In September 2016, the FDA embarked on a landmark effort to revise the definition of “healthy” – an implied nutrient content claim popular on-pack and in advertising. Prompted by Kind LLC’s Citizen Petition, FDA sought to better align the claim with current scientific understanding and the Dietary Guidelines for Americans (DGA).
In 2017, FDA collected public input on claim revisions via a Request for Information that garnered more than 1,100 comments and in a public meeting attended by more than 200 participants.
Following that March 9 public meeting, the FDA acknowledged in a blog post the incredible diversity of stakeholder views and the complexity of the challenge ahead.
To gauge public opinion and predict the FDA’s potential direction, FoodMinds analyzed 53 letters from key opinion leaders, a sample of the 1,139 comments submitted¹. This analysis revealed four key themes:
- Support for a Food Group and Nutrient “Hybrid” Approach. Recognizing the dietary guidance shift from nutrients to healthy dietary patterns, most comments supported incorporating both nutrients and food groups in an updated claim definition.
- FoodMinds’ Take: While this idea has scientific and public health support, it raises potential enforcement challenges. For example, stakeholders recommended measuring food groups in different ways, such as using USDA cup equivalents or ingredient weights.
- Keep Sodium, Change Fat Criteria. Comments revealed widespread support for retaining sodium criteria, but fat criteria considerations were more varied. They ranged from eliminating the total fat criterion altogether to exempting products with higher monounsaturated and/or polyunsaturated fat-to-saturated fat ratios.
- FoodMinds’ Take: Changes to total fat are likely given that FDA currently exercises enforcement discretion and the issue has 2015-2020 DGA support. A new criterion for trans fat also may be added, consistent with FDA’s 2015 decision to require the removal of partially hydrogenated oils from products.
- New Limit for Added Sugars. Approximately half of comments supported including an added sugars criterion in the revised “healthy” definition.
- FoodMinds’ Take: This change is likely given new nutrition labeling regulations require added sugars labeling, and the move has broad support from industry, science and consumer groups.
- Lots of Ideas, Little Consensus. Those first three themes represent near-consensus among commenters. Other, more surprising recommendations are below. It’s not clear if or how FDA will address these, but they illustrate the many considerations at play:
- Eliminate “healthy” claim altogether
- Ban certain categories – such as red and processed meats, fruit juice, candy, sugar-sweetened beverages and more – from using the claim
- Allow any nutrient with defined Dietary Reference Intakes to count toward a positive nutrition requirement
- Create new categories for “active” people, dairy/milk products, and beverages, and develop individual nutrient profiles for each category
A few months ago, most pundits anticipated that the likelihood of FDA advancing “healthy” regulations during the current presidential administration was slim. FDA’s newly published 2018 Strategic Policy Roadmap suggests otherwise. A final regulation on “healthy” could still be over a year away, but FDA Commissioner Scott Gottlieb announced in early February that he will deliver a speech in “a month or two” revealing more details.
What does this means for your business? Beyond “healthy,” other nutrient content and health claims are due for an update – most haven’t changed since the 1990s. What FDA does with “healthy” could set a new paradigm for U.S. labeling. Business leaders should start preparing now for major marketplace changes. Consider taking the following actions:
- Evaluate products and marketing that currently bears or will soon bear the “healthy” claim or its synonyms; anticipate changes to be made to the regulatory definition in the next 1-2 years.
- Understand that products with nutrition and health positioning likely will need to meet stricter/more progressive standards in the future, and consider innovation and reformulation efforts in this light.
- Anticipate greater scrutiny from consumers and watchdog groups on products bearing “healthy” claims, given that consumers associate “natural” with “healthy."
¹FoodMinds selected the sample of 53 comment letters based on our expert knowledge of food and nutrition affairs. The sample was intended to represent leading voices (based on historic engagement in nutrition policy) across various stakeholder segments, including public health, academia, consumer advocacy, professional membership associations, and consumer packaged goods companies. The sample was not intended to reflect the full array of comments.