You pick up a food product in the grocery store and read the ingredients list and “Contains” statement. The words wheat, barley, rye, oats and malt do not appear in the ingredients list and wheat is not listed in the Contains statement. The product does not appear to be made with any gluten-containing ingredients.

BUT, also included on the product label is a statement that reads something along the lines of “Allergen information: produced in a facility that also handles wheat.” What in the world are you supposed to do now? Should you still buy the product or leave it on the shelf?

It is important to understand that allergen advisory statements are voluntary. The Food and Drug Administration (FDA) does not require allergen advisory statements on food labels.

They also do not currently regulate these voluntary statements except to state that advisory labeling should not be a substitute for current Good Manufacturing Practice. Good Manufacturing Practice, among other things should reduce the risk of cross contact with allergens.

The FDA also states that advisory statements should be truthful and not misleading.

Before proceeding further, it is important to stress that allergen advisories should not be confused with allergen labeling which is mandatory for FDA-regulated foods. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), if an FDA-regulated food or ingredient in a food is or contains protein from one of the eight major allergens (including wheat), this must be clearly stated in the ingredients list or Contains statement. FALCPA only covers ingredients; it does not cover unintentional ingredients that end up in a food due to cross contact.

So, if you are holding two similar products and one contains allergen advisory language and the other does not, does this mean you should buy the product without the advisory? Not necessarily. Again, advisory language is voluntary. Just because a manufacturer does not include allergen advisory labeling on a product does not necessarily mean this product is manufactured in an allergen-free facility.

Likewise, if a manufacturer includes allergen advisory labeling on a product it does not necessarily mean this product is contaminated. Many, if not most manufacturers, including those who use advisory labeling have strict allergen control programs in place to reduce the likelihood of cross contact with allergens.

Based on her experiences with The Gluten-Free Certification Organization and her visits to manufacturing plants, Cynthia Kupper, RD Executive Director of The Gluten Intolerance Group, offers the following insights when a person with celiac disease or gluten sensitivity is faced with allergen advisory labeling:

“Large and many small manufacturers have quality control measures in place to control variables in processing. Control measures include the labeling and storage of allergens, product scheduling, airflow control, closed production systems, and separate lines or rooms for product production. These, along with Good Manufacturing Practices help to minimize cross contact or contamination. When these controls are in place it is unlikely that products will be contaminated with levels of gluten that would come close to reaching the proposed FDA definition of gluten free.”

The FDA understands that allergen advisory labeling is all very confusing. As a result, the FDA recently held a public hearing on the use of advisory labeling of allergens in foods.  The FDA also has a report available on line regarding cross contact and the use of advisory allergen labeling.

If you want to learn about a specific manufacturer’s allergen control plan, call the company and ask to speak with a quality assurance representative.

Update February 2, 2011: The National Institutes of Health recently released guidelines on the diagnosis and management of food allergies. These guidelines suggest that products with voluntary allergen advisory statements be avoided by individuals with food allergies.

Copyright © Tricia Thompson, MS, RD

Originally published September 2008. Updated February 2, 2011.

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Allergen advisory statements