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Food Additives Food and Drug Law Federal Code of Regulations Title 21

Food Additives Food and Drug Law Federal Code of Regulations Title 21. Regulations. Food Drug and Cosmetic Act (FD&C) 1938 1958 FD&C Act Amendment 1960 Color Additive Amendment to FD&C Act 1990 Nutritional and Education Act 1996 Food Quality Protection Act

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Food Additives Food and Drug Law Federal Code of Regulations Title 21

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  1. Food AdditivesFood and Drug LawFederal Code of Regulations Title 21

  2. Regulations • Food Drug and Cosmetic Act (FD&C) 1938 • 1958 FD&C Act Amendment • 1960 Color Additive Amendment to FD&C Act • 1990 Nutritional and Education Act • 1996 Food Quality Protection Act • 1997 Amendment to FD&C Act -Sec. 170.35--Affirmation of GRAS Status

  3. Key Web Sites • CFSAN Premarket ApprovalOffice of Pre-market Approval http://vm.cfsan.fda.gov/~lrd/foodadd.html • CFRhttp://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121 • FRhttp://www.access.gpo.gov/su_docs/aces/aces140.html • IFThttp//www.IFT.org

  4. The following slides are excerpted primarily from the food labeling regulations as published in the CRFhttp://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=4050315947+1+0+0&WAISaction=retrieve

  5. Food Additives • 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 as 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;

  6. -except that such term does not include - • (1) a pesticide chemical 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 the enactment of this paragraph? (footnote 2) pursuant to this Act, the Poultry Products Inspection Act (21 U.S.C. 451 and the following) or the Meat Inspection Act of March 4, 1907, (34 Stat 1260) as amended and extended (21 U.S.C. 71 and the following); • (5) a new animal drug; or • (6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.

  7. Color Additive – separate definition • The term ''color additive'' means a material which - • (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and • (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.

  8. Misbranding • If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.

  9. GRAS (Generally Regarded as Safe • Gras substances are based on scientific evidence of safe • For a list of GRAS substances, see http://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=41004421136+1+0+0&WAISaction=retrieve

  10. GRAS • General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. General recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.

  11. Self Affirmation of GRAS • Sec. 170.36(a)(1) provides that any person may notify FDA of a claim that a particular use of a substance is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is GRAS. The agency encourages manufacturers and developers of food substances and of new processes for producing food substances to use this notification procedure to inform FDA if such manufacturers or developers conclude that there is general recognition that use of a substance is safe.

  12. Allergens (FDA 2000) • FDA believes there is scientific consensus that the following foods can cause serious allergic reactions in some individuals and account for more than 90% of all food allergies.2, 3, 4 • Peanuts Soybeans Milk Eggs Fish Crustacea Tree nuts Wheat

  13. Allergens (2002) • Food allergy patterns in adults differ somewhat from those in children. The most common foods to cause allergies in adults are shrimp, lobster, crab, and other shellfish; peanuts (one of the chief foods responsible for severe anaphylaxis); walnuts and other tree nuts; fish; and eggs. • In children, eggs, milk, peanuts, soy and wheat are the main culprits. Children typically outgrow their allergies to milk, egg, soy and wheat, while allergies to peanuts, tree nuts, fish and shrimp usually are not outgrown. • Adults usually do not lose their allergies.

  14. Allergen Labeling (2000) • The FDA's policy with respect to allergens is that products that contain an allergenic ingredient by design must comply with section 403(i)(2) of the Act, which requires each ingredient in a food to be declared. Processing aids that contain allergenic ingredients must also be declared in accordance with 21 CFR 101.4(a)(1). Production practices that lead to unintentional addition of allergens to food may be considered insanitary conditions that may render the food injurious to health and cause the food product to be adulterated under section 402(a)(4) of the Act. • An allergen labeling program and a "code of practice" developed by the National Food Processors Association that calls for listing the eight most common food allergens in "plain language" are among the voluntary efforts being undertaken. • An example of "plain language" is using the word "milk" in a product's ingredient list as well as the less familiar "caseinate" or using "eggs" in addition to "albumin."

  15. Health Claims • Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including ``third party'' references, written statements (e.g., a brand name including a term such as ``heart''), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition.

  16. Health Claims • FDA will promulgate regulations authorizing a health claim only when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.

  17. Labeling • The term ''label'' means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. • The term ''labeling'' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

  18. Ingredients • Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by Sec. 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of Sec. 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with Sec. 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products.

  19. Ingredient Labeling • By declaring the established common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance except that, if the ingredient is a food subject to a definition and standard of identity established in subchapter B of this chapter that has specific labeling provisions for optional ingredients, optional ingredients may be declared within the parenthetical listing in accordance with those provisions.

  20. Nutritional Labeling • Except as provided in Sec. 101.9(h)(3), all nutrient and food component quantities shall be declared in relation to a serving as defined in this section. (1) The term serving or serving size means an amount of food customarily consumed per eating occasion by persons 4 years of age or older which is expressed in a common household measure that is appropriate to the food. When the food is specially formulated or processed for use by infants or by toddlers, a serving or serving size means an amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively.

  21. Nutritional Labeling • A variety pack, such as a package containing several varieties of single-serving units as defined in paragraph (b)(2)(i) of this section, and a product having two or more compartments with each compartment containing a different food, shall provide nutrition information for each variety or food per serving size that is derived from the reference amount in Sec. 101.12(b) applicable for each variety or food and the procedures to convert the reference amount to serving size in paragraph (b)(2) of this section.

  22. Nutritional Labeling • To promote uniformity in label serving sizes in household measures declared by different manufacturers, FDA has provided a guidance document entitled, ``Guidelines for Determining the Gram Weight of the Household Measure.'' The guidance document can be obtained from the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204.

  23. Calories • ``Calories, total,'' ``Total calories,'' or ``Calories'': A statement of the caloric content per serving, expressed to the nearest 5-calorie increment up to and including 50 calories, and 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. Energy content per serving may also be expressed in kilojoule units, added in parentheses immediately following the statement of the caloric content. • ``Calories from fat'': A statement of the caloric content derived from total fat as defined in paragraph (c)(2) of this section in a serving, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that label declaration of ``calories from fat'' is not required on products that contain less than 0.5 gram of fat in a serving and amounts less than 5 calories may be expressed as zero.

  24. Calories and lipids • Calories from saturated fat'' or ``Calories from saturated'' (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section in a serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. • ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A statement of the number of grams of polyunsaturated fat in a serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, • ``Cholesterol'': A statement of the cholesterol content in a serving expressed in milligrams to the nearest 5-milligram increment, except that label declaration of cholesterol information is not required for products that contain less than 2 milligrams cholesterol in a serving and make no claim about fat, fatty acids, or cholesterol content, or such products may state the cholesterol content as zero. • ``Trans fat'' or ``Trans'': A statement of the number of grams of trans fat in a serving, defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e., nonconjugated) double bonds in a trans configuration, except that label declaration of trans fat content information is not required for products that contain less than 0.5 gram of total fat in a serving if no claims are made about fat, fatty acid or cholesterol content. )

  25. Minerals • ``Sodium'': A statement of the number of milligrams of sodium in a specified serving of food expressed as zero when the serving contains less than 5 milligrams of sodium, to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium, and to the nearest 10-milligram increment when the serving contains greater than 140 milligrams. • ``Potassium'' (VOLUNTARY): A statement of the number of milligrams of potassium in a specified serving of food may be declared voluntarily, except that when a claim is made about potassium content, label declaration shall be required. Potassium content shall be expressed as zero when the serving contains less than 5 milligrams of potassium, to the nearest 5-milligram increment when the serving contains less than or equal to 140 milligrams of potassium, and to the nearest 10-milligram increment when the serving contains more than 140 milligrams.

  26. Carbohydrates • ``Carbohydrate, total'' or ``Total carbohydrate'': A statement of the number of grams of total carbohydrate in a serving expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, or if the serving contains less than 0.5 gram, the content may be expressed as zero. • ``Dietary fiber'': A statement of the number of grams of total dietary fiber in a serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required or, alternatively, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero. Except as provided for in paragraph (f) of this section, if dietary fiber content is not required and as a result, not declared, the statement ``Not a significant source of dietary fiber'' shall be placed at the bottom of the table of nutrient values in the same type size. • Soluble fiber voluntary, unless a claim is made.

  27. carbohydrates • ``Sugars'': A statement of the number of grams of sugars in a serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars in a serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Except as provided for in paragraph (f) of this section, if a statement of the sugars content is not required and, as a result, not declared, the statement ``Not a significant source of sugars'' shall be placed at the bottom of the table of nutrient values in the same type size. • ``Sugar alcohol'' (VOLUNTARY): A statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol).

  28. proteins • ``Protein'': A statement of the number of grams of protein in a serving, expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. • (Other labeling requirement are based on digestibility adjusted amino acid scores)

  29. vitamins • For purposes of declaration of percent of Daily Value as provided for in paragraphs (d), (e), and (f) of this section, foods represented or purported to be for use by infants, children less than 4 years of age, pregnant women, or lactating women shall use the RDI's that are specified for the intended group. For foods represented or purported to be for use by both infants and children under 4 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants from birth to 12 months of age and for children under 4 years of age. Similarly, the percent of Daily Value based on both the RDI values for pregnant women and for lactating women shall be declared separately on foods represented or purported to be for use by both pregnant and lactating women.

  30. Vitamin A, 5,000 International Units Vitamin C, 60 milligrams Calcium, 1,000 milligrams Iron, 18 milligrams Vitamin D, 400 International Units Vitamin E, 30 International Units Vitamin K, 80 micrograms Thiamin, 1.5 milligrams Riboflavin, 1.7 milligrams Niacin, 20 milligrams Vitamin B<INF>6,</INF> 2.0 milligrams Folate, 400 micrograms Vitamin B<INF>12,</INF> 6 micrograms Biotin, 300 micrograms Pantothenic acid, 10 milligrams Phosphorus, 1,000 milligrams Iodine, 150 micrograms Magnesium, 400 milligrams Zinc, 15 milligrams Selenium, 70 micrograms Copper, 2.0 milligrams Manganese, 2.0 milligrams Chromium, 120 micrograms Molybdenum, 75 micrograms Chloride, 3,400 milligrams The following RDI's and nomenclature are established for the following vitamins and minerals which are essential in human nutrition:

  31. Daily Recommended Values (DRV) • For the purpose of labeling with a percent of the DRV, the following DRV's are established for the following food components based on the reference caloric intake of 2,000 calories: • ------------------------------------------------------------------------ • Unit of Food component measurement DRV • Fat............................. gram (g).......... 65 • Saturated fatty acids........... (g)................ 20 • Cholesterol..................... milligrams (mg)... 300 • Total carbohydrate.............. grams (g)......... 300 • Fiber........................... (g)................ 25 • Sodium.......................... milligrams (mg)... 2,400 Potassium....................... (g)................ 3,500 • Protein......................... grams (g)......... 50

  32. Qualified Health Claims • Under a new program, to start Sept 1, 2004, the FDA will permit certain foods to make “qualified health claims” – similar to what the courts have allowed for more loosely regulated dietary supplements. This action has raised some controversy • Food manufacturers will have to seek FDA approval first, and FDA will respond be grading each potential claim: A for scientifically proven claims; B where the science is good, but not conclusive; C where there is limited science to support a claim; and D where there’s hardly any. • Claims rated a “B:, “C” or “D” would be considered qualified, and for the first time could be put on a food label next to a disclaimer that describes how much proof there is, or isn’t

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