- The goal of the temporary rule “is to provide regulatory flexibility to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic.”
- This will provide “flexibility for manufacturers to make minor formulation changes in certain circumstances without making conforming label changes” (because changing labels and re-printing boxes is a long and expensive process)
- “Minor formulation changes should be consistent with the general factors listed below, as appropriate: Safety: the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people, for example, glutamates)”
The other “general factors” are Quantity, (the changed ingredient should be 2 percent or less by weight of the finished food), Prominence (the ingredient should not be the main ingredient of the food), and Nutrition/Function (an omission or substitution of the labeled ingredient does not have a significant impact on the finished product, including nutritional differences or functionality.)
The part of the above that concerns me is the word they are using….”SHOULD”. This statement from the FDA tells companies their ingredient changes “should” comply with these rules, but we will have no idea if they are.
I asked the representatives from the GIG if they knew which foods are being affected by supply chain shortages. They did not know of any specific ingredient that is having a shortage but suggested that any company which purchases ingredients that are shipped or flown from another state or country could be affected.
If you want to get involved or stay informed as this progresses then here are some groups you can follow. These are all gluten related groups, but this affects ALL food allergies. If you have packaged products that you regularly eat, keep watch of this situation and if needed, give those companies a call to see if they have changed anything in the ingredients.
***GIG has co-signed a letter submitted to the FDA along with Gluten-Free Watch Dog, National Celiac Association, Beyond Celiac, Society for the Study of Celiac Disease, and the Celiac Community Foundation of Northern California, expressing their concerns as a community. You can view this letter here .