1、食品标签指南（2008 年 4 月修订版）Contains Nonbinding RecommendationsGuidance for Industry(1)A Food Labeling GuideThis guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the
2、public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call
3、the appropriate telephone number listed on the title page of this guidance.Table of ContentsI. Introduction II. Background III. General Food Labeling Requirements IV. Name of Food o Juices V. Net Quantity of Contents Statements VI. Ingredient Lists o Colors o Food Allergen Labeling VII. Nutrition La
4、beling o General o Nutrient Declaration o Products with Separately Packaged Ingredients/Assortments of Foods o Label Formats/Graphics General Specific Label Formats Trans Fat Labeling Miscellaneous Serving Size Exemptions/Special Labeling Provisions VIII. Claims o Nutrient Content Claims o Health Cl
5、aims o Qualified Health Claims o Structure/Function Claims IX. Appendix A: Definitions of Nutrient Claims X. Appendix B: Additional Requirements for Nutrient Content Claims XI. Appendix C: Health Claims XII. Appendix D: Qualified Health Claims XIII. Appendix E: Additional FDA Resources XIV. Appendix
6、 F: Calculate the Percent Daily Value (DV) for the Appropriate Nutrients XV. Appendix G: Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant and Lactating Women XVI. Appendix H: Rounding the Values According to the FDA Rounding Rules I. IntroductionIn a guide such as this, it i
7、s impractical to attempt to answer every food labeling question that might arise. The most frequently raised questions have been addressed using a “question and answer“ format. We believe the vast majority of food labeling questions are answered. They are grouped by the food labeling area of interes
8、t. The Table of Contents will help you locate your food labeling area of interest.Under FDAs laws and regulations, FDA does not pre-approve labels for food products. Questions concerning the labeling of food products may be directed to the Food Labeling and Standards Staff (HFS-820), Office of Nutri
9、tional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Telephone: (301) 436-2371.II. BackgroundThe Food and Drug Administration (FDA) is responsible for assuring that food
10、s sold in the United States are safe, wholesome and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries. The Federal Food, Drug, and Cosmetic Act (FD City or town; State (or country, if outside the United States); and ZIP code (or mailing code used
11、in countries other than the United States). 21 CFR 101.5IV. Name of FoodMarch 20081. What is the name of the food statement called and where must it be placed? 2. Should the statement of identity stand out? 3. What name should be used as the statement of identity? 4. Where should the statement of id
12、entity be placed on the label? 5. When are fanciful names permitted as the statement of identity? 6. Is it necessary to use the common or usual name instead of a new name? 7. Should modified statements of identity be used for sliced and unsliced versions of a food? 8. What food must be labeled as an
13、 “imitation“? 9. What type size and degree of prominence is required for the word “imitation“ in the product name? 10.Are there restrictions on label artwork? 11.Where should the country of origin be declared on an imported food? 12.Are foreign language labels permitted? Juices 1. What is the name o
14、f the food statement called and where must it be placed?Answer: The statement of identity is the name of the food. It must appear on the front label, or PDP as well as any alternate PDP. 21 CFR 101.32. Should the statement of identity stand out?Answer: Use prominent print or type for the statement o
15、f identity. It shall be in bold type. The type size must be reasonably related to the most prominent printed matter on the front panel and should be one of the most important features on the PDP. Generally, this is considered to be at least 1/2 the size of the largest print on the label. 21 CFR 101.
16、3(d)3. What name should be used as the statement of identity?Answer: The name established by law or regulation, or in the absence thereof, the common or usual name of the food, if the food has one, should be used as the statement of identity. If there is none, then an appropriate descriptive name, t
17、hat is not misleading, should be used. 21 CFR 101.3(b)4. Where should the statement of identity be placed on the label?Answer: Place the statement of identity in lines generally parallel to the base of the package. 21 CFR 101.3(d)5. When are fanciful names permitted as the statement of identity?Answ
18、er: When the nature of the food is obvious, a fanciful name commonly used and understood by the public may be used. 21 CFR 101.3(b)(3)6. Is it necessary to use the common or usual name instead of a new name?Answer: The common or usual name must be used for a food if it has one. It would be considere
19、d misleading to label a food that has an established name with a new name. If the food is subject to a standard of identity it must bear the name specified in the standard. 21 CFR 101.3(b)(2)7. Should modified statements of identity be used for sliced and unsliced versions of a food?Answer: Labels m
20、ust describe the form of the food in the package if the food is sold in different optional forms such as sliced and unsliced, whole or halves, etc. 21 CFR 101.3(c)8. What food must be labeled as an “imitation“?Answer: Generally a new food that resembles a traditional food and is a substitute for the
21、 traditional food must be labeled as an imitation if the new food contains less protein or a lesser amount of any essential vitamin or mineral.21 CFR 101.3(e)9. What type size and degree of prominence is required for the word “imitation“ in the product name?Answer: Use the same type size and promine
22、nce for the word “imitation“ as is used for the name of the product imitated.21 CFR 101.3(e) 10. Are there restrictions on label artwork?Answer: Do not use artwork that hides or detracts from the prominence and visibility of required label statements or that misrepresents the food. 21 CFR 1.21(a)(1)
23、, 21 CFR 101.3(a), 21 CFR 101.105(h)11. Where should the country of origin be declared on an imported food?Answer: The law does not specifically require that the country of origin statement be placed on the PDP, but requires that it be conspicuous. If a domestic firms name and address is declared as
24、 the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering. (FDA/CBP (Customs and Border Protection) Guidance and Customs regulation 19 CFR 134)12. Are foreign languag
25、e labels permitted?Answer: All required label statements must appear both in English and in the foreign language if any representations appear in a foreign language. 21 CFR 101.15(c)(2)JuicesJ1. What causes a juice beverage label to be required to have a % juice declaration?Answer: Beverages that pu
26、rport to contain juice (fruit or vegetable juice) must declare the % of juice. Included are beverages that purport to contain juice by way of label statements, by pictures of fruits or vegetables on the label, or by taste and appearance causing the consumer to expect juice in the beverage. This incl
27、udes non-carbonated and carbonated beverages, full-strength (100%) juices, concentrated juices, diluted juices, and beverages that purport to contain juice but contain no juice. 21 CFR 101.30(a)J2. Where and how is % juice declared?Answer: The % juice must be on the information panel (for packages w
28、ith information panels), near the top. Only the brand name, product name, logo, or universal product code may be placed above it. Use easily legible boldface print or type that distinctly contrasts with the other printed or graphic material. The type size for the % juice declaration must be not less
29、 than the largest type on the information panel, except that used for the brand name, product name, logo, universal product code, or the title phrase Nutrition Facts. The percentage juice declaration may be either “contains_% juice“ or “_% juice.“ The name of the fruit or vegetable may also be inclu
30、ded (e.g., “100% Apple Juice“). If the package does not contain an information panel, the percent juice must be placed on the PDP in a type size not less than that required for the net contents declaration and placed near the name of the food. 21 CFR 101.30(e); 21 CFR 101.30(g)J3. Are there any exce
31、ptions from the % juice requirement?Answer: An exception is that beverages containing minor amounts of juice for flavoring are not required to bear a % juice declaration provided that: (a) The product is described using the term “flavor“ or “flavored,“ (b) The term “juice“ is not used other than in
32、the ingredient list, and (c) The beverages do not otherwise give the impression they contain juice. 21 CFR 101.30(c)J4. How is the % juice calculated?Answer: For juice expressed directly from fruit or vegetables: Compute on a volume/volume basis.For juice made by adding water to concentrate: Calcula
33、te using values from the Brix table in 21 CFR 101.30(h)(1) as the basis for 100% juice. 21 CFR 101.30(j), 21 CFR 101.30(h)J5. Should my product be labeled as a “drink“ or a “beverage?“Answer: Beverages that are 100% juice may be called “juice.“ However, beverages that are diluted to less than 100% j
34、uice must have the word “juice“ qualified with a term such as “beverage,“ “drink,“ or “cocktail.“ Alternatively, the product may be labeled with a name using the form “diluted _ juice,“ (e.g. “diluted apple juice“). 21 CFR 102.33(g)J6. Is it necessary to use the term “concentrate“ on the label?Answe
35、r: Juices made from concentrate must be labeled with terms such as “from concentrate,“ or “reconstituted“ as part of the name wherever it appears on the label. An exception is that, in the ingredient statement, the juice is declared as “concentrated _ juice and water“ or “water and concentrated _ ju
36、ice,“ as appropriate. 21 CFR 102.33(g)J7. What name is used on a mixed fruit or vegetable juice beverage?Answer: When stated, names of juices (except in the ingredient list) must be in descending order of predominance by volume, unless the label indicates that the named juice is used as a flavor. Ex
37、amples:o “Apple, Pear and Raspberry Juice Drink“ o “Raspberry-Flavored Apple and Pear Juice Drink“ If the label represents one or more but not all the juices (except in the ingredient list), then the name must indicate that more juices are present. Examples:o “Apple Juice Blend“ o “Apple Juice in a
38、Blend of Two Other Fruit Juices“ When one or more, but not all, juices are named and the named juice is not the predominant juice, the name of the beverage must either state that the beverage is flavored with the named juice or declare the amount of the named juice in a 5% range. Examples (for a “ra
39、spcranberry“ beverage that is primarily white grape juice with raspberry and cranberry juices added):o “Raspcranberry Raspberry and Cranberry flavored Juice Drink“ o “Raspcranberry Cranberry and Raspberry Juice Beverage o “10-15% Cranberry Juice and 3-8% Raspberry Juice“ 21 CFR 102.33(b), 21 CFR 102
40、.33(c), 21 CFR 102.33(d)J8. What type sizes must be used in naming juices?Answer: The term “from concentrate“ or “reconstituted“ must be no smaller than one-half the height of the letters in the name of the juice. The 5% range information generally should be not less than one-half the height of the
41、largest type appearing in the common or usual name (may not be less than 1/16th inch in height on packages with 5 sq. in. or less area on the PDP, and not less than 1/8 inch in height on packages with a PDP greater than 5 sq. in.21 CFR 102.5(b)(2), 21 CFR 102.33(d), 21 CFR 102.33(g)J9. When does a b
42、everage purport to contain a fruit or vegetable juice?Answer: Under 21 CFR 101.30(a), a beverage purports to contain fruit or vegetable juice if the products advertising, label, or labeling, bears the name of, or makes any other direct or indirect representation with respect to any fruit or vegetabl
43、e juice, or the label or labeling bears any vignette (i.e., depiction of a fruit or vegetable) or another pictorial representation of any fruit or vegetable, or product contains color and flavor that gives the appearance and taste of a fruit or vegetable juice. The beverages may be carbonated or non
44、carbonated, full strength, diluted, or contain no juice.J10. Are bar mixes required to bear percent juice declarations under 21 CFR 101.30?Answer: Bar mixes are subject to the same requirements as other beverage products. Thus, a percent juice declaration would be required on labels of bar mixes tha
45、t meet the definition set out in 21 CFR 101.30(a).J11. Is a whiskey sour mix that contains lemon juice from concentrate as the only juice component and a number of juice flavors and other ingredients, and that makes no claim or bears no pictures of fruits/fruit juices on the label required to bear a
46、 percent juice declaration?Answer: No. A percent juice declaration would not be required on the whiskey sour mix if the only reference to the lemon juice is in the ingredient statement and no pictures of fruits/fruit juice appear on the label or in its labeling.J12. Would a strawberry daiquiri mix h
47、ave to bear a percent juice declaration?Answer: A strawberry daiquiri mix would purport to contain strawberries or strawberry juice because the term “strawberry“ appears in the identity statement. Also, there is no indication that the strawberry is present only as a flavor or flavoring. If its label
48、 or labeling also includes pictures of the juice dripping from strawberries or if the product looks and tastes like it contains strawberry juice or strawberry pulp, the product would have to bear a declaration of the percent of juice or the absence of such juice on the information panel of the label
49、. However, if the product were labeled “Strawberry flavored daiquiri mix “ and did not otherwise purport to contain strawberry juice, it would not need a percent juice declaration.J13. Must bloody mary mix bear a percent juice declaration?Answer: Bloody mary mix, by appearance and taste, purports to contain tomato juice and thus would be required to bear a statement as to the percentage of juice contained in the product.J14. Would a beverage that is made by reconstituting a blend of dehydrated fruits or vegetables be required to bear a percent juic
