While the FDA must complete the notification and comment process, the industry now has the agency`s current deliberations on what will be required. Given the investment required to amend product labels and the potential for misleading advertising litigation related to compliance with labelling requirements in recent years, companies should consider whether a health claim remains an option or whether they want to focus on a claim that is not limited by a strict regulatory definition. In all cases, manufacturers should consider the “clear impression” of the label and consider not only compliance with technical labels, but also how the watchful eye of the applicant`s bar can interpret claims. The FDA`s proposed framework for the updated definition of “healthy” is intended to ensure that nutrient-dense foods that help consumers develop a diet consistent with current dietary recommendations may qualify for the claim. To meet the proposed definition, a food product would have to contain a certain amount of foods from at least one of the food groups or subgroups (e.g., fruits, vegetables, grains, dairy products, and proteins) recommended by the 2020-2025 Dietary Guidelines for Americans. Specific limits for added sugars, saturated fats and sodium would be based on a percentage of the daily value of these nutrients. DVs are reference amounts of nutrients that must be consumed or not exceeded each day. The proposed criteria for determining the amount of food needed for a given food group (so-called food group equivalents) and the specific limits for the three nutrients vary for individual food products, mixed products (containing more than one food group), main dishes and meals, and are based on a commonly consumed reference intake, which serves as the basis for determining the size of a portion. Under the proposed definition, raw whole fruits and vegetables would automatically qualify for the claim “healthy” because of their nutritional profile and their positive contribution to an overall healthy diet. The proposed rule attempts to align the definition of “healthy” with current recommendations published in the 2020-2025 dietary guidelines for Americans.
Therefore, in addition to the nutrients to be restricted, the proposed definition of “healthy” uses a food group-based approach (based on the understanding that each food group contributes a number of important nutrients to nutrition), which has changed since 1994, when the current definition of “healthy” was published. The proposed rule would also require that a food contain a certain amount of at least one of the food groups or subgroups (vegetables, fruits, grains, dairy products and protein foods) recommended in the dietary guidelines to use the health claim, e.g., must contain at least 1/2 cup of fruits or vegetables, 3/4 cup of dairy products, a range of 1-1 and 1/2 ounce of protein depending on the type, or no less than 3/4 ounce of whole grains. In addition, the new rule rejects certain nutritional requirements as irrelevant and imposes limits on three specific nutrients – sodium, saturated fat and added sugar. The required quantities and limits are adjusted for each specific food group and for the type of item concerned (a mixed product, a main course, a meal). Finally, the proposed rule creates a food group, including raw and whole fruits and vegetables and water, that are automatically considered “healthy” and can use the claim without being subject to equivalent quantity requirements for food groups or nutrient limitations. In the political sphere, a fundamental right to health can only be realized by developing a norm that limits that right. This requires support for health sciences, clear differentiation, and repeated and continuous review. Interdisciplinary cooperation is therefore particularly important in the fields of health. Determining the meaning of health, treating equitably and achieving equality are problems that must be resolved cooperatively by medicine and law. FDA regulations prescribe qualification criteria for foods to support the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).
Among other things, a “healthy” food should generally contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving. (Fish and meat must contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving.) The FDA has received a petition from citizens urging the agency to revise the definition of “healthy” — which hasn`t changed since 1994 — to reflect current scientific understanding of the health benefits of many nutrient-dense foods. (3) Health is a political issue, especially when it is not just a question of the mere absence of disease. The basic legal structure of many States is strongly oriented towards guaranteeing fundamental economic rights (property rights, freedom to work, etc.). Changes in these structures to prioritize health will be met with resistance . The proposed definition requires that: a food must contain a certain amount of foods belonging to at least one of the food groups (fruits, vegetables, grains, dairy and protein products, oils, composite products, main dishes and meals); specific limits for added sugars, saturated fatty acids and sodium are based on a percentage of the daily value of these nutrients; Raw and whole fruits and vegetables are automatically eligible for the “health” claim. These requirements and limitations are illustrated in the following diagrams. Current thinking about the importance of WHO and its recommendations is approaching deliberate spoofing. In discussions in the health sciences, WHO and its stated commitment to the fundamental human right to health are regularly used – incidentally and without reference to the law – as a binding basis for decisions and actions and within the framework of national laws. Although this interpretation only partially expresses the truth, it refers to an intradisciplinary vision (initially purely theoretical in relation to the health sciences, but ultimately with practical implications) of international organizations and fundamental human and civil rights. WHO`s importance lies not in its ability to enforce health standards at the national and international levels through the implementation of health systems, but in the political sphere. WHO is relevant in how it expresses dominant (or, more importantly, not yet widespread) beliefs about the importance of health, including its legal regulation, and the development of a process-based approach to health.
WHO`s recommendations, including its Declaration of the Fundamental Human Right to Health, merely express abstract universal ideals and provide no basis for a fundamental human right to health. Human rights refer first and foremost to the moral rights from which moral claims may arise and which have a purely moral legal basis. The result is a universal claim to these rights, regardless of socio-cultural, historical, political, religious or other constellations and cultures. The definition of human rights at this level implies that their validity is independent of law enforcement mechanisms. The application or application of the law or assumptions, based on the Declaration of a Fundamental Human Right to Health, requires that such a right be enshrined in law at the national level and that legal mechanisms be put in place to enable individuals to assert their rights. The responsibility for implementing this change lies with each country and in particular with the experts in their public health systems, otherwise the idea remains an idea and nothing more. (3) The formulation of macro-social ideals by international institutions cannot create structures that maximize health. Optimizing health depends on access to health facilities, and regardless of the moral components, any universal right to health must be legal in the first place. Such a right requires concrete and binding standards and legal implementation.
The right to health claimed by the WHO must therefore be translated into “hard law” and therefore made directly applicable and binding. In a separate but related way, the FDA has begun exploring a symbol that industry can voluntarily use to label food products that meet the proposed “healthy” definition. The symbols can be especially useful for people with less nutritional knowledge to identify foods that can be the basis for healthy eating behaviors. The FDA has issued two Preliminary Quantitative Consumer Research Procedural Notices it plans to conduct on voluntary symbols that could be used in the future to convey the nutrient content claim as “healthy.” The first Communication was adopted in May 2021 and the second in March 2022. Federal agencies are required to publish a notice on the Federal Register of any proposed information collection and to give the public an opportunity to comment. The creation of the World Health Organization (WHO) as a specialized agency of the UN not only defined the responsibilities of the organization itself, but also defined health as a fundamental human right that deserves legal protection .