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FDA Issues Guidance for Industry on Food Labeling

The Food and Drug Administration has issued an April 2008 guidance for industry, which summarizes the required statements that must appear on food labels under federal laws governing food products under FDA's jurisdiction and their regulations.

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(The FDA states that this guidance supersedes the previous version issued in September 1994.)

Guidance Offers Compliance Information on Various Food Labeling Topics

The Nutrition Labeling and Education Act (NLEA), which amended the Federal Food, Drug, and Cosmetic Act, requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements. To help minimize legal action and delays, FDA recommends that manufacturers and importers become fully informed about the applicable laws and regulations before offering foods for distribution in the U.S.

The most frequently raised questions on labeling requirements have been addressed in FDA's guidance using a "question and answer" format and are grouped by the food labeling area of interest, including the following topics (partial list):

  • General Food Labeling Requirements
  • Name of Food
  • Juices
  • Net Quantity of Contents Statements
  • Ingredient Lists
  • Colors
  • Food Allergen Labeling
  • Nutrition Labeling
  • Nutrient Declaration
  • Products with Separately Packaged Ingredients/Assortments of Foods
  • Trans Fat Labeling
  • Serving Size
  • Exemptions/Special Labeling Provisions
  • Health Claims
  • Qualified Health Claims

(The FDA notes that this guidance represents its current approach to food labeling, and does not create or confer any rights for or on any person and does not operate to bind FDA or the public. The trade may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.)

FDA contact information -Office of Nutritional Products, Labeling, and Dietary Supplements(301) 436-2371

Guidance for Industry: A Food Labeling Guide (dated April 2008) available at http://www.cfsan.fda.gov/dms/2lg-toc.htmlftn1