On 19 December 2024, the FDA (Food and Drug Administration, USA) announced the publication of the ‘final rule’ that updates the conditions for using the term ‘healthy’ on food labels, on a voluntary basis, in the context of ‘nutrient content claims’.
It is hoped that this will help the US population to correct their diet and mitigate the endemic incidence of obesity, overweight and related NDCs (Non-Communicable Diseases). Argentina is introducing ‘warning labels’, as has already been done in Canada.
1) Diet and health, the American crisis
‘Diet-related diseases, including heart disease, cancer, and diabetes, are the leading cause of disability and illness in the United States and contribute to America’s status as the country with the lowest life expectancy among large, high-income countries.
The data show that:
- 77% of people exceed current dietary recommendations for saturated fat;
- 79% of people have eating habits low in dairy products, fruits and vegetables;
- 63% of people exceed current dietary recommendations for added sugars;
- 90% of people exceed the recommended daily limits for sodium’. (1)
A multimillion dollar lawsuit was also launched on 10 December 2024 against 11 Big Food giants, with a request for ‘exemplary and punitive damages’, for the spread of ultra-processed foods that are harmful to health. (2)
2) Food labelling and reformulation
‘Food labeling can be a powerful tool for change‘, said FDA Deputy Commissioner for Food Jim Jones. The nutritional claim ‘healthy’ on food labels:
– ‘can help promote a healthier food supply if manufacturers choose to reformulate their products to meet the new definition‘, and
– offers ‘an opportunity for industry and others to join us in making [the logo] ‘healthy’ a quick, ubiquitous signal to help people more easily create nutritious diets‘.
The US agency has also already established a public-private partnership with Instacart to implement the ‘Food Is Medicine’ policy, helping consumers find products with the ‘healthy’ claim through online shopping filters and a virtual storefront. (3)
3) Sodium/salt reduction
Reducing sodium/salt from food is in turn part of the ‘White House National Strategy on Hunger, Nutrition and Health’:
– on April 10, 2023, FDA proposed a rule to allow the use of salt substitutes in foods in which salt is a required or optional ingredient, and guidance on using the term ‘potassium salt’ instead of ‘potassium chloride’ to signal to consumers that the ingredient is a salt substitute; (4)
– on August 15, 2024, FDA published a draft guideline for the reformulation of foods in this sense, with the aim of bringing the average daily sodium intake in US citizens, currently excessive (3,4 g before 2021), within the maximum recommended threshold (2,1 g). (5)
4) ‘Dietary Guidelines for Americans’
On 10 December 2024 HSS (Department of Health and Human Services) and USDA (US Department of Agriculture) have submitted the draft ‘2025 Dietary Guidelines Advisory Committee’s (Committee) Scientific Report’ for public online consultation, in view of the upcoming adoption of the ‘Dietary Guidelines for Americans, 2025-2030’. (6)
Dietary guidelines form the basis for national nutrition programs, standards and education. The report is based on scientific evidence and current medical knowledge, as well as considering socio-economic, ethnic and cultural factors. (7) With a focus on promoting balanced dietary patterns at all stages of life.
5) FDA, ‘healthy’ wording on food labels
The indication of the wording ‘healthy’, on the labels of food products marketed in the USA, is subject to specific requirements that have been updated in light of the latest ‘Dietary Guidelines for Americans’. A food product designated as ‘healthy’ must therefore:
– contain a certain amount of ingredients belonging to at least one of the recommended food groups or subgroups (e.g. fruit, vegetables, cereals, fat-free and low-fat dairy products, protein foods), (8) and
– meet specific limits for added sugars, saturated fat, and sodium. Instead of just limits for fat and saturated fat, sodium, and cholesterol, as previously.
5.1) Criteria
Criteria to establish the amount of foods from each food group and their equivalents, as well as the specific limits for the three individual nutrients:
– vary for individual food products, mixed products (containing certain quantities of more than one food group), main courses and meals, and
– are referred to as a ‘Reference Amount Customarily Consumed’, which is the basis for determining the serving size. (9)
5.2) Healthy foods
A series of foods whose consumption is encouraged by dietary guidelines qualify a priori as ‘healthy’ – by virtue of their nutritional profile and positive contribution to an overall healthy diet – provided that they do not contain added ingredients other than water (i.e. ultra-processed foods):
– vegetables and fruit (including avocado)
– whole grains
– fat-free and low-fat dairy products
– lean game meat
– fish products (including fattier fish, i.e. salmon)
– egg
– legumes (e.g. beans, peas, lentils)
– dried fruit with shell and seeds
– olive oils (100%). (10)
The products that contain the recommended foods, with the addition of other ingredients, can instead qualify as ‘healthy’ provided they respect established limits for added sugars, saturated fats and sodium.
The revision of nutritional criteria for the use of this term has thus (finally) excluded products such as: fortified white bread, yoghurt, breakfast cereals and snacks with high sugar contents, fruit-enriched drinks other than ‘100% fruit’ juices.
6) ‘Healthy’ symbol
FDA also continues to study the development of a symbol that manufacturers could use on food labeling to show that a product meets the definition of ‘healthy.’
A logo standardized would in fact help support FDA’s goal of helping consumers identify food products that may be the basis of healthy eating patterns.
Two procedural notices for public comments were published by FDA, in May 2021 and March 2022, for the preliminary quantitative research on 2.000 consumers and an experimental study on 5.000 consumers, in relation to the ‘healthy’ symbol. (11) Unfortunately without investigating other FOPNL (Front-of-Pack Nutrition Labelling) systems, such as the Nutri-Score, which instead offer consumers precise information on the nutritional profiles of individual foods. (12)
7) Brief observations
It is observed how FDA’s attention has been shifted from the content in foods of single nutrients or micronutrients identified as ‘beneficial’ (8) – even if added, such as vitamins and minerals in ‘fortified’ white bread – to the presence of groups of healthy, natural or minimally processed foods.
This passage has an important educational function, as consumers are encouraged to understand the value of the healthiest food groups. As well as to reduce the consumption of ultra-processed foods that researchers, even before the ‘Law Firms’, indicate as harmful to health. (2)
8) Argentina, warning labels
In Argentina, in the meantime, despite the ultra-liberal approach of President Javier Milei, the ‘Ley de Promoción de la Alimentación Saludable’ is being approved, which is expected to introduce a system of mandatory nutritional labelling on the front of packages based on the different concept of ‘warning labels’, already widespread in Central and South America as well as in Canada (13,14.15).
The most contaminated which do not comply with the nutritional profiles established according to the WHO (World Health Organization) guidelines must therefore display the wording ‘excess sugar’, ‘excess total fat’, ‘excess saturated fat’, ‘excess sodium’, ‘excess calories’, as appropriate, to warn consumers of the possible health risks associated with their consumption. (16)
9) Provisional conclusions
The criteria update for the use of the nutritional claim ‘healthy’, in the USA, undoubtedly represents a great step forward for the consideration of added sugars – which the European Food Safety Authority itself has recommended to eliminate or reduce to a minimum, in 2022 (17) – and the attention to the food groups recommended in the dietary guidelines.
It is doubted however that the wording ‘healthy’ on some foods is sufficient to help consumers choose the most balanced products within the numerous food categories. Without offering summary information such as the Nutri-Score which – unlike ‘warning labels’ – offers complete information, even positive, on the nutritional profiles of individual products on the shelf. (18)
Dario Dongo
Footnote
(1) FDA Finalizes Updated “Healthy” Nutrient Content Claim. FDA. Press release, December 19, 2024 https://tinyurl.com/pnct3jm3
(2) Dario Dongo. US, million dollar lawsuit against Big Food. FT (Food Times). December 13, 2024
(3) Public-Private Partnerships. Food Is Medicine. Oash (Office of Disease Prevention and Health Promotion, US) https://tinyurl.com/4pbn97y
(4) Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods. A proposed rule by the Food and Drug Administration on 4.10.23 https://tinyurl.com/2yja2ufy
(5) FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods. FDA. Press release, August 15, 2024 https://tinyurl.com/5mjmbwwx
(6) 2025 Dietary Guidelines Advisory Committee. 2024. Scientific Report of the 2025 Dietary Guidelines Advisory Committee: Advisory Report to the Secretary of Health and Human Services and Secretary of Agriculture. US Department of Health and Human Services. https://doi.org/10.52570/DGAC2025
(7) HSS has indeed found that racial and ethnic minority groups, people with lower socioeconomic status, those living in rural areas and other underserved communities suffer disproportionately from diet-related chronic diseases, compared to the general population.
(8) Previously, products classified as ‘healthy’ were instead required to contain certain amounts of nutrients (e.g. protein, fibre) and micronutrients (e.g. vitamins A and C, calcium, iron, protein or fibre) identified as ‘beneficial’.
(9) Use of the Term Healthy on Food Labeling. FDA https://tinyurl.com/bddv4yyf
(10) In 2018, it is recalled, FDA gave the green light to two ‘qualified health claims’ on the relationship between the consumption of edible oils with at least 70% oleic acid, such as olive oils, and the reduction of the risk of cardio-coronary diseases. See the previous article by Dario Dongo. Oleic acid and coronary heart disease prevention, green light in the USA. GIFT (Great Italian Food Trade).
(11) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods. A notice from FDA on 3.28.22 https://tinyurl.com/283wkf2n
(12) Marta Strinati. NutriScore and three other nutritional labels compared. OECD study. FT (Food Times). February 16, 2024
(13) Dario Dongo. Mexico, off to nutritional warnings on the label front. FT (Food Times). February 10, 2020
(14) Dario Dongo. Canada, label warnings on saturated fat, sugar and salt. FT (Food Times). July 16, 2022
(15) Nutrition labelling: Front-of-package nutrition symbol. Government of Canada. July 11, 2024 https://tinyurl.com/mwn56wdp
(16) Communication from the FAC in favor of the Frontal Etiquette Law. Salud news 24 (ARG). 8.12.24 https://tinyurl.com/ynm5d74z
(17) Marta Strinati. The harmful role of sugars in the diet, EFSA opinion. FT (Food Times). March 1, 2022
(18) Dario Dongo. Nutri-Score and prevention of cardiovascular diseases, study in 7 countries. FT (Food Times). December 8, 2024
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
