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Labelling Requirements

4.1 Labelling Requirements

Without proper labelling, your product would not be allowed to enter the US. Some important details to include on your label include:

  • Name of food/product;
  • Country of origin for the product;
  • Ingredients;
  • Nutritional information;
  • English language labelling;
  • Food allergens; and
  • Any chemicals/food additives used.

The US food and beverage industry is regulated by the US Food and Drug Administration (FDA). "The FDA is responsible for assuring that foods sold in the United States are safe, nutritional and properly labeled. This applies to foods produced domestically, as well as foods from foreign countries. The Federal Food, Drug, and Cosmetic Act (FDC Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA's jurisdiction (US Department of Health Human Services ,2011)."

FDA indicates that food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary. Under FDA's laws and regulations, FDA does not pre-approve labels for food products but questions concerning the labeling of food products may be directed to the Food Labeling and Standards Staff (HFS-820), Office of Nutrition, 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.

According to the US Department of Health and Human Services, the following food labeling requirements generally apply:

(i) All required label statements are to be placed on the front label panel or the principal display panel (PDP) of the package or container.

(ii) Food labels must list:

  • Name and address of the manufacturer, packer or distributor. Unless the name given is the actual manufacturer, it must be accompanied by a qualifying phrase which states the firm's relation to the product (e.g., "manufactured for" or "distributed by");
  • Street address if the firm name and address are not listed in a current city directory or telephone book;
  • City or town;
  • State (or country, if outside the United States); and
  • ZIP code (or postal code used in countries other than the United States).

(iii) The name of the food must appear on the front label, or PDP as well as any alternate PDP.

(iv) A statement of identity which is the name of the product established by law or regulation should be placed on the PDP in lines generally parallel to the basis of the package. Where there is no statement of identity, the actual name of the food, if there is one, should be used.

(v)  If a foreign language is used anywhere on the label, all required label statements must appear both in English and in the foreign language.

(vi) Beverages that purport to contain juice "concentrated juice and (fruit or vegetable juice) must declare the percentage of real 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.

(vii) 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 vig- nettes on the label or physical resemblance of the beverage to juice such as pulp.

(viii) 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").

(ix) 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 a water" or "water and concentrated juice," as appropriate.

(x) Where the product is a mixed fruit or vegetable juice, 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.

(xi) Food labels printed must show the net contents in both metric (grams, kilograms, milliliters, liters) and U.S. Customary System (ounces, pounds, fluid ounces) terms.

(xii) Listing ingredients in descending order of predominance by weight means that the ingredient that weighs the most is listed first and the ingredient that weighs the least is listed last.

(xiii) When an approved chemical preservative is added to a food, the ingredient list must include both the common or usual name of the preservative and the function of the preservative by including terms such as "preservative," "to retard spoilage," "a mold inhibitor," "to help protect flavor," or "to promote color retention."

(xiv) Spices, natural flavors or artificial flavors may be declared in ingredient lists by using either specific common or usual names or by using the declarations "spices," "flavor" or "natural flavor," or "artificial flavor."

(xv) A "major food allergen" is an ingredient that is one of the following eight  foods or food groups or an ingredient that contains protein derived from one of them: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soy beans. All packaged foods regulated by FDA under the FD&C Act that are labeled on or after 1 January 2006 must comply with food allergen labeling requirements.

(xvi) The Nutrition Facts label is required on most food packages. In addition to the nutrients shown on the label in section 7 L2 manufacturers may add calories from saturated fat, polyunsaturated fat, monounsaturated fat, potassium, soluble and insoluble fiber, sugar alcohol, other carbohydrate, vitamins and minerals for which Reference Daily Intake (RDI's) have been established.

Several US agencies have specific labeling rules which, if not complied with, may result in goods not going beyond US Customs. The major agencies with special labeling rules include:

  • The Federal Trade Commission (FTC): www.ftc.gov  provides information about US legislation on food labeling requirements. One such piece of legislation is the Fair  Packaging  and Labeling  Act.  Information on this Act can be found at: http://www.ftc.gov/os/statutes/fplaju mp.shtm.
  • The US Food and Drug Administration (FDA) regulates food labeling in the US. The FDA's website provides substantial information on food  labeling:http://www.fda.gov/.
  • The Food Safety and Inspection Service (FSIS) within the US Department of Agriculture (USDA) has responsibility for ensuring that the commercial food supply in the US is safe. This safety extends not just to the quality of the product, but also to the labeling and packaging of foodstuff. The FSIS has a web page dedicated to labeling:http://www.fsis.usda.gov/Regulations_&_Policies/Labeling_Policies/index.asp#Basics

Exemptions

Nutrition Facts label is required on most food packages and the mandatory type specifications are listed in 21 CFR 101.9(d). The following are the listed categories of exemptions and regulations sections for the special provisions for nutrition labeling

Exemption

Regulation

Manufactured by small businesses

21 CFR 101.9(j)(1) and 101.9(j)(18)8

Food served in restaurants, etc. or delivered to homes ready for immediate consumption

21 CFR 101.9(j)(2)9

Delicatessen-type food, bakery products and confections

that  are  sold  directly  to  consumers  from the  location where prepared

21 CFR 101.9(j)(3)10

Foods that provide no significant nutrition such as instant

coffee (plain, unsweetened) and most spices

21 CFR 101.9(j)(4)11

Infant formula, and infant and junior foods for children up

to  4  years  of  age  (modified  label  provisions  for  these categories)

21 CFR 101.9(j)(5) and 101.9(j)(7)12

 

Exemption

Regulation

Manufactured by small businesses

21 CFR 101.9(j)(1) and 101.9(j)(18)8

Food served in restaurants, etc. or delivered to homes ready for immediate consumption

21 CFR 101.9(j)(2)9

Delicatessen-type food, bakery products and confections that are sold directly to consumers from the location where prepared

21 CFR 101.9(j)(3)10

Foods that provide no significant nutrition such as instantcoffee (plain, unsweetened) and most spices

21 CFR 101.9(j)(4)11

Infant formula, and infant and junior foods for children upto 4 years of age (modified label provisions for these categories)

21 CFR 101.9(j)(5) and 101.9(j)(7)12

Dietary supplements (must comply with  21 CFR 101.3613)

21 CFR 101.9(j)(6)14

Medical foods

21 CFR 101.9(j)(8)15

Bulk foods shipped for further processing  or packaging before retail sale

21 CFR 101.9(j)(9)16

Fresh produce and seafood (a voluntary nutrition labelingprogram covers these foods through the use of the appropriate means such as shelf labels, signs, and posters)

21 CFR 101.9(j)(10)17 and  101.4518

Packaged  single-ingredient fish or game meat may be labeled on basis of 3-ounce cooked portion (as prepared). Custom-processed fish and game are exempt from nutrition labeling.

21 CFR 101.9(j)(11)19

Certain egg cartons (nutrition information inside lid or oninsert in carton)

21 CFR 101.9(j)(14)20

Packages labeled "This unit not labeled for retail sale" within multiunit package, and outer wrapper bears all required label statements

21 CFR 101.9(j)(15)21

Self-service bulk foods--nutrition labeling by placard, or on original container displayed clearly in view

21         CFR          101.9(a)(2)          and

101.9(j)(16)22

Donated food that  is  given free (not sold) to the consumer.

Exporters are not required to put Nutrition Facts labels on donated food unless the donated food is later  placed  on  sale  (the  law applies only to food that is "offered for sale") -- 21 CFR 101.9(a)23

Game meats may provide required nutrition information or labeling in accordance with  21 CFR 101.9(a)(2)24.

21 CFR 101.9(j)(12)25

The FDA has many resources, guides and manuals to assist specialty food manufacturers. The following is a list of a few useful website links to provide more detailed information to assist with the export process:

Guidance for Industry

  • Food Labeling & Nutrition
  • A Food Labeling Guide
  • Food Ingredients and Packaging
  • Food Processing & HACCP
  • Food Safety
  • Small Entity Compliance Guides
  • Import and Export

Other Useful Resources