dence that nutrigenomics can make a difference in an individual’s health? It is also important to understand the cause-and-effect relationships being studied and the balance of the benefits and the risks involved in making lifestyle and diet changes that may be advised through a nutrigenomics-derived nutritional prescription.

A primary area of concern with the collection of the information to be used to generate a nutritional prescription is what happens to genetic information that is submitted to a company or a clinic for testing. It is important to consumers to know who has access to their information and whether their employers or insurers get access it. Other concerns include the use of personal information in a public database. Will it ever be completely deleted, or will it always be there for others to uncover if they really want to?

Consumers are also concerned with how nutrigenomics technology will be regulated. “They want the tests regulated,” Castle said. “They want the health claims regulated.” At the same time, consumers recognize that nutrigenomics will demand a type of regulation that is different from the types of regulation for both pharmaceuticals and foods, perhaps a type of regulation that contains elements of both.

“This is actually the principal challenge for regulators,” Castle said: “to understand what new innovative regulatory structures have to be developed in order to be able to handle this complex field.” The problem is that the government is used to regulating in vertically well-organized, tightly integrated fields, such as pharmaceuticals or foods, and when something like nutrigenomics that cuts across these fields comes along, there is no easy way to develop novel regulations. There are additional concerns about access and equity. Many individuals worry that nutrigenomics will turn out to be a luxury product that is available only to a few and that much of the world’s population will not benefit because of a lack of access.

These issues are closely tied to that of how nutrigenomics will be delivered to the public. Castle introduced two basic delivery models: private and public. These models parallel the scientific divide between the analysis of an individual’s DNA to provide a personalized dietary prescription and the use of an understanding of the relationship between genes and nutrients to make dietary recommendations that will apply to almost everyone. There are four separate delivery models. The first one is the consumer model, in which individuals pay for and consume nutrigenomics products on their own. An individual consumer might, for example, find a nutrigenomics company on the Internet, send away for a test kit, take a cheek swab, return it to the company, and then use the test results to shape his or her eating habits. The consumer model puts nutrigenomics into the hands of the public. It is convenient, empowers the



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