Support for Two Clinical Trials
The risk involved in this case is high since Pomegranate juice products claim to offers a solution to a wide array of people in the USA. About 84 million residents had one form of heart disease or the other in 2016 (Roth, Johnson, Abate, Abd-Allah, Ahmed, Alam, & Atey, 2018). The number is on the rise similar to erectile dysfunction problems. Using a simple set of conditions will imply leaving out a vast amount of possibilities (O'Hara, Beaudreau, Gould, Froehlich, & Kraemer, 2017). It would be difficult to ascertain, using one clinical trial, all the conditions under which the juice led to the relieve of erectile dysfunction, blood pressure, and prostate cancer effects. Additionally, POM’s juice products have as many characteristics of food as they have of pharmaceuticals. In this manner, it requires a thorough analysis to improve medical knowledge in that field. A single trial will not sufficiently determine the effectiveness of the drug in the two fronts. One trial would be for the food side while the second could go to the pharmaceutical aspect.
FTC Overstepping its Boundaries
The FTC oversteps its boundaries since it starts treating POM Wonderful as a pharmaceutical company yet it is strictly a foods company. The move will place a higher cost on POM as there would be a lot of stakeholders involved and additional resources required to carry out the second human trial (O’Hara, 2017). Such a requirement is unnecessary as several studies support the viability of the juice products as food. Therefore, the FDC should have authorized taking POM’s samples to the government laboratory for further research to find out the medical implications of using the juices to reduce the effects of the three health conditions. This process will be worthwhile since there is a difference between medical research and studies opinion surveys from consumers of the products. Therefore, further research on the product will help distinguish POM’s juice qualities as food and as drugs.
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References
O'Hara, R., Beaudreau, S. A., Gould, C. E., Froehlich, W., & Kraemer, H. C. (2017). Handling clinical comorbidity in randomized clinical trials in psychiatry. Journal of psychiatric research , 86 , 26-33.
Roth, G. A., Johnson, C. O., Abate, K. H., Abd-Allah, F., Ahmed, M., Alam, K., ... & Atey, T. M. (2018). The burden of cardiovascular diseases among US states, 1990-2016. JAMA cardiology , 3 (5), 375-389.
