Patrick Kennedy_Mérieux NutriSciences_USA

USA - FDA Developing New Regulatory Definition of ‘Healthy’

Hundreds of written comments to be evaluated
Mérieux NutriSciences_healthylabel

The U.S. Food and Drug Administration (FDA) recently held a public meeting (March 2017) to obtain insights from industry stakeholders and consumer advocacy groups regarding the definition and regulatory criteria for a “healthy” food labeling claim.  The meeting featured panel sessions, oral presentations and breakout sessions to facilitate a discussion regarding scientific data, consumer perceptions, and the current federal nutrition guidelines. 

Since the early 1990s, the FDA has permitted the use of “healthy” and related terms as an implied nutrient content claim on food labeling.   Currently,  the agency permits the use of the claim “healthy” if a product satisfies “specific criteria for nutrients to limit in the diet, such as fat, saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber” (21 CFR 101.65(d)).

The agency issued a guidance document in September 2016 entitled "Use of the Term ‘Healthy’ in the Labeling of Human Food Products" (81 FR 66527). The final guidance advised 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.  Within the guidance, the agency highlighted acceptable uses for the labeling term relative to low fat (dependent on the type of fat), and beneficial nutrients such as potassium and vitamin D. 
Since publication of the guidance and notice, the agency received nearly 900 public comments related to the use of the labeling term.  To support the revision of the regulatory definition, the September 2016 notice urged industry stakeholders to submit public comments and scientific data regarding the use of the term “healthy”, which will support the revised regulatory definition.  

Some industry stakeholders have suggested the FDA regulations for health claims and nutrient content claims should be updated to align with the latest nutritional science, including the recommendations published within the 2015-2020 Dietary Guidelines for Americans.  The guidelines suggest a healthy diet for the average adult should be higher in vegetables, fruits, whole grains, low- or non-fat dairy, seafood, legumes, and nuts. 

The revised definition is a critical issue for the food industry since surveys have shown the purchasing decisions of consumers can be influenced by nutrient content claims on food labels. In fact, the FDA’s 2014 Health and Diet Survey (May 2016) indicated nearly 80% of consumers will review a product’s label prior to purchasing a food for the first time.

During the rulemaking process, food manufacturers can continue to market products with “healthy” claims meeting the existing regulatory definition.  The 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 (21 CFR 101.65(d)) 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.

To resolve the labeling issue of “healthy”, the FDA must first review the hundreds of written comments and evaluate the information received the recent public meeting.
The agency has not indicated when the new regulatory definition of “healthy” will be published.

Source: Food and Drug Administration

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