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The Impact of Covid-19 on the Regulatory Framework – Part 4

Over the course of the following weeks and months, we will be sharing news that are directly linked to the Covid-19 pandemic and impacting the regulatory affairs markets such as dietary supplements, medical devices, cosmetics, and more.


Formulation Changes Without Label Changes


During the coronavirus crisis, manufacturers have faced supply chain issues and ingredient shortages which have impacted food production. The ability to access certain ingredients as well as personnel and work force limitations have prompted FDA response. FDA published a guidance document allowing for temporary flexibility in food labeling for certain situations. FDA notes that their “goal is to provide regulatory flexibility, where fitting, to help minimize the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability”. The following is summarized from the FDA Guidance Document1 and the FDA Q&A Document2.

This guidance will allow for some replacement or omissions of certain ingredients in minor and temporary formulation changes without requiring a change in the food label. This means that foods with minor formula adjustments due to COVID-19 supply chain issues or ingredient shortages may be able to keep using existing labels in certain situations. However, it should be noted that this flexibility is still limited. Per the guidance document, the following general factors should be considered when determining if the change would be permitted without a corresponding label change:

• SAFETY: the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities in some people, for example, glutamates);
• QUANTITY: generally present at 2 percent or less by weight of the finished food;
• PROMINENCE: the ingredient being omitted or substituted for the labeled ingredient is not a major (prominent) ingredient (for example, replacing rice flour for wheat flour in a muffin) or an ingredient that is the subject of a label statement (such as, butter in a cookie with a “Made with real butter” claim);
• CHARACTERIZING OR INGREDIENT IN NAME: the ingredient being omitted or substituted for the labeled ingredient is not a characterizing ingredient (such as omitting raisins in a raisin bread) where the presence of the ingredient has a material bearing on consumer purchasing;
• CLAIMS: an omission or substitution of the ingredient does not affect any voluntary nutrient content or health claims on the label; 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).


  • Use of slightly less of a minor ingredient (if there is not a significant change to the order of predominance), specific examples are provided in the guidance document
  • Substitutions of non-characterizing ingredients at less than 2% for other safe ingredients with similar technical functions
  • Replacement of lactic, malic, or citric acid with one another would not be objected to if used in accordance with good manufacturing practices
  • Certain flavor, spice, or color substitutions
  • Similar ingredients (for example, different variety of mushrooms)
  • Fats and oil substitutions of similar source/nutritional profile (for example, canola and sunflower oils)
  • Ingredients from a specific geographical region (for example, California raisins)
  • Substitution of bleached flour with unbleached flour

It is important to follow the specific guidelines laid out by FDA for each of the above examples and to avoid any substitution ingredients that would pose an allergenic risk.


The policy for flexibility in food labeling requirements will only be in effect for the duration of the COVID-19 pandemic emergency as determined by the Department of Health and Human Services. FDA indicates that they will communicate the termination or extension of this policy when the public health emergency is over.


Manufacturers should make all feasible efforts to adhere to regular food labeling requirements, even if the flexibility from FDA is permitted for a specific minor change. It is also recommended to evaluate the feasibility of alternative labeling when possible (for example a label sticker, website posts, etc.) to inform the consumer of the ingredient change made. The FDA Guidance Document should be consulted carefully to make sure the change is permitted within the policy. Care must also be taken to ensure that the ingredient changes made do not pose any health risk, particularly in regard to allergenic ingredients. Substitutions/replacements should not be made with allergenic ingredients without revising the product labeling, these would include:

  • Any of the eight major allergens – milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans
  • Other priority allergenic ingredients – including but not limited to – sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard
  • Ingredients that might cause adverse reactions – including but not limited to – glutamates and sulfites