Ingredient label

In late May the FDA released, with no warning, new temporary guidelines allowing manufacturers facing supply chain shortages amid the COVID-19 pandemic to make ingredient substitutions without changing food labels.

As the mother of a child with food allergies, Heather Sapp was well versed in reading labels and calling manufacturers to verify ingredients. For years, she kept her daughter’s diet free of the peanuts and tree nuts that could kill her.

Sapp herself developed adult-onset anaphylactic allergies to chickpeas, sesame and cilantro. More recently, Sapp, who lives in Phoenix, had an anaphylactic reaction to parsley.

None of Sapp’s allergens are among those the Food and Drug Administration requires to be individually listed on food labels. Parsley and cilantro regularly are included under “spices” or “natural flavors.” Like many Americans with food allergies, Sapp reads ingredient labels closely, often following up with a phone call to verify ingredients, and had developed a list of manufacturers and products she considered safe.

However, Sapp was stunned when in late May the FDA released, with no warning, new temporary guidelines allowing manufacturers facing supply chain shortages amid the COVID-19 pandemic to make ingredient substitutions without changing food labels.

While FDA spokesperson Peter Cassell declined to address specific concerns from consumers with food allergies, he said the new guidelines were developed in conjunction with other federal agencies as one of several temporary measures related to the COVID-19 pandemic. Manufacturers are required to make ingredient substitutions public.

“It’s a temporary guidance in order to make sure that the supply chains throughout the country are able to provide safe and ample food for America,” Cassell said.

Because the guidelines were issued as an emergency measure, no public comment period preceded them. The FDA is now accepting comments on the new guidelines, which will remain in place until the end of the declared public health emergency, Cassell said. At that point, the FDA will decide if it should continue the policy based on public comments and industry needs.

Under the emergency measure, manufacturers are not allowed to substitute ingredients that may have an “adverse health effect, including food allergens, gluten, sulfites or other ingredients known to cause sensitivities.” The top eight recognized food allergens in the U.S. — milk, eggs, fish, shellfish, peanuts, tree nuts, wheat and soy — as well as other priority allergens, including sesame, celery, lupin (a legume), buckwheat, molluscan shellfish and mustards, cannot be substituted under the new guidelines. The FDA still requires them to be listed on package labels.

But other minor ingredients can be temporarily substituted. With 170 known food allergens in the United States, and with concerns about cross-contact among ingredients, people with allergies are concerned about these unannounced substitutions.

For example, if a company hits a snag in the supply chain for a peppercorn it has been using, it can substitute another type of peppercorn. Some peppercorns are related to cashews and can trigger anaphylaxis in people allergic to cashews and other tree nuts. Or, while the FDA considers highly refined oils safe for people with food allergies, many consumers do not. The new guidelines allow manufacturers to substitute sunflower oil for canola oil, for example, because they share similar fatty acid profiles.

The FDA guidelines do not require new ingredient labels but recommend companies put an informational sticker on products with substituted ingredients or make that information available on their websites. The temporary guidelines went into effect on their May 22 release.

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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