Food And Drug Administration ( Fda )

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On November 22, 2013, 23andMe, Inc. was forced to stop allowing its clients to access their genetic information health reports because these genomic reports may be unreliable and misinterpreted, as expressed by the Food and Drug Administration (FDA). FDA’s main concern is that the customers may utilize their genomic information to pursue unprecedented measures that may place them at health risks by going to extremes to fix that allele, which may lead to higher rates of diseases when there may not even be a risk in having that allele, or cause them to underestimate their health conditions, if the consumers interpreted that they did not have a gene that codes for obesity. FDA’s restrictions were correct because the customers should not rely on these health reports to determine whether they have a genetic allele that predisposes them to obesity since genetic influences do not largely determine whether an individual is more susceptible to obesity throughout childhood and adolescence. Through further understanding, the FTO gene associated with BMI does not predispose the individual with higher risk of susceptibility of obesity, since FTO locus only explains 1% of the total BMI heritability and the role of epigenetics largely overshadows the influence of genetics.
Over the years, the genome-wide association studies (GWAS) have been used to identify the underlying genomic basis of diseases including obesity. But the slow progress and limited inference one can take away from the study of the 32-GWAS identified loci proves that the identification of an obesity risk allele on one of these loci or on the FTO gene is small and does not have enough weight to prove that the individual is actually predisposed to an obesity phenotype. Of 61 gen...

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...tability is a proportion and is still undeniably affected by environmental factors, and this is where epigenetics comes into play. Even though genetics play a role in BMI variation for individuals, this does not mean that our body weight is genetically predetermined because the ‘obesogenic’ environment one is in, the daily caloric intake, and amount of physical activities all play a role in determining our phenotype. The heritability of BMI is balanced by a combination of all these factors. So 23andMe, Inc. should not have the right to give its customers access to their genome health reports because having an obesity risk allele in the FTO gene does not necessarily put them at a higher risk of being predisposed to obesity, and could lead them to extremes to combat this disease, while a lack thereof the risk allele could loosen their precautions in combating obesity.

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