Tuesday, November 22, 2016

What is HealthyThe U.S. Food and Drug Administration (FDA) has started a public process to redefine use of the term “healthy” on food product labels. As part of the public process, FDA has published a Request for Information and Comments on Use of the Term “Healthy” in the Labeling of Human Food Products and issued Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products.

Currently, the term “healthy” or related terms (i.e., healthier) may be used as an implied nutrient content claim on the label of a food product if that product is “useful in creating a diet that is consistent with dietary recommendations” and if the food meets specific conditions set by the FDA. These conditions are for total fat, saturated fat, cholesterol, sodium and nutrients to encourage, including vitamin D, potassium, calcium, iron, protein, and dietary fiber (21 CFR 101.65(d)(2)). In addition, the food must comply with definitions and declaration requirements for any other nutrient content claims made on the label.

Redefining “healthy” is just one aspect of FDA’s overall plan to provide consumers with information and tools that will allow them to more easily make healthy food choices, consistent with public health recommendations such as the 2015-2020 Dietary Guidelines for Americans. The recently modified Nutrition Facts Label will now require the amounts of added sugars Vitamin D, and other nutrients to be declared on packaged food products, and updated the Daily Values for nutrients like sodium and dietary fiber. FDA saw a need to redefine use of the term “healthy” to align with the updated nutrient declaration requirements on the Nutrition Facts Label.

Redefining “healthy” will help to avoid misleading claims, and will likely help more consumers make improved food choices, therefore, ultimately improving public health. When consumers see the word “healthy” on the front of a food package, they can be confident that the product meets public health recommendations set in the 2015 Dietary Guidelines for Americans and matches the Nutrition Facts requirements developed by the FDA. FDA also hopes more companies will innovate and reformulate to develop healthier foods products so that they can use the “healthy” claim, providing consumers with a greater variety of “healthy” choices in the marketplace.

Per the guidance for industry, FDA will start to use enforcement discretion for any food label using the term “healthy”, to ensure it is consistent with current public health recommendations based on the latest scientific evidence. Any food product using the nutrient content claim “healthy” must meet FDA’s low fat requirement and must contain at least ten percent of the Daily Value for potassium, vitamin D, calcium, iron, protein, or dietary fiber. Whichever nutrient(s) is being used as the basis for eligibility to be considered as a healthy food product must be declared on the Nutrition Facts label. This guidance will likely evolve and be further developed once FDA has redefined “healthy”.

FDA has asked for public input on a range of questions about what “healthy” should mean from a nutrition science perspective. FDA also wants to know how consumers understand and use “healthy” food label claims. For example, what current dietary recommendations should be reflected in the definition of “healthy”? What are 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”? It is important that consumers and stakeholders, particularly those from the nutrition, food and public health communities, take action and share their feedback with FDA regarding use of the term healthy on food products by the January 26, 2017 deadline to ensure that food product labels help consumers achieve better health. Indeed, the American Society for Nutrition plans to respond.     

In addition, the Agency is planning several public forums as a way to receive additional public input from a broad range of stakeholders and consumers. FDA is also beginning work to evaluate other label claims to determine how they might be modernized. The Agency plans to engage with industry to explore other ways to encourage companies to reformulate and develop new food products to have an improved nutrition profile. This is part of FDA’s overall plan to provide consumers with information and tools that will allow them to more easily make healthy food choices that are consistent with public health recommendations.

For more, see our blog on What is Natural?


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