"Gluten-Free" Labeling of Food Products

The FDA's Rule for "Gluten-Free" Labeling

A proposed rule for the use of the term gluten free for food-labeling purposes was released by the FDA in January 2007. The FDA is proposing that a food product may be labeled gluten free if it does not contain any of the following:

• An ingredient that is any species of the grains wheat, barley, rye, or crossbred varieties of these grains.

What this means: If a food product contains any type of rye, barley, or wheat, including spelt, einkorn, emmer, kamut, and durum, it may not be labeled gluten free. Likewise, if it contains triticale (a cross between wheat and rye), it may not be labeled gluten free. Conversely, all other grains, including oats, may be included in foods labeled gluten free. However, all other grain products, including oat products, labeled gluten free must contain less than 20 ppm of gluten. Because most oats are likely to be contaminated with wheat, barley, and/or rye, the labels of gluten-free oat products may not imply that all oats are gluten free.

• An ingredient that is derived from one of these grains that has not been processed to remove gluten

What this means: Forms of rye, barley, and wheat that have not been processed to remove protein—including wheat bran, wheat germ, cracked wheat, crushed wheat, hydrolyzed wheat protein, farina, semolina, graham flour, malt, malt syrup, and malt extract—may not be labeled gluten free.

• An ingredient that is derived from one of these grains that has been processed to remove gluten but use of the ingredient results in the presence of 20 ppm or more of gluten in the final food product.

What this means: Products may not be labeled gluten free if they contain forms of rye, barley, and wheat, such as wheat starch, wheat-based modified food starch, and wheat starch hydrolysates (wheat-based dextrin, wheat-based glucose syrup), that have been processed to remove protein but whose use in a food product results in it containing 20 ppm or more of gluten. Conversely, wheat starch and wheat starch hydrolysates may be used as ingredients in foods labeled gluten free if their use results in the final food product containing less than 20 ppm of gluten.

• Twenty parts per million or more of gluten

What this means: No food product, regardless of what it contains, may be labeled gluten free if it contains 20 ppm or more of gluten.

Keep in mind that the information presented here is from the FDA's proposed rule. Facets of this rule may change when the final version is released in 2008.

"Gluten-free" labeling is voluntary. The lack of a statement on the label that a product is gluten free doesn't mean that it isn't. In fact, labels on foods that are inherently gluten free, such as milk, may not make a "gluten-free" claim unless the statement makes it clear that all foods of that type are gluten free. For example, a label could say, "Milk, a gluten-free food," or, "All milk is gluten free."

Why Gluten-Free Foods Are Allowed to Contain Gluten

In an ideal world, gluten-free food would not contain any gluten. However, there are reasons why a zero-gluten ruling is not feasible. First of all, there is no way to enforce such a rule, because there is no test available that can test to zero gluten. The most sensitive validated test available today is the R5 ELISA. Its limit of detection (the point at which gluten can be detected) is 3 ppm of gluten, and its limit of quantification (the point at which the amount of gluten can be quantified) is 5 ppm of gluten. Also, despite food manufacturers' best intentions, it is difficult to guarantee zero gluten, because there is always a chance (however low) of contamination.

That said, less than 20 ppm of gluten is a very low threshold. To make sure that this level is met, manufacturers will have to do everything possible to ensure the purity of the ingredients used in their products and eliminate potential sources of contamination in the manufacturing process. As a result, many (if not most) products labeled gluten free will undoubtedly contain less than 20 ppm of gluten. Rest assured that products labeled gluten free will be safe for you to eat.

Gluten-Free Foods That Contain Wheat

Once the "gluten-free" labeling rule takes effect, you may very well find foods labeled gluten free that also include the word wheat in the ingredient list or in the "Contains" statement. This is because the FDA may allow wheat starch and wheat starch hydrolysates to be used as ingredients in foods labeled gluten free (as long as the final food product contains less than 20 ppm of gluten). If you want to avoid ingredients containing wheat protein, choose products that do not contain the word wheat on the food label. Remember, under FALCPA, products containing wheat protein must be clearly labeled.

Science Class

One of the issues surrounding "gluten-free" labeling of food is the lack of standardized testing for gluten determination. At the present time, different organizations may use different methods to test for gluten. The FDA, in its proposed ruling, is tentatively considering the R5 ELISA. This is the same test endorsed by the Codex Alimentarius Commission. In addition to the R5 ELISA, other tests are available in the United States for gluten determination, including what is referred to as the omega-gliadin ELISA. This ELISA, while still used, is no longer considered state of the art.

When evaluating different programs and what their gluten-free symbols mean, it is important to know what test is being used to assess gluten content. If you would like more information about the tests used by the Celiac Sprue Association and Gluten-Free Certification Organization to assess the gluten content of the foods they certify, contact them and ask. Contact information is provided on their websites (csaceliacs.org and gfco.org).

Other Gluten-Free Symbols on Food Packaging

Besides the FDA requirements for "gluten-free" labeling, you may see two symbols on package labels identifying food products as gluten free. One is a symbol of the Gluten-Free Certification Organization (GFCO), a program run by the Gluten Intolerance Group. According to the group's website (gfco.org), a GFCO mark on a food product "assures that the product contains less than 10 ppm gluten (5 ppm gliadin) and similar proteins from rye and barley as measured by using testing methods that are accepted for gluten testing by analytical associations such as the Association of Analytical Communities (AOAC), testing researchers and other such agencies."

The second symbol, the CSA Seal of Recognition, is a program run by the Celiac Sprue Association. According to the association's website (csaceliacs.org), requirements for obtaining the seal include "ingredient review and verification by testing to assure products are free of wheat, barley, rye and oats" and "provision of written facility procedures and on-site facility audits to assure that procedures are in place to control any cross or outside contamination in processing and packaging."

If you see either of these two labels on a food product, rest assured that the product meets the requirements set by the issuing organization. For more information on these two programs, visit their websites.