On March 1, 2024, the Food and Drug Administration (FDA) issued a letter of enforcement discretion stating that it does not intend to object to the use of qualified health claims relating to the yogurt consumption and the reduction of type 2 diabetes risk.
What is a qualified health claim (QHC)?
In the USA, there are qualified health claims for which scientific evidence exists, but their level does not meet the more rigorous standard of “substantial scientific agreement” required for authorized health claims. In order not to mislead consumers, qualified health claim wording includes a disclaimer or qualitative wording that accurately communicates to consumers the level of evidence supporting the claim.
A food manufacturer may ask the FDA to consider the use of enforcement discretion for the use of a qualified health claim. In this circumstance, the FDA does not approve qualified health claim petitions. If the scientific evidence communicated in the petition for a QHC is credible, the FDA issues a letter of enforcement discretion specifying the specific claim language that reflects the level of substantiating scientific evidence and the details of the enforcement discretion under which the FDA will not object to the use of the QHC.
Subject of the qualified health claim:
The qualified health claim concerns yogurt as a food. It does not relate to a nutrient or a constituent, and is independent of sugar or fat content.
For what health effect?
The FDA has assessed the scientific evidence submitted and has concluded that there is credible but limited evidence to support a relationship between yogurt consumption and a reduced risk of type 2 diabetes.
For which level of yogurt to achieve the claimed effect?
On the basis of all the scientific evidence relating to yogurt consumption and the reduction in the risk of type 2 diabetes, the FDA considers that 2 pots (3 portions) of yogurt per week is the minimum quantity for this qualified health claim.
FDA qualified health claim wordings:
FDA intends to consider exercising its enforcement discretion for the following qualified health claims:
– “Eating yogurt regularly, at least 2 pots (3 servings) per week, may reduce the risk of type 2 diabetes. The FDA has concluded that there is limited information supporting this claim.”
– “Eating yogurt regularly, at least 2 pots (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”
To know more on the petition for the authorization of a qualified health claim for yogurt and reduced risk of diabetes.
Orchidali can support you to prepare, write and submit a health claim to the EU Commission.
Français
A qualified health claim for yogurt in the U.S.
On March 1, 2024, the Food and Drug Administration (FDA) issued a letter of enforcement discretion stating that it does not intend to object to the use of qualified health claims relating to the yogurt consumption and the reduction of type 2 diabetes risk.
What is a qualified health claim (QHC)?
In the USA, there are qualified health claims for which scientific evidence exists, but their level does not meet the more rigorous standard of “substantial scientific agreement” required for authorized health claims. In order not to mislead consumers, qualified health claim wording includes a disclaimer or qualitative wording that accurately communicates to consumers the level of evidence supporting the claim.
A food manufacturer may ask the FDA to consider the use of enforcement discretion for the use of a qualified health claim. In this circumstance, the FDA does not approve qualified health claim petitions. If the scientific evidence communicated in the petition for a QHC is credible, the FDA issues a letter of enforcement discretion specifying the specific claim language that reflects the level of substantiating scientific evidence and the details of the enforcement discretion under which the FDA will not object to the use of the QHC.
Subject of the qualified health claim:
The qualified health claim concerns yogurt as a food. It does not relate to a nutrient or a constituent, and is independent of sugar or fat content.
For what health effect?
The FDA has assessed the scientific evidence submitted and has concluded that there is credible but limited evidence to support a relationship between yogurt consumption and a reduced risk of type 2 diabetes.
For which level of yogurt to achieve the claimed effect?
On the basis of all the scientific evidence relating to yogurt consumption and the reduction in the risk of type 2 diabetes, the FDA considers that 2 pots (3 portions) of yogurt per week is the minimum quantity for this qualified health claim.
FDA qualified health claim wordings:
FDA intends to consider exercising its enforcement discretion for the following qualified health claims:
– “Eating yogurt regularly, at least 2 pots (3 servings) per week, may reduce the risk of type 2 diabetes. The FDA has concluded that there is limited information supporting this claim.”
– “Eating yogurt regularly, at least 2 pots (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”
To know more on the petition for the authorization of a qualified health claim for yogurt and reduced risk of diabetes.
Orchidali can support you to prepare, write and submit a health claim to the EU Commission.
Tags: