Need for regulation in nutrigenomics?

New research designed to help consumers create customised diets based on their genetic make-up will create ethical and legal challenges with serious implications for the scientific and medical communities, warns a new consultation paper by a panel of international experts.

The paper, Nutrition and Genes: Science, Society and the Supermarket,​ a joint project of the University of Toronto Joint Centre for Bioethics (JCB) and the University of Guelph philosophy department, examines ethical questions surrounding the rapidly emerging field of nutritional genomics, also called nutrigenomics. Nutrigenomics is the study of how nutrients and genes interact and how genetic variations can cause people to respond differently to food nutrients.

Research started in 2000 and is still in its infancy but scientists already predict that their work could bring about radical changes in how food is grown, processed and consumed, and lead to personalised diets tailored to genetic make-up. A major target will be the baby boomers, reaching their 50s and 60s and trying to forestall the onset of age-related health problems such as heart disease, arthritis, menopausal hot flashes and bone-density loss.

But the paper's authors warn against a headlong rush to embrace nutritional genomics before there has been a detailed examination of its moral and ethical implications, backed by national awareness campaigns and public consultations.

The paper, prepared by a nine-member panel of international experts for presentation at the 2nd International Nutrigenomics Conference (opening in Amsterdam this week), stops short of prescribing specific ethical guidelines for the development and implementation of nutritional genomics technology. Rather, it is designed to foster public debate, setting out issues that must be considered as consumers begin customising diets to prevent and mitigate chronic health conditions.

The panel will collect input at www.geneticsethics.net​ from professional groups, citizens' organisations and individuals before issuing recommendations next year.

"This is a new model to get people's input before the science is fully rolled out,"​ said JCB director Peter Singer. "By addressing the ethical issues before nutrigenomic technologies reach the supermarket, we hope they can ultimately be introduced in the most ethical way."​

"In future we may choose, for example, a breakfast cereal based on our genes,"​ he added. "It is hypothetical today but possible that if you have a particular gene, you will be advised to use a cereal that decreases your chance of heart disease and avoid another that would increase your chance of colon cancer."​

Science is uncovering more about the role of genetics in the development of diseases such as diabetes, obesity, cancer, heart disease, birth defects and food allergies, about how chemicals in foods can affect genes, and how genes can predict whether particular foods are likely to cause health problems.

Nutrigenomics looks set to improve individual health and lead to greater disease prevention. Genomic studies show some of the variation in such factors as blood pressure and bone density in people is genetically determined. In some people, food may cause genes to malfunction, which is why among people who consume the same diet, some do not suffer from a given disease, while others show elevated disease levels.

Dietary advice today is based on observations at the level of large populations. However, advice that is good for the majority of people can be bad for a minority with different genetics, the paper says. There are estimates that dietary guidelines designed for entire populations give recommendations that might only work for two people out of three. The result is that many people are doing little more than taking educated guesses about their nutritional needs.

Nutrigenomics promises to enable people to reduce risks of developing diet-related diseases, and may be able to treat existing conditions. Personalised recommendations for food may be used as an adjunct, or in some cases possibly as a replacement for prescription drugs. However, the use of a genetically customised diet should not be seen as a rapid 'cure' for diseases in the way an antibiotic can kill bacteria. It is more likely that adjustments to diets over a long time will strongly reduce the risks of a number of diseases and conditions.

The paper raises some of the biggest concerns about this new field, such as when is the science strong enough to market tests in a widespread way? Who should have access to nutritional genomics information, who should not, and how should improper access be prevented? How can society prevent potential nutritional genomics-related inequities, especially those created between developed and developing countries? Which nutritional genomics concerns should be the subject of regulation and oversight?

Nutrigenomics research raises many of the ethical concerns now associated with genetic testing, according to the paper, specifically looking at how genetic information is managed.

Governments are already looking at what if any regulations are needed to cover issues in this field, including scientific research, consent, counseling, testing technology and standards, who gets to provide nutritional genomics services, and access to nutritional genomics information.

"The collection, storage and use of genetic information will be one of the most hotly debated medical issues of the coming decade,"​ says Dr Abdallah Daar, director of the program in Applied Ethics and Biotechnology at the JCB​. "Even at this early stage, scientific progress is outstripping the public's ability to make informed choices about what kind of regulations should be introduced to address ethical and privacy concerns."​