The Food and Drug Administration (FDA) published the final rule for labeling of foods as gluten free on August 5, 2013. The rule went into effect on September 4, 2013. Manufacturers under the labeling jurisdiction of the FDA who choose to use a voluntary gluten-free claim on product packaging must be in compliance with the regulation by August 5, 2014.

Brief Summary of the Rule

Under the gluten-free rule, a food labeled “gluten free” (or any of its synonyms—“no gluten,” “free of gluten,” and “without gluten”) must either be:
• inherently gluten free (e.g. bag of raw carrots) Or meet ALL of the following criteria:
• must not contain an ingredient that is a gluten-containing grain (e.g. wheat)
• must not contain an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten (e.g. wheat flour)
• must not contain an ingredient that is derived from a gluten-containing grain and has been processed to remove gluten (e.g. wheat starch) if use of that ingredient causes the final food product to contain 20 parts per million or more gluten

And any unavoidable gluten in a product labeled gluten-free must be less than 20 parts per million of gluten.

In addition, if the word “wheat” is included in the ingredients list or Contains statement of a food labeled gluten-free due to the use of an ingredient such as wheat starch, the following verbiage must be included on the label, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”

Confusing Issues About the Rule for Manufacturers

Based on my experience running Gluten-Free Watchdog, there are two related issues pertaining to the rule that are tripping up manufacturers—the parts per million threshold and ingredients not processed to remove gluten.

Parts per million threshold: Many manufacturers believe the only criterion they have to meet to label a food gluten free is that the food contain less than 20 parts per million of gluten. However, meeting the parts per million threshold does not mean a manufacturer has met that criteria for labeling a food gluten-free. There are other criteria that must be met as outlined in the above rule summary, including not using ingredients that the FDA considers to be those not processed to remove gluten.

Ingredients not processed to remove gluten: Many manufacturers believe that if they test their food for gluten and it tests below 20 parts per million then they may include ingredients such as malt in the product. While this might sound logical, this is not what the rule stipulates. There are certain ingredients that are not allowed in gluten-free foods regardless of the parts per million level of gluten in the final food product. In addition to wheat flour, these ingredients include (among many others) barley flour, rye flour, malt, malt extract and malt syrup.

Malt

Gluten-free consumers have known since the time of their diagnosis that the ingredients “malt,” “malt extract” and “malt syrup” should not be included in their gluten-free diet. By definition these terms, when used in an ingredients list, mean barley unless another grain source of the ingredient is named (e.g. corn malt). While manufacturers may know that malt, malt extract and malt syrup are derived from barley, an increasing number appear to think that if a food containing malt or malt extract tests less than 20 parts per million of gluten then they can include these ingredients in their product. They can’t.

What the FDA Says about Malt

On March 12, 2014 an FDA staff member participated in an Academy of Nutrition and Dietetics Medical Nutrition Practice Group Webinar entitled, “New Rules for Gluten Free Labeling: Get the Facts from the Experts.” The following was stated during the webinar:

“… We have had several questions regarding malt extract and malt syrup so I thought I would just touch upon this a little bit. Malt is a product of barley germinated under controlled conditions. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of water extract of germinated barley with or without the preservative. Malt syrup is usually a brown and viscous liquid containing varying amounts of amylolytic enzymes with plant constituents. So, if malt syrup or malt extract are further processed in some way to remove proteins, we believe that would change its nature to such an extent and alter the characteristics of the ingredient so that they would no longer bear the same common or usual name. Malt extract and malt syrup are ingredients derived from gluten containing grains and containing gluten therefore we would consider them as ingredients not processed to remove gluten and they would not be permitted in foods bearing the claim gluten free.”

Bottom Line

The ingredients known by their common or usual name as “malt,” “malt extract” and “malt syrup” and defined in the FDA’s Code of Federal Regulations are not allowed in foods labeled gluten-free. Manufacturers using these ingredients in their labeled gluten-free foods have until August 5, 2014 to either reformulate or change the labeling of their products. However, the sooner these changes are made the better off gluten-free consumers will be.