All You Need to Know About Final FDA Gluten-Free Labeling Rule of August 14, 2014

In today’s world consumer demand is a driving force that provides opportunity for organizations to meet the demand through a well-defined marketing strategy. Along with the demand, however, comes responsibility to provide what the customer wants in a safe and controlled manner. Consumers are increasingly seeking products that are Gluten-Free due to general health considerations or more importantly due to intolerances such as Celiac Disease or other Gluten Disorders.

To provide consistency in product and protection for consumers, the Food and Drug Administration has established the FDA Gluten-Free Labeling Rule. This rule requires that all products, ingredients, or combinations / derivatives must comply with a 20-ppm (parts per million) or less guideline that also applies to accidental contamination of the product. Failure to comply with this requirement may result in a customer with sensitivity to Gluten, eating a product labeled as Gluten-Free and reporting the incident to the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System.

The FDA’s requirements provide these protections for the consumer but does not answer the producing organization question of how to achieve meeting the requirements

Source: Some content in the following was modified / developed from information found in   https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-gluten-free-food-labeling-final-rule

FDA Gluten-Free Requirements

  • General Requirements
    • Voluntary compliance with the FDA Gluten-Free Labeling Rule indicates compliance with “Gluten-Free” defined as: 
      • Inherently Gluten Free Food.
      • Food not containing Gluten such as wheat.
      • Any food that tests with Gluten < 20-ppm.
      • Any food derived from unprocessed grain containing Gluten or derived from grain containing Gluten that has been processed to remove gluten but still does not meet the < 20 ppm requirement IS NOT GLUTEN-FREE.
      • Also, any unavoidable presence of Gluten in the food MUST BE LESS than 20-ppm.
    • The FDA Gluten-Free Labeling Rule is for the benefit of consumers having Celiac or other Gluten Disorders and Manufacturers to ensure consistent application of Gluten-Free Claims.
    • Based on the definition of Gluten-Free, the FDA established labeling requirements to ensure safety of product for the consumer. Manufacturers are not required to label food products as Gluten-Free but lose the marketing value of that statement. Use of the Gluten-Free Label is voluntary. Those deciding to place the label on product indicating it is Gluten-Free however are required to meet the < 20-ppm requirement and have the product certified for safety.
    • The final FDA Gluten-Free Labeling Rule applies to all FDA-Regulated packaged foods or dietary supplements. Exclusions to the rule include but are not limited to:
      • Alcohol
      • Tobacco
      • USDA Regulated Products
      • Specific items with other regulation by the FDA such as eggs
  • Customer / Consumer Expectations
    • Accurate labeling of product to protect the consumer from adverse medical affects due to Gluten-Disorder or Celiac Disease.
    • Means of addressing and reporting non-compliance
      • Due to false labeling.
      • By restaurant distribution of product claimed to be Gluten-Free.
    • Ability to make self-determination of the health benefits of Gluten-Free Product based on consultation with their doctor or other health provider.
    • The Customer / Consumer cannot make the assumption that since some products by the manufacturer are labeled Gluten-Free that all product by that manufacturer meet that criteria.
  • Labeling Requirements
    • Federal Regulations “define” and “permit use of” the term “Gluten-Free” for labeling of foods but application is voluntary and the rule applies to product from any country.
    • Labels including the Gluten-Free Logo must be certified, truthful and not misleading. Implication that a product may be Gluten-Free is Not Allowed
    • Any statement indicating that product does not contain or is not made with Gluten-Containing Ingredients or is made in a facility that also processes food containing glutens must also be truthful.
    • The Gluten-Free Label can be applied to:
      • Food that by nature is Gluten-Free such as water.
      • Any grain or hybrid not categorized as containing Gluten if < 20-ppm and not impacted by cross-contact situations to be greater than 20-ppm. (Foods intentionally made with any amount of a grain containing Gluten cannot be labeled as Gluten-Free)
    • The term “Cross-Contact” refers to the unavoidable presence of Gluten due to contact with a Gluten-Containing Food. This may occur due to transportation or storage methods, shared production equipment, etc. This is not defined by the FDA but is allowed if it meets this definition and meets requirements for < 20-ppm.
  • Acceptable Gluten Levels
    • The FDA determined that methods for validating Gluten-Free content of product below 20-ppm was not reliable. In order to provide accurate enforcement of product results based on scientific methods and medical research determination that most people with Gluten-Disorders can tolerate amounts up to 20-ppm, they established < 20-ppm as the highest acceptable level of Gluten allowed even in cases where accidental or unintended contamination.
    • Any foods labeled as Gluten-Free by the manufacturer is tested to guarantee results certified by a third-party organization to contain Gluten Levels lower than the FDA Gluten-Free Labeling Rule criteria of < 20-ppm.

Where to go From Here? – Compliance

Utilize a consulting organization to develop your Gluten-Free Management System.

Since the FDA doesn’t specify requirements on how to achieve the product requirements, a qualified consultant can assist the manufacturer with compliance through experience and knowledge of:

  • How FDA audits / inspects / tests food manufacturers labeling and Gluten-Free Products for compliance with the requirements of the final rule
  • The relationship between the FDA, USDA, and TTB in determining compliance when applied to specific industry sectors
  • Availability of third-party Gluten-Free Certification Bodies.
    • Differing requirements based on selection
    • Additional benefits from those with more stringent requirements
    • Which Certification Body is the best suited application for your facility?
  • Level and frequency of testing that is needed to meet your organizations needs through selection of –
    • Which type of in-house Gluten Testing needed for your ingredients or finished products,
    • Need for utilization of a third-party laboratory for in-house Gluten Testing,
    • Necessary Certificates of Analysis from suppliers for Gluten content of ingredients.

Quality System Enhancement provides experienced assistance in implementation of your organization’s FDA Gluten-Free Labeling Rule by determining which certification is best suited for your organization and implementing a robust system that will meet all your organizations structural and testing needs and assisting in development of an extensive Quality Control & Testing Plan.

QSE offers training for top management and all levels of your organization to fully comprehend the FDA Gluten-Free Labeling Rule and testing or system requirements of your chosen certification body.

QSE can simplify your process by performing a brutal, thorough, and effective pre-certification audit / test of the effectiveness of your Quality Control & Testing Plan’s ability to consistently producing Gluten-Free product.

QSE can also be available to corrective actions; final preparation before the audit; and clarification during the certification audit.

QSE Difference: Quality Systems Enhancement Inc is a premium AuditingConsulting and Training firm involved in coaching, assisting and auditing, facilities to be certified to regulatory and international standards.  QSE will make sure that all changes to regulatory requirements are communicated to manufacturers during consultation and that documentation & testing change requirements are fully met. Over 25 years the firm has been engaged in this business and has helped over 900 facilities in achieving their certification goals. QSE has a disciplined 10 Step path towards certification which is insensitive to failure. QSE has helped organizations to get certified not only to Gluten Free Product Certification but also to several other International Standards such as ISO 9001, ISO 14001ISO 45001 and sector specific standards such as, IATF 16949:2016, AS 9100 D, TL 9000, FSSC 22000:2019, SQF Edition 8.1, BRC-8, IFS Food Safety and many more.

In today’s world consumer demand is a driving force that provides opportunity for organizations to meet the demand through a well-defined marketing strategy. Along with the demand, however, comes responsibility to provide what the customer wants in a safe and controlled manner. Consumers are increasingly seeking products that are Gluten-Free due to general health considerations or more importantly due to intolerances such as Celiac Disease or other Gluten Disorders.

To provide consistency in product and protection for consumers, the Food and Drug Administration has established the FDA Gluten-Free Labeling Rule. This rule requires that all products, ingredients, or combinations / derivatives must comply with a 20-ppm (parts per million) or less guideline that also applies to accidental contamination of the product. Failure to comply with this requirement may result in a customer with sensitivity to Gluten, eating a product labeled as Gluten-Free and reporting the incident to the FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System.

The FDA’s requirements provide these protections for the consumer but does not answer the producing organization question of how to achieve meeting the requirements

Source: Some content in the following was modified / developed from information found in   https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-gluten-free-food-labeling-final-rule

FDA Gluten-Free Requirements

  • General Requirements
    • Voluntary compliance with the FDA Gluten-Free Labeling Rule indicates compliance with “Gluten-Free” defined as: 
      • Inherently Gluten Free Food.
      • Food not containing Gluten such as wheat.
      • Any food that tests with Gluten < 20-ppm.
      • Any food derived from unprocessed grain containing Gluten or derived from grain containing Gluten that has been processed to remove gluten but still does not meet the < 20 ppm requirement IS NOT GLUTEN-FREE.
      • Also, any unavoidable presence of Gluten in the food MUST BE LESS than 20-ppm.
    • The FDA Gluten-Free Labeling Rule is for the benefit of consumers having Celiac or other Gluten Disorders and Manufacturers to ensure consistent application of Gluten-Free Claims.
    • Based on the definition of Gluten-Free, the FDA established labeling requirements to ensure safety of product for the consumer. Manufacturers are not required to label food products as Gluten-Free but lose the marketing value of that statement. Use of the Gluten-Free Label is voluntary. Those deciding to place the label on product indicating it is Gluten-Free however are required to meet the < 20-ppm requirement and have the product certified for safety.
    • The final FDA Gluten-Free Labeling Rule applies to all FDA-Regulated packaged foods or dietary supplements. Exclusions to the rule include but are not limited to:
      • Alcohol
      • Tobacco
      • USDA Regulated Products
      • Specific items with other regulation by the FDA such as eggs
  • Customer / Consumer Expectations
    • Accurate labeling of product to protect the consumer from adverse medical affects due to Gluten-Disorder or Celiac Disease.
    • Means of addressing and reporting non-compliance
      • Due to false labeling.
      • By restaurant distribution of product claimed to be Gluten-Free.
    • Ability to make self-determination of the health benefits of Gluten-Free Product based on consultation with their doctor or other health provider.
    • The Customer / Consumer cannot make the assumption that since some products by the manufacturer are labeled Gluten-Free that all product by that manufacturer meet that criteria.
  • Labeling Requirements
    • Federal Regulations “define” and “permit use of” the term “Gluten-Free” for labeling of foods but application is voluntary and the rule applies to product from any country.
    • Labels including the Gluten-Free Logo must be certified, truthful and not misleading. Implication that a product may be Gluten-Free is Not Allowed
    • Any statement indicating that product does not contain or is not made with Gluten-Containing Ingredients or is made in a facility that also processes food containing glutens must also be truthful.
    • The Gluten-Free Label can be applied to:
      • Food that by nature is Gluten-Free such as water.
      • Any grain or hybrid not categorized as containing Gluten if < 20-ppm and not impacted by cross-contact situations to be greater than 20-ppm. (Foods intentionally made with any amount of a grain containing Gluten cannot be labeled as Gluten-Free)
    • The term “Cross-Contact” refers to the unavoidable presence of Gluten due to contact with a Gluten-Containing Food. This may occur due to transportation or storage methods, shared production equipment, etc. This is not defined by the FDA but is allowed if it meets this definition and meets requirements for < 20-ppm.
  • Acceptable Gluten Levels
    • The FDA determined that methods for validating Gluten-Free content of product below 20-ppm was not reliable. In order to provide accurate enforcement of product results based on scientific methods and medical research determination that most people with Gluten-Disorders can tolerate amounts up to 20-ppm, they established < 20-ppm as the highest acceptable level of Gluten allowed even in cases where accidental or unintended contamination.
    • Any foods labeled as Gluten-Free by the manufacturer is tested to guarantee results certified by a third-party organization to contain Gluten Levels lower than the FDA Gluten-Free Labeling Rule criteria of < 20-ppm.

Where to go From Here? – Compliance

Utilize a consulting organization to develop your Gluten-Free Management System.

Since the FDA doesn’t specify requirements on how to achieve the product requirements, a qualified consultant can assist the manufacturer with compliance through experience and knowledge of:

  • How FDA audits / inspects / tests food manufacturers labeling and Gluten-Free Products for compliance with the requirements of the final rule
  • The relationship between the FDA, USDA, and TTB in determining compliance when applied to specific industry sectors
  • Availability of third-party Gluten-Free Certification Bodies.
    • Differing requirements based on selection
    • Additional benefits from those with more stringent requirements
    • Which Certification Body is the best suited application for your facility?
  • Level and frequency of testing that is needed to meet your organizations needs through selection of –
    • Which type of in-house Gluten Testing needed for your ingredients or finished products,
    • Need for utilization of a third-party laboratory for in-house Gluten Testing,
    • Necessary Certificates of Analysis from suppliers for Gluten content of ingredients.

Quality System Enhancement provides experienced assistance in implementation of your organization’s FDA Gluten-Free Labeling Rule by determining which certification is best suited for your organization and implementing a robust system that will meet all your organizations structural and testing needs and assisting in development of an extensive Quality Control & Testing Plan.

QSE offers training for top management and all levels of your organization to fully comprehend the FDA Gluten-Free Labeling Rule and testing or system requirements of your chosen certification body.

QSE can simplify your process by performing a brutal, thorough, and effective pre-certification audit / test of the effectiveness of your Quality Control & Testing Plan’s ability to consistently producing Gluten-Free product.

QSE can also be available to corrective actions; final preparation before the audit; and clarification during the certification audit.

QSE Difference: Quality Systems Enhancement Inc is a premium AuditingConsulting and Training firm involved in coaching, assisting and auditing, facilities to be certified to regulatory and international standards.  QSE will make sure that all changes to regulatory requirements are communicated to manufacturers during consultation and that documentation & testing change requirements are fully met. Over 25 years the firm has been engaged in this business and has helped over 900 facilities in achieving their certification goals. QSE has a disciplined 10 Step path towards certification which is insensitive to failure. QSE has helped organizations to get certified not only to Gluten Free Product Certification but also to several other International Standards such as ISO 9001, ISO 14001ISO 45001 and sector specific standards such as, IATF 16949:2016, AS 9100 D, TL 9000, FSSC 22000:2019, SQF Edition 8.1, BRC-8, IFS Food Safety and many more.

To help prepare for Gluten-Free Product Certification to the FDA Gluten-Free Labeling Rule and / or additional supporting Certification Body Requirements, please visit our website www.enhancequality.com or contact for immediate assistance by Phone 770-518-9967 or email: info@qsebackup.atlcreative.co

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