Temporary Changes to FDA Labeling Guidance Could Spell Danger for Allergic Families

Temporary Changes to FDA Labeling Guidance Could Spell Danger for Allergic Families

Whether you’re ordering your groceries online or you’ve pulled on your face mask and headed into the grocery store, you know that America’s supply lines have been stretched and challenged. You know that toilet paper and Lysol wipes haven’t been the only difficult thing to find. At times it’s been difficult to find specific ingredients or even entire categories of pre-packaged goods. Meat has been in tight supply. Yeast is practically non-existent. It’s been difficult on all of us, and as discussed previously, tight supplies have presented challenges to food-allergic families already limited to certain products based on what’s safe (and what’s not) for them.

The tight supplies haven’t just impacted our food options at the point of purchase. Food manufacturers are also experiencing challenges in securing specific ingredients needed to produce their packaged goods. In order to continue producing their products, manufacturers may opt to make changes to their formulations, and that’s presenting an entirely new, potentially dangerous challenge for food allergy families.

What’s Changed?

Recognizing the challenges manufactures face, the US Food and Drug Administration recently issued guidance that provides temporary flexibility in food labeling requirements. These rules apply specifically to manufacturers and vending machine operators. The goal was to help mitigate the impact of temporary supply chain disruptions on product availability. These guidelines give manufacturers the flexibility to make minor formulation changes without having to update their existing packaging. This means they can change an ingredient without reflecting the change on the label’s ingredient list if it is a minor one.

There are Caveats

Yes, the FDA’s guidance includes specific caveats that would make this change seem relatively insignificant to most consumers. For example, the substituted or omitted ingredient cannot be a major ingredient, it cannot impact voluntary nutrient content or health claims on the label, and it cannot have any significant impact on the finished product. In addition, and most significant to allergic families, the substitution cannot “cause any adverse health effect (including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people.)” 

Here’s Why That’s Not Good Enough

On the surface, it sounds safe enough. Right? The guidelines say the ingredient shift can’t cause any adverse health effect. It specifically mentions food allergies, so is that okay? No, it is not. To understand why, we need to take a step back and review the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). This law requires clear labeling for any of the top eight food allergens on the package of a food item regulated by the FDA. That means if milk, wheat, eggs, soy, peanuts, tree nuts, shellfish or fish are an ingredient, it must be clearly stated in plain English on the package.

Take a moment to look at that list again: milk, wheat, eggs, soy, peanuts, tree nuts, shellfish, and fish. What does that have to do with this new temporary guidance? Good question. When the FDA says manufacturers can’t make substitutions that would negatively impact food-allergic consumers, the scope of that directive is limited to those top 8 allergens covered under FALCPA. These allergens made the list because they are responsible for the vast majority of allergies. However, they are not the only food allergens. In fact, there are more than 170 foods that have been reported to cause reactions in the US.

Yes, you read that right. If you’re one of those individuals with an allergy to the other 162 foods that are known to cause a reaction, this temporary guidance may put you at risk. That includes families like mine. We manage a combined list of 30 severe food allergies between our two children. Being able to pick up a product and being able to trust that the ingredients listed on the package are the only ingredients in the product is how we help ensure our kids are safe.

This temporary change in labeling guidance from the FDA means that now, families like mine not only have to be concerned about potential cross contamination issues, we also have to be concerned with how safe our typically “safe” foods are, as well, because there is no way to know if the manufacturer has had to substitute a spice or a seasoning or a small ingredient that is on your list of allergens and is not covered in the FDA guidance. Let’s break that down: You may review a label, assume the item is safe, and then consume something that actually does contain your food allergen.

Labeling laws should not be relaxed. For those who don’t have to worry about these things, please enjoy ordering from all the restaurants and small food-related businesses. They truly need our help to stay in business. Our family just needs to stay safe, so we will continue cooking safe food at home and being extra-super-crazy cautious now that we once again, cannot trust what manufacturers are using.

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