Food Labeling & Nutrition

Guidance for Industry

Guidance documents contain nonbinding recommendations.

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 General

• A Food Labeling Guide (April 2008)
• Retail Labeling: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods (April 2008)
• Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance Guide (August 20, 2003)
• Guidelines for Determining Metric Equivalents of Household Measures (October 1, 1993)
• Food Allergens: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) (October 2006)
• Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers (June 10, 1996)

 Nutrition Labeling

• Small Business Nutrition Labeling Exemption (October 1, 2004; Updated May 7, 2007)
• FDA Nutrition Labeling Manual -- A Guide for Developing and Using Data Bases (March 1998)

 Label Claims

• Dear Manufacturer Letter Regarding Front-of-Package Symbols (December 2008)
• Dear Manufacturer Letter Regarding Food Labeling (January 2007)
• Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (July 1998)
• Structure/Function Claims: Small Entity Compliance Guide (January 9, 2002)
• Nutrient Content Claims: Dear Manufacturer Letter Regarding Sugar Free Claims (September 2007)
• Nutrient Content Definitions: Food Labeling; Nutrient Content Claims; Definition for "High Potency" and Definition for "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods Small Entity Compliance Guide (July 2008)

 Health Claims

• Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 10, 2003)
• FDA's Implementation of "Qualified Health Claims": Questions and Answers (May 12, 2006)
• Evidence-Based Review System for the Scientific Evaluation of Health Claims (January 2009)
• Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)
• Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (May 2009)

 Specific Products

• Beer: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance (August 2009)
• Juice: Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5-Log Pathogen Reduction (October 7, 2002)
• Milk: Interim Guidance on the Voluntary Labeling of Milk and Milk Products that have not been treated with Recombinant Bovine Somatropin (59 FR 6279, February 10, 1994)
• Shell Eggs: Food Labeling - Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution Small Entity Compliance Guide (July 2001)
• Soy Lecithin: Guidance on the Labeling of Certain Uses of Lecithin Derived from Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act (April 2006)
• White Chocolate: Standard of Identity for White Chocolate; Small Entity Compliance Guide (July 17, 2008)
• Whole Grain: Draft Guidance: Whole Grain Label Statements (February 2006)
• Biotechnology: Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (January 2001)
• Irradiation: Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Pub. L. No. 107-171, § 10809 (2002) regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated by Irradiation.
• Label Warning Statements: Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance Guide (October 17, 2003)
• Refrigeration: Guidance on Labeling of Foods that Need Refrigeration by Consumers (62 FR 8248, February 24, 1997)
• Serving Size: Food Labeling - Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance Guide (July 2001)