Food and Nutrition Labeling Policy and Regulations

Updated June 8, 2016

Food and nutrition labeling requirements impact food formulation and marketing of foods.  This web-based content is intended to help food scientists, regulatory, marketing, and other stakeholders stay up-to-date on labeling requirements.  It provides links to the labeling regulations of the United States and several other countries, and standards and resources from non-government organizations.

Food labels are designed to provide consumers with information to help make informed food choices.  In the United States, food laws such as the Federal Food, Drug and Cosmetic Act (FD&C Act), Food Quality Protection Act, Food Allergens labeling, and Consumer Protection Act impose different labeling requirements on foods and beverages.  These laws were passed to prevent consumer deception, ensure fair trade practices, ensure food safety, improve public health, inform about possible health risks (allergen labeling) etc.  Under provisions of the U.S. law, importers of food products intending to market in the U.S. are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. Similarly, food products exported from the U.S. should meet the packaging, labeling, and other special conditions required by the country.

In the U.S., food label is primarily regulated by the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), depending on the type of foods and beverages.  By law, several elements (listed below) are mandated on the food label, which impact the development of foods and food reformulation/formulation.

  • Statement of Identity
  • Net Contents
  • Nutrition Facts Panel
  • Ingredient Statement
  • Statement/Warning on Allergen
  • Country of Origin
  • Name and Place of Business

Food Label Regulations in the U.S.

Recent developments:

  • On May 27, 2016, the FDA announced the final rules on Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occassion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs Serving Size for Breath Mints; and Technical Amendments. The changes in the new Nutrition Facts label include:
    • Sugars added to foods will be required on the label in grams and as percent Daily Value (%DV). Added sugars will be declared as “Includes ‘X’ g Added Sugars” directly under total sugars.
    • Sugars will now be declared as total sugars.  
    • The %DV and the actual quantities of vitamin D and potassium will be required.
    • The actual quantities of calcium and iron will be required, in addition to the %DV.
    • The Daily Reference Values for sodium will be reduced to 2,300 mg/d from 2,400 mg/d.
    • Vitamin A and C are not required on the label, but can be included on a voluntary basis.  However, if a specific claim is made with regards to either nutrient, then it would need to be listed on the label.
    • The information on calories from fat will no longer be required.
    • For sodium, dietary fiber, and vitamin D, updated daily values will be required on the label.
    • The new rules will require listing the serving size that more closely reflect the amounts of food that people currently eat.
    • Food packages with multiple serving which could be consumed in one or multiple sittings will require both “per serving” and “per package” calorie and nutrient information. 
    • Food packages that contain between one and two servings, the calories and other nutrients will be required to be labeled as one serving because it is typically consumed in one sitting.
    • Larger type size for “Calories,” “Servings per container,” and the “Serving size” to make them more prominent.
    • Bolding the “number of calories” and the “Serving size.”
    • An abbreviated footnote to better explain the %DV - “The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”
    • The footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets will not be required.

    The final rules become effective on July 26, 2016.  The compliance date is July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales.

  • In December, 2014, the FDA issued final ruling on: 1) “Food labeling; nutrition labeling of standard menu items in restaurants and similar retail food establishments,” 2)  “Food labeling; calorie labeling of articles of food in vending machines.”
    • Menu and Vending Machines Labeling Requirements – provides information on the requirements for menu and vending machine labeling, addresses frequently asked questions, and provides educational resources for the consumers. 
    • FDA has extended the compliance date to December 1, 2016 for menu labeling.

Other food label regulations in the U.S.:

  • The Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act) gives FDA the authority to regulate food, inspect food plants, develop process to evaluate new ingredients, and prevent misbranding of food. Amendments to the FD&C Act related to food labeling include:
  • Label claims for conventional foods and dietary supplements – provides information on three categories (listed below) of claims permitted on food and dietary supplement labels. 
    • Health claims: describes relationship between a food substance (food, food component or dietary supplement ingredient) and reduced risk of a disease or health related condition. There are 3 categories of health claim:
      • Nutrition Labeling and Education Act of 1990 (NLEA) authorized health claim: permits the use of claims on labels that characterize a relationship between a food, food component or dietary supplement ingredient and risk of a disease. 
      • Health claims based on authoritative statements: the FDAMA authorizes use of health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research.
      • Qualified health claims:provides a mechanism to request FDA to review the scientific evidence when there is emerging evidence for a relationship between a food substance and reduced risk of a disease or health-related condition, but the evidence is not well enough established to meet the significant scientific agreement standard required for FDA to issue an authorized health claim regulation.
    • Nutrient content claims: the NLEA permits the use of claims that characterize the level of a nutrient such as free, high, and low, or compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite in a food. Nutrient claims have to be authorized by the FDA. 
    • Structure/function claim: may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, but cannot relate to the treatment or mitigation of a disease. Structure/function claims may appear on conventional foods and dietary supplements. Structure/function claims are not pre-approved by the FDA.
  • The Food Labeling regulation in the Code of Federal Regulations Title 21 (Chapter 1, subchapter B, Part 101) provides information on:
  • Labeling & Nutrition Guidance Documents & Regulatory Information – provides regulatory information and guidance documents for general, nutrition, and allergen labeling, and label claims.
  • The Federal Meat Inspection Act , Poultry Products Inspection Act, and Egg Products Inspection Act - prevents false labeling or misbranding of meat, poultry, and processed egg products.
  • The Organic Foods Production Act promulgated in 1990, effective in 2000 is regulated by the USDA. 
    • The National Organic Program (NOP) – develops the regulations for the production, handling, labeling, trade, and compliance criteria for producing organic animals, plants, and foods therefrom, which are under USDA and FDA jurisdiction, and oversees the enforcement of NOP requirements administered by third-party accredited organic certifying entities.
      • Four categories of labeling claims are allowed:
        • 100% organic
        • Organic
        • Made with organic
        • X% organic ingredients
  • The Federal Trade Commission Act (FTC Act) − prohibits "unfair or deceptive acts or practices." In the case of food products, the FTC Act prohibit "any false advertisement" that is "misleading in a material respect.” Since 1954, the FTC and the FDA have operated under a Memorandum of Understanding, under which the FTC has assumed primary responsibility for regulating food advertising, while FDA has taken primary responsibility for regulating food labeling.
  • Importing Food Products into the U.S.:
    • Under the FD&C Act, importers of food products into U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements. Imported food products are subject to FDA inspection. Both imported and domestically-produced foods must meet the same legal requirements in the U.S.
    • The FSIS is responsible for assuring that meat, poultry and egg products imported into the U.S. are safe, wholesome, unadulterated, and properly labeled and packaged.
  • Exporting Food Products from the U.S.: Food products exported from the U.S. should meet the packaging, labeling and other special conditions required by the country. Information related to food exports is available on the FDA  and USDA website.

Food Label Regulations in Other Countries

Australia and New Zealand

  • Food Labelling − provides guidance documents on labelling requirements. August, 2013.

Canada

China

European Union

India

Japan

  • The Consumer Affairs Agency established in 2009 is responsible for developing and introducing legislation regarding food labeling standards.

Malaysia

Mexico

Philippines

Singapore

Food Labeling Standards and Resources from Non-government organizations

Codex Alimentarius

Food and Agriculture Organization of the United Nations

  • Food labeling − provides information developed by governments and non-government international agencies on food labeling.
  • Innovations in food labeling – this book illustrates the multiple purposes food labelling serves and the many steps needed to implement a successful labeling policy. FAO. 2010.