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U.S. Department of Health and Human Services

Food

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Determining the Regulatory Status of a Food Ingredient

Any substance that is reasonably expected to become a component of food is a food additive that is subject to premarket approval by FDA, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Any food additive that is intended to have a technical effect in the food is deemed unsafe unless it either conforms to the terms of a regulation prescribing its use or to an exemption for investigational use. Otherwise, in accordance with section 409 of the Act, the substance is deemed an unsafe food additive. Any food that contains an unsafe food additive is adulterated under section 402(a)(2)(C) of the FFDCA. 

Similarly, any substance that is added to food and imparts color to the food is a color additive (see color additive definition in §201(t) of the FFDCA and 21 CFR 70.3(f)).  Any color additive in food is deemed unsafe unless its use is either permitted by regulation or exempt by regulation. Unlike the definition for food additive, there is no GRAS exemption for color additives. Any food that contains an unsafe color additive is adulterated under section 402(c) of the FFDCA.

The decision tree below will help in determining the regulatory status of a food ingredient. It is the responsibility of the manufacturer of any food to ensure that all ingredients used are of food-grade purity and comply with specifications and limitations in all applicable authorizations. The overall regulatory status of a food is affected by the regulatory status of each individual food ingredient. To determine compliance, consider each authorization to be composed of three parts:

  • The identity of the substance,
  • Specifications including purity and physical properties, and
  • Limitations on the conditions of use.

To assure a customer that an ingredient that is being shipped to them is not adulterated or misbranded, the ingredient manufacturer may want to provide a letter of guaranty with the shipment (see 21 CFR 7.13 for suggested forms of guaranty).

 

Food Ingredient Decision Tree

Q1: Is the substance reasonably expected to become a component of food from its intended use? If No, go to the right; if Yes, go down to next question.If answer No to Q1: Substance may be a contaminant. See Section 402(a)(1) of the FD&C Act (see reference 1) as to whether the food is deemed adulterated.
Q2 (if answer yes to Q1): Is the substance a dietary ingredient in a dietary supplement? If Yes, go right; if No, go down to next question.If answer yes to Q2: See Overview of Dietary Supplements (see reference 2).
Q3 (if no to Q2): Is the substance a pesticide chemical residue in or on a raw agricultural commodity (Section 201(r) of the FD&C Act) or processed food? If yes, go right; if no, go down to next questIf answer yes to Q3: The substance must comply with a tolerance or exemption from a tolerance (see Section 408 of the FD&C Act and 40 CFR part 180).
Q4 (if no to Q3): Is the substance a new animal drug? (see Section 201(v) of the FD&C Act). If Yes, go right; if No, go down to next question. If answer yes to Q4: Consult with FDA's Center for Veterinary Medicine.
Q5 (if answer no to Q4): Does the substance have an ongoing technical effect in food? If no, go right; if yes, go down to next question.If answer no to Q5: See Determining the Regulatory Status of Components of a Food Contact Material (see reference 3).
Q6 (if answer yes to Q5): Is the substance listed in Everything Added to Food in the U.S. (EAFUS) (see reference 4)? If No, go right; if Yes, go down to next question. If answer no to Q6 (EAFUS): Consult with FDA regarding the regulatory status of the substance for the intended use.  Substance may be unlisted but prior sanctioned or GRAS for the intended use. FDA also will consider its status in the Codex General Standard for Food Additives (GSFA) (see reference 5).
Q7 (if answer yes to Q6): Does the EAFUS listing have a corresponding regulation number (REGNUM)? If No, go right; if Yes, go down to next question. If answer no to Q7: Consult with FDA regarding the regulatory status of the substance for the intended use.
Q8 (If yes to Q7): Is the substance's proposed use authorized by the applicable regulation (see reference 6)?If answer no to Q8: If the substance is a direct food additive or color additive, and there is no authorizing regulation, then premarket approval is required through the petition process (see reference 7). Premarket approval is not required if the proposed use of the substance is GRAS (see 21 CFR 170.30 for GRAS criteria). Additional information about the GRAS exemption is available on the FDA's GRAS web page (see reference 8).
 If answer yes to Q8: Substance is acceptable for the proposed use. No further authorization is necessary.

References:

  1. Federal Food, Drug, and Cosmetic Act (FD&C Act)
  2. Overview of Dietary Supplements
  3. Determining the Regulatory Status of Components of a Food Contact Material
  4. Everything Added to Food in the U.S. (EAFUS)
  5. Codex General Standard for Food Additives (GSFA)
  6. FDA's Food and Color Additives Regulations
  7. Petition Process
  8. Generally Recognized as Safe (GRAS) 

 

 

Contact FDA

(240)-402-1200
Fax:(301)-436-2973
Office of Food Additive Safety

Additional Contact Information

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5100 Paint Branch Parkway

College Park, MD 20740-3835