June 12, 2017

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“Healthy” Update: Industry, Others Weigh In on ‘Healthy’ Claims

  • As previously reported on this blog, FDA received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods, and in September 2016, FDA issued a request for comments on the use of the term “healthy” on food labels. The Agency received over 1,000 comments by the time the comment period closed on April 26, 2017.

  • In its request for comments, FDA pointed out that the KIND Citizen Petition specifically requested that the Agency update its nutrient content claim regulations to be consistent with current federal dietary guidance, and that the regulation defining the nutrient content claim “healthy” be amended to emphasize whole foods and dietary patterns rather than specific nutrients. Many of the comments from industry focused on specific food products.

    • The New York City Departments of Health and Mental Hygiene, and of Consumer Affairs support allowing all raw, single-ingredient nuts, legumes, seeds, fruits and vegetables to be called “healthy.” However, several industry groups would like that list expanded. Sun-Maid Growers of California suggested that dried fruit with no added sugars should be equally eligible as raw, canned or frozen fruit to use the claim “healthy” on their labels, and the Juice Products Association requested that 100% fruit and vegetable juices and 100% juice blends should also be eligible. The Cranberry Institute stated that FDA should not negate a food’s ability to be labeled as “healthy” if it does not meet criteria for a single nutrient, such as total fat or added sugars; rather, it should be based on a food’s total nutrient content and its role in a healthy eating pattern.

    • Citing evolving scientific evidence supporting the health benefits of unsaturated fats like the type found in avocados, the Hass Avocado Board suggested that limiting the use of “healthy” to foods that are low in total fat is inconsistent with current federal dietary guidance. Also citing advances in science, the United Egg Producers stated that the regulatory threshold for cholesterol content is outdated and should be deleted in its entirety. The group added, “FDA should exempt foods from meeting the low-saturated-fat requirement for the ‘healthy’ claim if they are specifically identified as nutrient-dense.”

  • FDA has not provided a timeline as to when revisions to the definition of “healthy” might occur.  While FDA considers industry’s comments on how best to redefine the term “healthy”, food manufacturers may continue to use the term “healthy” on foods that meet the current regulatory definition (21 CFR 101.65(d)). FDA has also issued a guidance document, stating that FDA does not intend to enforce the regulatory requirements for products that use the term “healthy” provided that certain criteria described in the guidance document are met.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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