Example Of Research Paper On Dietary Supplements: The Benefits Of Regulation Over Having Better Labels
Type of paper: Research Paper
Topic: Dietary Supplements, Business, Products, Drugs, Supplement, Education, United States, Law
Individuals nowadays tend to stay within the walls of their home more than ever since the emergence of “better” technology such as the World Wide Web and Television. More become attracted to making their dealings through the Internet since online services are readily available anyway. With the lack of physical exercise and the emergence of fast food chains, obesity became one of the leading health problems around the globe. This then paved the way for the influx of slimming products that promises results without the forgotten-traditional methods of exercising. It literally redefined the well-known phrase “No pain, No gain” for it offers products that can give one the figure that they imagine they should have without the muscle pains and what-have-you, or at least less of it. Usually, these products come in the smallest packages that are known most commonly as your dietary pills or supplements. Since there is a huge demand for these products though, it also became one of the targeted products of “scammers”. Consumers are then faced with countless fraudulent, misbranded, dangerous and sometimes deadly products. While there is nothing wrong in wanting to aid the slimming down process with the help of supplements, there is a need to protect those who consume it with the dangers that a product may bring. Simply put, it is not anymore enough to require producers to just inform consumers of the ingredients of their products. A third party must enforce laws that may apprehend those with malicious intent, enough to dissuade them to create products that may impose harm to those who choose to buy the product.
This paper is divided into four parts to build the argument properly. The first section defines what dietary supplements are to provide common ground on how it is viewed and defined by the medical community and the government. Afterwards, it moves on to defining the status quo which will give the general condition on how dietary supplements are sold and manufactured. This is followed by building on the argument that there is an imminent need for the regulation of dietary supplements by presenting articles and studies related to effects of dietary supplements. Upon doing all this, it may then be concluded that better labeling is not enough to ensure the proper production and keeping the safety of consumers who uses dietary supplements.
Debate on dietary supplements cannot be made without first knowing or defining what they are. More often than not, individuals assume that dietary pills or supplements are classified like any other drugs into prescription or non-prescription drugs when in fact they are neither of the two. Dietary supplements are classified as a special kind of medicine, the implications of which will be discussed as the paper progress. In fact, given its nature, there was a need to enact a law that clearly defines what it is. In the case of the United States of America, this law is known as the Dietary and Supplement Health and Education Act of 1994. This act defines dietary supplements as quoted from Scarbrough:
“a product other than tobacco which includes one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, any other substance used to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above. Whatever the form, dietary supplements are considered a special category of food and are not considered drugs.” (Scarbrough 1)
Taken from the definition of dietary supplements from Dietary and Supplement Health and Education Act of 1994 which states that dietary supplements belong to a different category implies that it does not go through the same rigorous process that ensures he consumers of its safety like the regular drugs.
“Drugs are considered unsafe until proven safe” (American Cancer Society, FDA) is the usual mandate of the Food and Drugs Administration (FDA). This is the reason why before a drug is made available in the market, it goes through a series of controlled clinical testing. It does not stop there though, because after it is proven to be “market-worthy” the FDA carefully monitors the production of the drug and ensures that proper labeling is done to give the consumers all the necessary information that they will need. Moreover, the FDA monitors for any complaints that may arise after the product is released in the market. Through this process, the consumer is assured that the drug was examined and is proven to not just be safe but effective as well. However, dietary supplements do not go through the same process. Manufacturers of dietary supplements may be required to submit their facilities to the FDA, but it is not necessary for them to get an approval with the FDA before selling or producing any supplement. Basically, the FDA awaits the complaint before the drug is examined.
A study released by Statista shows that as of 2014, an average of 68% of the total respondents ranging from the age of 18-55 uses dietary pills. The same survey showed that two-thirds of the adult population of the United States of America uses dietary pills or supplements.
The facts presented above shows the huge number of users of dietary pills. Coupled with the knowledge that these individuals are given medicine that does not go through a rigorous scientific process that ensures its and the users’ safety is very alarming. True that a clause in the Dietary and Supplement Health and Education Act of 1994 states that these drugs are required to have the information of its ingredients, but it is common knowledge that proper labeling does not take into account the side effects that a drug may cause making it very much insufficient. At the same time, the lack of proper clinical testing further puts forth the question of the truthfulness behind these products. It is quite unfair that it is marketed in such a glamorous and fancy way and yet there is no legitimate party that approves this campaign leaving consumers without a choice, but to test the product themselves and just hope for the best.
It seems that without proper regulation, producers are given a very loose reign on creating their products when in fact the popularity of these products cannot be questioned that the debate on whether these supplements are effective or not is one that may be considered to have long sided with the pro. It is therefore necessary to ensure that there is a proper mediator on the affairs its affairs that will impose and maintain the standards that it must follow. After all, it is lives that it may affect.
The Need for Protection
The case that this paper is trying to make relies heavily on the premise that there is a threat to consumers of dietary pills and this may be alleviated with proper regulation. This premise though must bank upon proof of actual events that involves the use of dietary pills. One of which is the study made by Kryzlack et al. They studied the poison experience in two herbal dietary supplements namely Echinacea, and St. John's wort. Their results showed that in 2001, there were 406 exposures with Echinacea while 356 were found with St. John’s wort. Furthermore most of the recorded exposure shows that it was unintentional and is related with adverse effects. Another study was made by Swedish researchers regarding calcium dietary supplements wherein it was found out that amongst its respondents, women who had an intake of 1400 mg per day from the said type of supplement had higher chances of death compared to those having an intake of 600 to 1000 mg per day (Antinoro 50). Another study that supports this is that of the National Institutes of Health-AARP Diet and Health Study which studied approximately 388,000 people in a span of 12 years showed that men who had an intake of 1000 mg of calcium supplements per day had a significantly greater risk of dying from cardiovascular disease.
There are also reports on the adverse effects of dietary supplements such as the case of OxyElite Pro, a supplement that promised muscle building and weight loss, this 2013 where 56 people were reportedly using the product and developed an acute liver failure. Upon the complaints FDA had the facilities of the said distributor closed along with stopping the production of another supplement: Versa-1. While majority of the users came from Hawaii, there have also been reports from other parts of the United States as well.
As stated a while ago, this paper is presented in this arrangement in order to create a holistic view of the topic in arguing that there is a need for regulation which may be summarized into three points. First, the status quo tells us that the FDA is already imposing the rule of proper labeling and yet even with this consumers are still experiencing different risks with the use of dietary supplements. Second, since these dietary supplements “play” with living beings there must be an intervention from authorities in making sure that before these pills are allowed to circulate the market, it must have undergone a rigorous process of scientific tests to prevent side effects from occurring. Lastly, it is true that dietary supplements may have its positive effects, but that does not give anyone the leisure to be complacent with it. Numerous studies and news articles show that it has adverse effects. It is a consumers right to be able to use a product in an environment where he/she feels somewhat confident and secured. If this is the ultimate goal, then a third party that will maintain and impose the rules must be present to aid in the monitoring and apprehending of violators.
Antinoro, Linda. Calcium Controversy — Why Dietary Sources Trump Supplements. [Today’s Dietician. 2013. Web. 5 March 2015.
“Dietary Supplements”. [U.S Department of Health and Human Services]. 2014. Web. 5 March 2015
“FDA regulation of drugs versus dietary supplements”. [American Cancer Society]. 2014. Web. 5 March 2015
Gryzlack, BM et al. National Surveillance of Herbal Dietary Supplement Exposures: the Poison Control Center Experience. John Wiley & Sons, Ltd. 2007. Web. 5 March 2015
Scarbrough, Brian. Dietary Supplements: A Review of United States Regulation With Emphasis On The Dietary Supplement Health And Education Act of 1994 And Subsequent Activity. [LEDA at Harvard Law School]. 2004. Web. 5 March 2015
“Supplement Linked to Liver Failure, Hepatitis Recalled”. [UPI Health News]. 2013. Web. 5 March 2015