If 2020 was the year of supply chain uncertainty due to COVID-19, 2021 may well be the year that transparency in food labeling takes center stage, particularly for gluten-free products. 

Even in the best of times, food labeling is subject to regulatory changes, but last year was notable for two FDA rulings that product developers should keep an eye on in this new year. For the gluten-free community, these rule changes are a mixed bag. While the FDA has tightened restrictions on labeling fermented/hydrolyzed products gluten-free, the agency also has released a temporary rule that relaxes requirements for noting substitutions on ingredient lists, giving celiac groups cause for concern.

The FDA has played a major role in food labeling for gluten-free products since 2013, when the agency introduced a new standard requiring that products labeled as gluten-free contain less than 20 ppm of gluten. Creation of the standard was due in large part to pressure from consumers, who wanted assurance that products labeled as gluten-free lived up to those claims and that any goods containing gluten or allergens like wheat were clearly labeled. But the food industry recognized that “zero gluten” was not measurable, and requested that the FDA set a quantifiable threshold for gluten-free products. 

The FDA threshold of 20 ppm was not based on the FDA’s own safety-assessment, which indicated that the “limit of concern” for adverse health effects in persons with celiac disease was 0.01 to 0.06 ppm. Because of the high level of uncertainty around their “limit of concern” calculation, and the lack of analytical methods that can detect gluten at those low levels, the FDA 20 ppm limit is instead based on a conservative determination of the threshold at which testing kits can reliably detect gluten proteins. However, many testing kits can identify gluten at even lower levels, leading organizations like GFCO to adopt more stringent standards for certifying products as gluten-free. For example, GFCO requires gluten-free products to test at 10 ppm or less.

Fast forward to the present day, and the new frontier for gluten-free labeling is centered on fermented/hydrolyzed products. 

Because most kits are antibody-based, they do a good job of identifying intact gluten proteins but are less effective at identifying residual gluten once those proteins have been broken down by fermentation or hydrolysis. When the FDA realized that test kits couldn’t reliably detect the presence of residual gluten fragments, the agency issued a new regulation requiring fermented/hydrolyzed products labeled as gluten-free to be made from starting materials that don’t contain any gluten. To comply with the new regulation, products such as beer and soy sauce—which often are made from gluten-containing grains—must be made from alternative gluten-free ingredients.

While soy sauce and beer are two of the most common fermented products made from gluten-containing grains, there are many other foods and beverages that fall within the scope of the FDA regulation, including vinegar, cheese, yogurt, kimchee, sauerkraut, pickles and wine. Even though the chance of gluten contamination for some of these products is very low, manufacturers still must be able to document that they use only gluten-free starting ingredients to comply with the FDA regulation.

New product developers also should be aware that the FDA’s August 2020 ruling also covers distillation, and allows manufacturers to label distilled products—like, for instance, vinegar— made from barley, rye or wheat as gluten-free, because the distillation process removes all traces of residual protein, and therefore removes gluten. Three months after the FDA ruling, the Alcohol and Tobacco Tax and Trade Bureau (TTB) followed suit and allowed companies to advertise and label distilled spirits as gluten-free even if they are made from gluten-containing grains.

In addition to establishing clear requirements for labeling fermented/hydrolyzed products, the FDA’s ruling has provided an opportunity to educate manufacturers about the limits of gluten-free testing kits. Moreover, while the regulation imposes new documentation requirements, it doesn’t impose a substantial burden in terms of manufacturing facilities, equipment, processes or testing.

The FDA regulation brings some much-needed clarity to domestic labeling requirements for fermented/hydrolyzed products, but manufacturers should be aware that international labeling standards can vary widely when developing gluten-free products for export. 

For example, Australia prohibits manufacturers from labeling gluten-removed beer as gluten-free because gluten-removed beers may still contain residual gluten fragments. On the other hand, the UK allows beverage companies to label gluten-removed beers as gluten-free provided the beer is enzyme-treated to break down gluten and tests at less than 20 ppm with an R5 ELISA (enzyme-linked immunosorbent assay) testing method.

Although the gluten-free community has applauded the new regulation on fermented/hydrolyzed products, celiac groups are less than enthused about another recent rule change that allows manufacturers to make minor substitutions to ingredients in gluten-free products without updating ingredient lists. The new rule does advise manufacturers to consider allergen and gluten regulations when making these changes, but the guidance isn’t mandatory. Consequently, celiac advocates worry that manufacturers may inadvertently substitute an ingredient containing gluten without informing consumers of the switch.

Introduced during the early days of COVID-19, the rule was intended as a temporary change to address supply chain disruptions caused by the pandemic. However, the FDA published the rule without assigning an end date and the rule remains in effect. To reassure consumers that products really are gluten-free, celiac advocates recommend that manufacturers update ingredient lists whenever they substitute an ingredient.

As we head into 2021, the labeling of gluten-free products will continue to be a major focus for advocacy groups and consumers. Calls to improve testing methods for fermented/hydrolyzed products and for the required listing of wheat, rye and barley as gluten sources could impact gluten-free labeling requirements in the future. For manufacturers, staying on top of changing regulations is the best way to earn and retain consumer trust and build a market for your latest gluten-free products.

Laura K. Allred, Ph.D. is the regulatory manager for the Gluten Intolerance Group’s Gluten-Free Certification Organization (GFCO). Allred’s experience includes a doctorate in immunology and eight years of directing a food testing laboratory and test kit manufacturing operation. The GFCO certification logo is the symbol of trust for the gluten-free community, with more than 60,000 products certified worldwide.