Uso y publicidad del diagnóstico genético para dietas personalizadas en nutrición: comentario a la sentencia 317/2018 del Tribunal Superior de Justicia del País Vasco / Use and advertising of genetic diagnosis for personalised diets in nutrition: commentary on judgement 317/2018 of the High Court of Justice of the Basque Country

El presente trabajo comenta la sentencia 317/2018 del Tribunal Superior de Justicia del País Vasco, que desestima la solicitud de un farmacéutico diplomado en Nutrición de publicitar un asesoramiento nutricional individualizado mediante la realización de un test nutrigenético. El fallo del Tribunal y las alegaciones tanto del solicitante como del Departamento de Salud del Gobierno Vasco dan paso a un debate sobre cuál es la utilidad real de este método para la personalización de dietas, novedad hoy día de fácil acceso a la población general, y si ésta es suficientemente autónoma cuando toma la decisión de usarla. Finalmente analizamos a qué nivel debe enmarcarse el empleo de esta prueba

The present work comments sentence 317/2018 of the Superior Court of Justice of the Basque Country, which dismisses the request of a pharmacist qualified in Nutrition to publicize an individualized nutritional advice by performing a nutrigenetic test. The ruling of the Court and the allegations of both the applicant and the Health Department of the Basque Government give way to a debate on what is the real use of this method for personalizing diets, a novelty nowadays easily accessible to the general population, and if it is sufficiently autonomous when it makes the decision to use it. Finally, we analyze at what level the use of this test should be framed

Guide and Position of the International Society of Nutrigenetics/Nutrigenomics on Personalized Nutrition: Part 2 - Ethics, Challenges and Endeavors of Precision Nutrition.

Nutrigenetics considers the influence of individual genetic variation on differences in response to dietary components, nutrient requirements and predisposition to disease. Nutrigenomics involves the study of interactions between the genome and diet, including how nutrients affect the transcription and translation process plus subsequent proteomic and metabolomic changes, and also differences in response to dietary factors based on the individual genetic makeup. Personalized characteristics such as age, gender, physical activity, physiological state and social status, and special conditions such as pregnancy and risk of disease can inform dietary advice that more closely meets individual needs. Precision nutrition has a promising future in treating the individual according to their phenotype and genetic characteristics, aimed at both the treatment and prevention of disease. However, many aspects are still in progress and remain as challenges for the future of nutrition. The integration of the human genotype and microbiome needs to be better understood. Further advances in data interpretation tools are also necessary, so that information obtained through newer tests and technologies can be properly transferred to consumers. Indeed, precision nutrition will integrate genetic data with phenotypical, social, cultural and personal preferences and lifestyles matters to provide a more individual nutrition, but considering public health perspectives, where ethical, legal and policy aspects need to be defined and implemented.

Position of the Academy of Nutrition and Dietetics: nutritional genomics.

It is the position of the Academy of Nutrition and Dietetics that nutritional genomics provides insight into how diet and genotype interactions affect phenotype. The practical application of nutritional genomics for complex chronic disease is an emerging science and the use of nutrigenetic testing to provide dietary advice is not ready for routine dietetics practice. Registered dietitian nutritionists need basic competency in genetics as a foundation for understanding nutritional genomics; proficiency requires advanced knowledge and skills. Unlike single-gene defects in which a mutation in a single gene results in a specific disorder, most chronic diseases, such as cardiovascular disease, diabetes, and cancer are multigenetic and multifactorial and therefore genetic mutations are only partially predictive of disease risk. Family history, biochemical parameters, and the presence of risk factors in individuals are relevant tools for personalizing dietary interventions. Direct-to-consumer genetic testing is not closely regulated in the United States and may not be accompanied by access to health care practitioners. Applying nutritional genomics in clinical practice through the use of genetic testing requires that registered dietitian nutritionists understand, interpret, and communicate complex test results in which the actual risk of developing a disease may not be known. The practical application of nutritional genomics in dietetics practice will require an evidence-based approach to validate that personalized recommendations result in health benefits to individuals and do not cause harm.

Applied human genomics from an innovation systems perspective.

BACKGROUND/AIMS: Nutrigenetics remains at the forefront of applied human genomics, and for this reason it draws scrutiny from several different perspectives. Most conspicuous among these perspectives is the interest demonstrated in the regulation of nutrigenetics. There are other, equally important factors affecting the fate of nutrigenetics which can be considered alongside regulation. Using innovation systems theory to guide the analysis provides insights into the future of nutrigenetics innovation. METHODS: Innovation systems theory is used to analyze the opportunities and constraints on nutrigenetics. RESULTS AND CONCLUSION: Regulation of nutrigenetics has preoccupied the attention of many commentators, but other constraints such as intellectual property and access to venture capital are serious and probable impediments to future commercial development of nutrigenetics.

Future perspectives of nutrigenomics foods: benefits vs. risks.

Nutrigenomics, defined as the application of high-throughput genomics tools in nutrition research is now past its incubation phase. The poorly understood associations of diet and disease prevention in particular will likely be the single most important catalyst to its accelerated and continued growth. Whether the goal of matching foods to individual genotypes to improve the health of those individuals can be attained, and personalised nutrigenomic foods enter the world's food markets, depends on numerous hurdles being overcome: some scientific in nature, some' technical and others related to consumer, market or ethical issues. Public adoption of new technologies is an important determinant for their success. Many of the drivers behind the trend in personalisation of food are now known, particularly ethical, legal, and social issues (ELSI) are the major drivers. Future development in the field of nutrigenomics undoubtedly will place its seemingly huge potential in better perspective. From the scientific responsibility point of view, one hopes that the new perspectives to be gained and progress to be made in this field will be so managed as to take the public at large on board, if we are to avoid another nutrition education disaster of the genetically modified organism type and dimension.

Nutrigenomics patents and commercialization: old wine in a new bottle?

This paper looks at the ethical, legal, and social issues (ELSI) associated with commercialization and patenting through the lens of nutrigenomics. These are two areas have generated a great deal of ELSI literature, although very little specific to nutrigenomic research. Nutrigenomic researchers seem likely to face the same patent concerns as those associated with gene patents more generally--specifically, that patents will hurt research and the distribution and uptake of useful technologies. Likewise, there is concern that commercialization pressure will lead to the inappropriate and premature implementation of nutrigenomic services. This paper concludes that while the patenting issues do not seem unique or particularly worrisome in the context of nutrigenomics, the early commercialization of testing is cause for concern and worthy of careful policy consideration.

Nutrigenomics and ethics interface: direct-to-consumer services and commercial aspects.

A growing variety and number of genetic tests are advertised and sold directly to consumers (DTC) via the Internet, including nutrigenomic tests and associated products and services. Consumers have more access to genetic information about themselves, but access does not entail certainty about the implications of test results. Potential personal and public health harms and benefits are associated with DTC access to genetic testing services. Early policy responses to direct-to-consumer (DTC) genetic testing often involved calls for bans, and some jurisdictions prohibited DTC genetic tests. Recent policy responses by oversight bodies acknowledge expansion in the range of DTC tests available and suggest that a "one-size-fits-all" regulatory approach is not appropriate for all genetic tests. This review discusses ethical and regulatory aspects of DTC genetic testing, focusing particularly on nutrigenomic tests. We identify policy options for regulating DTC genetic tests, including full or partial prohibitions, enforcement of existing truth-in-advertising laws, and more comprehensive information disclosure about genetic tests. We advocate the latter option as an important means to improve transparency about current evidence on the strengths and limits of gene-disease associations and allow consumers to make informed purchasing decisions in the DTC marketplace.

Ethical and legal issues in nutritional genomics.

Advances in the ability to study how common variations in genes affect the metabolism of drugs and foods suggest that genetic information about individuals is of increasing relevance to clinical practitioners, including registered dietitians. The acquisition, storage, and use of genetic information in nutrition counseling will pose difficult ethical and legal questions involving the maintenance of confidentiality, the right to privacy, and the risks of discrimination in decisions about insurance coverage and employment. In addition, genetic analysis of children poses new questions about the limits of parental authority. Although the field of nutritional genomics is in its infancy, it is appropriate for registered dietitians to begin now to fashion a code of conduct about the proper use of genetic information. Relevant legal topics, such as federal and state legislation and judicial decisions, are discussed.