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The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)

What FALCPA Means for Gluten-Free Food Shopping

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Updated November 04, 2008

We depend on food labels to provide facts about the foods we buy, but everyone on a gluten-free diet knows that food labels do not always disclose the presence of gluten. A law passed in 2004, called The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), tries to address this problem -- and others faced by people with food allergies -- by instituting sweeping changes to the way foods are labeled in the United States.

In the first phase of FALCPA, which took effect in 2006, manufacturers of any food product that contains milk, eggs, tree nuts, peanuts, shellfish, soy and wheat were instructed to clearly disclose, in plain English, the presence of these allergens on the ingredients label. Congress limited the FALCPA labeling requirements to these 8 allergens because they account for more than 90% of all food allergies in the United States. Since 2006, manufacturers must do at least one of the following:

  • Clearly name the allergen(s) in the list of ingredients, for example:
    Ingredients: Flour (wheat), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, lecithin (soy).
  • After the list of ingredients, place the word "Contains" followed by a list any of the 8 common allergens that may be in the food, for example:
    Contains Wheat, Milk, Eggs

Obviously it's helpful for people on gluten-free diets to have wheat shown on food labels, but it doesn't solve the whole problem, because derivatives of barley and rye, and cross-contaminated oats, can still be hidden in the product.

The second phase of FALCPA -- the part most important to people who shop for gluten-free food -- has not yet been implemented. FALCPA ordered the Food and Drug Administration (FDA) to develop an official definition of the term "gluten-free" for the purpose of labeling gluten-free foods, along with a rule for manufacturers on how and when to use a "gluten-free" label.

The FDA published its "proposed rule" for gluten-free labeling in 2006. While the final rule may be different in some respects from the proposed rule, one thing is sure: It will have an enormous impact on the ease or difficulty with which shoppers can identify gluten-free products. The final rule was to have been issued in August 2008, but it will be delayed as the FDA seeks comments from the food manufacturing industry and consumers.

How Does the FDA Propose to Define "Gluten-Free"?

According to the proposed rule, a "gluten-free" label would mean that a food does not contain any of the following:
  • An ingredient that is a prohibited grain
  • An ingredient derived from a prohibited grain that has not been processed to remove gluten
  • An ingredient derived from a prohibited grain that has been processed to remove gluten, if 20 parts per million (ppm) or more gluten will remain in the food
  • 20 ppm or more gluten

Why Did the FDA Decide a Food With 20 ppm of Gluten Could Still Be Considered "Gluten-Free"?

The FDA explains on its website that it chose this level because according to published scientific research, current analytic technology can reliably and consistently detect gluten in food at levels of 20 ppm.

The FDA also plans to use scientific data and methods to estimate a "safe" level of gluten exposure, and it intends to use the results of this assessment in developing its final rule.

How Does the 20 ppm Limit for Gluten-Free Food Labeling Compare With Limits in Other Countries?

Diplomats have been working to limit worldwide variations in the amount of gluten that can remain in foods labeled "gluten-free." The international Codex Alimentarius Commission, which provides the standards for Europe, is finally lowering its limit from less than 200 ppm to less than 20 ppm. Some countries, such as Canada, have already been adhering to this lower limit. The Gluten Free Certification Organization sets a limit of less than 10 ppm gluten. The Celiac Sprue Association (CSA) establishes a limit of less than 3 ppm for manufacturers wishing to display the CSA Seal of Recognition.

How Does the FDA Define "Prohibited Grain"?

The FDA proposed rule defines "prohibited grain" as any of the following:
  • Wheat, meaning any species belonging to the genus Triticum
  • Rye, meaning any species belonging to the genus Secale
  • Barley, meaning any species belonging to the genus Hordeum
  • Crossbred hybrids of wheat, rye or barley (for example, triticale, which is a cross between wheat and rye)

If a Product Is Gluten-Free, Will Manufacturers Have to Say So?

No. Use of the "gluten-free" label on gluten-free foods will be voluntary.

What Labeling Will Be Allowed for Foods that Are Naturally Gluten-Free?

This has been a controversial question. According to the proposed rule, any food (except oats) that is naturally free of gluten can be labeled "gluten-free," but both of the following requirements must be met:
  • The food cannot contain 20 ppm or more gluten.
  • The label must say that all foods of the same type are gluten-free (for example, "milk, a gluten-free food," or "all milk is gluten-free").

The problem with this requirement can be illustrated by taking rice as an example. If a shopper sees a label that says "Rice, A Gluten-Free Food," the shopper might take it to mean "all rice is gluten free. But in fact, many rice mixes contain seasoning blends and multiple ingredients that are not gluten-free. As everyone with celiac disease knows, no one can ever say that "all" of anything is gluten-free.

This rule could also cause confusion about foods with only inherently gluten-free ingredients. Wegman's Supermarkets, for example, sells several different product lines of tortilla chips made from organic white corn, canola oil, salt, and calcium hydroxide. One product line is gluten-free, produced by a manufacturer with a dedicated gluten-free facility. The other product line is produced in a facility with a risk of cross-contamination, and so it is not considered gluten-free. According to the proposed FDA rule, the gluten-free product would have to be labeled "A Gluten-Free Food" -- possibly leading consumers to believe that all corn tortilla chips are gluten-free, which of course is not the case.

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