Understanding FALCPA & FDA Food Allergen Labeling Laws

We’ve written about this topic before, but a few things have changed in the past couple of years (hello sesame!). So, we thought we’d provide an update on the latest and greatest food allergen labeling laws. After all, proper labeling helps ensure that your food is a source of fuel, not fear. 😉

As a food allergy mom and the Chief Marketing (and Mom!) Officer at Allergy Amulet, I’m often asked: What do I need to know about reading food labels? When you’re newly diagnosed with a food allergy, food labels suddenly become the gatekeeper of your shopping cart—as this article explains, they can be difficult to decipher.

When I think back to the first days after my daughter was diagnosed with peanut and tree nut allergies, I vividly remember the first grocery shopping trip—standing in the aisles for HOURS confused and scared because I realized I didn’t know HOW to read food labels. I kept picking up food items that didn’t list tree nuts or peanuts as ingredients but read "manufactured in a facility that processes tree nuts" or "may contain nuts." Even products my daughter had safely eaten in past were suddenly off-limits. I started to wonder, What do these warnings mean? Should I call the manufacturer for more information? Can I trust these labels? Why aren’t they streamlined to read the same way?! 

This article is an effort to shed some light on the laws behind food allergen labeling and better equip you and your family for those first grocery store visits post-diagnosis. So, let’s kick things off by talking about FALCPA. 

WHAT DOES THE LAW SAY? 

Enacted January 1, 2006, the Food Allergen Labeling and Consumer Protection Act (FALCPA) mandates that nationally distributed packaged foods containing any of the “top eight” major food allergens (fish, shellfish, wheat, soy, peanuts, tree nuts, milk, and eggs) must be identified in plain language (easily readable/understandable) and listed in either the ingredients section OR in a “contains” statement (usually following the ingredient list). At the time of the FALCPA allergen labeling passage, these eight foods accounted for 90% of food allergies and serious allergic reactions in the U.S. 

NEW: On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, adding sesame to the list of top allergens (now 9!) that must be declared on federally regulated packaged products in the U.S. The FASTER Act goes into effect on January 1, 2023.  

WHAT FOODS ARE NOT COVERED?

FALCPA includes federally regulated packaged foods and dietary supplements, but it does NOT include meat, poultry, and egg products (these are regulated by the USDA). Alcoholic beverages are NOT covered, as they are regulated by the Alcohol and Tobacco Tax and Trade Bureau. Additional items NOT regulated by FALCPA: drugs, cosmetics, raw agriculture commodities (e.g., fresh fruits and veggies), and foods not sold in international commerce—these would not trigger federal regulations (e.g., cookies only sold at your local farmers market stand). Notably, highly refined oils derived from one of the major food allergens, and any ingredient derivatives of highly refined oils, are exempt. 

IS READING THE ENTIRE LABEL IMPORTANT? 

YES! It’s important for someone with a food allergy or sensitivity to read BOTH the ingredients list AND the “contains” statement (if one is included) on the label. Why? Because FDA food allergen labeling requires by law that the top allergens be included in ONE of these sections (not both). 

Additionally, if the label includes a generic descriptor such as “spices” or “natural flavors,” the manufacturer must state if one of them contains even trace amounts of a top allergen. 

Unfortunately, if your food allergy is not among these top allergens, identifying trace amounts may require a bit more detective work. For example, mustard seeds and corn are fairly common allergens in the U.S., but they do not need to be listed on packaging.

Finally, the U.S. considers coconut, shea nut, and lychee all tree nuts—despite the fact that lychee is a fruit and a good majority of folks with a tree nut allergy can eat coconut (coconut food allergies are rare!). A coconut is technically a drupe, which interestingly can be classified as either a fruit, nut, or seed! Similarly, pine nuts are classified as tree nuts in the U.S. but are considered seeds in the EU. If you’re traveling to Europe and have a pine nut allergy, take note!

“MANUFACTURED IN A FACILITY” STATEMENT

Last but not least, in the U.S., it is VOLUNTARY for a manufacturer to include a statement on their package regarding whether their manufacturing facility also processes any of the top nine allergens. Some manufacturers voluntarily list that certain food allergens are processed on a shared line or in a shared facility, while others don’t include any statement. It is therefore up to the consumer to decide how to proceed with these statements. I know some people that always avoid foods with these cautionary statements and others that don’t. Manufacturers sometimes list cautionary statements out of liability concerns, not necessarily because of genuine correlative risk.

Since this stuff is confusing, here are a couple of real-world examples. 

This first ingredient label is for a popular children’s snack. This manufacturer bolds the major ingredients in the ingredient list, includes a “contains” statement for major allergens, and a voluntary “made on shared equipment” callout.

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In this next example, you can see that the major allergens (wheat, soy, and egg) are listed in the long form ingredients label, but there is no “contains” statement. The manufacturer does not volunteer any information about major allergens that may be in the facility or shared on the same equipment. In this case, you’d want to use your best judgment. You can also always contact the manufacturer for more information.

There’s much debate among the food allergy community about the current FDA approach to food allergen labeling—many people agree the labeling process needs streamlining and should be more straightforward. It’s hard to evaluate risk under the current system or know where and what to look for when checking labels for allergens. 

One thing is for certain: I am thankful to be a food-allergic family in today’s world. Although the system isn’t perfect, far more information is available to consumers today about the ingredients and allergens in their food than there was just 15 years ago. In those moments of frustration at the grocery store, I’m grateful not to be managing my child’s food allergies in the ‘80s. 

— Meg and the Allergy Amulet Team