Not Ready for Prime Time: The Commercialization of Nutrigenomic Services Public Deposited

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  • March 22, 2019
  • Sterling, Rene
    • Affiliation: Gillings School of Global Public Health, Department of Health Policy and Management
  • Nutrigenomic researchers hope to improve health through study of relationships among diet, genes, and disease, but many consider the sale of nutrigenomic services to be premature. Gaps in the oversight of genetic services increase the potential for harm to consumers who may use services without a full understanding of their benefits, risks, and limitations. Using nutrigenomic services as a case study, the goal of this dissertation was to inform policy development to improve oversight of genetic services. Research aims included: 1) identify and describe websites that sell or promote the use of nutrigenomic services, 2) identify what genetic professionals think consumers should know about nutrigenomic services, and 3) assess the adequacy of US FDA guidelines for the classification, pre-market review, and labeling of nutrigenomic services. In October 2006, diverse organizations (N=64) hosting nutrigenomic websites were identified in a comprehensive search. Few websites presented information about important caveats associated with genetic testing. The vast majority of genetic professionals completing an on-line opinion survey (N=300), found the following attributes of nutrigenomic services very important to share with consumers: if consumer information or specimens would be shared with third parties; use and utility of recommended supplements; non-genetic factors impacting test accuracy; and laboratory compliance with government standards. Few attributes were considered unimportant to share raising concerns about information overload. Using definitions established in FDA guidelines, three companies presented information on their websites classifying nutrigenomic tests as moderate risk medical devices in need of FDA review. Websites rarely presented warnings or precautions associated with test use, as recommended for the proper labeling of medical devices. Nutrigenomic services may be particularly appealing to consumers given their relatively low cost, ease of access, and association with more common and less severe conditions. Organizations promoting nutrigenomic services on-line can use various Web-based tools and recommendations from researchers, professional societies, and policy makers to improve website content. Such efforts in the absence of regulation can help industry regain or maintain public trust. In the absence of good faith efforts, policy makers will continue to struggle to keep pace with innovation and minimize threats to consumer health and safety.
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  • ... in partial fulfillment of the requirements for the degree of Doctor of Philosophy in the Department of Health Policy and Management.
  • Mebane, Felicia E.

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