Monday, November 30, 2020

Protein Shoppe Red-E Male Enhancement Supplement Recall

 The Protein Shoppe has been a supplement company for many different supplements, some for the gym and others for people’s health and wellbeing. The Protein Shoppe has never had any complaints about their products from customers or FDA analysis. However, their credibility was questioned after the FDA found a drug in their Red-E male enhancement supplement, even though there were no complaints from customers who had purchased this supplement it is still something that needs to be reported and dealt with as soon as possible. This issue caused negative publicity for the company and added damage on the brand as a whole. The supplement is reported as always being something that has worked well and no harsh side effects for their customers that reported on it. What makes the Protein Shoppe take a negative hit is the lies to their consumers about the active ingredients and the FDA about the impact of asbestos-contaminated talc on public health, thousands of affected consumers are seeking justice after developing cancer.

            Ethical theories would analyze the Protein Shoppes actions in many different ways. An Individualist would say that the Protein Shoppe did not maximize profits for the business within the law because they failed to inform the public and their stakeholders about the scientific findings of their supplement. A Utilitarian would say that the Protein Shoppe is unethical because of the consequences of their mistakes. They knew that the drug which was sildenafil caused health risks for people with other health problems, but they continued to sell the supplement anyways. A Kantian would view the Protein Shoppe as unethical because they manipulated their consumers in buying this supplement by selling it with sildenafil which was completely unsafe, because of that they were evidently implementing bad will. Under the Virtue Theory, the Protein Shoppe is considered unethical because they exhibited many bad character traits. Proving that they do not care about the safety and health of their consumers. Protein Shoppe needs to focus its resources on testing their product, reestablishing their values, and monitoring product safety in order to portray empathy for the consumers, for the company to just recall the product is not good enough. Above all, the Protein Shoppe needs to have open relationships with consumers and stakeholders for the sake of reinstating their brand and ensuring good ethics after this supplement made the company look very irresponsible  

 

Ethics Case Controversy


            A Supplement store named, Protein Shoppe, was selling a male enhancement pill that was recently recalled. The supplement shop was an online store that was selling this pill has a nutritional supplement and not as a medication. This pill was working very well, some say it was working too well. The pill is in the shape of an octagon and has the word “Red” embossed on both sides of it. The pill was sold individually in a small plastic bag with a black label stapled to it. The Protein Shoppe recently voluntarily recalled all of its Red-E tablets, this recall “has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 inhibitor” (Center). This inhibitor is an active ingredient in another drug for erectile dysfunction and this other drug is also approved by the FDA, but the Red-E tablet is not. The presence of sildenafil in the Red-E supplement is what makes it an unapproved drug. This is because the safety and efficacy of this drug in the supplement has not been established yet and because of that is why the Protein Shoppe had to make the call to recall it. Two of the largest FDA approved male enhancement drugs, Viagra and Levitra, have very similar ingredients, and  both of these approved enhancement drugs have an active ingredient of sildenafil. Viagra has sildenafil and Levitra has vardenafil, which are both very similar and have the same side effects. A medical team leader of the Office of Compliance in the agency’s Center for Drug Evaluation and Research says, “this undisclosed presence of prescription drug ingredients, and similar compounds known as analogs of the drugs, can lead to serious side effects in users” (Commissioner). If a consumer is using other prescription drugs and takes Red-E or other male enhancement drugs without knowing the overlap of ingredients can cause serious problems.

            Having the PDE-F inhibitor (sildenafil) present in the  supplement makes it a very serious health concern. The serious health risks are highly possible in consumers that have other underlying medical issues. This PDE-F inhibitor “may interact with nitrates found in some prescription drugs, such as nitroglycerin, lowering blood pressure to dangerous levels that is life threatening and could result in serious adverse health consequences” (Center). There are a lot of people that take nitrates for health reasons, and because of that it is dangerous, the people that normally take nitrates are people that have health conditions like diabetes and high blood pressure. Since the recall has occurred the Protein Shoppe has not had any adverse events due to what was recalled about the supplement, this is a positive thing for the company and the consumers as a whole.

Stakeholders

            The Protein Shoppe, along with all companies, holds their relationships with stakeholders very high. Companies can get new ideas along with business plans from their stakeholders so it is important to always include them. It is important to listen to stakeholders to get feedback in areas they think need to be improved. Listening to stakeholders is important because you build a relationship with them and they help make the company successful. The Protein Shoppe engages with their stakeholders to understand their expectations and how the company’s activities would impact them as a whole. The owners of the business, the FDA, the employees and the customers would be the stakeholder in this case because the Protein Shoppe is not a publicly traded company. The FDA (Food and Drug Administration) are stakeholders who did the recall of the product, this makes them involved in the Red-E pills testing and investigating of the ingredients now and after the recall.

Individualism

            Individualism is the principle or habit in independent thought or action, it is the pursuit of an individual rather than for the overall common interests of everyone. The first way to view Individualism is according to Milton Friedman, Milton says that the only goal of business is to profit within the constraints of the law.  The second way to view it is by Tibor Machan, he calls it “Classical Individualism.”  According to Machan the only direct goal of business is to profit, and the primary obligation of the businessperson is to maximize the profit (Salazar, 17-18). For the Protein Shoppe, they are acting as the principle of individualism states, this is because the company tried to pass a supplement knowingly that there was sildenafil in it and that was not disclosed on the ingredients. This would make it getting passed by the FDA nearly impossible. The Protein Shoppe did this not caring about customers health, but more about maximizing profits.  They would do this because if the drug was passed by the FDA it would make it more actively distributed in the market making it easier for more customers to get their hands on it. Therefore, it would drive up sales and cause the Protein Shoppes revenue to rise.

Utilitarianism

            Utilitarianism is the principle that something is morally right if it is useful or benefits the majority. Utilitarianism takes the same approach as a stakeholder; it says to maximize happiness in yourself and other people. Its goal is to maximize happiness for all affected parties and to minimize unhappiness for all affected parties. Utilitarianism can be described as pleasure and the absence of pain.  Ultimately, Utilitarian’s consider the costs and benefits of actions for all affected, not just the company or one individual (Salazar, 19-20). The Protein Shoppe is not acting in a utilitarian manner because they are were thinking of themselves and trying to make the company successful. The company knew that this substance called sildenafil was present and they tried to hide it. They knew that the product would work better with the sildenafil in the pill and caused the company to be more successful compared to if they were honest. If the sildenafil was not present in the enhancement pill, then the company would not have so many people buying the pill. Having the sildenafil not on the ingredient list made the Protein Shoppe look bad and irresponsible. They also put their customers health in danger by not labeling the product correctly and people with underlying conditions could have serious problems but luckily the company got away with it by not having anyone’s health seriously damaged in the process.

            A Utilitarian thinker could also argue the other way, by saying that they were trying to maximize happiness, and they were doing so by recalling the enhancement pills before anyone told them to, and they did this knowing that they would damage themselves but save their customers in the long run. The Protein Shoppe was holding themselves responsible for their previous actions, and trying to maximize the happiness of their customers by fixing the problem and not trying to hide it from the media and the customers involved.

Kantianism

Kantianism was developed by a man named, Immanuel Kant, and focuses primarily on rationality and Good Will.  Kant says that it is wrong to manipulate and exploit people for their own advantage. The four basic principles of Kantianism are defined to act rationally, to help others make rational decisions, to respect people, and to be driven by Good Will, looking to do the right thing because it is right. In this theory there is something called the Categorical Imperative, this is a test that decides whether an action is permissible or impermissible.  One of the main parts of the Categorical Imperative is The Formula of Humanity, this states that it is wrong to use people as a means to get what you want because it exploits them (Salazar, 21-22). 

            Kantianism is the philosophy of rational morality, for the Protein Shoppe, they recalled the Red-E supplement pill so they acted moral in that state. Not having the labeling and telling the consumer that the ingredient of sildenafil was not present in the pill is where the Protein Shoppe was using consumers as a mere means and not acting morally. They were using their customers as a mere means because the Protein Shoppe was trying to use them to push their supplement and even their brand as a whole to grow it. They also were using the FDA approval as a mere mean to show that their supplement was safe to use. The FDA would not approve the supplement because of the presence sildenafil in it, the Protein Shoppe is now trying to recall the product and look like the “good guys”, but the truth is that the damage is already done. The company put their customers in danger and that cannot be forgiven, not only did they put their customers in danger but they tried to get the FDA to approve it to push their supplement even further without making it safe. That is where the Kantian theory shows how the Protein Shoppe was not acting morally correct and was using everyone as a mere means for the company’s success and growth.

Virtue Theory

Virtue Theory was developed by Aristotle, this theory focuses on rationality and whether a person/entity is virtuous or not. There are 4 main virtues, which include courage, honesty, temperance, and justice. Aristotle said that rationality is what differentiates characteristics of people and that people need to be rational in order to live a virtuous life. Aristotle also said that people need to be rational in order to function well and said that if a thing achieves its function then the thing is happy. Therefore, people who function well will live a virtuous life (Salazar, 23).

For virtue theory, the Protein Shoppe is considered unethical because they showed many bad character traits for this theory. The company was dishonest with their consumers with the ingredient of sildenafil being active in their enhancement pill. They kept information regarding this ingredient and tried to pass it through the FDA in an attempt to increase profit. This follows the second bad character trait that the Protein Shoppe tried to get, which was greed. The company hid this ingredient which made their product “better” and “stronger” for the consumer. This showed that the company only cares about maximizing profits so that owners and stakeholders can benefit as well. This proves that they do not care about the safety and health of their consumers. Finally, the Protein Shoppe acted very selfishly, when they said that they were going to recall it out of their own choice, this made the company look like they cared, but all they were doing was trying to save their own image before it completely shattered. The Protein Shoppe is not a virtuous company and does not aid the flourishing of individuals within the society with their actions.

Justified Ethics Evaluation

            In my opinion, the Protein Shoppe was very unprofessional and unethical in their recent actions with the Red-E supplement. In order to avoid this situation, the company should have got FDA approval in the beginning stages of this product without the ingredient of sildenafil, and seen if the FDA would have approved it that way. Another way to avoid this situation is if the company was truthful with what they were selling their consumers, because other products that are similar to the Red-E pill also have this ingredient and they do very well in the marketplace. For the Protein Shoppe to not be transparent with their customers and try to have the FDA pass it and then recall it themselves trying to be the “good guys”, it does not look good for them at all.

            You can now argue that the Protein Shoppe is now acting in a morally correct and ethical way because they are recalling their product because it is “unsafe”. If you were to actually think about it, they are only recalling it before they get even more backlash because they have been selling this product even before the FDA tried to approve it so consumers have already been risking their safety since the product was released. In the end, their unethical business actions costed people their health and made them untrustworthy all because they focused more on their own self-interest and growing the business then being truthful about their product.

Action Plan

            Due to their mistake, the Protein Shoppe needs to roll back their Red-E supplement. As previously stated, the Protein Shoppe should have first had the FDA approve the product before selling on the market. Next, they should have put warning labels on the Supplement, showing that sildenafil is an ingredient that may cause other health issues to arise. With that being said, the Protein Shoppe could have resolved the issue right away by contacting the FDA and trying to pass their supplement first. If the FDA said no first, then they could have changed the ingredients and made it safer for their customers, they could have avoided the negative publicity and the overall uncertainty of their product. Now it is a possibility that their customers will never trust them again with this specific supplements and others to come. They should relook at their values and maybe make some new ones that incorporate values like Honesty, Integrity, Compassion and Safety for Customers.

1.)    Honesty- it is important for a company to value honesty, to be able to have trust and respect in a company that you deal with. Having honesty creates a positive environment for all involved in the company and outside the company.

2.)    Integrity- holding actions to a high level of integrity should always be important. This is important because it promotes an environment that is professional and lets people depend on others and treat them with respect.

3.)    Compassion- it is important for companies to act human too, and to be understandable and show that the company cares about their customers

4.)    Safety for Customers- there should always be an effort to ensure that the safety of employees and customers are met. If there is something unsafe it is everyone’s job within the company to help fix it. A company should try and exceed the expectations of customers and go above and beyond their expectations when it comes to safety.

A company that states their missions and values can not only state it but also prove that these missions will be met. Sometimes companies’ actions speak more than what they might write down, so therefore the Protein Shoppe must put new systems in place to ensure their company will grow again. First, they should be in contact with the FDA ensuring that their products do not contain any ingredients, like sildenafil, that may cause another issue. They should also monitor their communication with the FDA so that they can check in and see if they are making progress. The Protein Shoppe should implement a department that collects data and suggestions from consumers or stakeholders. Doing this is just another way to ensure that everyone is involved and can hold decisions for product safety. With these new policies, hiring of new employees and creating a product that can be FDA approved the company can continue to be successful.

Another thing that the Protein Shoppe should look into is marketing their product once the ingredients change and they get approved by the FDA. Although this marketing would cost a lot, my plan will promote business profits and productivity. By implementing a new mission statement, values, policies, and marketing, the Protein Shoppe can recreate their brand and show good ethics. Doing this would show that actions, in this case positive ones, would speak more than words.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

References

Center for Drug Evaluation and Research. “The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the ‘Red- E’ Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil.” U.S. Food and Drug Administration, FDA, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/protein-shoppe-llc-issues-voluntary-nationwide-recall-red-e-male-enhancement-tablet-due-presence.

Commissioner, Office of the. “Hidden Risks of Erectile Dysfunction 'Treatments'.” U.S. Food and Drug Administration, FDA, www.fda.gov/consumers/consumer-updates/hidden-risks-erectile-dysfunction-treatments-sold-online.

NY, FOX 5. “'Male Enhancement' Tablet Recalled Due to Undeclared Erectile Dysfunction Drug.” FOX 5 New York, FOX 5 New York, 4 Sept. 2020, www.fox5ny.com/news/male-enhancement-tablet-recalled-due-to-undeclared-erectile-dysfunction-drug.

Salazar, Heather. The Business Ethics Case Manual. n.d.

Staff, NCPA. “The Protein Shoppe Recalls Red-E Male Enhancement Tablets.” NorthcentralPA.com, 4 Sept. 2020, www.northcentralpa.com/life/the-protein-shoppe-recalls-red-e-male-enhancement-tablets/article_30bd705a-ed9f-11ea-b688-0f9af3010e95.html.

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