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Does this indicate a stumbling block for nutrigenomic marketers?
Nutrigenomic supplements are in the FTC’s crosshairs-not because of the nature of the products, but because a nutrigenomic dietary supplement firm made unauthorized disease claims. The FTC announced today it has approved a final settlement agreement with two nutrigenomic companies, GeneLink Inc. and its former subsidiary Foru International Corp., over the firms’ claims that its personalized-nutrition products could treat diabetes, heart diseases, arthritis, and insomnia. The case serves as a warning to supplement companies looking to get into nutritional genomics (“nutrigenomics”)-an area of growing interest in the dietary supplements market.
Nutrigenomics is the study of how nutrition can impact-and potentially improve-human gene expression. Through nutrigenomics, the goal is “to reduce and ultimately eliminate health disparities resulting from adverse environment x genome interactions, particularly those involving nutritional, economic, and cultural factors,” explains the website of the Center of Excellence for Nutritional Genomics (CENG) at the University of California, Davis.
“Our goal is to devise evidence-based nutritional interventions to prevent, mitigate, and delay the onset of diseases such as obesity, type 2 diabetes, cardiovascular disease, malnutrition, and certain cancers,” says Raymond Rodriguez, PhD, professor and director of CENG.
That goal is fine for researchers, but for marketers of supplements-nutrigenomic, conventional, or otherwise-FDA’s golden rule still applies: supplement firms are not allowed to make claims that their products treat, prevent, mitigate, or reduce the risk of disease.
According to the FTC, GeneLink sold supplement and skincare products customized to each customer’s own, unique DNA. Once customers submitted cheek swab samples to the company, the firm would then use that DNA information to custom-formulate products. The FTC said that the firm’s health claims were false or unsupported, including marketing claims that “the customized nutritional supplements could compensate for an individual’s genetic disadvantages,” the agency says.
In addition to making disease claims, the company is said to have failed to adequately secure customers’ personal information, including genetic information, Social Security numbers, and payment information. (The company charged customers more than $100 monthly for the products.)
“This case is about the consequences of making false claims,” said Jessica Rich, FTC’s director, in the agency’s press release.
FTC’s consent orders include prohibiting the companies from making any disease claims unless claims are supported by two adequate and well-controlled studies. “The companies may not make any other claims about the health benefits, performance, or efficacy of any drug, food, or cosmetic by modulating the effect of genes, or the consumers’ customized genetic assessment-unless the claim is true and based on competent and reliable scientific evidence,” the FTC states.
More specifically, where the companies’ nutrigenomics products are concerned, the FTC specifies that “claims that a product effectively treats or prevents a disease in persons with a particular genetic variation must be backed up with randomized controlled trials conducted on subjects who have that genetic variation.”
Does this indicate a stumbling block for nutrigenomic marketers? Is it feasible for companies to customize studies according to genetic makeup-provided they are looking to make certain claims?
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