FDA: We need to look again at the conditions of use for ‘healthy’ claims

The move – outlined in a blog post by Douglas Balentine, PhD, director, Office of Nutrition and Food Labeling at FDA’s Center for Food Safety and Applied Nutrition – follows a spat with snack bar maker KIND, which was engulfed in a media firestorm (and a flurry of false advertising lawsuits) after the FDA took issue with its use of the term ‘healthy’ on pack in 2015 (click HERE).

The problem, according to KIND – which uses lots of nuts in its bars - is that food labeling regs mandate that the term ‘healthy’ can only be used as a nutrient content claim to describe foods that (among other things) contain 3g or less total fat and 1g or less of saturated fat per serving, with the exception of fish and meat (which are subject to slightly different criteria).  

In other words, said KIND, the regulations require that the majority of foods marketed as ‘healthy’ must also meet the criteria for ‘low fat’ and ‘low saturated fat’ claims, “regardless of their nutrient density,” which means that fat-free puddings and sugary cereals can be labeled as ‘healthy’, while “nutrient-rich foods such as nuts, avocados, olives and salmon” cannot.

FDA: Our thinking on nutrition has evolved

After some soul searching –and a citizen’s petition from KIND – the FDA has since told KIND it can use the term ‘healthy’ – with certain caveats – and unveiled plans to re-evaluate its conditions of use for 'healthy' and other nutrient content claims.

According to Dr Balentine: “As our understanding about nutrition has evolved, we need to make sure the definition for the ‘healthy’ labeling claim stays up to date. For instance, the most recent public health recommendations now focus on type of fat, rather than amount of fat. They focus on added sugars, which consumers will see on the new Nutrition Facts label. And they focus on nutrients that consumers aren’t getting enough of, like vitamin D and potassium.

“We have started to consider the criteria or terms for an updated definition of ‘healthy’ but don’t have all the answers. As a first step, we are asking for public input on a range of questions about what ‘healthy’ should mean from a nutrition perspective and how consumers understand and use “healthy” food label claims.

“While we are working on the ‘healthy’ claim, we also will begin evaluating other label claims to determine how they might be modernized.”

Questions stakeholders are being asked to consider include:

• What current dietary recommendations should be reflected in the definition of ‘healthy’?
• What are the public health benefits of defining the term ‘healthy’?
• What do consumers expect of foods that carry a ‘healthy’ claim?
• What factors and criteria should be used for the new definition of ‘healthy’?  

“We appreciate that the FDA has taken action to implement interim labeling guidance – a recommendation put forth in our Citizen Petition. The new direction is more consistent with the latest nutrition guidance, which encourages the consumption of nutrient dense foods that contain predominantly unsaturated fats.” 

Justin Mervis, head of regulatory affairs, KIND

FDA will exercise enforcement discretion

A new FDA guidance document that is “immediately effective” meanwhile, states that FDA will not enforce current regulatory requirements for products that use the term ‘healthy’ if they:

(1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

(2) Contain at least 10% of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Readers can submit comments to docket folder FDA-2016-D-2335

"We are re-evaluating the regulatory criteria for use of the implied nutrient content claim 'healthy' in light of the latest nutrition science and the current dietary recommendations and seek input on possible future rulemaking to update the existing regulations for this claim. Because the rulemaking process can sometimes be lengthy, we intend to exercise enforcement discretion in the interim with respect to some of the existing criteria for the nutrient content claim 'healthy' if the alternative nutrient criteria described below are met."

FDA: Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry, Sept 2016