity and quality of information supporting the safety of a food additive.
Some examples of GRAS ingredients include canola oil, vinegar, and spices such as black pepper.
Any person, typically a food or ingredient manufacturer, who has concluded that using an ingredient can meet
the standard for GRAS may notify the FDA through the FDA’s GRAS Notification Program. The FDA has
established a GRAS Notification Program to help ensure that these ingredients are safe for how they will be used
and to help the industry meet its responsibility for ensuring the GRAS status of ingredients they intend to use in
food. This notification is not mandatory; however, the FDA strongly encourages manufacturers to contact the
agency and follow the available procedures for our oversight of GRAS conclusions by submitting a GRAS notice.
The FDA also assists the food industry through our regulations and guidance documents.
When the FDA evaluates a GRAS Notice, the agency considers whether the notice demonstrates that the
ingredient is safe under the conditions of its intended use and whether the criteria for general recognition are
satisfied. When evaluating the use of a GRAS ingredient, the FDA considers all relevant and reliable
information to understand:
• What is the food ingredient?
• How will the food ingredients be made?
• How much of the ingredients will be in food?
• What types of foods will the ingredient be used in?
• How much of the food ingredient will consumers eat?
• How does the body metabolize food ingredients (absorption, digestion, metabolism, and excretion)?
• What are the results of relevant scientific studies on the ingredient's safety?
The FDA consults with the U.S. Department of Agriculture during the review process for GRAS notices for
ingredients proposed for use in meat and poultry products.
Following this evaluation, the FDA responds to the manufacturer with a letter describing whether we question
the basis for the manufacturer’s GRAS conclusion. The FDA manages and maintains a public inventory where
all GRAS notices filed by the agency, along with the supporting data and the FDA’s final response letters to
manufacturers, are available to the public. Manufacturers who choose not to go through the FDA’s GRAS
Notification program are still responsible for producing products that comply with the law.
