What Does the FDA's Definition of 'Gluten-Free' Mean for You?

Nine Facts You Need To Know About Gluten-Free Labeling

What is gluten-free? According to the FDA, it's products with less than 20 parts per million of gluten. © Jane Anderson

What does the FDA's definition of gluten-free mean for you?

The U.S. Food and Drug Administration has formally defined the term "gluten-free" as less than 20 parts per million (ppm) of gluten. But what does this mean for your day-in, day-out grocery shopping? Here are your questions answered.

Question: What are the basics of this new gluten-free rule from the FDA?

Answer: The FDA gluten-free label rules mean food companies need to follow certain specific guidelines in order to label something "gluten-free."

According to these guidelines, something with a "gluten-free" designation on the packaging:

  1. Can't contain the gluten grains wheat, barley and rye, or crossbreeds of these grains, such as spelt or Einkorn wheat (note that there's an exception to this rule, which I detail below)
  2. Must contain less than 20 parts per million of gluten

Here's the exception to the first rule: a product can contain ingredients derived from the gluten grains wheat, barley and rye, as long as those ingredients have been processed to remove the gluten, and as long as the resulting final product contains less than 20 parts per million of gluten.

Examples of ingredients derived from gluten grains but processed to remove gluten can include: wheat germ oil, wheat or barley grass, and barley-based enzymes.

Question: Does this rule mean that products labeled "gluten-free" will contain zero gluten?

Answer: No, not at all. Under the FDA's rules, products carrying a "gluten-free" designation can have up to 20 parts per million of gluten in them.

According to the FDA, "most" people with celiac disease can handle a small amount of gluten in their food each day (the studies haven't been done to see whether that much gluten harms people with non-celiac gluten sensitivity).

However, plenty of people react to levels of gluten below 20 ppm. So if you get glutened after trying a new "gluten-free"-labeled product, don't assume you're reacting to something other than gluten — it's perfectly possible that you're reacting to the trace gluten in that product, even if it meets the FDA's legal definition of "gluten-free."

Here's some more information on this:

Question: Are companies required to label something gluten-free if it doesn't contain any gluten?

Answer: Nope. The regulations are strictly voluntary. However, many companies are well aware of the growing popularity of the gluten-free diet, and want to serve the gluten-free market.

Question: Do the regulations now require companies to disclose gluten in products?

Answer: No again — the rules governing disclosure of allergens haven't changed. See more on this here: Do food labeling laws require manufacturers to disclose gluten ingredients?

Question: How long do manufacturers have to comply with the new rules?

Answer: They have until August 1, 2014. However, the FDA says that 95% of all gluten-free-labeled products on store shelves right now actually meet the requirements just fine.

Question: Do the FDA rules require manufacturers to test their products for trace gluten if they're labeling those products "gluten-free"?

Answer: Unfortunately, no, they don't. If it's important to you that you buy only food products that are tested periodically for trace gluten, then you'll have to contact individual manufacturers to see if they test their products.

Question: I found a barley kernel in my lentils. Do the new FDA regulations address this kind of gluten cross-contamination issue?

Answer: Yes. The FDA is well aware of problems that stem from shared harvesting and storage facilities for various commodities (see more on this here: Wheat Harvest Time Shows How Cross-Contamination Occurs). Under the FDA rules, food products — even single-ingredient products like sorghum flour or your lentils — cannot sport a "gluten-free" label unless they are tested to contain less than 20 ppm of gluten. I doubt your lentils would qualify.

Question: What about "gluten-removed" beer made from barley — can that carry a gluten-free label?

Answer: As of right now, no, it can't. There are two federal agencies that govern beer: the FDA and the Alcohol and Tobacco Tax and Trade Bureau. The alcohol bureau told brewers in 2012 that it wouldn't allow a gluten-free label for beer made from barley because the tests to detect gluten in those brews may not be reliable. The FDA, meanwhile, is studying the issue and intends to propose a new rule detailing its approach to making sure these types of products meet gluten-free labeling standards.

Learn more on this:

Question: So will these new FDA rules change how we shop for gluten-free food?

Answer: Quite honestly, probably not that much. The FDA notes that the rules can give us confidence that the food products we buy meet the agency's gluten-free standards ... but the vast majority of products on the market today (19 out of every 20) already do meet those standards.

If you can eat most of the gluten-free-labeled products out there now without getting sick, you should be able to continue that (and it's possible you'll get glutened even less often than before). If, however, you're sensitive to trace gluten below the 20ppm standard, you'll still need to carefully shop for products you know meet a more stringent standard, such as those that are certified gluten-free.

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