Nutrigenomics and the Future of Nutrition Proceedings of a Workshop (2018) / Chapter Skim
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5 Nutrigenomics: Regulatory, Ethical, and Science Policy Considerations
5 Nutrigenomics: Regulatory, Ethical, and Science Policy Considerations
Pages 85-106
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From page 85... ...
meeting in Atlanta, Georgia. The title of that talk was "A Critical Appraisal of the Scientific Basis of Commercial Genomic Profiles Used to Assess Health Risks and Personalize Diet and Lifestyle Inter entions." At the time, she recalled, there were many companies selling v personalized diet DNA tests via the Internet, with many people believing what Janssens referred to as the "myths about weight loss." For example, Genotrim was among the first companies to introduce a DNA-customized "solution" for weight, telling consumers that the advice being provided would last a lifetime because, the company claimed, "your genes are not a 85
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From page 86... ...
(Roller) • Key regulatory issues that merit further consideration as nutrigenomics moves forward in a commercial context include the adequacy of the existing FDA regulatory framework to accommodate nutrigenomics claims for foods without triggering "drug" status.
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From page 87... ...
Reviewing the Evidence Behind Company Claims That Gene Variants Are Associated with Disease Risk In an article published in the American Journal of Human Genetics, Janssens and colleagues (2008) review the scientific literature for evidence of any association between the gene variants being tested by those early companies and disease risk.
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From page 88... ...
In cases in which a weak association was demonstrated, she noted, the evidence was based on only a limited number of studies. These authors concluded, "As solid scientific evidence is lacking, commercially available nutrigenomics tests cannot be presently recommended." Janssens remarked that, as a critical reviewer of scientific literature, she is always aware of confirmation bias.
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From page 89... ...
. Neither Vitagene nor its affiliates warrant that the information on this site is accurate, reliable or current.
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From page 90... ...
To explore further the concept of beneficence in personalized nutrition, Janssens described the analytic framework used by the U.S. Preventive S ervices Task Force (USPSTF)
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From page 91... ...
; and (b) whether DNA testing (combined with a survey and other lab tests)
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From page 92... ...
Autonomy In addition to beneficence, Janssens views autonomy as an ethical problem with current nutrigenomics companies. She explained that many websites use proprietary algorithms that provide consumers with no insight into how the company makes its recommendations based on a consumer's DNA profile.
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From page 93... ...
how to leverage trends in the biomedical sciences in nutrition-based health care, touching on themes addressed by previous speakers; (2) how to identify, verify, and vet nutrition strategies for individuals, borrowing strategies used in cancer and chronic disease management; and (3)
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From page 94... ...
Specifically, he was referring to the 21st Century Cures Act, signed into law by President Obama in December 2016, which under certain conditions allows companies to provide "data summaries" and "real-world evidence," such as results of observational studies, insurance claims data, patient input, and anecdotal data, rather than full clinical trial results (FDA, 2017a)
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From page 95... ...
As an example of work in this area, Schork referenced a study by Zeevi and colleagues (2015) , who developed a strategy for collecting a large amount of data on a group of individuals and then matching those profiles to certain dietary recommendations in an attempt to identify subgroups of individuals who would respond best, or optimally, to particular dietary interventions.
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From page 96... ...
But he envisioned the approach being used more in nutrition in the future, leveraging wireless technology to collect phenotypic information continuously. There are several different N-of-1 study designs, Schork continued, including the sequential design (i.e., making decisions in real time)
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From page 97... ...
, using a personal as opposed to a population threshold can minimize the amount of time a person might have latent disease. POTENTIAL REGULATORY POLICY CONSIDERATIONS PRESENTED BY NUTRIGENOMICS IN THE COMMERCIAL CONTEXT The third and final speaker of this session, Sarah Roller, Kelly Drye & Warren, LLP, shared her thoughts on key regulatory issues she believes merit further consideration as nutrigenomics moves forward commercially.
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From page 98... ...
Finally, she would be highlighting some key regulatory considerations for the commercialization of nutrigenomics moving forward. Federal Legal Framework for Health-Related Genetic Testing Roller explained that all laboratories that perform health-related testing, including genetic testing, are subject to federal regulatory standards administered by the Centers for Medicare & Medicaid Services (CMS)
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From page 99... ...
Roller emphasized that only health-related genetic tests qualify as medical devices. So, for example, Helix's many applications, which she noted that Janssens had also mentioned during her presentation (in the context of her discussion of the contrast between companies' claims and dis laimers c about the genetic tests they are selling)
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From page 100... ...
"Food" encompasses conventional foods and beverages, including nutritionally fortified and enriched foods; dietary supplements, which are foods that are not in conventional food form and are consumed to supplement the diet with an essential nutrient or other dietary ingredient; foods for special dietary use, which Roller noted is a very old category, one that includes foods designed to serve particular dietary needs due to a physical, physiological, pathological, or other condition, such as disease convalescence, pregnancy, lactation, food allergy, underweight, or overweight; and medical foods, which are foods that are formulated to be consumed or administered orally under the supervision of a physician and are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements have been established that cannot be satisfied by dietary modification alone (FDA, 2017b)
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From page 101... ...
In contrast with FDA, she elaborated, the scope of FTC's authority does not cover products, only acts and practices. In the context of nutrigenomics, she explained, FTC authority encompasses advertising claims for genetic testing and food products and services, as well as data security practices of companies that produce and store personal consumer information (e.g., social security numbers and personal genetic test results)
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From page 102... ...
, epidemiologic evidence may be an acceptable substitute for clinical data, especially when supported by other evidence. As an example of recent FTC enforcement, Roller reported that in 2013, FTC took an enforcement action against Genelink, Inc., and foruTM International Corporation, alleging that both companies had violated the FTCA by making false and unsubstantiated health benefit claims about their genetic tests and genetically customized dietary supplements, and by using inadequate data security practices, putting consumers at risk of identity theft.
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From page 103... ...
. Summary In closing, Roller recapped issues that she believes merit further consideration as nutrigenomics moves forward, such as the adequacy of • existing CMS and FDA frameworks for regulating genetic tests, including LDTs that are used in DTC products and services; • existing FDA regulatory framework to accommodate nutrigenomics claims for foods without triggering "drug" status; • existing claim substantiation guidance with respect to claims pro moting genetic tests and foods in the context of nutrigenomics, such as what "competent and reliable scientific evidence" should mean in this context; and • data security and disclosure practices concerning the personal ge netic information that is being collected.
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From page 104... ...
The audience member also commented on the fact that there is no established format for labeling medical foods, in contrast with dietary supplements and conventional foods. The term "medical food" does not appear on foods that are intended to be medical foods, she elaborated,
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From page 105... ...
In her opinion, something not being well defined can actually be a "good thing." Transparency of 23andMe Ahmed El-Sohemy commented on Janssens's approval of 23andMe's handling of its DTC genetic testing. Janssens clarified that she has, in fact, criticized 23andMe many times in the past and that there are still things about the company she does not like, mainly in relation to its presentation of health risks.
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From page 106... ...
Whether developing this evidence requires a randomized controlled trial or an observational study, she suggested starting with the latter; then, when sufficient observational evidence exists, see if a randomized controlled trial is still needed. She explained that she holds this view because the field is changing too rapidly to rely on randomized controlled trials.
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