How Worried You Should be About Allergen Advisory Statements

When you see the label “gluten free” on food, how does it make you feel? Confident? Secure? Or do you still have questions about whether the food is genuinely gluten free? What about statements like “made in a shared facility with wheat” or “may contain wheat” on foods labeled gluten free? Do those phrases cause you to think twice?

The gluten-free labeling rule, which went into effect in 2014, was intended to help gluten-free consumers easily identify foods that are safe to eat. It also provided specific guidance to manufacturers on what is, and what is not, allowed in gluten-free food. Before the gluten-free labeling rule, there were no set standards for the labeling of gluten-free foods, so it was a significant step forward for the gluten-free community.

Recently, however, consumers have begun discovering that there are foods labeled gluten-free on store shelves that contain ingredients that don’t meet the requirements of the rule. Also, allergen advisory statements indicating a labeled gluten-free food was manufactured on shared equipment or in a facility with wheat cause concern among gluten-free consumers. Is the Food and Drug Administration (FDA) doing enough to protect the gluten-free consumer?  

Allergen advisory statements

Perhaps no other phrase on a food package is more unsettling to a gluten-free consumer than an allergen advisory statement. Statements warning of shared equipment, shared facility or the even more ominous “may contain wheat” may make consumers feel like manufacturers are trying to hide something.


“Many find it nonsensical to see both a gluten-free claim and a ‘may contain wheat’ statement on a product label, and who can fault them?” notes Tricia Thompson, MS, RD, founder of the independent gluten testing organization Gluten Free Watchdog, LLC. Unlike mandatory food allergy labeling for wheat, allergen advisory statements are voluntary and not covered by any federal regulation. “Some manufacturers use them, and others do not,” notes Thompson.

Even more confusing, the gluten-free labeling rule allows these precautionary statements to be included on foods labeled gluten free, provided the final product meets the required standard. 

In 2016 and 2018, Thompson and her team of researchers reviewed products with and without gluten-free labels to determine if an allergen advisory statement was helpful in predicting gluten contamination. What they found surprised many in the gluten-free community. “Based on our database reviews, four out of 45 (9 percent) products that did include an allergen advisory statement for wheat or gluten on product packaging contained quantifiable gluten,” says Thompson. “But 52 out of 384 (14 percent) of products that did not list an allergen advisory statement for wheat or gluten on product packaging contained quantifiable gluten.” In short, an allergen advisory statement was not a good predictor of gluten contamination.


The type of allergen advisory statement (shared facility/equipment or may contain) was also not useful in determining risk. “In our latest research, 31 products contained an allergen advisory statement, but only three contained quantifiable gluten,” says Thompson. “The three foods that contained quantifiable gluten carried an advisory statement for a shared facility, not shared equipment or ‘may contain wheat.’”

Despite studies like this, allergen advisory statements still tend to cause a lot of worry and confusion, notes Thompson. As part of her 2018 study, she conducted an informal poll on Twitter asking how gluten-free consumers felt when they saw an allergen advisory statement on a gluten-free product. The poll indicated that consumers viewed allergen advisory statements in a generally negative light. In particular, shared equipment and “may contain wheat” caused the most concern.

Thompson hopes that the FDA will take action to help make these statements more useful to the consumer. “The FDA should strongly consider regulating allergen advisory statements, especially in light of the recent Food Safety and Modernization Act,” she says. “They should be standardized and related to consumer risk. Allergen advisory statements should be helpful to consumers. Currently, due to lack of regulation, they result in a lot of confusion.”


In the meantime, consumers can ask questions when they see an allergen advisory statement. Calling the manufacturer may be helpful; it’s important to speak to someone who is familiar with how the facility controls for allergens. Ask about specific procedures regarding how equipment is cleaned, whether gluten-free products are made on separate days (or at least before gluten-containing foods), and whether there are particular areas or employees who are dedicated to the production of gluten-free foods.

Facial misbranding

“At Gluten Free Watchdog, we use the term ‘facial misbranding’ to describe a product label displaying a ‘gluten-free’ claim but the ingredients list includes an ingredient that is prohibited under FDA rules from being contained in any product labeled ‘gluten-free,’” says Thompson. “It tends to involve the same ingredients, which include barley malt, barley malt extract/barley malt syrup, barley malt vinegar and wheat-based soy sauce.” Consumers notify Thompson about products that contain prohibited ingredients frequently, in everything from malt vinegar potato chips to ice cream containing dry malt extract.

When she receives these reports from consumers, she investigates, and then she brings it to the manufacturer’s attention. The reactions she receives from the manufacturers run the gamut, she says. “Some are incredibly appreciative and take immediate corrective actions. Others refuse to make any changes to their product labeling.” Thompson believes that some manufacturers don’t fully understand the rules. “They believe that the only criterion for making a gluten-free claim is that the product contains a level of gluten below 20 parts per million (ppm),” she says. “This is not true. Certain ingredients are not allowed in foods labeled gluten free in the U.S.”


In August of 2017, Thompson filed a citizen petition to the FDA listing numerous food products on store shelves that met the definition of facial misbranding. The petition requested that the FDA establish protocols for better surveillance, investigation and, most importantly, enforcement of products that are potentially misbranded. Additional lists of misbranded products were sent to the FDA in 2018. Despite the FDA stating that enforcement of the gluten-free labeling rule includes food label reviews, Thompson says she did not see action to remove these products from stores shelves. Since the beginning of 2016, the FDA has issued only two recalls of food products that were misbranded.

Thompson took to social media to encourage gluten-free consumers to tweet the FDA with the hashtag #EnforceGFRule, andcontinued to encourage and educate consumers about how to properly report misbranded product. In late 2018, the FDA took action. “We had a positive meeting with several folks from the FDA on gluten-free labeling issues. The nation’s most prominent gluten-free and celiac groups participated in the meeting, including representatives from the National Celiac Association, Beyond Celiac, Gluten Intolerance Group and the Celiac Disease Foundation, she reports. “We discussed consumer reporting issues, enforcement issues, and education and awareness. This is the first of hopefully many more interactions with the FDA to help solve the various issues we’ve identified related to facial misbranding and consumer trust in the gluten-free claim.”

Thompson does caution that there are some situations where food may appear to be misbranded when it is not. The most common one that she sees is the presence of an allergen advisory statement on a food with a gluten-free label. “Consumers should not report perceived facial misbranding due to the presence of an allergen advisory statement on a labeled gluten-free food,” she says. “These statements are allowed on foods labeled gluten-free in the U.S.”


Thompson encourages gluten-free consumers to be patient, however. “Change does not happen fast. We are grateful for all movement in a positive direction and for FDA’s willingness to engage and meet with us,” she says. “While we wait for change to take place, it is really important for consumers to continue reporting facial misbranding to the FDA and USDA [United States Department of Agriculture] and to Gluten Free Watchdog.”

Mandatory Food Allergy Labeling vs. Allergen Advisory Statements

  Mandatory Food Allergy Labeling Allergen Advisory Statements
What is it? The Food Allergen Labeling and Consumer Protection Act (FALCPA) specifies that any of the eight major food allergens (wheat, egg, dairy, soy, tree nuts, peanuts, fish and shellfish) on FDA-regulated products must be clearly listed under their “common and usual name” in either the ingredients list or in a Contains statement. Usually, it’s in both places. Allergen advisory statements such as “may contain,” “made on shared equipment” and “made in a shared facility” refer to manufacturing practices. They may be present on foods labeled gluten-free as long as the final product meets the standard set by the gluten-free labeling rule (< 20 ppm). The use of an allergen advisory statement is voluntary on the part of the manufacturer.
Are they regulated? Yes. FALCPA is mandatory. It is important to note that FALCPA refers to ingredients only, not to manufacturing practices such as shared facility or shared equipment. No. Allergen advisory statements are not regulated by any agency. However, the FDA does state that they should be “truthful and not misleading” and should not be “used as a substitute for adherence to Good Manufacturing Practices.”

What should you do if you spot a misbranded food?

FDA-Regulated Foods (most packaged foods, shelled eggs, dietary supplements)

  1. Take photos that capture the entire label. It is critical to photograph the UPC code (12-digit numeric code).
  2. Contact an FDA consumer complaint coordinator. A state-by-state listing or regional listing is available at

USDA-Regulated Foods (meat products, poultry products, mixed products that contain more than 3 percent raw meat or 2 percent cooked meat or poultry, egg products including dried, frozen or liquid eggs.)

  1. Take photos that capture the entire label. For USDA-regulated foods it is critical to photograph the establishment number/EST number).
  2. Contact the USDA at 1-888-674-6854.

If you have any questions or are unsure about whether a product is misbranded, you can contact Gluten Free Watchdog at [email protected]

Test your knowledge

True or False: Choosing a product without an allergen advisory statement for wheat guarantees it was made in a dedicated gluten-free facility.

False: Allergen advisory statements are voluntary. Choosing a product without one does not guarantee a gluten-free facility. The product could have been made on shared equipment or in a shared facility, but the manufacturer chose not to use an allergen advisory statement.


True or False: A product listed as “made in a shared facility” is a safer choice than “made on shared equipment” or “may contain wheat.”

False: Recent research has shown that the type of allergen advisory statement listed is not a useful predictor of the risk of gluten contamination.

True or False: A gluten-free product with a “may contain wheat” statement is not considered misbranded.

True: “May contain wheat” and other allergen advisory statements are permitted on gluten-free products, provided the final product meets the standard of the gluten-free rule.


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