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FDA Issues Final Rule to Define Gluten-Free Labeling

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SGS informs you on FDA final rule on gluten-free food labeling.
SGS informs you on FDA final rule on gluten-free food labeling.
2013-09-06 11:32:30 - On 2 August 2013, the U.S. Food and Drug Administration (FDA) issued a final rule defining “gluten-free” for food labeling. It will help consumers, especially those living with celiac disease, to rely on items labeled “gluten-free” to meet a defined standard for gluten content. The regulation was published in the Federal Register (1).

Labeling Gluten-Free Food

The FDA published a new regulation defining the term "gluten-free" for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten-free diet (2).

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth

retardation, infertility, miscarriages, short stature, and intestinal cancers.

Standards for Gluten-Free Food Claims

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. The final rules define the term “gluten-free” to mean that the food bearing the claim does not contain:

1 - an ingredient that is a gluten-containing grain (e.g., spelt wheat);

2 - an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour);

3 - or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch),

if the use of that ingredient results in the presence of 20 parts per million (ppm, equivalent to mg/kg) or more gluten in the food (1). This is identical to the European Union Regulation (EC) No 41/2009 which states that products may bear the term ‘gluten-free’ if the gluten content does not exceed 20 mg/kg in the food as sold to the final consumer (3).

Harmonize Definitions

The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free” otherwise they will be considered misbranded. FDA issued the final rule under the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have to bring their labels into compliance with the new requirements by 5 August 2014.


(1) Food Labeling, Gluten-Free Labeling of Foods, US Federal Register ( ..)
(2) FDA defines “gluten-free” for food labeling, US Food and Drug Administration (August 2, 2013) (
(3) Commission Regulation (EC) No 41/2009 ( ..)

About SGS Food Safety Services

SGS is committed to keeping you informed of regulatory news and developments. Leveraging a global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical testing, audits, certifications, inspections, technical support and food label reviews ( ..). SGS continually invests in world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality.

For further information please do not hesitate to contact the SGS experts.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75 000 employees, SGS operates a network of over 1 500 offices and laboratories around the world.

Press Information:
SGS Consumer Testing Services

SGS Germany

Contact Person:
Ron Wacker, PhD
Global Food Testing Business Development Manager
Phone: +49 6039 4696
email: email


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