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Revised Guidance in the US Regarding ‘Healthy’ Claims

Revised Guidance in the US Regarding ‘Healthy’ Claims

In September 2022, the Food and Drug Association (FDA) proposed new guidance regarding the use of the term ‘healthy’ on food labels. The move is in response to a report that found that the majority of people in the US don’t consume enough fruit, vegetables and dairy. So, what’s the plan behind the new guidance, and how will it affect labels?

A report by the FDA found that more than 80% of people in the US don’t consume enough fruit, vegetables and dairy, and instead are eating too many added sugars, saturated fats and sodium [1]. To help empower consumers to make better, clearer and more informed diet choices, the FDA is hoping to counteract these food-related health issues with new guidance on the term ‘healthy’.

With type-2 diabetes and cardiovascular disease being leading causes of death in both men and women in the US, the FDA wants to better educate consumers on their food choices when purchasing items [2]. This new legislation will clearly highlight foods that are healthier, such as fruit, vegetables, whole grains, and products with limited saturated fat, sodium and higher dietary fiber, so that it may encourage healthier food choices, and in turn, reduce the risk of diet-related disease.

What are the key changes that the revised guidance on ‘Healthy’ claims introduces?

In order to display the claim ‘healthy’, the FDA is bringing in strict criteria that manufacturers must abide by. If the food product doesn’t meet these, then labeling and marketing can no longer use the definition ‘healthy’ in any manner:

  • Food products must contain a certain amount of food – a food group equivalent – from at least one of the food groups or subgroups, as recommended by the Dietary Guidelines, 2020-2025.

These food groups/subgroups include vegetables, fruits, grains, dairy, protein, oils.

  • Food products must be limited in certain nutrients.

Current legislation dictates that limits are in place for saturated fat and sodium, but added sugars will also be introduced.

  • Recordkeeping requirements for foods bearing the ‘healthy’ claim where compliance cannot be verified through information on the product label, must be met and maintained.

What are the motivations for this revised guidance?

The main focus of this rule is to improve the overall health of US consumers – by being able to clearly showcase to them products that are a ‘healthy’ choice, the FDA hopes that they will make better choices, and overall improve health and reduce the risk of diet-related diseases.

It also links with the National Strategy [3], which states the changes and advancements they wish to make within US society by 2030. This includes: ending hunger, improving nutrition and physical activity, reducing diet-related disease, and closing disparity gaps.

What does this mean for manufacturers?

This proposed rule allows manufacturers to showcase the product’s healthfulness to consumers clearly. Therefore, companies producing ‘healthy’ products that contain whole grains, healthy fats, and are low in sodium, have a better opportunity to showcase their nutritional benefits.

What changes are consumers likely to notice?

Prior to this newly released guidance, foods like white bread, sugary cereals and yogurts were considered healthy simply because they were low in fat. However, under this updated regulation, these foods, along with many other products previously emphasized as being healthy choices, are no longer able to bear this claim.

This will enhance standardization and provide a clearer understanding for consumers about what is considered to be healthy. Previously, a variety of statements could be found on labels, which were deemed to be confusing to comprehend and compare, including low in fat, low in sugar, and less added sugar.

How will this be identifiable on the packaging?

The FDA recognizes that consumers lead busy lifestyles, and researching a product’s healthiness or reviewing the ingredients list during a shop isn’t always a viable or suitable option. For this reason, they’re developing a universal symbol to be added to Front of Pack (FOP) labels, which will allow consumers to easily and clearly identify healthy options in-store. In turn, they hope this will create a wider awareness of the quality and benefits a food product will bring, and eventually improve the overall health of US citizens.

What challenges are likely to be faced?

With many of the ‘healthy’ products being whole fruits and vegetables, which are typically sold loose or without food labels, the logo would be futile in many cases. Due to this, there’s much speculation about whether the addition of the symbol will be useful, or whether it will miss the mark and become redundant.

What do manufacturers, retailers and businesses need to do?

It’s crucial that manufacturers, retailers and businesses that currently have products claiming to be ‘healthy’ re-evaluate this claim against the proposed changes and the newly introduced criteria. If it no longer meets it, then this definition must be removed from all labels and marketing items.

Plus, manufacturers of products that do qualify with the revised definition of ‘healthy’ within the US market should acknowledge this by including the relevant logo and claims on labels. This will ensure that consumers are fully informed, can accurately review the market as a whole when purchasing food items, and can make accurate choices to aid their diet and overall health.

With an ever-increasing consumer awareness of food products – their healthiness, and the benefits it has on our health and wellbeing – manufacturers need to review their current claims and definitions used. If they no longer comply with the revised legislation, labels for products sold in the US will need to be adapted appropriately to ensure they don’t mislead consumers.

Ashbury provides practical guidance to help you navigate FDA regulations, such as those that apply to ‘healthy’ claims. Get in touch to protect your brand today.

[1] www.fda.gov/news-events/press-announcements/fda-proposes-updated-definition-healthy-claim-food-packages-help-improve-diet-reduce-chronic-disease

[2] www.cdc.gov/diabetes/library/features/diabetes-and-heart.html

[3] www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf

Kayleigh Lieberman, Senior Regulatory Affairs Advisor

Author: Kayleigh Lieberman

I am a Registered Dietitian with a passion for food and beverage innovation. Since 2016, I've worked closely with leading brands to bring compliant products to the US market. I am thrilled to help businesses tackle this complex space in a practical and positive way.

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