Author Jules Shepard recently attended the FNCE – Food and Nutrition Conference & Expo 2018 in Washington DC and attended an important session about gluten-free labeling and the FDA. Here is her recap of the session about gluten-free labeling.
Regulatory Runaround: Does the Gluten Free Label Really Protect the Public?
Presented by Tricia Thompson, MS, RD, Founder Gluten Free Watchdog, LLC and Amy Keller, Chief Clinical Dietitian at Mary Rutan Hospital
In 2007, the Food and Drug Administration (FDA) began to try to define “gluten free” for the purposes of labeling consumer food products. The process languished, however, and no rule was issued until the gluten-free community rallied together to pressure the FDA to finalize a rule in 2011. The rules drafted in 2011 became final on August 2, 2014.
They cover FDA-regulated packaged foods, including dietary supplements. FDA will work with the U.S. Department of Agriculture (USDA) and Alcohol and Tobacco Tax and Trade Bureau (TTB) to make these requirements uniform across all three agencies’ jurisdictions. In general, USDA regulates the labeling of meats, poultry and certain egg products (FDA regulates shell eggs). The TTB regulates the labeling of most alcoholic beverages including beers made with malted barley.
While the regulations defined many aspects of what may and may not be labeled gluten-free, the core principles were essentially the following:
- A food manufacturer may voluntarily label a product “gluten-free” if the food is inherently gluten-free or does not contain any of the following:
- An ingredient that is any type of wheat, rye, barley or a crossbreed of these grains;
- An ingredient derived from these grains that has not been processed to remove gluten;
- An ingredient derived from these grains (like wheat starch) that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten;
- 20 ppm or more gluten or 20 micrograms or more gluten per gram of food.
The FDA explained that “[t]he goal of manufacturing any food labeled gluten-free should be for the food not to contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten.”
As the FDA explained in its Q&A document, “[o]ne goal of the FDA’s regulatory definition of the term ‘gluten-free’ is to limit consumer confusion when reading ingredient lists of foods labeled gluten-free.”
Under this rule, if a food bears the claim “gluten-free” (or similar description), but fails to meet the requirements of this rule, it would be deemed misbranded and subject to regulatory action by the FDA.
It has now been four full years since the finalization of this gluten-free food labeling rule. The session presented by Thompson and Keller highlights one of the most troublesome issues which has developed since adoption of the rules: the facial misbranding of foods labeled gluten free, but also made with ingredients prohibited under FDA rules from being contained in any products labeled gluten-free.
Examples of facial misbranding occur in products made in the United States, but also in products imported from other countries with different labeling regulations. The most common prohibited ingredients appearing in gluten-free labeled foods include: barley malt or extract or syrup or vinegar; wheat-based soy sauce; and other non-obvious wheat ingredients like spelt or couscous. (see photos of two such facially misbranded products sent to the author [Jules Shepard] and then forwarded to Thompson for inclusion in her list sent of such products sent to the FDA)
To address consumer confusion over this kind of labeling inconsistency, the USDA with guidance from FDA has recently clarified its rule with regard to soy sauce and malt, specifying that wheat-based soy sauce and barley malt ingredients are NOT permitted in foods also making a gluten-free claim. Because soy sauce containing wheat “undergoes a fermentation wherein the gluten fragments are broken down … [t]here is uncertainty in interpreting the results of current gluten test methods for fermented or hydrolyzed foods on a quantitative basis that equates the test results in terms of intact gluten.”
However, despite the fact that the FDA has assured consumers that it will use its full range of post-market monitoring activities to enforce this rule – including sampling, periodic inspections of food manufacturing facilities, food label reviews, follow-up to industry and consumer complaints reported, and gluten analyses of food samples – the FDA has not committed to taking such actions in every case. In fact, despite consumer and industry complaints, to date, FDA has failed to act across the board to address facial misbranding of gluten free products.
Thompson has started a citizen petition to the FDA related to facially misbranded products and met with the FDA in mid-November for them to discuss the confusing and dangerous nature of such products, and how the FDA intends to address them.
Thompson advises consumers to read more than just the “gluten-free” label, but to also read the full ingredient label of every product, and to report any facial misbranding or other labeling violations or concerns regarding gluten-free labeled products to her at firstname.lastname@example.org and to the FDA Consumer Complaint Coordinator for the state in which the food was purchased or the USDA at 888-674-6854.Originally posted January 2019