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Update on the FDA’s Gluten-Free Labeling Regulations (2011)

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The Food and Drug Administration has taken a very long time to decide how gluten-free products should be labeled. Many people with celiac disease are extremely frustrated at the slow pace with which the FDA seems to be moving. However, it was not long ago that there were no laws in place whatsoever to make sure food with problematic ingredients in it was labeled appropriately. The “Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)” changed that.

The FDA has had the authority to regulate foods and drugs since 1938. The original legislation has been modified many times since then, to keep up with the need to safeguard consumers in regards to both food and drugs.  In 2004, FALCPA was passed, which required the labeling of products containing one of the eight common foods most likely to cause allergic reactions as well as protein derived from these foods. This includes wheat, peanuts, soybeans, cow’s milk, eggs, fish, crustacean shellfish (such as shrimp and crabs), and tree nuts.

The labeling was meant to make the presence of these items in foods very clear. The Act states in part:

“… the word `Contains’, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients… the common or usual name of the major food allergen in the list of ingredients required …is followed in parentheses by the name of the food source from which the major food allergen is derived…”

This means that products containing wheat should be clearly labeled. Realizing that gluten also needs to be on labels, FALCPA states, “Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods.”

This means that regulations about gluten labeling should have been in place no later than 2008. The FDA did propose guidelines and set aside a time period for comments on them. This process was to have finished in 2008. However, no regulations have been finalized, and the FDA just reopened the subject for comments.

Here is the statement by the FDA, reviewing its proposed regulations and announcing the time for hearing comments, issued on 8/2/2011.

“In 2007, FDA proposed to allow manufacturers to label a food ‘gluten-free’ if the food does not contain any of the following:
•    an ingredient that is any type of wheat, rye, barley, or crossbreeds 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 it results in the food containing 20 or more parts per million (ppm) gluten
•    20 ppm or more gluten

In the notice reopening the comment period, FDA states that it continues to believe the proposed definition of “gluten-free” is the correct one.

FDA’s notice also describes current analytical methods that can reliably and consistently detect gluten at levels of 20 ppm or more in a variety of foods.

After FDA reviews and considers the comments, the agency will issue a final rule that defines “gluten-free” for labeling food products, including dietary supplements.”

The 20 ppm gluten level is generally in agreement with the levels used in other countries. For example, the Codex Alimentaris, which was established by the Food and Agricultural Organization of the United Nations (FAO) and the World Health Organization (WHO) to protect the health of consumers and ensure fair practices in food trade suggests 20 mg/kg, which is the same as 20 ppm gluten as an appropriate cut off for the definition of gluten-free foods. This is the amount used in many European countries as well as Canada.

However, there are a number of questions left unanswered by these proposed regulations. One is about the proper label for oat products. Since there is still no consensus on whether or not oats processed completely separately from other grains are safe for people with celiac disease, there will be disagreement about how to label such oats.

Also, the FDA believes that food which is naturally gluten free should not be able to use that fact as advertising, unless they make clear that all foods of the same type are gluten free. Examples of this include milk and 100% fruit juice. To use the gluten-free label the following would have to be true:

“The wording of the claim clearly indicates that all foods of the same type, not just the brand bearing this labeling claim, are gluten-free (e.g., ‘milk, a gluten-free food,’ ‘all milk is gluten-free’); and the food does not contain 20 ppm or more gluten.”

If the FDA sticks to its own timetable, the time for comments should be up 60 days after August 3, 2011. After reviewing the comments, the FDA should announce its regulations. Since there is no actual date set by which they must make their recommendations (having missed 2008 already), there is no way to know when the FDA will act.

Until then, consumers have to rely on manufacturers and food producers to include gluten on labels when present. In many cases, there is also the option of looking for products that have been certified by a non-government group, the Gluten-Free Certification Organization. They certify products as gluten free if they have less than 10 ppm of gluten. This is a lower level than what the FDA is likely to require.

In Canada, a definitive date has been set to begin new labeling regulations (including gluten), and will come into effect on August 4, 2012. Where all pre-packaged foods must be in compliance with the new regulations, including domestically produced food as well as imported.

If you are having symptoms on a gluten-free diet and you are not sure about some of what you are eating you can check with The Gluten-Free Certification Organization and find options that are more likely to be gluten free.

References:
August 2011 announcement
FAQ about gluten labeling
Gluten Intolerance Group
Canadian Food Inspection Agency
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