FDA Review: The Role of Health Claims in Exporting Food Specialties to the USA

To sell food in America, labels must be compliant

The United States Food and Drug Administration has made a significant decision that could impact Italian companies interested in exporting, importing, and selling food products in the American market. In a letter, the FDA stated that it will approve certain health claims (or Qualified Health Claims) related to the consumption of yogurt and the reduction of type 2 diabetes risk, provided these claims are made in a way that does not mislead consumers and that other criteria for their compliant use are met.

What does this mean for labels on products destined for the American market?

Labels on food products for export to America, as well as those for import and sale in the American market, play a crucial role in communicating the benefits and characteristics of the products to consumers. The FDA's decision opens up new possibilities for food companies wishing to highlight the potential health benefits of yogurt on their labels, expanding marketing opportunities and product positioning in the US market.

Requirements for Qualified Health Claims (QHC)

A qualified health claim is supported by scientific evidence but does not meet the more stringent standard of "significant scientific agreement" required for an authorized health claim. The FDA responded to a petition regarding such a claim submitted by Danone North America, requesting the agency to examine the use of a claim concerning the relationship between yogurt consumption and the reduction of type 2 diabetes risk for all types of yogurt that meet the FDA's Standard of Identity.

After reviewing the petition and other evidence related to the proposed claim, the FDA determined it will not object if Danone states that yogurt consumption reduces the risk of type 2 diabetes. There is indeed some evidence supporting a relationship between yogurt intake and a lower risk of developing diabetes.

The authorized claims are as follows:

• “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim." (Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. The FDA has concluded that the information supporting this indication is limited);
• Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.” (Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes, according to limited scientific evidence).

Implications for Importing Food Products into the United States

For companies aiming to export food products to America, understanding and adhering to the FDA's guidelines is crucial to ensure market access and successful sales. The recent FDA decision regarding yogurt emphasizes the importance of basing health claims on credible scientific evidence and communicating these benefits transparently and non-deceptively through product labels. Needless to say, if the rules are followed, health claims can be valuable allies for food businesses in the US market.