Thread by @woodrumlaw

A thread of some of my thoughts reading through the guidance temporarily relaxing food labeling regulations...

You can read the whole thing for yourself here:

fda.gov/regulatory-inf…

Not a fan of the lack of options for public comment in advance. The guidance states: "[...] this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate [...]"

The guidance goes on to indicate it is just that, guidance, but it appears it could have very real effects on consumers if manufacturers take advantage of the options set forth in the guidance to make changes to formulations without changing packaging to reflect that.

The background: "[A] food is deemed to be misbranded unless its label is truthful and not misleading and bears, among other requirements, a complete list of ingredients and, when applicable, allergen information."

(Usually food is misbranded if it has undeclared ingredients.)

Here's where it gets dicey:

"The food industry has requested flexibility when manufacturers need to make such minor formulation changes
[...] that may cause the finished food label to be incorrect, but that do not pose a health or safety issue [...]."

(The question everyone is asking, of course, is how a formulation change is determined not to pose a health or safety issue. That is because there are other allergens besides the top 8 and label disclosures of ingredients are a lifeline for #FoodAllergy families.)

The FDA, while strongly encouraging continued adherence to labeling requirements, then opens the door to not doing so. They do write that, "there are labeling alternatives such as stickers that can be used to inform consumers of any changes" - but don't require even doing it.

Here's their reasoning for not requiring notice of changes on packaging: "The application of stickers that inform consumers of the formulation change might not be practicable because of these limited resources."

(Do we have a national sticker shortage I don't know about?!)

Per the FDA: "[W]e do not intend to object if manufacturers make certain temporary and minor formulation changes due to supply chain challenges during this time without making conforming label changes [...]."

They then suggest but do not require websites to disclose changes.

For reference, here's an area where the FDA defines "major food allergens" as they do seem to ask for consideration of food allergies regarding formulation changes:

law.cornell.edu/cfr/text/27/7.…

27 CFR § 7.22a

The guidance uses the term "food allergens" but not "major food allergens" which I find interesting. So many more ingredients in food can be allergens beyond the top 8 in the US (which are peanuts, tree nuts, milk, egg, wheat, soy, fish, and shellfish).

It does therefore go a little broader than the top 8, spelling out that, "[...]sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard) are recognized as priority allergens in other parts of the world, including Canada, European
countries, and Japan."

Remember back at the start though that every thing in this is just guidance - so what manufacturers know is that the FDA is relaxing labeling enforcement but they aren't then binding them to other obligations if they start substituting ingredients.

The guidance provides as an example: "Substitution of a flavor that poses an allergenic risk without a corresponding label change would not be appropriate. For example, some flavors may contain protein from allergens such as milk or peanut."

This is not reassuring to me, though.

The reason I'm not reassured is because you still have the FDA only going further than the top 8 by a little. I know people allergic to strawberries or banana who would be I'll served by relaxed labeling requirements under this guidance.

Part of me wants to do a FOIA request to find out which manufacturers asked for this change and avoid them. Another part wants to start asking manufacturers to publicly commit to not taking advantage of this temporary guidance.

Food has a shelf life that goes beyond the pandemic. That is another major concern here because it will be hard to know how long the effects of this will linger on store shelves.

The reality for #FoodAllergy, #Celiac, and other communities is that somehow their constant vigilance has to increase at a time when they already have access issues for ingredients and products they really upon. Hopefully this thread helps break the document down a little.