FDA Temporarily Loosens Formulation, Vending Machine Regulations
05.28.20
It appears that the new policy will last throughout the COVID-19 public health emergency.
On May 22, FDA issued a temporary policy which will loosen certain regulations surrounding both formulation changes and vending machines.
Companies under FDA regulation which make minor formulation adjustments in response to ingredient shortages or supply chain disruptions as a result of the COVID-19 pandemic will not have to change labeling in order to reflect those changes, as would ordinarily be required immediately to prevent the sale of products that are misbranded or adulterated.
As a result of the COVID-19 pandemic, FDA reports that the food industry informed them that manufacturers have had to resort in large scale to formulation changes, including the omission or substitutions of minor ingredients, and that in order to make labeling changes, these companies would have to slow down production and distribution of some foods.
Any ingredient that is being substituted for a labeled ingredient must not cause any adverse health effect, including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities. Additionally, any changes must be present at 2% or less by weight in any finished food product. Additionally, any ingredient being omitted or substituted for the labeled ingedient must not be a prominent ingredient, such as FDA’s provided example of substituting rice flour for wheat flour in a muffin, or any ingredient that is the subject of a label statement, such as butter in a cookie with a “made with real butter” claim.
Ingredients cannot be omitted or substituted if they are a characterizing ingredient, or are an ingredient in the name of a product. Additionally, the omission or substitution of an ingredient must not affect any nutrient content or negate any health claims on a label, and must not have a significant impact on “nutritional differences or functionality.”
FDA doesn’t intend to object if a manufacturer substitutes an artificial flavor with another artificial flavor, or a natural flavor with another natural flavor, so long as the flavors aren’t “characterizing” and do not introduce new allergens. Colors and Acids can also be substituted if the substitutions are manufactured with good manufacturing practices and do not pose an allergenic risk.
“FDA is issuing this guidance to food manufacturers to provide temporary and limited flexibilities in food labeling requirements under certain circumstances. Our 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 agency said in a statement.
“This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services, including any renewals made by the HHS Secretary […] However, we recognize that the food and agricultural sector may need additional time to bring its supply chains back into regular order. Therefore, upon termination of the public health emergency, FDA intends to consider and publicly communicate regarding whether an extension, in whole or in part, is warranted, based on comments received to this guidance and our experience with its implementation.”
Additionally, vending machine operators with 20 or more vending machines will not be required to disclose the calorie information for food sold from vending machines, subject to certain exemptions, at this time, though they are encouraged to do so.
“As a result of the COVID-19 public health emergency, we do not intend to object if covered vending machine operators do not meet the vending machine labeling requirements under section 403(q)(5)(H)(viii) of the FD&C Act (21 U.S.C. 343(q)(5)(H)(viii)) and 21 CFR 101.8 during the duration of the public health emergency,” FDA said.
Companies under FDA regulation which make minor formulation adjustments in response to ingredient shortages or supply chain disruptions as a result of the COVID-19 pandemic will not have to change labeling in order to reflect those changes, as would ordinarily be required immediately to prevent the sale of products that are misbranded or adulterated.
As a result of the COVID-19 pandemic, FDA reports that the food industry informed them that manufacturers have had to resort in large scale to formulation changes, including the omission or substitutions of minor ingredients, and that in order to make labeling changes, these companies would have to slow down production and distribution of some foods.
Any ingredient that is being substituted for a labeled ingredient must not cause any adverse health effect, including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities. Additionally, any changes must be present at 2% or less by weight in any finished food product. Additionally, any ingredient being omitted or substituted for the labeled ingedient must not be a prominent ingredient, such as FDA’s provided example of substituting rice flour for wheat flour in a muffin, or any ingredient that is the subject of a label statement, such as butter in a cookie with a “made with real butter” claim.
Ingredients cannot be omitted or substituted if they are a characterizing ingredient, or are an ingredient in the name of a product. Additionally, the omission or substitution of an ingredient must not affect any nutrient content or negate any health claims on a label, and must not have a significant impact on “nutritional differences or functionality.”
FDA doesn’t intend to object if a manufacturer substitutes an artificial flavor with another artificial flavor, or a natural flavor with another natural flavor, so long as the flavors aren’t “characterizing” and do not introduce new allergens. Colors and Acids can also be substituted if the substitutions are manufactured with good manufacturing practices and do not pose an allergenic risk.
“FDA is issuing this guidance to food manufacturers to provide temporary and limited flexibilities in food labeling requirements under certain circumstances. Our 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 agency said in a statement.
“This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services, including any renewals made by the HHS Secretary […] However, we recognize that the food and agricultural sector may need additional time to bring its supply chains back into regular order. Therefore, upon termination of the public health emergency, FDA intends to consider and publicly communicate regarding whether an extension, in whole or in part, is warranted, based on comments received to this guidance and our experience with its implementation.”
Additionally, vending machine operators with 20 or more vending machines will not be required to disclose the calorie information for food sold from vending machines, subject to certain exemptions, at this time, though they are encouraged to do so.
“As a result of the COVID-19 public health emergency, we do not intend to object if covered vending machine operators do not meet the vending machine labeling requirements under section 403(q)(5)(H)(viii) of the FD&C Act (21 U.S.C. 343(q)(5)(H)(viii)) and 21 CFR 101.8 during the duration of the public health emergency,” FDA said.
