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by April Kates

Under normal circumstances, food producers have many plates to spin in order to comply with food regulations, including food labeling requirements. Most especially, in order to assure accurate food ingredient, allergen and nutrition labeling, manufacturers must be certain they possess the most recent characteristics and breakouts of their compound ingredients, and that the nutrition information provided by suppliers is updated regularly (ideally, once a year), so that they can assure their products’ labeling is as accurate as possible.

Reformulation or cost-reducing a product will sometimes result in labeling revisions if there are new ingredients added, existing ingredient modifications or if proportions of a formula’s components are revised. Geographic sourcing, of ingredients can be another issue, if this is something claimed on the label. Based on the density characteristics of the revised product, there could be impacts on the product finished weight as well.

With the COID-19 pandemic, all of the above become possible change-points in a food product almost overnight, and each could be a source of labeling inaccuracies. Almost every facet of a food product can be forced to change due to sourcing, transport, and even potentially a change of manufacturing location due to the impact of disease on the workforce population.

The good news about all this is that the Food and Beverage Issues Alliance (FBIA), which consists of over 55 FDA-regulated food manufacturing organizations, has developed protocols for the food industry during this pandemic. FBIA consulted with FDA and the CDC as these documents were developed. Among the documents published thus far, the FBIA has developed Food Industry Recommended Protocols When Employee/Customer Tests Positive for COVID-19, Proper Usage of Face Masks, Emergency Prevention Measures to Achieve Physical Distancing in Food Manufacturing Facilities as Related to Covid-19, and steps for Screening Food Industry Employees for Covid-19 Symptoms or Exposure. These can be found at their website, FeedingUs.org.

In addition, the FBIA approached FDA to develop proactive guidelines for the food industry as it is impacted with the aforementioned issues impacting the accuracy of food labeling.

On May 22, 2020, FDA issued a guidance entitled, Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Reformulation Changes and Vending Machines.” The guidance is in effect during the public health emergency; FDA plans to consider whether an extension of the policy will be warranted after the end of the emergency as the food and agriculture sectors return to normal.

In the guidance, FDA sets out a framework including General Factors for Minor Formulation Changes during the Pandemic. These factors include: Safety (where allergens or sulfites not on the ingredient list are not introduced), Quantity (the policy applies to ingredients present at 2% or less by weight of a finished food), Prominence (where the ingredient being omitted or substituted for the ingredient on the label is not a major (or claimed) ingredient, Characterizing or Ingredient Name (where the omitted ingredient is not a characterizing ingredient (lemons in lemonade, for example)), Claims (where the omitted ingredient is not affecting any labeled nutrient content or health claim), and Nutrition/Function (where an ingredient does not have a major impact on the finished food).

Regarding Ingredient Omissions or Reductions: FDA states in their guidance they do not intend to object if minor, non-characterizing ingredients are temporarily reduced in amount or omitted from a formulated food without corresponding label changes. One criteria FDA notes is that the reduction of an ingredient will not cause a big impact in the order of predominance of ingredients.

For Ingredient Substitutions, FDA as well does not intend to object if an ingredient is substituted for a minor ingredient where it is temporary, where the substitute ingredient is non-characterizing, is present at less than 2%, does not cause the label to be inconsistent with labeling requirements, and there are no safety or allergen issues. FDA specifically discusses flavoring and spice blend ingredient substitutions as well as food colorings and organic acids.

For substitutions of ingredients present at greater than 2 percent, FDA notes in these cases, they would permit substitutions when another variety of the same ingredient is substituted for another, as long as it is not a characterizing ingredient and the name of the variety is not made on the label outside of the ingredient list. An example would be substitution of green bell pepper with red bell pepper. Different fats and oils may also be substituted temporarily, if they are not prominent ingredients, the oils are highly refined, and the oils are from the same category of vegetable, animal or marine oils with a similar fatty acid profile.

Insofar as voluntary geographic origin label claims are concerned, the Agency also does not intend to object if a firm has to substitute another ingredient that does not meet the geographic origin claim, during the pandemic.

FDA is also providing flexibility with regard for substitutions of unbleached flour for bleached flour as an ingredient in food, and also as the finished food product offered for sale, due to ingredient shortages of flour bleach during the pandemic.

Additionally, with regard to vending machine food labeling, FDA is not intending to object for vending machine operators not meeting the calorie labeling requirements during the public health emergency.

Some consumer groups have raised questions and provided comments to the FDA docket regarding certain aspects of the Temporary Policy, especially with regard to minimizing the potential for inadvertent allergen introduction. The food industry is aware of these concerns and plans to be communicate any ingredient substitutions to consumers by manufacturer websites or at point of sale.

FDA has already been open to providing more flexibility for the industry because of the pandemic. They have issued several guidance documents to assist the food industry.

On March 26, 2020, FDA issued a Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. This action notes FDA will not object to restaurants selling packaged foods directly to consumers, or to the sale of packaged foods by food manufacturers to restaurants, without a nutrition label, provided there is no nutrient content claim and these foods still display a statement of identity, ingredient statement, name and place of business of the manufacturer, packer or distributor, the net quantity of contents, and allergen information. FDA stated they wouldn’t object to this until retail packaging is available for these products.

FDA additionally stated they will not focus on enforcement of the new nutrition facts labeling regulations for the remainder of this year, which gives the industry an additional 6 months to comply.

On April 1, 2020, FDA issued a guidance, “Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency.” In this temporary policy, FDA stated that while they encourage covered firms to comply with menu labeling requirements, it would not object if covered restaurants and food establishments do not meet the normal menu labeling requirements under 21 CFR 101.11.

On April 3, 2020, FDA published a “Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency.” This guidance provides temporary flexibility regarding eggs sold in cartons or flats without labels, provided the retailer clearly displays at the point of purchase the statement of identity, the name and place of business of the manufacturer, packer, or distributor, and safe handling instructions for shell eggs that have not been processed to destroy all viable Salmonella. The shell eggs must be sold by the complete carton or flat, and there must be no nutrition claims at the point of purchase for the shell eggs. FDA does not intend to object if the food lacks a nutrition facts label, but as availability of packing and labeling materials improve, FDA expects full labeling on these products as soon as possible.

On the supply side of the egg issue, on April 6, 2020 FDA published a Temporary Policy Regarding Enforcement of 21 CFR Part 118 (Egg Safety Rule) during the Covid-19 Public Health Emergency. The goal of this guidance is to help correct inbalances in the egg market due to the COVID-19 pandemic. The Policy states that because of increased demand for eggs sold directly to consumers in retail establishments, FDA is providing temporary flexibility to allow producers who normally only sell eggs to facilities for further processing, to sell their eggs to retail establishments, when certain specific conditions are present at individual poultry houses.

No matter what the changes are to your product, your best friend is documentation for what changes have been made to a product formula, and the nutrition labeling and ingredient statement impact of the formula changes on the product, versus the information on the current label in use. Such documentation not only helps a firm keep their records clear for employees to follow, it also provides a backup for when a regulatory agency inspects your firm and is wanting to know whether and if there are documented changes and why. If litigation issues should arise, good recordkeeping shows you followed recommendations from government regulatory authorities.

Posted in COVID-19, Foods, Issue of the Month.