By: Daniel Dwyer, Jacqueline Chan, and Vanessa Fulton
On May 22, 2020, FDA issued a guidance document providing temporary flexibility for certain food labeling requirements for manufacturers and vending machine operators related to the COVID-19 pandemic (“Guidance”).[1] Specifically, FDA recognized that COVID-19 has caused supply chain issues or shortages for some ingredients, which may require manufacturers to make certain formulation changes (such as omissions or substitutions of minor ingredients) which would typically require the manufacturer to make conforming label changes. Notably, although the Guidance is intended to remain in effect only for the duration of the public health emergency, FDA intends to consider whether an extension would be warranted and will publicly communicate the same.
Minor Formulation Changes and Food Labeling
The Guidance explains that, in certain circumstances, FDA will not object to the food industry making certain temporary and minor formulation changes without making conforming label changes when there are supply disruptions or ingredient shortages as a result of the COVID-19 pandemic. The Guidance provides several general factors describing what FDA considers to be “minor” formulation changes. It also provides that formulation changes that are not considered “minor” would not be subject to FDA enforcement discretion; examples of such changes are: (1) changes to a characterizing ingredient, (2) changes that add a potential allergen or ingredient that can cause sensitivity, or (3) changes that affect nutrient content claims and health claims.
Of note, FDA strongly encourages manufacturers to continue making conforming label changes (including by use of stickers) when they need to make formulation changes due to COVID-19-related supply disruptions or shortages. If label change revisions are not possible, then FDA recommends manufacturers use alternative ways to inform consumers of ingredient changes, such as posting information on the product/company’s website or through point of sale labeling.
Although FDA intends to exercise enforcement discretion for “minor” formulation changes without conforming label changes, companies should also consider the risk of a consumer or competitor challenge. We recommend that companies consider their product labels holistically and assess the risk of potentially misleading consumers whose purchases are dependent on the label. FDA’s temporary policy would be unlikely to effectively insulate companies from consumer or competitor challenges.
We provide a brief summary of the Guidance below.
- FDA encourages the food industry to check existing regulations that already provide some labeling flexibility that would not require a label change when a substitution is made (e.g., use of generic terms for flavors, spices, and certain colors; use of “and/or” labeling for certain ingredients).
- Formulation changes to foods that involve a food standard (e.g., 21 CFR parts 130 through 169) are generally not covered under the Guidance, with the exception of omitting bleach from bleached flour. (21 CFR § 137.105(b)(2)).
- Changes should not introduce any allergens, foods that can cause sensitivities (e.g., gluten, sesame, sulfites, glutamates), adverse reactions, or other safety concerns.
- Changes or substitutions to characterizing ingredients are generally not covered under the Guidance. This applies regardless of the percentage of ingredient in the food.
- Examples of substitutions not covered under the Guidance include replacing mushrooms with peas in a mushroom soup, or replacing strawberry flavoring with chocolate flavoring in a strawberry popsicle.
- Changes to a variety of an ingredient may be covered under the Guidance, as long as a specific variety is not itself a characterizing ingredient or the subject of a claim on the product label.
- For example, replacing portobello mushrooms with button mushrooms in a mushroom soup where the label states “made with portobello mushrooms” would not be covered under the Guidance.
- In contrast, replacing portobello mushrooms with button mushrooms in a mushroom soup that only includes “portobello mushrooms” on the ingredient list (and nowhere else on the product label) may be covered by the Guidance.
- Changes to minor non-characterizing ingredients (omissions, reductions, and substitutions) may be covered by the Guidance as long as:
- any reduction does not significantly change the order of predominance on the ingredient list;
- the change does not affect any nutrient content claims or health claims on the label;
- the change does not have a significant impact on the finished product, including nutritional differences or functionality;
- any substitution does not pose any safety or allergen concerns, is safe and suitable for the intended use, and is used in accordance with GMPs.
- Fats and oils, even those present at 2% or greater, may be substituted for each other as long as: (1) the fat or oil is not a prominent ingredient; (2) the oil is highly refined; (3) there is no potential allergenic risk; (4) the replacement is in the same oil “category” (i.e., vegetable, animal, or marine); and (5) the oils have similar fatty acid profiles to minimize the impact on nutritional profile.
- Substitutions of ingredients from different geographic origins are permitted as long as the substitution is not for the food itself. Note, however, that this does not alter the requirement for accurate country-of-origin labeling under Customs and Border Protection and/or USDA laws.
Vending Machine Labeling
FDA recognizes that there are currently multiple COVID-19 related disruptions to the vending machine industry, and that it may be difficult for vending machine operators to comply with specific labeling requirements for calorie information. As a result, the Guidance provides that FDA will not object if vending machine operators do not meet the vending machine labeling requirements under 21 U.S.C. § 343(q)(5)(H)(viii) and 21 CFR § 101.8 during the public health emergency related to COVID-19.
Conclusion
Since the beginning of the COVID-19 pandemic, FDA has actively engaged the food and beverage industry. FDA has issued – and continues to issue – guidances to address COVID-19-related complications affecting the food and beverage industry, including guidances on nutrition labeling and manufacturing issues (e.g., closure and reduction of production by food establishments; FSMA-related issues; shell egg production). FDA’s full list of COVID-19-related guidances may be found here. We will continue to monitor these guidances. Please let us know if you have any questions or would like to discuss further.
[1] FDA Guidance for Industry: Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines (May 2020).