November 3, 2016

Patrick Kennedy, Mérieux NutriSciences USA

FDA Updates Criteria for “Healthy” Foods

Issued a final guidance regarding the approved use of the labeling claim “healthy” on packaged foods
Mérieux NutriSciences Healthy Foods

The U.S. Food and Drug Administration (FDA) issued a final guidance regarding the approved use of the labeling claim “healthy” on packaged foods.  The agency has requested industry comments to support FDA’s efforts to align the term “healthy” with the upcoming rules updating the Nutrition Facts Panel and serving size information for packaged foods. The final guidance advises food manufacturers of the agency’s intent to exercise enforcement discretion regarding the use of implied nutrient content claim “healthy” relative to the latest recommendations.  The guidance highlights acceptable uses for the labeling term relative to low fat, and beneficial nutrients such as potassium and vitamin D.  

Currently, the FDA rules permitting the nutrient content claim “healthy” require that a food meet specific criteria for nutrients to limit in the diet (e.g. fat, saturated fat, cholesterol, sodium) and beneficial nutrients (e.g. calcium, iron, protein, fiber, etc).  
The new guidance for the term “healthy” addresses several changes mandated by the final rules for revising the Nutrition Facts Panel. Under the new rules, certain nutrients are no longer recognized to be significant issues for public health, including vitamins A and C.   

Discretionary enforcement will permit manufacturers to continue to market products with “healthy” claims meeting the existing regulatory definition. 
During the rulemaking process, FDA will exercise enforcement discretion for a food bearing the “healthy” claim but not containing at least 10% of Daily Value (DV) per RACC of the approved nutrients provided the food contains at least 10% of the DV per RACC of potassium or vitamin D, or for foods not low in fat, the fat must be predominately mono- and polyunsaturated fats.
Within a Federal Register notice, the agency requested industry comments on the following topics:  

  • What types of food, if any, should be allowed to bear the term “healthy”?
  • What nutrient criteria should be considered for defining “healthy”?
  • How should the definition address nutrients that should be limited or encouraged in the diet?
  • Should the nutrients be intrinsic to the foods, or could they be provided in part – or in total – via fortification?
  • What costs would the industry incur as a result of the change? 

The agency will accept public comments on the labeling term “healthy” until January 26, 2017.  Going forward, the industry should expect the FDA to reconsider additional health and nutrient content claims due to the evolving scientific evidence and federal dietary recommendations.

Mérieux NutriSciences offers food labeling and regulatory services to assist manufacturers to navigate the complex world of nutrition labeling regulations. Our food label consulting service is well versed with global regulations and can support companies seeking to expand into international markets.

Source: Food and Drug Administration

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