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By EAS Senior Advisor for Food & Color Additive Safety Robert Martin

Before releasing any food ingredient into the market, it is incumbent upon the manufacturer/supplier to ensure that the product is safe for its intended use. Oftentimes, deciding how to approach this can be confusing. Under the Federal Food, Drug, and Cosmetic Act, the manufacturer/supplier has primary responsibility for ensuring that a food ingredient is safe, and FDA has the primary legal responsibility for determining that the ingredient is safe under its intended conditions of use. Since 1958, manufacturers have had several options for determining that an ingredient is safe for use in food. These options are listed in the Table below.

Table I: FDA Recognized Approaches to Food Ingredients

Regulatory Option Regulatory Citation Comments
Food Additive Petitions Direct food additive Secondary direct food additive Indirect food additive 21 CFR 171.1 Today used mainly for direct food additives; most indirect food additives use the FCN route if they qualify; some secondary direct additives may also qualify for the FCN route.
Color Additive Petition 21 CFR 71.1 Required for colors
GRAS Petitions 21 CFR 170.35 May be direct or indirect additive; superseded by GRAS Notice program
GRAS Notice See 62 FR 18938ff; April 17, 1997 Voluntary; in practice since 1997; FDA has received more than 400 GRAS Notices since the inception of this program.
Independent GRAS Determination Section 201(s) of the FD&C Act An option; before undertaking, we suggest discussing this option with EAS.
Threshold of Regulation 21 CFR 170.39 Restricted to indirect additives
Food Contact Notification 21 CFR 170.100 This route is now the main route for seeking approval of indirect additives.
New Dietary Ingredient 21 CFR part 190 In effect since 1994; the Dietary Supplement Health and Education Act (DSHEA) amended the FD&C Act to distinguish dietary ingredients as a special case of food ingredients. Prior to 1994, dietary ingredients were treated as other food ingredients.

In effect since 1994; the Dietary Supplement Health and Education Act (DSHEA) amended the FD&C Act to distinguish dietary ingredients as a special case of food ingredients. Prior to 1994, dietary ingredients were treated as other food ingredients.

Food additives can be classified into four main groups: 1) food additives; 2) color additives; 3) ingredients for which either the FDA or the U. S. Department of Agriculture specifically authorized use prior to 1958, the so-called “Prior Sanctioned Substances”; and, 4) GRAS substances, i.e., substances that are agreed upon as safe by the general scientific community on the basis of scientific evidence or history of use prior to 1958. Only food and color additives require premarket approval.

The manufacturer/supplier should first decide which regulatory options meet the intended use. FDA has issued definitions for these food ingredients to assist in this decision. The definitions below are taken from FDA’s Food Ingredients and Packaging Terms.

Direct food additives are those added to a food for a specific purpose in that food.

Color additives may be any dye, pigment or substance which when added or applied to a food, drug, or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting colors.

GRAS (Generally Recognized as Safe) ingredients are those ingredients that are generally recognized by experts to be safe, based on either an extensive history of use in food prior to 1958, or based on published scientific evidence. The determination that a substance is GRAS is not exclusive to FDA. Scientists outside FDA may also make this determination based on the available evidence. However, manufacturers/suppliers may request that FDA review their determination by submitting a GRAS Notification to FDA for review and concurrence. After completion of its review, if FDA concurs, the agency will issue a “No Questions” letter to the submitter indicating that “FDA has no questions at this time …” regarding the GRAS determination.

Any ingredient used in food is expected to be produced and used consistent with Good Manufacturing Practice (GMP) conditions to ensure its safe use. The responsibility for establishing GMP conditions rests primarily with the manufacturer/supplier. Once in use, it is important that the manufacturer/supplier continue to monitor the use of the product to ensure its use continues to be within safe limits.

FDA has also issued several guidance documents to assist manufacturers/suppliers in their effort to seek approval of their food ingredient(s). These guidance documents are posted on the agency’s website.

Should a manufacturer/supplier wish to add an unregulated ingredient to food, we invite them to contact EAS. EAS has a large network of expert scientists with many different areas of expertise and regulatory experience. Among these are food scientists, chemists, toxicologists, and regulatory experts. For specific expertise not available within the EAS network, we also maintain contact with a large number of outside experts to assist on any project.

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