§ 101.18 21 CFR Ch. I (4–1–12 Edition)

(8) Persons engaged in handling or misdescriptive. A trademark or trade storing packed shell eggs for retail dis- name composed in whole or in part of tribution shall permit authorized rep- geographical words shall not be consid- resentatives of FDA to make at any ered deceptively misdescriptive if it: reasonable time such inspection of the (i) Has been so long and exclusively establishment in which shell eggs are used by a manufacturer or distributor being held, including inspection and that it is generally understood by the sampling of the labeling of such eggs as consumer to mean the product of a par- may be necessary in the judgment of ticular manufacturer or distributor; or such representatives to determine com- (ii) Is so arbitrary or fanciful that it pliance with the provisions of this sec- is not generally understood by the con- tion. Inspections may be made with or sumer to suggest geographic origin. without notice and will ordinarily be (3) A part of the name required by ap- made during regular business hours. plicable Federal law or regulation. (9) No State or local governing entity (4) A name whose market signifi- shall establish or continue in effect cance is generally understood by the any law, rule, regulation, or other re- consumer to connote a particular class, quirement requiring safe handling in- kind, type, or style of rather than structions on unpasteurized shell eggs to indicate geographical origin. that are less stringent than those re- quired in paragraphs (h)(1) through Subpart B—Specific Food Labeling (h)(5) of this section. Requirements [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977; 49 FR 13690, Apr. 6, § 101.22 ; labeling of spices, 1984; 49 FR 28548, July 13, 1984; 61 FR 20100, flavorings, colorings and chemical May 3, 1996; 62 FR 2249, Jan. 15, 1997; 63 FR preservatives. 8118, Feb. 18, 1998; 63 FR 37055, July 8, 1998; 63 (a)(1) The term artificial or arti- FR 63982, Nov. 18, 1998; 66 FR 17358, Mar. 30, ficial flavoring means any substance, 2001; 65 FR 76111, Dec. 5, 2000; 72 FR 46378, the function of which is to impart fla- Aug. 20, 2007] vor, which is not derived from a spice, § 101.18 Misbranding of food. fruit or fruit , vegetable or vege- table juice, edible yeast, herb, bark, (a) Among representations in the la- bud, root, leaf or similar plant mate- beling of a food which render such food rial, , fish, poultry, eggs, dairy misbranded is a false or misleading products, or fermentation products representation with respect to another thereof. Artificial flavor includes the food or a drug, device, or cosmetic. substances listed in §§ 172.515(b) and (b) The labeling of a food which con- 182.60 of this chapter except where tains two or more may be these are derived from natural sources. misleading by reason (among other rea- (2) The term spice means any aro- sons) of the designation of such food in matic vegetable substance in the such labeling by a name which includes whole, broken, or ground form, except or suggests the name of one or more for those substances which have been but not all such ingredients, even traditionally regarded as foods, such as though the names of all such ingredi- onions, garlic and celery; whose signifi- ents are stated elsewhere in the label- cant function in food is seasoning rath- ing. er than nutritional; that is true to (c) Among representations in the la- name; and from which no portion of beling of a food which render such food any volatile oil or other flavoring prin- misbranded is any representation that ciple has been removed. Spices include expresses or implies a geographical ori- the spices listed in § 182.10 and part 184 gin of the food or any of the of this chapter, such as the following: food except when such representation is either: Allspice, Anise, Basil, Bay leaves, Caraway (1) A truthful representation of geo- seed, Cardamon, Celery seed, Chervil, Cin- namon, Cloves, Coriander, Cumin seed, Dill graphical origin. seed, Fennel seed, Fenugreek, Ginger, (2) A trademark or trade name pro- Horseradish, Mace, Marjoram, Mustard vided that as applied to the article in flour, Nutmeg, Oregano, Paprika, Parsley, question its use is not deceptively Pepper, black; Pepper, white; Pepper, red;

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Rosemary, Saffron, Sage, Savory, Star ani- (d) A food shall be exempt from com- seed, Tarragon, Thyme, Turmeric. pliance with the requirements of sec- tion 403(k) of the act if it is not in Paprika, turmeric, and saffron or other package form and the units thereof are spices which are also colors, shall be so small that a statement of artificial declared as ‘‘spice and coloring’’ unless flavoring, artificial coloring, or chem- declared by their common or usual ical preservative, as the case may be, name. cannot be placed on such units with (3) The term natural flavor or natural such conspicuousness as to render it flavoring means the essential oil, oleo- likely to be read by the ordinary indi- resin, essence or extractive, hy- vidual under customary conditions of drolysate, distillate, or any product of purchase and use. roasting, heating or enzymolysis, (e) A food shall be exempt while held which contains the flavoring constitu- for sale from the requirements of sec- ents derived from a spice, fruit or fruit tion 403(k) of the act (requiring label juice, vegetable or vegetable juice, edi- statement of any artificial flavoring, ble yeast, herb, bark, bud, root, leaf or artificial coloring, or chemical preserv- similar plant material, meat, seafood, atives) if said food, having been re- poultry, eggs, dairy products, or fer- ceived in bulk containers at a retail es- mentation products thereof, whose sig- tablishment, is displayed to the pur- nificant function in food is flavoring chaser with either (1) the labeling of rather than nutritional. Natural fla- the bulk container plainly in view or vors include the natural essence or ex- (2) a counter card, sign, or other appro- tractives obtained from plants listed in priate device bearing prominently and §§ 182.10, 182.20, 182.40, and 182.50 and conspicuously the information required part 184 of this chapter, and the sub- to be stated on the label pursuant to stances listed in § 172.510 of this chap- section 403(k). ter. (f) A fruit or vegetable shall be ex- (4) The term artificial color or artificial empt from compliance with the re- coloring means any ‘‘color additive’’ as quirements of section 403(k) of the act defined in § 70.3(f) of this chapter. with respect to a chemical preservative (5) The term chemical preservative applied to the fruit or vegetable as a means any chemical that, when added chemical prior to harvest. to food, tends to prevent or retard de- (g) A flavor shall be labeled in the terioration thereof, but does not in- following way when shipped to a food clude common , , , manufacturer or processor (but not a spices, or oils extracted from spices, consumer) for use in the manufacture substances added to food by direct ex- of a fabricated food, unless it is a fla- posure thereof to wood smoke, or vor for which a standard of identity chemicals applied for their insecticidal has been promulgated, in which case it or herbicidal properties. shall be labeled as provided in the (b) A food which is subject to the re- standard: quirements of section 403(k) of the act (1) If the flavor consists of one ingre- shall bear labeling, even though such dient, it shall be declared by its com- food is not in package form. mon or usual name. (c) A statement of artificial fla- (2) If the flavor consists of two or voring, artificial coloring, or chemical more ingredients, the label either may preservative shall be placed on the food declare each ingredient by its common or on its container or wrapper, or on or usual name or may state ‘‘All flavor any two or all three of these, as may be ingredients contained in this product necessary to render such statement are approved for use in a regulation of likely to be read by the ordinary per- the Food and Drug Administration.’’ son under customary conditions of pur- Any flavor ingredient not contained in chase and use of such food. The specific one of these regulations, and any non- artificial color used in a food shall be flavor ingredient, shall be separately identified on the labeling when so re- listed on the label. quired by regulation in part 74 of this (3) In cases where the flavor contains chapter to assure safe conditions of use a solely natural flavor(s), the flavor for the color additive. shall be so labeled, e.g., ‘‘strawberry

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flavor’’, ‘‘banana flavor’’, or ‘‘natural vor may be declared simply as ‘‘fla- strawberry flavor’’. In cases where the vor,’’ ‘‘natural flavor,’’ or ‘‘flavoring.’’ flavor contains both a natural flavor The ingredient shall be declared by its and an artificial flavor, the flavor shall specific common or usual name as pro- be so labeled, e.g., ‘‘natural and artifi- vided in § 102.22 of this chapter. cial strawberry flavor’’. In cases where (i) If the label, labeling, or adver- the flavor contains a solely artificial tising of a food makes any direct or in- flavor(s), the flavor shall be so labeled, direct representations with respect to e.g., ‘‘artificial strawberry flavor’’. the primary recognizable flavor(s), by (h) The label of a food to which flavor word, vignette, e.g., depiction of a is added shall declare the flavor in the fruit, or other means, or if for any statement of ingredients in the fol- other reason the manufacturer or dis- lowing way: tributor of a food wishes to designate (1) Spice, natural flavor, and artifi- the type of flavor in the food other cial flavor may be declared as ‘‘spice’’, than through the statement of ingredi- ‘‘natural flavor’’, or ‘‘artificial flavor’’, ents, such flavor shall be considered or any combination thereof, as the case the characterizing flavor and shall be may be. declared in the following way: (2) An incidental additive in a food, (1) If the food contains no artificial originating in a spice or flavor used in flavor which simulates, resembles or the manufacture of the food, need not reinforces the characterizing flavor, be declared in the statement of ingredi- the name of the food on the principal ents if it meets the requirements of display panel or panels of the label § 101.100(a)(3). shall be accompanied by the common (3) Substances obtained by cutting, or usual name of the characterizing fla- grinding, drying, pulping, or similar vor, e.g., ‘‘vanilla’’, in letters not less processing of tissues derived from fruit, than one-half the height of the letters vegetable, meat, fish, or poultry, e.g., used in the name of the food, except powdered or granulated onions, garlic that: powder, and celery powder, are com- (i) If the food is one that is com- monly understood by consumers to be monly expected to contain a character- food rather than flavor and shall be de- izing food ingredient, e.g., strawberries clared by their common or usual name. in ‘‘strawberry shortcake’’, and the (4) Any salt () used as food contains natural flavor derived an ingredient in food shall be declared from such ingredient and an amount of by its common or usual name ‘‘salt.’’ characterizing ingredient insufficient (5) Any used to independently characterize the food, as an ingredient in food shall be de- or the food contains no such ingre- clared by its common or usual name dient, the name of the characterizing ‘‘monosodium glutamate.’’ flavor may be immediately preceded by (6) Any pyroligneous acid or other ar- the word ‘‘natural’’ and shall be imme- tificial smoke used as an ingre- diately followed by the word ‘‘fla- dient in a food may be declared as arti- vored’’ in letters not less than one-half ficial flavor or artificial smoke flavor. the height of the letters in the name of No representation may be made, either the characterizing flavor, e.g., ‘‘natural directly or implied, that a food fla- strawberry flavored shortcake,’’ or vored with pyroligneous acid or other ‘‘strawberry flavored shortcake’’. artificial smoke flavor has been (ii) If none of the natural flavor used smoked or has a true smoked flavor, or in the food is derived from the product that a seasoning sauce or similar prod- whose flavor is simulated, the food in uct containing pyroligneous acid or which the flavor is used shall be la- other artificial smoke flavor and used beled either with the flavor of the prod- to season or flavor other foods will re- uct from which the flavor is derived or sult in a smoked product or one having as ‘‘artificially flavored.’’ a true smoked flavor. (iii) If the food contains both a char- (7) Because protein hydrolysates acterizing flavor from the product function in foods as both flavorings and whose flavor is simulated and other flavor enhancers, no protein hydroly- natural flavor which simulates, resem- sate used in food for its effects on fla- bles or reinforces the characterizing

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flavor, the food shall be labeled in ac- priately descriptive generic term in cordance with the introductory text lieu of naming each flavor, e.g., ‘‘arti- and paragraph (i)(1)(i) of this section ficially flavored fruit punch’’. and the name of the food shall be im- (4) A flavor supplier shall certify, in mediately followed by the words ‘‘with writing, that any flavor he supplies other natural flavor’’ in letters not less which is designated as containing no than one-half the height of the letters artificial flavor does not, to the best of used in the name of the characterizing his knowledge and belief, contain any flavor. artificial flavor, and that he has added (2) If the food contains any artificial no artificial flavor to it. The require- flavor which simulates, resembles or ment for such certification may be sat- reinforces the characterizing flavor, isfied by a guarantee under section the name of the food on the principal 303(c)(2) of the act which contains such display panel or panels of the label a specific statement. A flavor user shall be accompanied by the common shall be required to make such a writ- or usual name(s) of the characterizing ten certification only where he adds to flavor, in letters not less than one-half or combines another flavor with a fla- the height of the letters used in the vor which has been certified by a flavor name of the food and the name of the supplier as containing no artificial fla- characterizing flavor shall be accom- vor, but otherwise such user may rely panied by the word(s) ‘‘artificial’’ or upon the supplier’s certification and ‘‘artificially flavored’’, in letters not need make no separate certification. less than one-half the height of the let- All such certifications shall be re- ters in the name of the characterizing tained by the certifying party through- flavor, e.g., ‘‘artificial vanilla’’, ‘‘arti- out the period in which the flavor is ficially flavored strawberry’’, or ‘‘grape supplied and for a minimum of three artificially flavored’’. years thereafter, and shall be subject (3) Wherever the name of the charac- to the following conditions: terizing flavor appears on the label (i) The certifying party shall make (other than in the statement of ingre- such certifications available upon re- dients) so conspicuously as to be easily quest at all reasonable hours to any seen under customary conditions of duly authorized office or employee of purchase, the words prescribed by this the Food and Drug Administration or paragraph shall immediately and con- any other employee acting on behalf of spicuously precede or follow such the Secretary of Health and Human name, without any intervening writ- Services. Such certifications are re- ten, printed, or graphic matter, except: garded by the Food and Drug Adminis- (i) Where the characterizing flavor tration as reports to the government and a trademark or brand are pre- and as guarantees or other under- sented together, other written, printed, takings within the meaning of section or graphic matter that is a part of or is 301(h) of the act and subject the certi- associated with the trademark or fying party to the penalties for making brand may intervene if the required any false report to the government words are in such relationship with the under 18 U.S.C. 1001 and any false guar- trademark or brand as to be clearly re- antee or undertaking under section lated to the characterizing flavor; and 303(a) of the act. The defenses provided (ii) If the finished product contains under section 303(c)(2) of the act shall more than one flavor subject to the re- be applicable to the certifications pro- quirements of this paragraph, the vided for in this section. statements required by this paragraph (ii) Wherever possible, the Food and need appear only once in each state- Drug Administration shall verify the ment of characterizing flavors present accuracy of a reasonable number of in such food, e.g., ‘‘artificially flavored certifications made pursuant to this vanilla and strawberry’’. section, constituting a representative (iii) If the finished product contains sample of such certifications, and shall three or more distinguishable charac- not request all such certifications. terizing flavors, or a blend of flavors (iii) Where no person authorized to with no primary recognizable flavor, provide such information is reasonably the flavor may be declared by an appro- available at the time of inspection, the

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certifying party shall arrange to have label declaration stating both the com- such person and the relevant materials mon or usual name of the ingredient(s) and records ready for verification as and a separate description of its func- soon as practicable: Provided, That, tion, e.g., ‘‘preservative’’, ‘‘to retard whenever the Food and Drug Adminis- spoilage’’, ‘‘a mold inhibitor’’, ‘‘to help tration has reason to believe that the protect flavor’’ or ‘‘to promote color supplier or user may utilize this period retention’’. to alter inventories or records, such ad- (k) The label of a food to which any ditional time shall not be permitted. coloring has been added shall declare Where such additional time is pro- the coloring in the statement of ingre- vided, the Food and Drug Administra- dients in the manner specified in para- tion may require the certifying party graphs (k)(1) and (k)(2) of this section, to certify that relevant inventories except that colorings added to , have not been materially disturbed and , and ice cream, if declared, may relevant records have not been altered be declared in the manner specified in or concealed during such period. paragraph (k)(3) of this section, and (iv) The certifying party shall pro- colorings added to foods subject to vide, to an officer or representative §§ 105.62 and 105.65 of this chapter shall duly designated by the Secretary, such be declared in accordance with the re- qualitative statement of the composi- quirements of those sections. tion of the flavor or product covered by (1) A color additive or the lake of a the certification as may be reasonably color additive subject to certification expected to enable the Secretary’s rep- under 721(c) of the act shall be declared resentatives to determine which rel- by the name of the color additive listed evant raw and finished materials and in the applicable regulation in part 74 flavor ingredient records are reason- or part 82 of this chapter, except that ably necessary to verify the certifi- it is not necessary to include the cations. The examination conducted by ‘‘FD&C’’ prefix or the term ‘‘No.’’ in the Secretary’s representative shall be the declaration, but the term ‘‘Lake’’ limited to inspection and review of in- shall be included in the declaration of ventories and ingredient records for the lake of the certified color additive those certifications which are to be (e.g., Blue 1 Lake). Manufacturers may verified. parenthetically declare an appropriate (v) Review of flavor ingredient alternative name of the certified color records shall be limited to the quali- additive following its common or usual tative formula and shall not include name as specified in part 74 or part 82 the quantitative formula. The person of this chapter. verifying the certifications may make (2) Color additives not subject to cer- only such notes as are necessary to en- tification and not otherwise required able him to verify such certification. by applicable regulations in part 73 of Only such notes or such flavor ingre- this chapter to be declared by their re- dient records as are necessary to verify spective common or usual names may such certification or to show a poten- be declared as ‘‘Artificial Color,’’ ‘‘Ar- tial or actual violation may be re- tificial Color Added,’’ or ‘‘Color Added’’ moved or transmitted from the certi- (or by an equally informative term fying party’s place of business: Pro- that makes clear that a color additive vided, That, where such removal or has been used in the food). Alter- transmittal is necessary for such pur- natively, such color additives may be poses the relevant records and notes declared as ‘‘Colored with shall be retained as separate docu- llllllll’’ or ‘‘llllllll ments in Food and Drug Administra- color,’’ the blank to be filled in with tion files, shall not be copied in other the name of the color additive listed in reports, and shall not be disclosed pub- the applicable regulation in part 73 of licly other than in a judicial pro- this chapter. ceeding brought pursuant to the act or (3) When a coloring has been added to 18 U.S.C. 1001. butter, cheese, or ice cream, it need (j) A food to which a chemical pre- not be declared in the ingredient list servative(s) is added shall, except when unless such declaration is required by a exempt pursuant to § 101.100 bear a regulation in part 73 or part 74 of this

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chapter to ensure safe conditions of use with the name of the particular fruit or for the color additive. Voluntary dec- vegetable. laration of all colorings added to but- (3) If the beverage contains 100 per- ter, cheese, and ice cream, however, is cent juice and also contains non-juice recommended. ingredients that do not result in a dim- inution of the juice soluble solids or, in [42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44 FR 37220, June 26, the case of expressed juice, in a change 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, in the volume, when the 100 percent Jan. 6, 1993; 63 FR 14818, Mar. 27, 1998; 74 FR juice declaration appears on a panel of 216, Jan. 5, 2009] the label that does not also bear the in- gredient statement, it must be accom- § 101.30 Percentage juice declaration panied by the phrase ‘‘with added for foods purporting to be bev- lll,’’ the blank filled in with a term erages that contain fruit or vege- such as ‘‘ingredient(s),’’ ‘‘preserva- table juice. tive,’’ or ‘‘sweetener,’’ as appropriate (a) This section applies to any food (e.g., ‘‘100% juice with added sweet- that purports to be a beverage that ener’’), except that when the presence contains any fruit or vegetable juice of the non-juice ingredient(s) is de- (i.e., the product’s advertising, label, or clared as a part of the statement of labeling bears the name of, or variation identity of the product, this phrase on the name of, or makes any other di- need not accompany the 100 percent rect or indirect representation with re- juice declaration. spect to, any fruit or vegetable juice), (c) If a beverage contains minor or the label or labeling bears any vi- amounts of juice for flavoring and is la- gnette (i.e., depiction of a fruit or vege- beled with a flavor description using table) or other pictorial representation terms such as ‘‘flavor’’, ‘‘flavored’’, or of any fruit or vegetable, or the prod- ‘‘flavoring’’ with a fruit or vegetable uct contains color and flavor that gives name and does not bear: the beverage the appearance and taste (1) The term ‘‘juice’’ on the label of containing a fruit or vegetable juice. other than in the ingredient statement; The beverage may be carbonated or or noncarbonated, concentrated, full- (2) An explicit vignette depicting the strength, diluted, or contain no juice. fruit or vegetable from which the fla- For example, a soft (soda) that vor derives, such as juice exuding from does not represent or suggest by its a fruit or vegetable; or physical characteristics, name, label- (3) Specific physical resemblance to a ing, ingredient statement, or adver- juice or distinctive juice characteristic tising that it contains fruit or vege- such as pulp then total percentage table juice does not purport to contain juice declaration is not required. juice and therefore does not require a (d) If the beverage does not meet the percent juice declaration. criteria for exemption from total juice (b)(1) If the beverage contains fruit or percentage declaration as described in vegetable juice, the percentage shall be paragraph (c) of this section and con- declared by the words ‘‘Contains l per- tains no fruit or vegetable juice, but cent (or %) lll juice’’ or ‘‘l percent the labeling or color and flavor of the (or %) juice,’’ or a similar phrase, with beverage represents, suggests, or im- the first blank filled in with the per- plies that fruit or vegetable juice may centage expressed as a whole number be present (e.g., the product adver- not greater than the actual percentage tising or labeling bears the name, a of the juice and the second blank (if variation of the name, or a pictorial used) filled in with the name of the representation of any fruit or vege- particular fruit or vegetable (e.g., table, or the product contains color ‘‘Contains 50 percent apple juice’’ or and flavor that give the beverage the ‘‘50 percent juice’’). appearance and taste of containing a (2) If the beverage contains less than fruit or vegetable juice), then the label 1 percent juice, the total percentage shall declare ‘‘contains zero (0) percent juice shall be declared as ‘‘less than 1 (or %) juice’’. Alternatively, the label percent juice’’ or ‘‘less than 1 percent may declare ‘‘Containing (or contains) lll juice’’ with the blank filled in no lll juice’’, or ‘‘no lll juice’’, or

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