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Matt Raider Professor Gabriela R. Ros ENC 1102 3 June 2013 Stakeholder Analysis INTRO For many years the FDA (Food and Drug Administration) has been regulating food and drugs all over the United States. One thing they dont regulate fully are DS (dietary supplements). The reason for this is that they treat these DS like food rather than medication. As long as these supplements have all natural ingredients the FDA cant do anything at the beginning of their use but until some harmful effects start taking effect which can let them regulate the DS. Everything and everybody has a stake in this controversy. I have gathered research to show the top stakeholders who are shaping this controversy in the present and also the future. Whether its the people that take the supplements, a person that is involved with its 25 billion dollar industry, or even how public health care can be involved. This paper is to show you what is at stake for these groups of people. The User and Their Affects on Others One important stakeholder in the controversy that the FDA should regulate dietary supplements is the United States military. After two of their soldiers in training died they found a very powerful stimulant, DMAA (dimethylamylamine), in their bodies. This stimulant has

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effects of raising blood pressure and the heart rate which leads the reason it killed these soldiers. The two soldiers consumed this DMAA through a pre-workout sold at your local dietary supplement retailer. Not only did the user lose his life, but the parents have to go through this tragedy. It is in the familys interest to help this problem, but as we see they dont have the power. The Army immediately shut down 100 local GNCs (supplemental retailer) and banned the product from the stores on military bases. The power of this situation is that the military can regulate its own spatial praxis to keep people away from the harmful drugs. If you are a soldier you would have to go out of your way to obtain the pre-workout, which then might lead to laziness or obedience into not using the product. Due to the response the military has taken due to the death of its soldiers, they have the maximum interest over this issue in order to save lives of their own. If the FDA were to regulate the drug before it was out, the military wouldnt lives at stake. I interviewed my friend that uses a product with this powerful stimulant DMAA, and asked him a few questions on how he feels about the FDA regulating this product. Hector is a very devoted person when it comes to the gym. He goes everyday religiously for as long as I known. In his answers to the interview questions seems to be ignorant to his health and just cares about his gains in muscle building. For instance, I asked Are you aware that two people have died from the use of this supplement? He replied defensively with I wasn't aware, but it doesn't make a difference to me. People die from things every day. It got even worse when I asked him What if the FDA has banned this powerful stimulant perman ently from your

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market? Again he tells me that it wont happen and if it does he will find a way to get around it. He does make a valid point because steroids are illegal and people still use it, its just would he go that far to get the powerful stimulant. The stake for Hector is if the FDA does regulate these powerful DS, he might keep his life one day. In his eyes though, he doesnt care if the FDA took control because he doesnt care about the affects of these dangerous products. For the gym go-er that doesnt care about his health and only his muscle, they wont care if the FDA takes control. The stake that affects all of us in the United States is our health. There is a misconception widely held by the American public that natural products are sa fe, and therefore, dietary supplements marketed as natural may be perceived as safe when in fact they are not (Soontae 2012). People seem to already think that there is regulation coming from the government, aside from the fact that all natural means it cant harm you. A study from a medical hospital reported that 52% of all patients thought that their drugs were being regulated (Soontae 2012). I didnt tell you yet, but I myself also use these products that can be very well banned in the next years. If they banned the stimulant, that would make me healthier and less prone to health risks. Aside from saving my life, I dont think I would complain that the FDA has too much power over what the consumer can buy.

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The Industry To start this stake holder, 54% of all Americans reported using a DS at least once. Like I said before, at least half of these people probably assume the government has checked if these supplements are safe. The industry is very sufficient over the way DS is not regulated. This is a 25 billion dollar industry with more than 30,000 products and 1000s of new DS a year being introduced to the market every year (Soontae 2012). If the FDA was able to regulate these drugs before they are able to leave the market, and even before they show harm to people, this could hurt the billion dollar industry. Between 2004 and 2012, records show that 465 drugs were subject to a Class I recall. Of these, 51 percent were labeled as dietary suppleme nts (Skikos 2013). If the FDA could banned these drugs before they came into the market, the industry would have lost a lot of its revenue. With revenue that is raising 4.7% a year annually (Soontae 2012). How does the industry feel about these deaths? Lets go back to our previous example with the product Jack3d and see how the industry has responded to the fatal events. Jack3d is a product with well-established dangers, and the F.D.A. and medical community have made that abundantly clear, Ms. Andrews said. GNC has chosen financial gain over the safety of the consumer (Singer 2013). Even if their product shows a possibility of causing deaths and death causing symptoms, they simply care about their economic status in the industry. If the FDA does regulate these severe DS, would it even matter if they could get away with, theres no way of proving it. In 2011, more than 100 million dollars worth of DMAA supplements were out in the market (Klean 2013). It matters with some of the products on the markets but it does

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show that the industry has a lot of power over the situation no matter what the outcome might be. Public Health Care Whether it is the FDA, another government agency, or a nongovernmental third party, the American public and their health care providers would benefit by being able to access one central agency responsible for acquiring and organizing reliable, unbiased safety information about DS( Vatistas 2012). This is a worthy plan for the future that would make sense to use. The stake for this is that it will save peoples lives and would be economical. From the statistics described before people dont know the affects of these DS. People think they are harmless and are only there to help. The industry and the freedom of the people are in the way of this live-saving plan. Conclusion The top stake-holders show their power and interest throughout the whole scheme. The users dont have too much of a power but more of an interest. They seem to show that they are the ones being harmed and are causing the controversy, but also they are the ones that are using the DS and either have the interest to keep using them or wanting the government to ban them. The Industry doesnt have the interest for the FDA to regulate DS anymore than they are but do have the power to do whatever they want at the moment. Government shows the power and interest because it can do the action, however, will the people and industry let them

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with their interest. Public health care systems show interest with little power, as we saw; the public proposes plans, but will the government act on it. With all my research I have found that there are multiple groups at stake. Keep in mind there could be infinite stakeholders whether its a single person like Hector, or a whole broader group such as the industry. The lesson here is that you will always need the power and interest to work together to make an outcome.

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Annotated Bibliography "Hector and His DS Intake." Telephone interview. 14 June 2013. I interviewed my friend several questions regarding his concern on the DS regulation by the FDA. Overall he answered with not much interest regarding his health, but with a lot of interest regarding his muscle gains in the gym which are improved using these DS. Klein, Janet, Lauren Specter, and Adrian Taylor. "Deadly Workout Supplement? Jack3d outside FDA's Reach." NBC News. Rock Center, 11 Apr. 2013. Web. 19 June 2013. <http://rockcenter.nbcnews.com/_news/2013/04/11/17707934-deadly-workoutsupplement-jack3d-outside-fdas-reach?lite>. This source talks about how industry and the FDA play a role in the banning DMAA problem. They get a Dr. Cohen to research some effects of DMAA and he responds that it could have been the reason for the deaths of the people at the military base. You also see that GNC, the retailer, has responded with an assurance that you cant prove that it was their product that killed them. Overall, it gives shows you how the industry reacts to the blame, and how they get away with getting sued for the product. Singer, Nastasha, and Peter Lattman. "A Workout Booster, and a Lawsuit." New York Times. N.p., 13 Feb. 2013. Web. 19 June 2013. <http://www.nytimes.com/2013/02/14/business/death-after-use-of-jack3d-shows-gapin-regulation.html?pagewanted=all&_r=0>.

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The stimulant that is causing controversy as a dietary supplement is DMAA. It is a stimulant that raises the heart level and blood pressure that increase the serious risk of heart attacks. The one consumer product that contains this stim ulant is Jack3d. The military has had 2 deaths with the supplement possibly being the reason for those deaths and therefore banned Jack3d from their shelves. The parents were shocked that after their kid died they saw that their local GNC was still selling the product. The main controversy in my problem is that GNC has chosen financial gain over the safety of the consumer. There were other deaths across the globe, which resulted permanent deletion of the drug in countries like Britain, France, and others. The problem with the US is that the FDA cant prove it was killing these people, but the clues are significantly daring to blame the substance. Skikos, Skikos C. "Study Says Most Dangerous Drugs Recalled Are Dietary Supplements." Skikos Crawford Skikos Joseph Attorneys at Law Blog RSS. Skikos, 29 Apr. 2013. Web. 19 June 2013. <http://www.druglitigationnews.com/2013/04/study-says-most-dangerousdrugs-recalled-are-dietary-supplements.shtml>. This source talks about the recall statistics of DS overall. It shows you how many supplements got recalled in the past year, and how the FDA has been banning certain products. Soontae An, et al. "Dietary Supplement Advertising In The US." International Journal Of Advertising 31.3 (2012): 547-577. Business Source Premier. Web. 19 June 2013.

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This source talks about how the industry has made DS a public wide appearance. It gives you the statistics on the markets of the product along with how the FDA goes about the banning process. It goes into detail on how the FDA bans certain products and what their limitations are. Vatistas, Thomas J, and Joanne G Samuels. "The Regulation Of Dietary Supplements In The United States: Advocating For A Reasonable Approach, Protecting Patient Safety, And The Role Of Nursing." Policy, Politics & Nursing Practice 13.2 (2012): 113-116. MEDLINE. Web. 19 June 2013. This source shows us how people are affects by this controversy. It explains how people are blind by how these DS could be bad for you. They also propose a plan for the government to help cure this problem. It also points out how the industry makes a lot of money from DS in sum. Overall, it explained how the FDA is limited on this outcome and how people in power can help.