Regulating Nutrigenetic Tests: An International Comparative Analysis

By Ries, Nola M. | Health Law Review, Summer 2008 | Go to article overview
Save to active project

Regulating Nutrigenetic Tests: An International Comparative Analysis


Ries, Nola M., Health Law Review


Introduction

In September 2007, the decoded genome of J. Craig Venter, a pioneering genetics researcher, was released to the world. (1) This achievement attracted worldwide media attention, with stories making the inevitable leap from the publication of one man's genome to the promise of personalized medicine for many. The Globe and Mail, a Canadian national newspaper, proclaimed: "Scientists have for the first time decoded the complete DNA sequences of a single human being, a mammoth feat that ... marks a historic step toward the era when medical care can be tailored to an individual's genes." (2) Remarkable advances in modern genetic research are revealing the genetic foundations of human traits, including genes that promote or protect against development of complex, common diseases. (3) As knowledge of genomics expands, patients/consumers, health care practitioners, firms that develop and sell genetic testing services and related products, and government policy-makers and regulators, all develop increasing interest in a field that may offer means to improve individual and public health.

The field of nutritional genomics is an area where "early results from the human genome project [are being translated] into publicly accessible applications." (4) Some nutrigenetic tests are currently available for consumers to purchase directly from a company or to obtain through a health care provider. Genetic test kits for home use--where a consumer collects a genetic sample at home and then mails it to a laboratory for analysis--raise several concerns: the consumer may not fully understand the test and the benefits and risks of learning the results; the consumer may conduct the test incorrectly and submit a sample and information that are inaccurate; and the consumer may not receive adequate interpretation and follow-up regarding the results and any recommended future action. (5) Consequently, the hazards associated with genetic testing include "potential physical, medical, psychological, and social and economic risks to individuals being tested and to members of their families." (6) Benefits, in contrast, include the ability to take steps to mitigate known disease risks, tailor treatment options or gain peace of mind. Concerns associated with genetic tests, particularly when marketed directly to consumers, have attracted much attention by governmental bodies, (7) "watchdog" agencies, (8) and academic commentators. (9)

Regulation of genetic tests--and, for that matter, all medical devices--depends on the intended use and risks. Factors relevant to assessing risks involved in genetic testing include whether: the test is diagnostic or predictive; the disease is rare or common; the genetic mutation is of high or low penetrance; interventions are available for individuals who have a genetic predisposition; and affected individuals or groups will be exposed to stigmatization or discrimination. (10) The mode of delivery of the test is also relevant: tests marketed for home use are typically viewed as posing greater risks than tests available only through a health care intermediary.

To date, most concerns expressed about nutrigenetic tests do not focus on medical, psychological and social risks, but rest on the view that nutrigenomic science is still too premature to offer clinically useful information and advice to consumers. Trujillo and colleagues note: "Although unprecedented opportunities exist for the expanded use of foods and bioactive food components to achieve genetic potential, increase productivity, and decrease risk of disease, the science to make such decisions has not reached a level of confidence to achieve personalized nutrition recommendations." (11) Arab contends: "The information needed to individualize recommendations is largely unavailable for most nutrients." (12) The immediate risk in nutrigenetic testing, then, is primarily economic: consumers who purchase nutrigenetic tests are wasting their money.

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
Loading One moment ...
Project items
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited article

Regulating Nutrigenetic Tests: An International Comparative Analysis
Settings

Settings

Typeface
Text size Smaller Larger
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

While we understand printed pages are helpful to our users, this limitation is necessary to help protect our publishers' copyrighted material and prevent its unlawful distribution. We are sorry for any inconvenience.
Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.

Are you sure you want to delete this highlight?