FAQs Regarding Gluten-Free (GF) Labeling
Links to FDA Info
ACDA Press Release
FDA Safety Assessment Analysis

FAQs Regarding Gluten-Free (GF)
Labeling of Foods

How is FDA proposing to define the term GF for labeling of foods?
FDA proposed to define the term GF for voluntary use in the labeling of foods to mean that the food does not contain any of the following:

• an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid of these grains;
• an ingredient derived from these grains and that has not been processed to remove gluten;
• an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
• 20 ppm or more gluten.

What is the GF standard in other countries?
The 27 countries of the European Union (EU) adopted the Codex Alimentarius standard of <20ppm in 2009.  That standard will go into effect in January 1, 2012.  The Codex and EU allow a product to be labeled ‘low-gluten’ if it contains > 20ppm up to 100ppm.  Australia and New Zealand require food that claims to be free from gluten to have no detectable gluten present and foods that claim to have a low-gluten content to have less than 20 mg of gluten per 100 g of food (200ppm).

Should the < 20 ppm become the GF standard, and tests become available to detect gluten at lower levels, will FDA consider revising the definition of GF?
The FDA has stated it “remains open to the feasibility and desirability of revising” the standard:

• as more sensitive methods to detect gluten become available or
• if FDA determines in the future that further research on CD indicates that the adoption of a lower gluten threshold level for GF-labeled foods is warranted to be adequately protective of Americans with CD.”

In 2007, the ACDA commented to the FDA that, “we strongly encourage the agency to regularly review the scientific research supporting this standard and revise it as appropriate to ensure the safety of celiac consumers.” This point will be reiterated in our comments to FDA this year, too.

Why doesn’t ‘Gluten-Free’ mean NO gluten?
Today, there is no method of testing that can measure a level of zero gluten.  Additionally, having a zero gluten standard would significantly reduce the number and availability of products for celiacs.  It would also increase the cost of making GF products, and could affect an individual’s ability to comply with the GF diet and is not necessary.

A precedence for “free” indicating less than 100% has been established in the FDA with fat-free and sugar-free (meaning less than 0.5 grams) and cholesterol free meaning less than 2 milligrams (mg) cholesterol and 2 grams or less of saturated fat

When finalized, will this standard also be applied to products like packaged meats?
The FALCPA law only applies to food products regulated by the FDA.  According to the USDA:  “FSIS is not planning at this time to conduct rulemaking to define “gluten free.” Rather, once FDA’s final rule becomes effective, if a meat, poultry, or egg product establishment chooses to make the claim “gluten free” they will need to follow the requirements for the use of the claim in FDA’s regulations. This is similar to what FSIS has required when establishments choose to make health claims and label trans-fat on meat, poultry, and egg products (i.e., FSIS allows the use of FDA regulated health claims and the declaration of trans-fat on labels provided the establishments follows FDA’s regulations). This would ensure consistency for the use of the claim “gluten free” across all food groups for consumers. FSIS will clarify this position through policy guidance published on its web-site.”

Why are we supporting the 20 ppm threshold? 
The <20ppm standard has been adopted for use in international trade (Codex Alimentarius) and throughout the European Union.  Research conducted by Dr. Carlo Catassi with colleagues from the University of Maryland Center for Celiac Research has indicated that a 20ppm standard is safe for most individuals with celiac disease.

When will the new standard go into effect?
FDA Deputy Commissioner Michael Taylor has stated that the agency is targeting 3rd quarter of 2012 (July-September) to issue the final GF labeling standard.  It is unclear at this time, when the rule will actually become effective.  There will be a waiting period, of sorts, for industry to come into compliance.

You may recall, that FALCPA became law in August 2004, but the allergen labeling requirements did not go into effect until January 1, 2006.

How will we know if a company is actually complying with the new standard?
Once the regulation goes into effect, companies seeking to label their products GF will need to comply with the requirements prescribed by the FDA. This may include specific details about when products are to be tested, placement of the GF claim on packaging, etc. 

If a product labeled GF is found to exceed the standard, FDA has a number of enforcement tools it can use to protect celiac consumers. These include: issuing warning letters, civil and/or criminal penalties, seizure of products, or even recalling mislabeled products.

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Links to FDA Info

• FDA’s Questions and Answers on the gluten free labeling proposal
• Federal Register Notice August 3, 2011
• FDA Press Release

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ACDA Press Release