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US government body slams nutrigenomic tests

10 August 2006   |   By Dr Philippa Brice   |   News story

Congressional investigators from the US Government Accountability Office (GAO) have added their voice to the recent warning over direct-to-consumer genetic tests by the US Federal Trade Commission (see previous news story), warning the public to beware. Nutritional genomics, or nutrigenomics, is a relatively new field that looks at how interactions between genes and diet may influence health. It is postulated that ‘personalized nutrition’, whereby analysis of genetic factors might be able to dictate the optimum healthy diet for different individuals, might one day arise from this sort of study, but the interactions between multiple genes, nutritional and other environmental factors are highly complex and as yet there is no validated evidence to support this sort of approach. However, some companies are already offering genetic tests that can reportedly provide individualised nutritional advice, and a congressional probe set out to investigate four of these internet based test providers using fictitious customer profiles, to see whether their claims were legitimate.

The advice provided was general, advocating a healthy diet and avoidance of smoking, but one company reportedly recommended a dietary supplement blend, costing more almost $2000 year, to repair damaged DNA (see GAO report). Not only was this claim totally false, but the ‘personalized’ supplement was also recommended to three different fictitious customers with different DNA, medical and lifestyle data. Another company recommended a nutritional supplement $1200 a year that proved to contain multivitamins that could be purchased in any pharmacy for around $35. The report concluded that providers of nutrigenetic tests “may mislead consumers by promising results they cannot deliver” and issue medical predictions that may either needlessly alarm or in some cases, falsely assure, consumers about their health. It called for improved regulatory oversight of the production and marketing of new forms of genetic test, adding that: “as demand for these new tests continues to rise, it will become increasingly important for consumers to have reliable information in order to determine which tests are accurate and useful”.

The Senate Special Committee on Aging (SSCA) held a special hearing on direct-to-consumer genetic tests, at which the GAO report was presented along with testimony from Kathy Hudson, Director of the Genetics and Public Policy Center, who described how such tests fall between gaps in the current regulatory framework for genetic testing in the US. The two federal agencies charged with regulating genetic tests (the FDA, which regulates tests as devices and the CMS, which regulates laboratories) also gave evidence to the Congressional hearing. The tests involved fall between these two agencies because they are developed in-house and as such have not been subject to pre-market review by FDA. Senator Gordon Smith, Chair of the SSCA, expressed his concern at potential for consumer harm and the current gaps in regulation. Asked by Sen. Smith whether FDA should plug these gaps by extending their oversight to in-house tests, Dr Steve Gutman, Director of the Office of In Vitro Diagnostics at FDA, concurred. FDA has now invited Clinical Data, the laboratory that conducts many of these tests on behalf of companies such as Sciona, to discuss the regulatory status of their tests.

Representatives from the gene-testing companies asserted that they provided an important service and had been unfairly criticized by the report.

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