Introduction To The Health Issue
The health issue discussed is on the safety of dietary supplements. Dietary supplements are used to enhance the nutrition quality of food and only supplement but should not replace food. The Food and Drug Administration (FDA) defines a supplement as a substance taken orally and contains a dietary ingredient intended to increase the quality of the diet. The nutritional components may include vitamins, minerals, herbs, amino acids or other substances such as enzymes, organ tissues, glandulars, and metabolites. While supplements are beneficial to the human body's functioning, concerns over the safety of some of the supplements sold at our local retail shops continue to rise. Some supplements do not contain the ingredients on the labels and are different things from consumers think they are buying such as powered rice and laxatives in place of St. John's wort and black walnut in place of ginkgo loba.
Some supplements have compromised qualities regarding the specified ingredient quantities for the supplements. Known nutritional supplements such as OxyElite Pro, a common over the counter supplement associates with many cases of severe hepatitis and liver failure. More than five hundred supplements in the market are modified with pharmaceuticals analogs such as novel anabolic steroids, banned weight loss medications and untested sildenafil analogs (Cohen, 2014), posing a great danger to the human health. Supplements such as ephedra cause arrhythmias in the subjects, those containing anabolic steroids lead to infertility in its users with gynecomastia in men, and the supplement ginseng has led to chest pain among its users. Most supplements in the market today pose great health dangers to the consumers, a health issue that requires close monitoring to ensure supplements safety for the consumers.
Determinants Of The Health Issue
A major contributory factor to the release of many unsafe supplements in the market is the limitation on the Food Drug and Administration board on the monitoring of the whole manufacturing process. The Dietary Supplement Health Education Act (DSHEA) guiding the regulation of dietary supplements by the FDA contains significant gaps that limit the regulation process. First, the act does not require the registration of products before or after marketing, and as a result, the FDA does not know what is in the market at any specific point in time, allowing most unsafe products in the market. Secondly, the acts set a high standard for the FDA to demonstrate a safety action before the regulatory action (Kapoor & Sharfstein, 2016). An example is with the case of the dietary supplement ephedra that caused severe health complications before pulling the ingredient out of the market; it took nearly ten years for the FDA to manage to pull the supplement out despite the reported adverse effects due to the limitations brought about by the act.
Finally, the law does not require a preview of the safety and the efficacy of the dietary supplements before releasing them into the market as with pharmaceuticals and high-risk medical services. A company can, therefore, develop, manufacture a particular product and put it to the market without it undergoing the necessary quality review. Major loopholes in the act regulating the FDA on its role in ensuring safety products release into the market are the significant determinants compromising the safety of dietary supplements availed for consumers.
Key stakeholders in this health issue are the manufacturing companies, the Food and Drug Administration board, and the consumers. Inspection of facilities that manufacture dietary supplements revealed a violation of the manufacturing procedures by most of the companies. Out of four hundred and fifty firms inspected by the FDA from the years 2008 to 2012, more than half of them were found to be violating the manufacturing procedures (Marcus, 2016). The procedures violated included lack of recipes for their products and unsanitary conditions including infestation by rodents. In the DNA analysis of forty-four herbal samples from twelve companies, only two of the companies contained products listed on their labels. The remaining samples contained other products not listed such as rice, soya beans and other potentially toxic substances including senna and feverfew.
In another testing commissioned by the attorney general of the New York state, a bottle of gingko loba believed to be lacking wheat, in reality, contained corn, houseplants, and powered radish. Most manufacturing companies, therefore, their profits through dishonest means. Some manufacturers have also come up with ways of evading regulatory requirements by making changes in the chemical composition of the same brand over time. Evidence of this is the case of a dietary supplement referred to as power tabs containing blue colored capsules (Gilard et al., 2015). Three different formulations of the same supplement were in the market successfully for three years in 2008, 2009 and 2012.
Manufacturers also continue to ignore manufacturing practices as evidenced by the presence of impurities and degradation products in supplements sold. All these unorthodox methods by the manufacturers increase their gain in the business with consumers, on the other hand, continue facing the effects of unsafe products. The Food and Drug administration board has a task to regulate the dietary supplements manufacturing process as guided by the Dietary Supplement Health Education Act (DSHEA).
Legal And Ethical Considerations
A primary characteristic of ethics in healthcare is first not to harm (McLean, 2016). The phrase means that everything done must have the goodwill of the consumers at heart. Manufacturing companies should have the goodwill of their consumers at heart and therefore whatever products they endeavor to develop must of benefit to the clients. Most supplement manufacturing companies have however ignored this principle and allowed selfishness, and egocentric natures take the course at the priority of the consumers. It beats logic that companies prefer to dilute their products and insist on them being pure products. Reports of death and adverse health effects continue to fill the air due to toxic substances released to the market with labels appraising the state of their purity which many times is not the case.
Most studies done continue to give evidence to the presence of toxic quantities and modified pharmaceutical chemicals in what manufacturing companies insist on being pure. Ethics has, therefore, stopped being the guiding principle and instead whatever brings most gain seems to now be the priority. There is a need for manufacturing companies to uphold ethical considerations in their processes and where there is a violation of ethics, the law should take the course. Manufactures should learn to adhere to the Dietary Supplement Health Education Act (DSHEA) that provides guidelines on how to carry out their processes. The Canada health act also sets out its primary objective which is to protect, promote and restore the physical and mental well-being of residents and facilitate reasonable access to health services without financial or other barriers, an objective which manufacturing companies should also use as their guiding principle.
Potential solutions to the problem may include giving the FDA more power to oversee the whole process. An amendment to allow the FDA review supplements before their release into the market will ensure only safe products release into the market. Preview of the safety and efficacy of dietary supplements before releasing them to the market will ensure quality from the manufacturer's side. H NMR spectroscopy is also useful in detecting the presence of adulterants in dietary supplements and quantifying them (Gilard et al., 2015). The spectroscopy analysis applied in a study done one hundred and fifty nutritional supplements marketed to improve sexual performance produced alarming results. As opposed to the claim that the only substances in the supplements were natural compounds, plant extracts, and vitamins, the supplements contained adulterated compounds including phosphodiesterase-5-inhibitors such as sildenafil, tadalafil and vardenafil and also structurally modified analogs. The supplements also had other pharmacological treatments for sexual dysfunction disorders including yohimbine, phentolamine, and testosterone. H NMR spectroscopy will, therefore, form part of the solution in curbing the release of unsafe supplements into the market. Measures to ensure strict adherence to manufacturing procedures by the manufacturing companies will also help to ensure quality.
The government should also support more research programs in determining the effectiveness of dietary supplements and nutritional products released into the market to only allow that which is beneficial to the consumers (LeDoux et al., 2015). Closing down of companies that do not meet the regulations set up by the FDA will also serve to caution other manufacturing companies on the need to stick to the manufacturing procedures thus offering solutions to the widespread release of unsafe supplements into the market.
In conclusion, the issue of unsafe dietary supplements release to the market is a significant health issue and therefore regulations to limit this are of great importance.
Cohen, P. A. (2014). Hazards of hindsight-monitoring the safety of nutritional supplements. New England journal of medicine, 370(14), 1277-1280.
Kapoor, A., & Sharfstein, J. M. (2016). Breaking the gridlock: Regulation of dietary supplements in the United States. Drug testing and analysis, 8(3-4), 424-430.
Marcus, D. M. (2016). Dietary supplements: What's in a name? What's in the bottle?. Drug testing and analysis, 8(3-4), 410-412.
Gilard, V., Balayssac, S., Tinaugus, A., Martins, N., Martino, R., & Malet-Martino, M. (2015). Detection, identification and quantification by 1H NMR of adulterants in 150 herbal dietary supplements marketed for improving sexual performance. Journal of pharmaceutical and biomedical analysis, 102, 476-493.
LeDoux, M. A., Appelhans, K. R., Braun, L. A., Dziedziczak, D., Jennings, S., Liu, L., ... & Griffiths, J. C. (2015). A quality dietary supplement: before you start and after it's marketed-a conference report. European journal of nutrition, 54(1), 1-8.
McLean, S. A. (Ed.). (2016). First do no harm: Law, ethics and healthcare. Routledge.
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