In March 2020, the coronavirus pandemic was declared a US national emergency, demanding new state regulations throughout the country, an array of CDC and WHO cautions and guidelines, and procedural changes around the most prevalent methods of disease spread and people groups with more propensity to be affected.
Temporary Labeling Is a Response to COVID-19
As a result, the Food and Drug Administration (FDA) rolled out a new temporary regulation for relaxing food labeling requirements: Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. This guidance provides flexibility to food manufacturers, labeling manufacturers, and restaurants/food service establishments following food industry reports of reduction in supply chains because of COVID-19 (FDA, 2020).
The concern is that, without our extra diligence in reading labels and searching manufacturer websites for substitute ingredient information, the FDA’s response to COVID-19 could potentially compromise the safety of our campers and staff with food allergies.
The FDA Guidance is targeted to:
- Restaurants/food service operations
- Food manufacturers with food in stock that is labeled for use in restaurants and food services for the public
- Manufacturers continuing to produce food for use in restaurants for which retail packaging is unavailable. (However, this food may not be sold to restaurants/food services until packaging is available.)
- Restaurants/food services wishing to sell packaged foods directly to other businesses or consumers for consumer point of sales.
For the targeted groups, the FDA guidance says that packaged foods may lack a Nutrition Facts label so long as the food has no nutrition claims. However, other required information includes the following (FDA, 2020):
- A statement of identity
- An ingredient statement
- The name and place of the business of the food manufacturer, packer, or distributor
- Net quantity of contents
- Allergen information required by the Food Allergen Labeling and Consumer Protection Act (FDA, 2006).
Aside from the preceding guidance, the FDA will cooperate with manufacturers concerning ingredient omissions and substitutions and label changes. The FDA does not plan to enforce actions until after the beginning of 2021.
The FDA suggests, but does not require, that manufacturers make consumers aware of any ingredient substitutions or alterations not reflected on the product label by including this information on their websites and on point-of-sale labels.
Minor Formulation of Ingredient Changes During the COVID-19 Pandemic
The FDA allows the food industry to make temporary and minor formulation changes to food ingredients without making label changes when they experience supply disruptions or ingredient shortages resulting from the pandemic. The guidance states that minor formulation changes should be consistent with (FDA, 2020):
- Safety: substituted ingredient for the labeled ingredient “does not cause any adverse health effect” (food allergens, gluten, sulfites, or other known sensitivity causing ingredients, e.g., glutamates).
- Quantity: substituted ingredient is 2 percent or less in weight of the finished food.
- Prominence: omitted or substituted ingredient for labeled ingredient may not be a major (prominent) ingredient (such as replacing potato flour for wheat flour) or label statement ingredients (for example, butter in a baked product labeled with “Made with real butter”). Ingredients less than 2 percent “minor ingredients” may also be listed in any order. A quantifying statement must follow.
- Characterizing or Ingredient in Name: omitted or substituted ingredient not a characterizing ingredient (such as omitting blueberries in blueberry muffins).
- Claims: omitted/substituted ingredients do not affect the truthfulness of the nutrient and health claims printed on the product label.
- Nutrition/Function: nutritional differences or functionality must not be greatly impacted by the omitted or substituted ingredient.
The guidance further suggests that food manufacturers avoid allergen ingredient substitutions that could threaten safety for those with allergies to the eight recognized major food allergens in the US, as well as other priority allergens recognized in Europe, Canada, and Japan — such as sesame, lupin, buckwheat, mustard, and molluscan shellfish — and ingredients that can cause reactions. Before substituting ingredients in these categories, manufacturers should make a label change or find another avenue to inform consumers.
Still, consumers with a serious but non-government-recognized food allergy could be in jeopardy. For example, I have a friend who has a somewhat rare allergy to eggplant, with hives as her primary symptom. If eggplant were substituted for zucchini in a grilled vegetable medley, she would want to know.The FDA also allows for substitutions of different varieties of the same ingredient, such as subbing one type of mushroom, a portabella, for another, a button mushroom). This practice is not without danger. While it may not be a problem to switch to a button mushroom, a switch to a shiitake mushroom could cause a toxic reaction because of the starch-like compound lentinan residing in shiitakes. Symptoms occur in those who have allergies to mold or fungus or a salicylate sensitivity, and manifest in skin reactions caused by blood vessel dilation underneath the skin (Erickson, n.d.).
Flavor and spice substitutions are allowed — artificial for another artificial, or natural for another natural — with the exception of a flavor that is not a characterizing flavor. A corresponding label change is not required unless the substituted flavor is an allergenic risk.
The caveat with this suggestion to manufacturers is that some similar flavor substitutions can be dangerous, and some cases fatal. For example, a manufacturer of frozen packaged hot chicken wings usually containing hot paprika chili powder could lack the ability to secure this ingredient for their recipe, and instead substitute cayenne pepper, a very similar spice within the same family. Unfortunately, some who are allergic to cayenne pepper can suffer severe allergic reactions, including wheezing, nausea, diarrhea, hives, and life-threatening anaphylaxis (Dorman, n.d.).
Other common spice and herb allergies include:
- hibiscus (University of Nebraska-Lincoln Institute of Agriculture and Natural Resources, 2014).
The FDA enacted temporary regulatory relaxations of labeling and ingredient substitution requirements because the pandemic has caused interruptions in supply chains, and food manufacturers are understandably unable to operate business as usual. However, we have campers and staff under our care, consuming our cuisine, who could be affected by one minor change in labeling or an ingredient. The onus is on us to carefully note every camper/staff allergy and research all ingredients via labels, websites, and/or phone calls.
- Dorman, K. (n.d.). The signs & symptoms of a cayenne pepper allergy. Livestrong. Retrieved from livestrong.com/article/515108-the-signs-symptoms-of-a-cayenne-pepper-allergy/
- Erickson, R. (n.d.). An allergy to shiitake mushrooms. Livestrong. Retrieved from livestrong.com/article/379032-an-allergy-to-shiitake-mushrooms/
- Food and Drug Administration. (2020, March). Guidance for industry: Temporary policy regarding nutrition labeling of certain packaged food during the COVID-19 public health emergency. FDA. Retrieved from fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-regarding-nutrition-labeling-certain-packaged-food-during-covid-19-public-health
- Food and Drug Administration. (2006, November). Guidance for industry: Questions and answers regarding food allergens (Edition 4). Center for Food Safety and Applied Nutrition. Retrieved from fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergens-edition-4
- University of Nebraska-Lincoln Institute of Agriculture and Natural Resources. (2014, March 10). Allergenic foods and their allergens. Food Allergy Research and Resource Program. Retrieved from farrp.unl.edu/informallspicesherbs
Kimberly Whiteside Truitt writes from experience as a camp food service manager and presented at the 2020 North American Camp Food Service and Maintenance Conference. She is married to Thomas and Mom to Eagle Scouts Harrison and Ben.