Guidance for Industry: A Food Labeling Guide (4. Name of Food)
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- What is the name of the food statement called and where must it be placed?
- Should the statement of identity stand out?
- What name should be used as the statement of identity?
- Where should the statement of identity be placed on the label?
- When are fanciful names permitted as the statement of identity?
- Is it necessary to use the common or usual name instead of a new name?
- Should modified statements of identity be used for sliced and unsliced versions of a food?
- What food must be labeled as an "imitation"?
- What type size and degree of prominence is required for the word "imitation" in the product name?
- Are there restrictions on label artwork?
- Where should the country of origin be declared on an imported food?
- Are foreign language labels permitted?
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 101.3
Answer: Use prominent print or type for the statement of 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 101.3(d)
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, that is not misleading, should be used. Brand names are not considered to be statements of identity and should not be unduly prominent campared to the statement of identity. 21 CFR 101.3(b) & (d)
Answer: Place the statement of identity on the PDP in lines generally parallel to the base of the package. 21 CFR 101.3(d)
Answer: 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)
Answer: The common or usual name must be used for a food if it has one. It would be considered 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)
Answer: Labels must 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)
Answer: Generally a new food that resembles a traditional food and is a substitute for the 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)
Answer: Use the same type size and prominence for the word "imitation" as is used for the name of the product imitated. 21 CFR 101.3(e)
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 firm's name and
address is declared as 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)
Answer: If a foreign language is used anywhere on the label, all required label statements must appear both in English and in the foreign language. 21 CFR 101.15(c)(2)
J1. What causes a juice beverage label to be required to have a % juice declaration?
Answer: Beverages that purport 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 includes 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 with 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 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 included (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 exceptions 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 the ingredient list, and (c) the beverages do not otherwise give the impression they contain juice such as with the use of explicit vignettes on the label or physical resemblance of the beverage to juice such as pulp. 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: Calculate 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% juice 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(a)
J6. Is it necessary to use the term “concentrate” on the label?
Answer: 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 ____ juice,” as appropriate. 21 CFR 102.33(g)
J7. What statement of identity is used on a mixed fruit or vegetable juice beverage?
Answer: When stated, names of juices must be in descending order of predominance by volume, unless the label indicates that the named juice is used as a flavor. Examples:
- “Apple, Pear and Raspberry Juice Drink”
- “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:
- “Apple Juice Blend”
- “Apple Juice in a 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 “raspcranberry” beverage that is primarily white grape juice with raspberry and cranberry juices added):
- “Raspcranberry Raspberry and Cranberry flavored Juice Drink”
- “Raspcranberry Cranberry and Raspberry Juice Beverage”
- “10-15% Cranberry Juice and 3-8% Raspberry Juice”
21 CFR 102.33(b), 21 CFR 102.33(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 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 beverage 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 product's advertising, label, or labeling, bears the name of, or makes any other direct or indirect representation with respect to any fruit or vegetable 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 noncarbonated, 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 that 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 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 have 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 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. 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 juice declaration? If so, how is the percentage determined?
Answer: The declaration is required if the product purports to contain juice. However, because FDA has not established specific procedures for calculating the percentage of juice when beverages are prepared by rehydrating juice solids, it will evaluate labels of products made by this process on a case by case basis. Brix values, where provided in 21 CFR 101.30(h), may be used as guidelines in calculating the level of total juice solids necessary to prepare full strength juices, provided the beverage does not contain other non-juice ingredients.
J15. Do lemon and lime juices, used for mixed drinks, have to bear a percent juice declaration?
Answer: Yes. The percentage juice declaration would be based on the anhydrous citric acid content of the lemon juice or lime juice, listed in 21 CFR 101.30(h)(1).
J16. Is apple cider required to bear a percent juice declaration?
Answer: Apple cider is juice that is expressed from apples and must bear a declaration of the percent of juice.
J17. Does apple cider vinegar have to bear a percent juice declaration?
Answer: No. Apple cider vinegar does not purport to be a beverage and thus is not required to bear a percent juice declaration. Although the product is made from apple juice, it is not considered to be a juice beverage.
J18. Must concentrated juices bear percent declarations? If so what percentage is to be declared?
Answer: Concentrated juice products must bear a percentage juice declaration and that declaration may not be greater than 100 percent. The label may explain that when the product is diluted according to label directions, the product yields a “___percent juice from concentrate,” with the blank being filled in with the correct percentage based on the Brix values set out in 21 CFR 101.30(h)(1), as applicable.
J19. Is there an exemption from the requirement that the percent juice declaration be on the information panel for multi-unit packages that are packed in a secure shrink wrap and are not for sale by individual unit, and the percentage of juice is declared on the outer shrink wrap?
Answer: No, there is no specific exemption from the requirement that the percent juice declaration be on the information panel of individual juice packages packed in a multi-unit shrink wrap pack.
J20. Must the entire common or usual name of a juice beverage be in one place and in a single type size? Some juice beverages will have very complex common or usual names, like “cranberry-raspberry flavored juice drink in a blend of three other juices from concentrate.”
Answer: The entire common or usual name must be in one place. If some or all of the juices listed in the name are from concentrate, the term “from concentrate” must follow the names and may be in a smaller type size, but not less than one half the height of the letters in the other part of the common or usual name. 21 CFR 102.33
J21. Regarding vignettes on juice labels, do the pictures have to be proportional to the fruits in the juice? Does any fruit that is present at a level of less than 2 percent by volume have to be depicted in the vignette?
Answer: FDA has not established specific requirements for vignettes on labels of juice beverages. FDA urges manufacturers to use vignettes that accurately depict each fruit or vegetable contained in the multiple juice products. However, a vignette depicting only some of the fruits or vegetables may not be considered misleading, if the name of the food adequately and appropriately describes the contribution of the pictured juice. For example, a 100 percent juice consisting of apple, grape and raspberry juices, in which raspberry juice provides the characterizing flavor, and bears a vignette that only depicts raspberries, would not necessarily be misleading if the identity statement were “raspberry juice blended with apple and grape juices.” Alternatively, the statement of identity may be “raspberry flavored fruit juice blend” or “raspberry juice in a blend of two other juices, 3 to 8 percent raspberry juice” (58 FR 2897 at 2921).
J22. Do I make any adjustments to the analytical Brix value in declaring the percentage of juice when tomato juice contains added salt or other dry ingredients (e.g., spices)?
Answer: Yes. The soluble solids content for tomato juice must be determined before addition of any spices. The soluble solids for tomato juice, determined by refractometer, should be corrected for salt content as prescribed in 21 CFR 156.3(b) and (c).
J23. I have a 100% juice drink and add a non juice ingredient. May I still call it 100% juice?
Answer: If the added ingredient does not dilute the juice or, for an expressed juice, change its volume, you may continue to call it 100% juice but the percent juice statement must identify the added ingredient e.g., “100% juice with added preservative.” 21 CFR 101.30(b)(3) and 101.54(e)
J24. What if the added substance is also a nutrient such as Vitamin C (ascorbic acid)?
Answer: If ascorbic acid is added at levels consistent with fortification of the juice, a declaration as part of the percent juice statement would constitute a nutrient content claim which would trigger compliance with more claims including the required accompanying information. If it were added at the level used as a preservative, then a statement such as 100% juice with preservative could be used. In this case it would be listed in the ingredient statement as a preservative in accordance with 101.22(j).
J25. Do I have to say “fruit punch from concentrate” or “lemonade from concentrate”?
Answer: No. Section 102.33(g) states that if one or more of the juices in a juice beverage is made from concentrate, then the name of the juice must include the term “from concentrate” or “reconstituted.” Because the names “fruit punch” and “lemonade” do not include the name of a specific juice, these names do not have to contain the term “from concentrate” or “reconstituted.”
J26. Is the declaration on a lemonade made in terms of the lemon juice only, exclusive of sugar?
Answer: Yes, before adding sugar.
J27. We have a juice product for food service only, and we are exempt from nutrition labeling for this product (we know that is never goes to club stores). Are we also exempt from percent juice declarations?
Answer: No. There are no exemptions from the requirement for label declaration of the percentage of juice on food service containers of juices.
J28. Is the common or usual name regulation in 21 CFR 102.33 applicable to 100 percent juices or only to diluted juices?
Answer: The regulation is applicable to both.
J29. We have very small labels, about 7 square inches. How do you name a citrus punch which contains five juices in which three are from concentrate and two are expressed juices, and the expressed juices are not citrus juices nor do their flavors characterize the beverage? Also, what if one of the citrus juices is an expressed juice and is present only in a minor amount, must it be identified by name?
Answer: There are several alternatives. In the first case, the common or usual name may be “a blend of 3 citrus juices from concentrate with ______ and ____ juices”, the blanks filled in with names of the expressed juices. In the second case, the citrus juice that is not from concentrate should be listed as in the example given above in order of predominance, i.e., a blend of 2 citrus juices from concentrate with _____, ______, and ______ juices, with the third citrus juice listed in one of the blanks, along with the other expressed juices. Alternatively, a name such as “citrus punch” or “citrus flavored punch” may be used as the statement of identity without further identification of the component juices.
J30. Is it necessary to state that juices are from concentrate when they are contained in a beverage such as punch?
Answer: Yes, sometimes. If the juices are specifically named in the statement of identity, and the juices are from concentrate, their names must be followed by the term “from concentrate” in accordance with 21 CFR 102.33(g). If no reference is made to specific juices in the name of a punch that is made from concentrated juices, the statement of identity does not have to include the term “from concentrate.” However, each of the concentrated juices used in the punch must be declared in order of predominance in the ingredient statement of the label.
J31. Does a punch have to be made from fruit juice?
Answer: No. FDA does not have a specific definition or standard of identity for punch, or any other requirement that a punch contain fruit juice. A punch may be an artificially flavored beverage, with or without natural flavorings, or it may be made from tea and other ingredients, exclusive of fruit juice. Such products must be clearly distinguished from products which are made from fruit juices or fruit concentrates or purees. Products containing artificial or natural flavors must be labeled in accordance with 21 CFR 101.22.
J32. In the case of a vegetable juice cocktail that is 100 percent juice, can the name include the term “cocktail”?
For questions regarding this document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371.