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  5. Understanding How the FDA Regulates Food Additives and GRAS Ingredients
  1. Food Additives and GRAS Ingredients - Information for Consumers

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 uses of ingredients that are food additives and generally recognized 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:

To learn about how the FDA regulates indirect food additives, see Food Packaging and Other Substances that Come into Contact with Food Information for Consumers.

The following information on this page is about direct food additives.

Direct food additives are those that 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 the ingredient label of foods.

Under the Federal Food, Drug, and Cosmetic Act, a food additive must be authorized by the FDA 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 in a different way than how the FDA has currently approved it. The FDA consults with U.S. Department of Agriculture during the review process for food additives that are proposed for use in meat and poultry products.

Food additive petitions must provide evidence that the substance is safe for the ways in which it will be used – including the foods it will be used in and the intended levels of use. We have guidance documents available on the FDA's 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 demonstrates its use 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 ingredient be made?
  • How much of the ingredient 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 the food ingredient (including absorption, digestion, metabolism, and excretion)?
  • What are the results of relevant scientific studies on the safety of the ingredient?

The FDA determines an Acceptable Daily Intake or the amount of a substance considered safe to consume each day over the course of a person’s lifetime. This level includes built in a safety margin that includes factors accounting for potential uncertainties in the data and known variability within the population and vulnerable populations, such as people who are pregnant and children. We also consider expected exposure for consumers who eat the average amount of foods containing the food additive and for consumers who eat much more than the average amount of foods containing the food additive. These approaches ensure that the consumption of an additive from an approved use is much lower than what would be expected to have any adverse effect.

For every food additive the FDA approves, the agency issues a regulation that authorizes uses of the food additive that meet the safety standard for food use. The food additive regulations are in the U.S. Code of Federal Regulations (CFR). These regulations may specify the types of foods in which the food additive can be used, the maximum amounts to be used in those foods, and how it should be identified on food labels. Manufacturers are also required to limit the amount of food additives to the amount necessary to achieve the desired effect.

The FDA manages and maintains a public inventory where we list all of the food additive petitions under active FDA review or that are filed but not active because deficiencies were identified during the FDA’s review.

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 the uses of ingredients that are Generally Recognized as Safe (GRAS). As such, these ingredients do not require pre-market review by the FDA. For the use of an ingredient to be considered GRAS, all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts. In addition, GRAS uses must meet the same safety standard as for food additives, a reasonable certainty of no harm under the conditions of its intended use and have the same quantity and quality of information that would support 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, that has concluded that the use of 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 the ways in which they will be used and to help 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 ingredient be made?
  • How much of the ingredient 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 the food ingredient (including absorption, digestion, metabolism, and excretion)?
  • What are the results of relevant scientific studies on the safety of the ingredient?

The FDA consults with U.S. Department of Agriculture during the review process for GRAS notices for ingredients that are 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 that have been filed by the agency, along with the supporting data, and FDA’s final response letters to manufacturers are available to the public. Manufacturers that choose not to go through the FDA’s GRAS Notification program are still responsible to produce products that are compliant with the law.

Post-market Assessment Related to Food Ingredients

The FDA stays abreast of the latest science available about food additives and GRAS ingredients in a variety of ways. We participate in international scientific and standard setting activities related to food ingredient safety such as the Codex Alimentarius Commission and the Joint FAO/WHO Expert Committee on Food Additives, attend scientific conferences, and engage other public health and research stakeholders. These activities help us stay informed about the safety and exposure of food additives in scientific literature and released by other agencies.

FDA scientists also assess the science about the exposure and safety of a food ingredient each time we file a food additive petition or review a GRAS notice. Additionally, we may proactively choose to assess a food additive or GRAS ingredient in food when new information about its safety profile warrants assessment. The FDA has strict data requirements that must be met to establish safe conditions of use during review of a pre-market submission, and as new scientific information becomes available, we may re-evaluate the safety assessments. This includes reviewing published scientific literature and studies from other regulatory and health agencies in the U.S. and in other countries, and updated information when the same substance is the subject of a new submission. In some of our assessments, we identify areas where additional information is needed. We may work with research partners on studies to help fill these data gaps. We are exploring how to obtain better information on the post-market use of food ingredients from industry and other stakeholders.

If after the FDA’s assessment of a food additive or GRAS ingredient we have determined its use meets our safety standard, the regulatory status of the food additive or GRAS ingredient would remain unchanged. If after the FDA’s assessment of a food additive or GRAS ingredient, we have determined its use does not meet our safety standard, the agency can take various actions to protect public health. These actions include issuing a public warning letter to companies that manufacture or distribute the food ingredient and/or food containing the food ingredient, issuing a public alert, and taking enforcement action to stop distribution of the food ingredient and foods containing it on the grounds that such foods are or contain an unapproved food additive. Some changes can take time such as revoking a food additive approval because we are required to follow certain regulatory processes, such as providing an opportunity for public comment. Some recent examples include the agency’s work to remove trans fat and warn companies marketing Cannabidiol (CBD) and Delta-8 THC products:

The Post-market Determinations that the Use of a Substance is not GRAS is a public inventory of certain food ingredients that the FDA has determined to have unsafe uses in food because they are unapproved food additives.

 
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