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Standard of Identity, Petitions, Food Additives, Food Product Claims, and Organic Food

This page introduces U.S. federal law pertaining to standard of identity for food products; petitioning for regulations; food ingredients, additives and GRAS; claims a manufacturer may make about its food product and an introduction to standards for organic foods.

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This page addresses these food law topics:

  • standard of identity for food products,
  • international standards (such as Codex)
  • petitioning for a regulation to establish a standard of identity, a food additive or other standards,
  • food additives and ingredients (including GRAS)
  • color additives
  • food product claims
  • organic food standards

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Standards of Identity for Food Products

The Food Drug and Cosmetic Act (FDCA) directs the FDA to establish definitions and standards for food, see 21 U.S.C. §341.

  • Paraphrased, the statute states:  in an effort to promote honesty and fair dealing for the benefit of consumers, the FDA is authorized to establish by regulation, a common or usual name, a reasonable definition and standard of identity, a reasonable standard of quality, and reasonable standards of fill of the container for any food.

The statute also defines a  food as  misbranded if there is a standard of identity in the regulation but the food item does not conform to the definition or standard of identity (21 U.S.C. §343(g)). Thus food manufacturers, for example, must use the standard of identity on the label of a food product.  Likewise, foods labeled according to a standard of identity must meet the characteristics of the food as specified in the regulation.

Despite the breadth of this statute, FDA has focused primarily on establishing standards of identity; FDA has not directed much attention to quality standards.

  • FDA has 300 identity standards in 20 categories of food -- 21 CFR Parts 130 to 169
    • For example, the standard of identity for sherbert is specified in 21 CFR 135.140
    • Note the differences among the standard of identity for fruit butter (21 CFR 150.110), fruit jelly (21 CFR 150.140), and fruit jam (21 CFR 150.160). These several examples illustrate the level of detail considered in establishing a food identity.
  • FDA standards of identity specify minimum and maximum requirements, optional ingredients, and prohibited ingredients.
    • For example:  12 CFR 139.110 Macaroni products.
      (a) Macaroni products are the class of food each of which is prepared by drying formed units of dough made from semolina, durum flour, farina, flour, or any combination of two or more of these, with water and with or without one or more of the optional ingredients specified in paragraphs (a) (1) to (6) ...
      (1) Egg white, frozen egg white, dried egg white, or any two or all of these, in such quantity that the solids thereof are not less than 0.5 percent and not more than 2.0 percent of the weight of the finished food.
      (2) Disodium phosphate, in a quantity not less than 0.5 percent and not more than 1.0 percent of the weight of the finished food.
      (3) Onions, celery, garlic, bay leaf, or any two or more of these, in a quantity which seasons the food.
      (4) Salt, in a quantity which seasons the food.
      (5) Gum gluten, in such quantity that the protein content of the finished food is not more than 13 percent by weight. The finished macaroni product contains not less than 87 percent of total solids ...

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FSIS (USDA) also establishes standards of identity for the food products it regulates;

  • See “Definitions and Standards of Identity or Composition” for meat products at 9 CFR Part 319 (authorized by Meat Inspection Act)
  • Also see 9 CFR §381.155 to §381.174 for standards for poultry products.
  • For example: 9 CFR Sec. 381.171 Definition and standard for "Turkey Ham.''
    (a) "Turkey Ham'' shall be fabricated from boneless, turkey thigh meat with skin and the surface fat attached to the skin removed. The thighs shall be that cut of poultry ...
    (b) The product may or may not be smoked ...
    (c) The cooked finished product weight shall be no more than the original weight of the turkey thigh meat used prior to curing.
    (d) The product name on the label shall show the word "Turkey" in the same size, style, color, and with the same background as the word "Ham'' and shall precede and be adjacent to it.
    (e) The product name shall be qualified with the statement "Cured Turkey Thigh Meat.'' ...
    (f) If the product is fabricated from pieces of turkey thigh meat that result from the cutting through the muscle (as opposed the whole thighs intact or whole thighs with some incidental separation of muscle tissue during removal of the bone), the product name shall be further qualified by a descriptive statement ...

 

For some background information about the purpose of standard of identity for food products, see FDA's Standards for High Quality Foods

  • (copied from an earlier version) "Originally, these requirements were set forth to protect consumers from contaminated products and economic fraud. Later, the standards were also used to improve nutrition. The hallmark of most of these regulations has been their attention to details that include not only each product's name and mandatory and optional ingredients, but in many cases also the minimum levels of valuable constituents and the manufacturing process. The standards for canned cherries, for example, specify that "not more than 15 percent by count of the cherries in the container are blemished with scab, hail injury, discoloration, scar tissue or other abnormality. A cherry showing skin discoloration (other than scald) having an aggregate area exceeding that of a circle of 9/32 inch in diameter is considered to be blemished."

 

Some points for consideration

  • Identity standards are established to help consumers.
  • The standards establish a common name for the food product; if the appropriate name is not used, the food is considered misbranded.
  • The standards also set content requirements for the food product; if the content requirement is not met, the food is considered misbranded.
  • Identity standards do not address quality issues - such as inadvertent adulteration, or whether the item meets the consumer's individual nutritional needs.
  • What about identity standards for products from commingled commodities, e.g., frozen dinners? See 21 CFR 102.26, for example.

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Do not overlook standards established by other entities, such as the international food standards specified by the Codex; see Current Official Standards.

 

Question:  When there is no standard of identity, is the processor free to name the food product whatever it wants?

Response:  Generally see 21 CFR 102

  • 21 CFR 102.5(d) -- A common or usual name of a food may be established by common usage, by establishing a common or usual name by regulation (see 21 CFR 102.19), or by establishing a standard of identity by regulation (see 21 CFR 130.5).
  • An interested person may petition for FDA to establish, by regulation, a common or usual name for a food product (21 CFR 102.19).
  • An interested person may petition for a standard of identity (21 CFR 130.5).
  • Also see 21 CFR 10.30 for general information relating to a "citizen petition".

 

 

The following example may illustrate the "petition" procedure.

 

Petitioning for a Regulation

The process of petitioning for a regulation is NOT limited to establishing a common name for a food or standard of identity; it also is used in establishing food additives, color additives and other standards.  For example, see

  • 21 CFR 10.30 (citizen petition)
  • 21 CFR 71 (color additive petitions)
  • 21 CFR 102.19 (petition for common or usual name) (based on 21 U.S.C. 341)
  • 21 CFR 130.5 (petition of standard of identity) (based on 21 U.S.C. 341)
  • 21 CFR 171 (food additive petition)
    • A food additive shall ... be deemed ... unsafe ... unless ... there is in effect ... a regulation issued ... prescribing the conditions under which such additive may be safely used ... 21 U.S.C. 348(a).
    • Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used. Such petition shall, in addition to any explanatory or supporting data, contain ... 21 U.S.C. 348(b).
    • The Secretary may at any time, upon his own initiative, propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used ... 21 U.S.C. 348(d).
  • 21 CFR 101.69 (Nutrient Content Claim)
  • 21 CFR 101.70 (Health Claim)

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    Note, the burden of providing information to support the petition is on the petitioner.  Once a regulation has been promulgated, other food businesses can rely on the petition in operating their business.

    Petitioning for a regulation is mentioned as other topics are discussed on this web site.

    Also see Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety; Draft Guidance at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2021277.htm.

     

    A point to emphasize:  Most foods will be considered adulterated or misbranded unless there is a regulation allowing the product name on the label or the inclusion of the additive in the product.  The regulatory agencies generally will not initiate new regulations; the legal system expects an interested food entity to "petition for a new regulation" if the current regulations do not address the additive or the product name.  So food businesses need to ask themselves: "are all the necessary regulations in place for the food product I intend to manufacture and sell, or do I need to expend the time and cash to petition for a regulation that will allow me to produce and market my desired food product?"

     

    Food Additives and Food Ingredients

    As stated previously, U.S. federal law prohibits adulterated food from entering interstate commerce, and it is well-recognized that food can be adulterated in a variety of ways.  This section discusses food that is adulterated as a result of directly adding unsafe or unacceptable substances during processing and food that is indirectly adulterated when it contacts a) substances on the surface of processing or manufacturing equipment or b) food packaging materials. 

    • Indirect food additives are more recently being referred to as "food contact substances" (see 21 CFR 170.3(e)(3)).

    In regulating substances that are directly or indirectly added to food, U.S. law begins with an encompassing prohibition that can be summarized as “any food to which something (e.g., a substance) has been added is adulterated.”  The following statutory excerpt offers some detail.

    • "A food shall be deemed to be adulterated … if it is or if it ... contains any food additive that is unsafe..." (21 U.S.C. §342(a)(2)(C)(i))

    The next step in the law, however, is to define exceptions to this broad, encompassing prohibition; that is, the statute allows FDA and USDA to specify (i.e., approve) substances that can be directly added to food, or indirectly added to food as a result of contact with a surface or packaging.  The three broad categories of substances that can be directly or indirectly added to food without adulterating the food are

    1. Prior-Sanctioned substances,
    2. substances that are Generally Recognized as Safe (GRAS), and
    3. Food Additives whose use is governed by a regulation. 

    These three categories are described in the following sections.

     

    Mandatory Reading -- Now is a good time to read an edited excerpt from the Federal Register April 17, 1997; it explains many of the events impacting the regulation of food additives beginning in 1958.

     

    A Point to Emphasize:  The law recognizes that both the substance and its use must be safe.

    When a substance is approved to be added to food, the approval considers both the substance and the use of the substance.  Substance A may be approved for use X, but that does not approve substance A for use Y.  For example, see 21 CFR §172.130:  The food additive dehydroacetic acid and/or its sodium salt may be safely used as a food additive if

    a) Dehydroacetic acid: Melting point, 109 °C-111 °C; assay, minimum 98 percent (dry basis); Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry basis),

    b) it is used as a preservative for cut or peeled squash, and is so used that no more than 65 parts per million expressed as dehydroacetic acid remains in or on the prepared squash, and

    c) the label of any package of the additive intended for use in food shall bear adequate directions for use to insure compliance with this regulation.

    Note that both the substance and its use are specified in this food additive regulation.

     

    Additional Historical Perspective

    Congress enacted the Food Additives Amendment in 1958 to require that, before a new additive could be used in food, its producer (user) provide scientific evidence to demonstrate the safety of the additive (for example, through the petitioning process described above). The statute a) defined the term “food additive'', b) established a premarket approval process for food additives, and c) declared any food that contains any unsafe (unapproved) food additive as adulterated.

    Congress also recognized that many substances would not require a formal premarket review to assure the substance’s safety, either a) because the safety of the substances had been established by a long history of use in food or b) by virtue of the nature of the substance, its customary use, and the information generally available to scientists about the substances. Therefore, Congress excluded substances from premarket approval if the substance is generally recognized (by qualified scientific experts) to be safe under the conditions of the substance’s intended use.  Congress also excluded substances from premarket approval if -- in the case of a substance used in food prior to January 1, 1958 -- it is generally recognized (through either scientific procedures or through experience based on common use in food) to be safe under the conditions of the substance’s intended use. 

     

    The Statute

    See 21 U.S.C. 321(s):

    The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—

    1. a pesticide chemical residue in or on a raw agricultural commodity or processed food; or
    2. a pesticide chemical; or
    3. a color additive; or
    4. any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 601 et seq.];

     

    Prior-Sanctioned Substances

    21 U.S.C. 321(s)(4) creates the “prior sanction” exception  to the general prohibition against adding substances to food.  An associated regulation is codified at 21 CFR 170.3(l)

    Prior sanction means an explicit approval granted with respect to use of a substance in food prior to September 6, 1958, by the Food and Drug Administration or the United States Department of Agriculture pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry Products Inspection Act, or the Meat Inspection Act.”

    Restated, a substance whose use in or on food is the subject of a letter issued by FDA or USDA offering no objection to a specific use is considered approved as a prior sanction. The prior sanction exists only for a specific use of a substance in food delineating level(s), condition(s) and product(s) set forth by explicit approval by FDA or USDA prior to September 6, 1958.

     

    All prior sanctioned substances are listed in 21 CFR Part 181:  “The Commissioner will publish in this part all known prior sanctions.”

    • A prior sanction shall exist only for a specific use(s) of a substance in food (i.e., the level(s), condition(s), product(s)) for which there was explicit approval by the Food and Drug Administration or the United States Department of Agriculture prior to September 6, 1958.
    • Sanctions granted for the use of substances in the manufacture of packaging materials are listed in 21 CFR sections 181.23, 181.24, 181.25, 181.26, 181.27, 181.28, 181.29, and 181.30.
    • Sanctions granted for the use of substances for purposes other than packaging materials are listed in 181.32, 181.33 and 181.34.  For example, sections 181.33 and 181.34 are USDA prior-sanctions for using nitrates and nitrites in curing meat and poultry.

     

    “Prior-sanctioned substances” is a somewhat limited category.  To qualify as prior-sanctioned, USDA or FDA had to recognize the substance and its use prior to September 6, 1958.  The recognition was generally in the form of a letter from one of the two agencies.  All prior-sanctioned substances are listed in 21 CFR 181.  Most of the substances are used in packaging materials, except USDA’s sanction (approval) to use nitrite and nitrate in curing meat and poultry.  Obviously, this list cannot be expanded but it could be contracted if the agency decides to re-evaluate the substance and its use as a food additive.

    As one commentator stated, the USDA sanction to use nitrite and nitrate for curing meat and poultry does not permit nitrite and nitrate to be applied to a vegetable, for example.  Permission for such an additional use would need to be granted as a food additive regulation or as GRAS (if permission is granted at all).

    In summary, the major prior-sanctioned direct additives are the nitrites and nitrates that USDA had approved for curing meat and poultry prior to September 6, 1958.

     

    GRAS v. Food Additive

    The other two exceptions to the broad prohibition against adding substances to food are GRAS and Food Additives.  These concepts have similarities and differences.  Consider FDA's Guidance for Industry: Frequently Asked Questions About GRAS.  Note questions 3 and 4.

    • "Regardless of whether the use of a substance is a food additive use or is GRAS, there must be evidence that the substance is safe under the conditions of its intended use."
    • "A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use ... The data and information relied on to establish the safety of the use of a GRAS substance must be generally available (e.g., through publication in the scientific literature) and there must be a basis to conclude that there is consensus among qualified experts about the safety of the substance for its intended use...

    "For a GRAS substance, generally available data and information about the use of the substance are known and accepted widely by qualified experts, and there is a basis to conclude that there is consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use.

    "For a food additive, privately held data and information about the use of the substance are sent by the sponsor to FDA and FDA evaluates those data and information to determine whether they establish that the substance is safe under the conditions of its intended use.

    "Thus, the difference between use of a food additive and use of a GRAS substance relates to the widespread awareness of the data and information about the substance, i.e., who has access to the data and information and who has reviewed those data and information."

     

    Statutory and Regulatory Authority

    The statutory basis for regulating food additives is 21 U.S.C. 348; see 21 CFR parts 170 to 189 for regulations addressing food additives.

    Both GRAS and food additives are identified in the regulations.  Introductory regulations include

    • Part 170 -- Food Additives (addresses general provisions and general principles)
    • Part 171 -- Food Additives Petitions (describes the process for pursuing a Food Additive petition)

     

    The "Redbook"

    The safety of a food substance is generally determined by considering the potential cumulative effect of the substance in consumers and the probable consumption of the substance in the diet. The potential cumulative effects are determined by the outcome of toxicity studies and knowledge of compounds and their structures.  As stated previously, the producer (user) of a food substance is responsible for conducting the studies and submitting the scientific data necessary to determine the safety of a food substance. 

    The FDA published the "Redbook" to provide guidance regarding the submission of a) food additive petition, b) color additive petition, c) a food contact or d) a GRAS notification.  The guidance document is intended to assist petitioners and notifiers who are considering whether to submit a petition or notification in completing the following steps:

    • determining the need for toxicity studies
    • designing, conducting, and reporting the results of toxicity studies
    • conducting statistical analyses of data
    • the review of histological data
    • the submission of this information to the FDA as part of the safety assessment of food ingredients.

    See "Toxicological Principles for the Safety Assessment of Food Ingredients" (Redbook 2000) at
    http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm078044.htm

     

    GRAS and Food Ingredients

    A substance can be used in food (or its packaging) if it is generally recognized as safe based on long history of use or scientific evidence, see Title 21 of CFR.

    • Part 181 -- Prior-sanctioned Food Ingredients (as discussed in a previous section)
    • Part 182 -- Substances Generally Recognized as Safe 

     

    GRAS and Good Manufacturing Practice

    "(a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use. This part [21 CFR 182] includes additional substances that, when used for the purposes indicated, in accordance with good manufacturing practice, are regarded by the Commissioner as generally recognized as safe for such uses. – 21 CFR 182.1 

     

    (b) For the purposes of this section, good manufacturing practice shall be defined to include the following restrictions:

    • (1) The quantity of a substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritional, or other technical effect in food; and
    • (2) The quantity of a substance that becomes a component of food as a result of its use in the manufacturing, processing, or packaging of food, and which is not intended to accomplish any physical or other technical effect in the food itself, shall be reduced to the extent reasonably possible.
    • (3) The substance is of appropriate food grade and is prepared and handled as a food ingredient. Upon request the Commissioner will offer an opinion, based on specifications and intended use, as to whether or not a particular grade or lot of the substance is of suitable purity for use in food and would generally be regarded as safe for the purpose intended, by experts qualified to evaluate its safety."

     

    Having GRAS status means the substance can be used in the food product as long as the substance is used for its intended purpose and in accordance with good manufacturing practices (GMP); for example, see 21 CFR 184.1(b).

     

    Remember that GRAS status addresses both the substance and how the substance is being used; for example, a substance may be GRAS for one use but not for another use, or a substance may be GRAS for a particular use as long as it is used within the specified limit. For example, see acetic acid at 21 CFR 184.1005.

    • See 21 CFR Part 182 for a list of GRAS substances. However, the large number of substances intended for use in food renders it impracticable to list all substances that are GRAS.
    • GRAS status may be based only on (1) scientific procedures or (2) common use in food prior to January 1, 1958 (21 CFR 170.30).
    • GRAS status based on scientific procedures is ordinarily based on published scientific studies
      • Safe means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. (21 CFR 170.3(i)).
    • GRAS status based on common use in food prior to 1958 is based solely on the food use of the substance prior to 1958 and generally available data and information. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS.
    • An ingredient not in common use in food prior to 1958 may achieve GRAS status only through scientific procedures.

     

    Affirming GRAS

    Since the late 1960s/early 1970s, FDA has been reaffirming GRAS substances.

    • Part 184 -- Direct Food Substances Affirmed as Generally Recognized as Safe
    • Part 186 -- Indirect Food Substances Affirmed as Generally Recognized as Safe 

     

    • "Beginning in 1969, the Food and Drug Administration has undertaken a systematic review of the status of all ingredients used in food on the determination that they are GRAS or subject to a prior sanction. All determinations of GRAS status or food additive status or prior sanction status pursuant to this review shall be handled pursuant to Secs. 170.35, 170.38, and 180.1 of this chapter."
    • Over time, substances on the GRAS list will be re-evaluated. Based on the outcome, the substance will be listed as 1) “affirmed as GRAS'' (see 21 CFR part 184 or 186) 2), “food additive regulation'' (see 21 CFR parts 170 through 180), 3) “interim food additive regulation'' (see 21 CFR part 180), or 4) “prohibited from use in food'' (see 21 CFR part 189) (21 CFR 182.1(d)).
    • "Affirmation of GRAS status shall be announced in part 184 or Sec. 186.1 of this chapter." Taken from 21 CFR 170.30(e).
    • As these re-evaluations occur, the significance of the 1958 date will decline, and substances will be removed from "Part 182" of the regulations to one of the other "parts," as described in the preceding point.

     

    • The Commissioner, either on his initiative or on the petition of an interested person, may affirm the GRAS status of substances that directly or indirectly become components of food.  Source:   21 CFR 170.35(a)
    • The direct human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed. Source:  21 CFR 184.1(a)
    • The indirect human food ingredients listed in this part have been reviewed by the Food and Drug Administration and determined to be generally recognized as safe (GRAS) for the purposes and under the conditions prescribed, providing they comply with the purity specifications… Source:  21 CFR 186.1(a) 

     

    Food Additives Subject to "Food Additive Regulation"

    Now let us address how to seek approval of an additive if it does not quality as a GRAS ingredient; that is, what process does a food business use to have a regulation put into effect that prescribes how the additive may be used.

    • 21 U.S.C. 348(b)(1) Any person may, with respect to any intended use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.

     

    A food additive that is not GRAS (including packaging) cannot be used unless there is a regulation for the substance and the use; see Title 21 of CFR.

    • Part 172 -- Food Additives permitted for Direct Addition to Food for Human Consumption
    • Part 173 -- Secondary Direct Food Additives permitted in Food for Human Consumption

    “According to FDA's regulations (21 CFR Part 173), secondary direct food additives are substances whose functionality is required during the manufacture or processing of a food and are ordinarily removed from the final food. Although residuals might carry over to the final food, residuals must not exhibit any technical effects. Secondary direct food additives are consistent with FDA's definition of a processing aid so labeling is not required. Examples of secondary direct food additives are acidified sodium chlorite (21 CFR 173.325) and peroxyacids (21 CFR 173.370).

    “According to FDA's regulations (21 CFR Part 172), direct food additives are used to provide a technical effect in the final food. The antioxidants BHA and BHT are examples of substances that are approved as direct food additives.”

    See http://askfsis.custhelp.com/app/answers/detail/a_id/947/~/what-are-secondary-direct-food-additives-and-direct-food-additives%3F

     

    Packaging and Other Indirect Food Additives

    [more recently referred to as Food Contact Substance]; see 21 CFR parts 186 and 174 to 178

    • Part 174 -- Indirect Food Additives:  General
    • Part 175 -- Indirect Food Additives:  Adhesives and Components of Coatings
    • Part 176 -- Indirect Food Additives:  Paper and Paperboard Components
    • Part 177 -- Indirect Food Additives:  Polymers
    • Part 178 -- Indirect Food Additives:  Adjuvants, Production Aids and Sanitizers

     

    GRAS Notification Program

    To simplify the GRAS process, FDA proposed a GRAS notification process in 1997.

    • "a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS ... [The] agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA responds to the notifier by letter."
    • For additional explanation, see
      • Federal Register at http://www.gpo.gov/fdsys/pkg/FR-1997-04-17/pdf/97-9706.pdf , page 18941:  "FDA has tentatively concluded that the proposed notification procedure has advantages over the current petition process because the resource-intensive rulemaking that is associated with a petition would be eliminated ... FDA believes that the substitution of the proposed notification procedure for the current GRAS petition process would not adversely affect the public health because the agency would be replacing one voluntary administrative process with a different voluntary administrative procedure that would utilize FDA’s resources more effectively and efficiently."
      • About the GRAS Notification Program at http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm2006851.htm.  Key points:  FDA proposed in 1997 a rule/regulation to establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA started accepting GRAS notices in 1998. The agency evaluates whether the notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA responds to the notifier by letter.  In general, FDA's response has been in one of three categories:
      1. The agency does not question the basis for the notifier's GRAS determination;

      2. The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or

      3. The response letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice.

     

    Interim Approval

    Several substances are expected to be safe but still need more study.  Until the study is completed, however, the substances can be used.

    • Part 180 -- Food Additives permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study

     

    Restatement of Key Points

    As explained previously, a food business intending to use a new substance in its food product must petition for FDA approval (21 CFR part 171) prior to using the substance. The business is expected to submit data it has on the safety of using the substance as a food component. FDA will provide an opportunity for public and industry comment on the request. Based on the information and comments, FDA will determine a status for the substance, e.g., GRAS, a food additive, or prohibited. This determination will be incorporated into FDA’s regulations. The requesting business and other businesses can then use the substance according to FDA’s determination.

    • A substance that is not GRAS, but can be used as a food additive, generally has limitations imposed on its use. For example, see dehydroacetic acid at 21 CFR 172.130. For a more complete listing of food additives, see 21 CFR parts 172 to 178.
    • Note the distinction between direct and indirect food additives. For example, a direct food additive is intended to become a component of the food or affect the characteristic of the food (see 21 CFR 170.3(e)). An indirect additive includes "substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels..." 21 CFR 174.6).
    • "... “food additive” means any substance the intended use of which results ... , directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food ...) if such substance is not generally recognized, among experts ... as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use ..." (21 U.S.C §321(s))
    • "A food additive shall, with respect to any particular use ... , be deemed to be unsafe ... unless ... there is in effect, and it and its use ... are in conformity with, a regulation ... prescribing the conditions under which such additive may be safely used..." (21 U.S.C. §348(a)(2))

     

    “A substance that will be added to food is subject to pre-market approval by FDA (and thus it is a food additive) unless its use is generally recognized as safe (GRAS) by qualified experts.” Excerpt from GRAS Notification Program.  The following statements are excerpts from FDA regulations.

    • Food additives includes all substances … the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food.
    • “A material used in the production of containers and packages is subject to the definition [of food additive] if it may reasonably be expected to … affect the characteristics … of food packed in the container … If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive.
    • “A substance that does not become a component of food, but that is used, for example, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.”
    • Source: 21 CFR 170.3(e)(1).

     

    Prohibited Substances

    Some substances are prohibited from being used in food; see 21 CFR Part 189 -- Substances Prohibited from use in Human Food

     

    USDA FSIS and Food Additives

    USDA FSIS discusses food additives in meat and poultry products in “Additives in Meat and Poultry Products” at http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/food-labeling/additives-in-meat-and-poultry-products/additives-in-meat-and-poultry-products.

    FSIS oversight of food additives for meat and poultry is closely coordinated with FDA's overall regulation of food additives.

     

    Summary for Food Substances

    The law recognizes that substances can be added to the food 1) as a component of the food, 2) through contact with packaging material, and 3) through contact with surfaces on processing equipment.

    All substances added to food are considered unsafe, EXCEPT:

    • Those substances that were recognized as safe prior to 1958 due to long established practice of being added to food (such as salt) or scientific evidence; these substances are referred to as Prior Sanctioned.
    • Those substances that have been shown, since 1958, through generally available scientific evidence to be safe.
      • Substances considered safe due to 1) long established use or 2) generally available scientific evidence are referred to as Generally Recognized as Safe (GRAS).
    • Those substances that have been shown, through scientific research (often provided by a food company) as safe for the manner in which the substance will be used (a food additive).
      • As stated previously, if a substance that has been shown as safe will be used in a different way, the second use will not be considered safe unless there is additional scientific evidence establishing that the second use also is safe. Substances that are shown to be safe for their intended use are referred to as food additives.

    The process of establishing GRAS and food additives was initiated in 1958 but FDA is in the process of reaffirming GRAS.  The process of "reaffirming" began in the late 1960s/early 1970s.

    FDA will publish a food additive regulation if the substance and use are found to be safe.

    A food business can have a substance or its use added to the list of Food Additives by petitioning FDA and providing the necessary scientific evidence.  Any other business can then use the substance for that use without having to incur the expense of petitioning for a regulation.  The primary expense of petitioning for a regulation is developing the needed scientific evidence to support the petition.

    FDA has information about food additives on its web site; that FDA web page includes links to an "Overview" and several "Industry Guidances".

     

    Color Additives

    Color additives also are regulated but because color is added to drugs and comestics, as well as food, color additives are addressed in a separate set of FDA regulations, see

    Color Additives: FDA's Regulatory Process and Historical Perspectives

    "The Color Additive Amendments of 1960 defined "color additive" and required that only color additives ... listed as "suitable and safe" for a given use could be used in foods, drugs, cosmetics, and medical devices... Under these amendments, the approximately 200 color additives that were in commercial use at the time were provisionally listed and could be used on an interim basis until they were either permanently listed or terminated due to safety concerns or lack of commercial interest. Permanently listing a color additive for a proposed use was prohibited unless scientific data established its safety."

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    See 21 U.S.C.  §379e -- "A color additive in or on food... [shall] be deemed unsafe unless there is in effect a regulation listing such additive for such use, including ... conditions under which such additive may be safely used, and such additive either (i) is from a batch certified or (ii) has, with respect to such use, been exempted from the requirement of certification ..."

    • 21 CFR 70.3(f) A color additive is any material capable of imparting color to food
    • 21 CFR 70.3(i) "Safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive."

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    See 21 CFR parts 70 to 82 for regulations addressing color additives

    • 21 CFR part 73 -- color additives and uses allowed without having to be "batch certified;" that is, they have been exempted from the reguirement of certification.
    • 21 CFR part 71 -- process for petitioning that a color additive be exempted from certification.
    • 21 CFR part 74 -- color additives and uses that must be "batch certified."
      • Each batch of color additive needs to be certified?
    • 21 CFR part 80 -- process for requesting that a batch of color additive be certified.

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    International Standards

    • Do not overlook international standards, such as Codex.

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    Supplier Verification

    Congress, in the Food Safety Modernization Act, imposed greater expectations on food processors in terms of assessing the safety of the raw ingredients using in food manufacturing.  The question is "food processors, have you assessed the safety of the ingredients your firm is receiving and using in food processing?"

    The law requires that any food facility receiving raw materials and other ingredients must establish and implement a risk-based supply-chain program for materials and ingredients for which the food facility has identified a hazard.  The strategy then is to implement a supply-chain-applied control.

    The law also requires that if a receiving facility determines that the supplier is not controlling hazards, the receiving facility must take prompt action, and document its prompt action, to ensure the ingredients from the supplier do not cause the food the receiving firm is processing to be adulterated.

    The law allows the receiving facility to rely on audits conducted by third-party auditors, rather than having to directly inspect the supplier's firm.

    The FDA regulation lists numerous documents the receiving firm must maintain, for example:

    • a written supply-chain program
    • approval of a supplier
    • written procedures for receiving raw materials
    • documentation demonstrating use of the written procedures for receiving raw materials
    • documentation of appropriate supplier verification activities
    • written results of appropriate inspection of the supplier
    • actions taken if supplier is not conforming
    • document the receiving facility's review of the supplier firms' documentation

    See 21 CFR 117.405 et seq. and 21 CFR 1.500 et seq.

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    Food Product Claims

    Like any seller of a product or service, the food industry wants to attract consumers; and like most businesses, sellers want to make claims about the quality of their product in an effort to attract buyers. But for food ...

    Claims about food products need to meet that FDA regulations  But claims about the product can be made only if the claim meets the requirements set forth in the law. The following discussion introduces each type of claim. Additional information about these claims can be found in the appendices of the Food Labeling Guide (chapter 8).

    There are four categories of claims at this time.  These claims often are explained in context of product labeling and food advertising -- as discussed on another page.  This introduction identifies the four types of claims, cites the regulations, and identifies FDA guidance documents that provide additional descriptions.

    The four types of claims are

    • Nutrient Content Claims
      • See 21 CFR §101.13 and §§101.54 to 101.69.
      • Also see Appendix A: Definitions of Nutrient Content Claims
      • Also see Appendix B: Additional Requirements for Nutrient Content Claims
      • Nutrient Content Claim is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., "low fat," "high in oat bran," or "contains 100 calories")
        • "Nutrient content claims describe the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite."
      • Nutrient content claims specify when a food product can be described as free, low or reduced for calories, total fat, saturated fat, cholesterol, sodium, or sugars;
      • "Light" "Reduced" and "Added" (or "Extra," "Plus," "Fortified," and "Enriched") "More" and "Less" (or "Fewer") "High," "Rich In," or "Excellent Source Of" "Good Source," "Contains," or "Provides" "More," "Fortified," "Enriched," "Added," "Extra," or "Plus" "Lean" "Extra Lean" "High Potency" "Modified" "Fiber" Claims Claims using the term "antioxidant"
      • "Healthy":  low fat, low saturated fat, sodium, cholesterol, beneficial nutrients, fortification
      • Claims on Foods for Infants and Children Less than 2 Years of Age

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    • Health Claims
      • See 21 CFR §101.14 and §§101.70 to 101.83.
      • Also see Appendix C: Health Claims
      • Health claim means any claim made on the label ... that ... characterizes the relationship of any substance to a disease or health-related condition. Implied health claims ... suggest ... that a relationship exists between the presence ... of a substance in the food and a disease or health-related condition.  Health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.  For example, calcium and osteoporosis; calcium, vitamin D, and osteoporosis; dietary fat and cancer; sodium and hypertension; dietary saturated fat and cholesterol, and risk of coronary heart disease; fiber-containing grain products, fruits, and vegetables and cancer; fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and risk of V coronary heart disease; fruits and vegetables and cancer; and others
      • A claim made on the food label that expressly or implicitly relates any substance in the food to a disease or health-related condition. A health claim can be made only if allowed by FDA regulation and the health claim meets the Significant Scientific Agreement (SSA) standard and Qualified Health Claims (QHCs) characterizes the relationship between a food substance and its ability to reduce the risk of a disease or health-related condition.
      • "A "health claim" by definition has two essential components: (1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or health-related condition. A statement lacking either one of these components does not meet the regulatory definition of a health claim."
      • "Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition."
      • Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease
      • Soy Protein and Risk of Coronary Heart Disease
      • Plant Sterol/stanol esters and Risk of Coronary Heart Disease
      • Whole Grain Foods and Risk of Heart Disease and Certain Cancers'
      • Potassium and the Risk of High Blood Pressure and Stroke
      • Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease

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    • Structure/Function Claims at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006881.htm.
      • Review:  a dietary supplement may bear certain statements on its label or in its labeling if the claim
      • Structure/Function Claims -- labeling of dietary supplements
      • "Structure/function claims 1) describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones" ... 2) may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity" ... 3) may describe general well-being from consumption of a nutrient or dietary ingredient ... and 4) may describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States."
      • Review:  Claims That Can Be Made for Conventional Foods and Dietary Supplements (December 2013). Also note discussion of Nutrient Content Claims and Structure/Function Claims
      • The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading."
      • Dietary Supplements -- see 21 CFR §101.36 and §101.93.

     

    • Organic
      • Another claim intended to attract consumers is that the "food product is organic."  But to make this claim, the food must meet the USDA standards for organic food.
      • USDA is responsible for administering the National Organic Program (NOP); food intended to be marketed as organic must be labeled as organic and meet the standard for organic food.
      • Regulations for the National Organic Program are codified at 7 CFR Part 205
      • Crops, livestock, livestock products, or other agricultural products intended to be sold, labeled, or represented as organic must be certified (7 CFR 205.100)
      • Crop or livestock production or handling operation can be certified as organic by an accredited certifying agent (see definition of Certified Operation at 7 CFR 205.2)
      • A certifying agent can be accredited by USDA (see Certifying Agent) at 7 CFR 205.2)
      • An organic agricultural product can be “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” (7 CFR 205.102)
      • Producer or handler intending to sell, label, or represent agricultural products as organic must develop an organic production or handling system plan that is agreed to by an accredited certifying agent (7 CFR 205.201)
      • Organic production and handling requirements are specified in 7 CFR 205.200 et. seq.  Requirements address
        • land; soil fertility and crop nutrient management; seeds and planting stock; crop rotation; crop pest, weed, and disease management; wild-crop harvesting
        • origin of livestock; livestock feed; livestock health care; livestock living conditions; pasture practice
        • organic handling; facility pest management; commingling and contact with prohibited substance
      • Products labelled as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group(s))” must meet the product composition specified in 7 CFR 205.301
      • A statement that the food is Organic generally is not considered a claim, yet it is similar in that the statement is intended to attract consumers. 

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    Summary

    This page discussed domestic and international food standards of identity, food additives, product claims, and the process of seeking a regulation to authorize additional standards or additives.

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    Email David.Saxowsky@ndsu.edu

    This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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