Temporary FDA Guidelines for Food Allergens

In response to supply chain shortages amid the COVID-19 pandemic, in late May the United States Food and Drug Administration (FDA) released, without warning, new temporary guidance that allows manufacturers facing those supply chain shortages to substitute ingredients without changing food labels.  For those with food allergies, this is a very scary thing! Without further ado – FDA Guidelines for Food Allergens:

Limits to Regulation Are Not Sufficient to Calm Concern

There are limits to the substitutions that manufacturers are allowed to make.  Under this emergency order, manufactures are not allowed to substitute for known allergens without changing the label.  Some ingredients are known to cause “adverse health effect, including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities.

Certain substitutions are not allowed, such as:

• milk
• eggs
• fish
• shellfish
• peanuts
• tree nuts
• wheat
• soy
• sesame
• celery
• lupin
• buckwheat
• molluscan shellfish
• mustards

These ingredients are still required to be listed on the ingredient labels.  However, there are plenty of other allergens – albeit less common, that do not make the list.  Ingredients such as parsley and cilantro can often be included under “spices.”  Those with these allergies or sensitivities must always follow up with a phone call with the manufacturer.

My allergy did not make the list either.  Personally, I am allergic to coconut oil.  You would not believe the number of products that contain coconut oil.  It is found as an emulsifying agent in many products and snuck into breakfast bars and peanut products.  If coconut oil was used instead of palm oil in a food product, I would be very confused as to why my favorite snack might be giving me ulcers in my mouth.  Particularly if I have been consuming the same product and brand for years.  That could very well be the case under this temporary guidance.

I am lucky that my allergy only results in acute oral reaction.  For some with a more life-threatening anaphylactic reaction, the outcome could be more fatal.

FDA Claims it is for the Greater Good

FDA spokesperson Peter Cassell would not address specific food-allergic consumer concerns, only stating that the new guidelines were developed in conjunction with other federal agencies and is only one of several temporary measures put into place to respond to the challenges faced during the COVID-19 pandemic.

He includes that manufacturers are still required to make ingredient substitutions public.  But would I, as a consumer, think to look for this information.  If I were not writing this post and you were not reading it, would you have known this was taking place?  I think not!

The FDA claims this new guidance, or lax of guidance is for the greater good.  “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,” says Cassell.

Generally, policies like this have a public comment period before etched in stone.  Due to the temporary nature of the guidance, this public comment period did not take place.  I suppose it is only etched in wood after all.  According to Cassell, the FDA is now accepting comments on the guidelines, though they will remain in place until the end of the declared public health emergency.  At that point the FDA will make a decision to continue to the policy or axe it based on public comments and industry needs.  Considering “the new normal” is probably going to be put in the dictionary, as an affected party I have grave concerns.

Why is This a Problem?

Why is this product substitution a big deal, if the big ones don’t apply to the revised guidelines?  I know that I am not the only one with a dog in this fight.  With 170 known food allergens in the United States, and concerns about even cross-contact among ingredients, I am not alone in my worries.

Say you are allergic to cashews.  That is clearly on the list of “Not Allowed to Substitute.”  But the manufacturer is unable to get the peppercorn it has been using in the recipe, so they substitute for another type of peppercorn.  Peppercorn isn’t on the list.  They don’t have to change the label.  Some peppercorns, such as the pink peppercorn is related to the cashew.  Those with a cashew or tree nut allergy may have an anaphylactic response to consuming this substituted peppercorn.

What about an allergy to sunflower seeds or oil?  The FDA considers highly refined oils such as sunflower oil safe for people with food allergies, however some people are extremely sensitive.  Those people choose not to risk their health and avoid sunflower oil.  After all, there are so many others out there.  But what if the supplier of canola oil in the brownie product you buy opts to use sunflower for a short run instead.  The flavor won’t change.  And under the temporary guidelines, no label change would be necessary.  The potentially allergic consumer would not know until it was too late.

A Sticker is Suggested but Not Required

While the FDA guidelines do not require new ingredient labels, they do suggest companies put an informational sticker on products that are made with substitute ingredients.  But this is not a requirement.  I am not alone in thinking that even this suggestion to appease the public is not good enough.

Sharon Wong, food allergy advocate, recipe blogger, and experienced mother of food-allergic children with two sons that have 30 food allergies between them agrees.  She explains that while many Americans have the time to cook from scratch, this isn’t the case for everyone.  Contacting manufactures requires resources and time that some families just don’t have.

“If it’s not on the label, it’s an equity issue,” she said.  “Not everybody has access to the internet.  Not everyone can call during business hours.  Some people have language issues.” How are those people protected?

What Can I Do to Help?

This is a very scary time to live in.  Not just with these FDA Guidelines for Food Allergens. We have enough everyday stressors.  Now with the pandemic threat that has altered most of our lives in some way or another, food-allergic individuals now have another worry.

You may be asking, what can I do to help.  Spread the word.  Share this post.  Tell everyone you know to tell everyone they know.  It might be a minor annoyance with a sore in my mouth for me, but for someone with an anaphylactic reaction it could be the end.

By: Heather Van Tassell