FDA Gluten-Free Labeling Laws

Any FDA-regulated foods, including dietary supplements and imported foods, packaged after August 5, 2014, that are labeled “gluten-free” must meet the following requirements:

“the food either is inherently gluten free; or does not contain an ingredient that is:

1) a gluten-containing grain (e.g., spelt wheat);

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

3) derived from a gluten-containing grain 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) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.” (FDA)

Other phrases that meet this standard are “gluten free,” “no gluten,” “free of gluten,” and “without gluten” (FDA). It is important to note that companies are not required to label gluten-free packaged foods; this new regulation is in place to standardize the term “gluten-free” when it is used on packaged food labels.

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Additionally, all packaged foods must label any major food allergen that is present. FDA identifies “major food allergens” as milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans (FDA). Please note that products labeled “wheat-free” are not always gluten-free because gluten is found in grains other than just wheat. For extremely sensitive consumers, it is also critical to look for the phrase “processed in a facility that contains wheat,” which may indicate a high risk of gluten contamination.

Consumers may notice other labels that indicate packaged food may be gluten-free—these labels may be a symbol or a different phrase such as “no gluten ingredients.” Third-party certification programs and any other phrasing used on labels do not necessarily meet the FDA standards for gluten-free. It will meet the standards if these labels or phrases are found on a package that also is labeled “gluten free,” “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.” One of these four phrases must be found on the label to indicate it meets the FDA standard of less than 20 ppm of gluten.

Why 20 ppm?

According to FDA, this level was selected for two reasons:

1) there is currently no test to reliably detect the presence of gluten lower than 20 ppm and

2) most individuals can tolerate this level of gluten without adverse effects on health.

Used in combination, these labeling laws give gluten-free consumers greater confidence in making their food selections and afford manufacturing companies the opportunity to effectively and safely serve the ever-expanding gluten-free market.

caution signIt’s a great start; however, there are several concerns about these laws:

  • This gluten-free standard does not cover foods such as meats, poultry, certain egg products and most alcoholic beverages regulated by United States Department of Agriculture (USDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB) (FDA).
  • It is more accurate to label this standard as “low-gluten” versus “gluten-free,” which is an important distinction because the most gluten-sensitive people may react to gluten in any amount in food products, even if it technically meets the standard for “gluten-free.”
  • This label is voluntary and companies are not required to label foods “gluten-free” even if they meet the standard, which probably hurts companies more than consumers but should still be noted.
  • This label does not currently include non-packaged foods, such as gluten-free menu items in restaurants. FDA recommends restaurants use this standard definition but cannot enforce it. If eating pre-packaged foods at a restaurant, such as sauces or marinades, you can request to see nutrition labels for them.
  • Any package labeled before August 5, 2014, may still appear on store shelves. The rule only applies to packages labeled after that date. This issue will obviously lessen over time.
  • The label does not necessarily indicate the food has been tested for gluten. FDA recommends many quality control methods that are available, but the manufacturer is ultimately responsible for ensuring that it meets this standard. There are penalties for failing FDA checks or being reported by consumers made ill by mislabeled foods, but there is no current standard for testing gluten-free packaged foods. Additionally, ELISA (enzyme-linked immunosorbent assays)-based methods cannot adequately detect gluten in fermented and hydrolyzed foods; testing in these cases would be inconclusive (FDA).

Gluten-free FDA-regulated foods are not required to be labeled as “gluten-free;” these regulations simply standardize the term when it is used. If a product is not labeled gluten-free, it may still be safe to consume. While these laws provide a helpful start, it is the consumers’ responsibility to understand the benefits and risks of the FDA labeling laws to make educated decisions about their purchases.

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