FDA ruling unlocks the first ever qualified health claim for yogurt
The dairy major had been petitioning the Food and Drug Administration (FDA) for nearly five years to approve a health claim that links yogurt consumption with a reduced risk of developing type-2 diabetes.
Health claims linked to a particular disease can lower the risk of healthy people developing that disease, according to FDA. The agency only allows substances, including food products, to be subject of health claims if these are backed up by sufficient scientific evidence. The agency took almost five years to review evidence provided by Danone North America.
The company supplied 117 publications as evidence to substantiate yogurt’s therapeutic effects, including 50 observational studies, 33 human intervention studies, 11 reviews, 8 meta-analyses and 9 publications related to nutrition, among others. Of these, FDA concluded that 28 observational studies were suitable to draw scientific conclusions from, and 9 publications were considered of a high methodological quality.
In particular, FDA pointed out that most of the statistically significant associations between yogurt intake and reduced risk of type 2 diabetes were found in studies with a high methodological quality, leading the regulator to conclude that there was ‘some credible evidence’ to support the relationship between yogurt intake and reduced risk of the disease. However, this evidence was limited, the agency said.
This means that brands would be able to make health claims that link yogurt consumption with reduced risk of type 2 diabetes, but only if companies clearly state that the claims are based on ‘limited’ evidence.
The regulator has also said a minimum amount that enables the claimed health benefits, rather than a firm serving recommendation, should be included on-pack.
An example health claim would look like this: “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”
“Based on FDA’s consideration of the scientific evidence and other information submitted with your petition, and other pertinent scientific evidence and information, FDA concludes that the current scientific evidence is appropriate for consideration of qualified health claims for consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are appropriately worded to avoid misleading consumers,” FDA wrote in conclusion.
Danone North America’s vice-president of health and scientific affairs, Miguel Freitas, PhD, said: “We know that a growing body of research suggests regular yogurt consumption could reduce your risk of developing one of the most significant and rapidly rising health ailments in the United States.
“That's why we decided to submit a petition for this first-of-its-kind qualified health claim. Our hope is that this announcement will empower consumers with simple, actionable information they can use to help lower their risk of developing type 2 diabetes through a realistic, easy-to-make dietary modification.”
Diabetes is among the 10 major causes of death in the US and impacts more than 37 million Americans (almost 1 in 10), according to the latest CDC data. Around 1.4 million new cases are diagnosed each year, and the majority of these cases are type 2 diabetes. The illness is associated with high blood sugar and is often developed over time and unnoticeably, since symptoms can be hard to spot. Type 2 diabetes can be managed through healthy eating and increased physical activity as well as medications, e.g. insulin.
