Unilever and Johnson & Johnson: Recall Antiperspirant Products After Elevated Levels of Benzene had been Discovered (March 31, 2022)

 Case Controversy

It has been discovered that numerous media organizations have published news and articles in response to various corporations who have released aerosol items that have since been recalled due to the discovery of carcinogens. One company in particular that has experienced their products containing cancer causing chemicals is Unilever. Due to the presence of “benzene”, a cancer causing chemical, in several products, Unilever in March of 2022 had announced to the public that they had to recall everyday consumer products due to carcinogens being found in testing samples.  These products were recalled from the shelves of stores and pulled from online sales due to the concern that benzene, which has been associated with various types of cancer after long-term exposure, was present in a couple of commodities. During an internal investigation, high quantities of benzene were discovered product samples which lead to Unilever having to announce the voluntary recall of two different kinds of Suave 24 hour aerosol antiperspirants. Suave 24 Hour Protection Aerosol Antiperspirant Powder (4 oz. and 6 oz.) and Suave 24 Hour Protection Aerosol Antiperspirant Fresh (6 oz.), with an expiration date through September 2023, were the two commodities that had been affected and contained benzene (Albert, 2022). Unilever spoke out on their recall and stated “while benzene is not an ingredient in any of our products, our review showed that an unexpected level of benzene came from the propellant that sprayed the product out of the can” (FDA, 2021). The company also went on to say that the exposure to the quantity of benzene observed from review, on a daily basis is unlikely to be harmful to one’s health. However Unilever has initiated this recall that is voluntary for the two Suave antiperspirant aerosol products as a result of these findings and out of an excess of caution for the consumer (Torchinsky, 2022). When it comes to the question of how benzene could have exactly gotten into these aerosol products that individuals use on a daily basis, the company went on to say that “investigators believe it may be due to the manufacturing process and cross-contamination” (Yates, 2021). Suave products were only available in limited quantities in retail stores and online stores in the United States and were discontinued in October of 2021. 

Recalled Sauve Products (Image from Unilever Recall Page)

A month after the product was discontinued a class action lawsuit was filed against Unilever following a study made by Valisure. On November 3rd, 2021 Valisure released a petition requesting the Commission of Food and Drugs to request recalls and revise industry guidance. Valisure found that body sprays and found that 54% of the samples tested contained elevated levels of benzene and in some as much as 18 parts per million (ppm) (Valisure). Which is much greater than the FDA’s limit of 2 ppm if  “unavoidable to produce a drug product with a significant therapeutic advance” (FDA Alerts). The Suave Powder Aerosol products in 4 oz. and 6 oz. sizes contained an average of 5.21 ppm and 0.97 ppm respectfully. Suave Fresh contained an average of 2.30 ppm within tested samples. This is a huge concern for customer safety because the Environmental Protection Agency (EPA) has  “estimated that lifetime exposure to benzene at 0.4 parts per billion (‘ppb’), or 0.0004 ppm, will increase the risk of developing cancer in humans” (Valisure). Making these products harmful to consumers uses them everyday. Furthermore, Valisure also stated that if a contaminated product was used in the bathroom (20 sq. ft. with 8 ceilings) the air could contain benzene at 6 ppb. So if someone used a contaminated aerosol product everyday, in an enclosed space, they would dramatically increase their chance of getting cancer. 

Retailers had been informed the recalled products must be removed from their shelves. The company also stated that the customers that had been affected by these purchased products would be reimbursed by Unilever. Recalls regarding the chemical, “benzene”, was not the best news for Unilever nor is it a great look to have cancer associated with their products. On the other hand, this was great news for the general public that regulators were able to quickly discover the problem.

Not only have antiperspirants been recalled in recent months, but Johnson & Johnson (J&J) has also voluntarily recalled four of their sunscreen products. Specifically, Neutrogena® Beach Defense, Neutrogena® Cool Dry Sport, Neutrogena® Invisible Daily™ defense, Neutrogena® Ultra Sheer, and Aveeno® Protect + Refresh. All five of these products are aerosol sunscreen and all of them were found to have benzene contained within the propellant, similar to Unilever’s Sauve products. J&J also advises customers to do the same as Unilever, to stop using the products and dispose of them properly. Any customers with questions are encouraged to call J&J’s Customer Care Center at 1-800-458-1673.

Recalled Neutrogena Products (Image from ksat.com) 

Timeline of Events

Stakeholders

Any sizable business has plenty of stakeholders to help the business strive and grow. The responsibilities of a stakeholder include contribution of not only their money but more importantly time to better the company. In this case we are talking about the stakeholders involved with Neutrogena. Unfortunately over the last few years we have become very familiar with Neutrogena stakeholders. That being Johnson and Johnson(J&J). J&J works side by side with Neutrogena to promote sustainability. Main end goal is to maintain the competitive advantage over other rival companies. The current CEO to date for Neutrogena is Alex Gorsky and CFO Alexander Caruso.  Now the thing with stakeholders is that when the company is thriving they get a good amount of credit, on the contrary when the company is doing poorly they take most of the hit. As one could imagine during this time in which the recalls began a lot of it fell on J&J. Another major stakeholder that was involved are called external stakeholders. This includes doctors and other organizations that promote these Neutrogena products and ensure safe and healthy use. Now imagine how the doctors felt once they discovered that Benzene was in the product. This makes people lose trust in the doctors even though it shouldn't be. The stakeholders allow for the reputation of the product to remain positive and Neutrogena did just that and are still one of the top selling cosmetic companies globally.

Unilever stakeholders are different in comparison to Neutrogena, Unilever prides itself on having a strong relationship with many of its stakeholders ranging from customers to suppliers, shareholders, scientists, as well as trade associations. When conducting research it was difficult to find the exact names of these stakeholders, but  is it important to notice that Unilever makes a point to take into consideration all of them. The current CEO of Unilever is Alan Jope as of 2019 which is fairly recent. As mentioned above, many of the stakeholders' responsibilities are to grow the company as much as possible.  

The General Public is affected because Unilever and J&J  are very large corporations spread across many industries and are owners of same brand products like Ben & Jerry’s and Neutrogena. Due to a lack of quality control/product investigation there could be other products also containing potentially harmful products without anyone knowing. 

Individualism

In this class there were two theories of Individualism: Friedman's Individualism and Machan’s Individualism. Friedman’s Individualism states “The only goal of business is to profit, so the only obligation that the business person has is to maximize profit for the owner or stockholders within the law of the land” (Salazar). This theory does not take into the consideration the identity of the company and the motivations of investors and customers to choose socially responsible businesses. However, Machan’s Individualism does take this into account, stating that the primary goal of the business is to profit, with the law, BUT may have goals not aimed at profits (such as being a socially responsible business).

In the case of Unilever, under both Friedman’s and Machan’s Individualism Unilever used unethical business practices to gain profits because they were above the legal limit of benzene in their products. A class action lawsuit was filed, against Unilever, on November 12th, 2021 claiming that “as much as 5.51 parts per million (ppm) of benzene” (Shaak) were found in Unilever products. This is above the FDA’s limit of 2 ppm if the presence of benzene is “unavoidable” during the manufacturing of a product. The actions of Unilever are impermissible under an individualist point of view because they did not follow the rules & recommendations set forth by the FDA. While the lawsuit states that not all of the tested samples contained benzene, this shows that the presence of benzene is not “unavoidable” because some products were able to be produced without containing benzene. 

Let's say for example Unilever was below the FDA’s regulation 2 ppm in their product. It highlights one of the shortcomings of Freidman’s Individualism because investors are supporting a non-socially responsible business. An individualist would view Unilever’s actions as ethical because they are profiting within the law. However, Unilever did do the socially responsible thing by voluntarily recalling their product but this did occur 4 months after the lawsuit was filed. Back to the case at hand,  Unilever’s business practices were not ethical because they did not profit within the law.

Utilitarianism

Ethical theory played an important role in this decision, because the companies could have attempted to hide these findings in order to uphold the companies name and overall stature. As soon as the lab results came back immediate action was taken in order to protect the health and safety of its consumers. The two Suave antiperspirant arousal sprays were immediately recalled to protect the lives of the consumers. This case stated above can be linked to the ethical theory of utilitarianism. Utilitarianism states that all parties are treated honestly and with the utmost respect, as well as promotes happiness among the greatest number of people. “Utilitarianism is one of the most powerful and persuasive approaches to normative ethics in the history of philosophy”(Stanford). A Utilitarian wants everyone's happiness to count as the same, in other words maximizing the good. After conducting a sufficient amount of research one can conclude that even though the Unilever situation was extremely severe the company did everything to make sure that it had full transparency and despite  being in the wrong. When Unilever realized their mistake there made sure that the appropriate actions were taken in the benefit of all who were affected. Their biggest concern was the consumer, further explaining how the ethical theory of utilitarianism can be closely connected to this case. The company took the necessary precautions for the good of the people. The only aspect that wasn't fully explained was how the products get contaminated in the first place. Now the company could be hiding the aspect, however if what they say is true they might not have an actual answer.  

Kantianism

Unilever voluntarily recalled their two Suave antiperspirant aerosol products due to the potential of cancer-causing chemicals. From a Kantian perspective, this was the most ethically desirable approach to handle the situation for almost everyone involved. Like Kantian ethics in general, the Kantian understanding of business ethics encourages acting with respect toward all human individuals. Rational decisions must be ethical, according to Kantian business ethics theory. Being ethical refers to the rules or standards that govern proper behavior or performance. The decision you make should be driven by obligation rather than self-interest. Good will is at the heart of Kantian ethics. According to Kantian Business Ethics, the definition of good will is: “rationally which chooses to do what is right for the reason it is good” (Salazar). We, as individuals, all have value derived from our moral and cognitive abilities, and therefore we should all act in ways that demonstrate our gratitude for that value. When you’re in control of a company that services millions of human individuals, you should constantly be faithful and trustworthy to the customers who support you while also helping them. A company should not be exempt from ethical principles in general. Kantianism's four essential principles are to act logically, to assist others in making rational decisions, to respect individuals, and to be motivated by Good Will, looking to do the right thing because it is the correct thing to do. In this case, Unilever responded in accordance with its duty to protect its customers’ well-being by issuing a statement warning its customers who had purchased the product that benzene, a cancer causing chemical, had been discovered in the aerosol cans. Despite the fact that the amount of benzene identified on a daily basis is unlikely to be hazardous to one's health, they made certain to inform clients, be honest, and demonstrate that they care about their error. Unilever has ensured that the health and safety of individuals were prioritized, as well as the well-being of customers. 

The Categorical Imperative which is the Law of Rationality, is a test that determines whether a behavior is acceptable or unacceptable, is part of this theory. The Formula of Humanity, which asserts that using people as a method to get what you want is immoral because it exploits them, is one of the most important formulations of the categorical imperative. (Salazar) According to this ethical theory, Unilever passed the Categorical Imperative since they voluntarily recalled Suave aerosol cans for the health and safety of its customers, not for the sake for the company to make more money when they knew that quantity of benzene on a daily basis is unlikely to be harmful to one’s health. Unilever does not gain anything by recalling the product, if anything they are the ones that are losing and are the ones that actually care about their customers' health currently and down the line. After Analyzing from Kant's ethical theory, it is clear that Unilever actions were acceptable and that they had followed all four essential principles. Remember life is precious and we must protect it. 

Virtue Theory

Back in the 4th century B.C., Aristotle developed the virtue theory which consists of four main characteristics. These include courage, temperance/self-control, honesty, as well as justice/fairness. For starters, the virtue theory was established to help those differentiate between what’s good, and what isn’t good. Understanding that seeking a purpose and only doing what best to achieve that said purpose, results in virtue. The courageous characteristic takes a part in this case, representing the risk-taking and willingness to take a stand for the right ideas and actions (Salazar, 7). After the review of both Suave products, the recall notice explained that the benzene levels came from the propellant that sprays the product. Immediately, Unilever acted and issued a nationwide recall. Research concluded that the levels of benzene found were slightly elevated and only capable of causing little to no harm. 

However, the company chose to make the ethical decision, and take the product off the market anyways, even though there is a high percent chance that the benzene may have never been noticed, and or cause any problems. Moving on to temperance which is defined as “reasonable expectations and desires” (Soloman, 34), the case ties into this characteristic considering Unilever uses this knowledge to grant their customers with trustworthy products. People have faith in the companies they are giving their money too and expect nothing less than reasonable products that contribute to their purpose. Unilever ethically recalled their products considering it was unsafe, and only wishing to purchase safe products, is a reasonable customer request. Not to mention, Unilever also ethically chose to take the honest route and alert the FDA on its benzene findings as soon as it was discovered, remaining in agreement with their customers. Lastly, Unilever maintains justice to its company overall, remaining true to their business model that I previously mentioned above. Recalling their products was the ethical move considering they are still known for their high-quality products and maintaining their consumer’s trust.

Action Plan

There have been many companies in past months recalling their products because they contain human carcinogens. Two of Unilever’s Suave antiperspirant products contained elevated levels of benzene and J&J’s Neutrogena products also contained benzene. This is a problem because carcinogens are materials or substances that can cause cancer, which can lead to potential deadly health conditions. For example, from prolonged exposure to benzene it can cause the blood cancer Leukemia. Leukemia which can lead to weakened immune systems and weight loss. This is especially a problem when consumers do not know that the products contain human carcinogens. Since benzene was only found in the propellant that sprays the antiperspirant, in the Suave products, it should be very easy for Suave to remove the benzene from their products.

A new mission statement for Unilever and J&J would be very helpful in helping them recover from these controversies’. For instance, the new mission statement might be “We are dedicated to the health and safety of our customers and promise to produce safer quality products.” To go along with the mission statement these companies should also follow some core values going forward. Some values may be customer health, quality consistency, customer services, and trust. The companies will meet these values when releasing products that have no carcinogens within them (that have also been tested for common carcinogens and other harmful substances). Also, they publish documentation that there are no harmful substances in all of their products and even add a URL to the documentation on the product. This will build trust because customers will know exactly what they are buying. One step these companies can take to ensure they practice ethical business in the future is to have informative courses on Good Manufacturing Practice (GMP). GMP are regulations promoted by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (ISPE). By having management and executives take this informative course it will ensure that Unilever and J&J have consistent quality products being produced. The last part of the plan could be to send out coupons, with the documentation, to customers to encourage them to buy new products. This plan will promote business profits and productivity because customers will know that the product they are purchasing is safe, healthy, and free of harmful substances and therefore be more inclined to purchase the products. Also, by including documentation of safety and quality of the product it will show that Unilever and J&J are trustworthy and are dedicated to being an ethical business.  

References

Albert, Victoria. “Two Types of Suave Aerosol Deodorant Recalled Due to Elevated Benzene Levels.” CBS News, CBS Interactive, 2 Apr. 2022, www.cbsnews.com/news/suave-recall-deodorant-two-types-aerosol-recalled-benzene/. 

FDA. “FDA Alerts Drug Manufacturers to the Risk of Benzene Contamination.” U.S. Food and Drug Administration, FDA, 23 Dec. 2021, https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs. 

FDA. “Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene.” U.S. Food and Drug Administration, FDA, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unilever-issues-voluntary-nationwide-recall-suave-24-hour-protection-aerosol-antiperspirant-powder#recall-announcement.

ISPE. “Good Manufacturing Practice (GMP) Resources.” ISPE, 23 Jan. 2019, https://ispe.org/initiatives/regulatory-resources/gmp. 

Salazar, Heather. “Does Business Ethics Make Economic Sense? .” Economics and Individualism Online Lecture, 5 May 2022, Springfield, Massachusetts. 

Shaak, Erin. “Class Action Alleges Carcinogen Benzene Detected in Certain Suave Antiperspirant Products.” ClassAction.org, Newswire, 16 Nov. 2021, https://www.classaction.org/news/class-action-alleges-carcinogen-benzene-detected-in-certain-suave-antiperspirant-products. 

Torchinsky, Rina. “Suave Antiperspirants Are Recalled Because Benzene Was Found in Some Samples.” NPR, NPR, 1 Apr. 2022, www.npr.org/2022/04/01/1090343033/suave-antiperspirants-are-recalled-because-benzene-was-found-in-some-samples.

Valisure, “Valisure Citizen Petition on Benzene in Body Spray Products” 3 Nov. 2021

Yates, Jacqueline Lauren. ABC News, ABC News Network, 21 Dec. 2021, abcnews.go.com/GMA/Style/pg-recalls-products-pantene-herbal-essences

                spice/story?id=81863689.

Prevagen: 'Brain Boosting' supplement under fire by FDA for safety (2020)

 

Abstract

The war against aging has been waged for as long as we know. One of the most prominent battles within this war is the fight against memory loss. As people age their brains begin to deteriorate, leading to absentmindedness, decreased ability to multitask, difficulty with name and face recognition, along with other side effects. The race to create a drug that can reverse or even halt neurological diseases and age induced memory loss has been booming with advancements in the study of memory. Spear heading this race is a company called Quincy Bioscience and their exceedingly popular supplement, Prevagen. Although it has boosted revenue and sales for years, the Food and Drug Administration (FDA) and other agencies have questioned its safety and efficacy. Quincy Bioscience is now being tried for false/misleading advertising, creating improper procedures during production, and not specifying how it controlled production, which would all ensure quality and safety for consumers.

Prevagen uses protein found in jellyfish 

When analyzing this through the lens of the ethical theories, they would vary in responses. Individualists, who believe the only ethical responsibility is to increase profits of the owners, within the law, would not condemn Quincy Bioscience. They would applaud the company’s use of loopholes to remain within the law while maximizing profits. Utilitarianism argues that one must maximize the happiness for the majority of people to be ethical. Using this theory, a utilitarian would disapprove of this company’s practices because the majority of the people effected are the stakeholders and they are negatively impacted, leading to decreased happiness. The Kantian ethical theory analyzes the motivations and reasonings behind someone’s actions to tell if it was ethical or not. In this case a Kantian can argue that the founders of Prevagen are not ethical because their motivation to create this supplement was to make money fast, not necessarily for the betterment of its consumers. Finally, Virtue theorists would notice there is dishonesty, greed, self-interest, disrespect, and lack of empathy involved in this case. All of which completely go against the cardinal virtues described in the theory. Quincy Bioscience needs to listen to the FDAs recommendations, along with discontinuing to mislead the public about its supposed supplement.

Ethics Case Controversy

Timeline of events

Prevagen was advertised as a miracle drug that improved memory, learning, word recall, and executive function. Since the conception of the company, there has been controversy. For starters, Mark Underwood the founder, stole the idea for the product from his mother. Her intent was to use a protein found in jellyfish to create a proven medical treatment that can help people with neurological diseases. Mark took this idea and started Quincy Bioscience with the premise being to “make a totally obnoxious amount of money at an early age and spend the rest of my life spending it” (Wired). For years, the FDA has tried to make cases and find flaws in the marketing and production of Prevagen, always ending in Quincy Bioscience finding another loophole and avoiding disciplinary action. To begin, Quincy Bioscience took advantage of the differences between regulations for drugs and dietary supplements. Although they are both regulated, they are held to quite different standards. For drug manufacturers, the FDA requires them to undergo numerous testing to ensure that before the drugs are introduced, they are safe and effective. On the other hand, supplements are loosely monitored and have less regulations. In Underwood’s eyes, it was a no brainer to classify Prevagen as a supplement because he wanted to make money fast, “we didn't want to wait another 10 years—the time it could take to conduct clinical trials and request approval as a drug” (Wired). For example, for supplements, the companies are the ones responsibility of ensuring their products are safe and effective. This rule even applies if there is a new supplement introduced to the market, in many cases these companies do not have to notify the FDA and are presumed safe until proven otherwise. The exception to this rule is, if there is a supplement that contains a new dietary ingredient that is not in the current food supply. In this case, they must provide the FDA with evidence that the substance is safe for people to consume at least 75 days before the company introduces the product to consumers. This was an issue for Prevagen at the beginning because their main ingredient, a protein from jellyfish called apoaequorin, has never been a part of the current food supply. Although they needed to submit the documents for this “new dietary supplement” with 75 days’ notice, Underwood signed the forms a day before his company started selling Prevagen. Quincy Bioscience began sales in 2007, in 2011 the FDA began doing inspections to observe the procedures and manufacturing process that Underwood used to create and produce his supplement. During their inspections, the agents found many violations in Quincy Bioscience’s manufacturing process, quality control testing, which is used to safeguard the consumers from unsafe products, and the companies handling of customer complaints. While conducting their check up at Quincy Bioscience headquarters in Madison, Wisconsin, the FDA found records of “more than 1,000 adverse events and product complaints that had been reported to the company since May 2008. Only two adverse events had been relayed to the FDA by Quincy. An inspection report documents significant potential violations, or “observations,” investigators listed 18 cases that Quincy had decided not to classify as serious and did not share with the FDA. They included five reports of seizures, three of strokes or mini-strokes, and four of vertigo, dizziness, or falling that merited medical attention” (Wired). The FDA then realized that Underwood was manufacturing apoaequorin synthetically and not naturally as they stated earlier. They wrote Quincy a letter explaining that after review, the manufacturing of apoaequorin is considered not safe. The Federal Trade Commission (FTC) also question the claim made by Underwood that Prevagen can pass through the gastrointestinal system and cross the blood-brain barrier. If a company claims that a supplement can improve a part of human health through a process, while being taken orally, the company must prove and support that claim with evidence. This evidence was never brough forth, further discrediting the product and leading to more lawsuits. Studies have showed that these claims made by Underwood are false and misleading, “the product cannot work as advertised because its only purported active ingredient, apoaequorin (a protein), is completely destroyed by the digestive system and transformed into common amino acids no different than those derived from other common food products” (Justice). In contradiction, Quincy Bioscience relies on one study done, the Madison Memory Study. In this experiment, Quincy workers took individuals, gave half of them a placebo pill and the other half a Prevagen pill, they then had them do tasks and accessed how well they did, continuing this process for 90 days, recording results after 30, 60, and 90 days. They concluded that the individuals taking Prevagen has increased cognitive function, along with other mental benefits. This study is scrutinized because it did not show statistical improvement when observing the population as a whole, the study was sponsored by Quincy and authored by company employees, which leads to implicit bias. “As “proof” of power, a bar graph shows a rise from 5% to 10% to 20% over 90 days in “recall tasks.” But there is no way to know what these numbers refer to, how many people were studied, or other important details. And no information is provided about effects on memory after 90 days. The fine print under the graph says that the supplement “improved recall tasks in subjects” without explaining what this means” (Harvard). This study was used in all their advertisements and sales calls to mislead people into believing this supplement is effective. A Quincy Bioscience sales team member, Jovan Chavez, said he capitalized on the Madison Memory Study because it allegedly showed improvements in memory within 90 days. Using this information to his advantage, he encouraged customers to buy a three-month supply because purchasing more bottles decreased the shipping cost, while giving you the supply of Prevagen you need. Along with this, he promoted a more expensive extra strength variation, that will help customers faster. Eventually, this direct sales team was discontinued because customers would call and tell the employees about adverse side effects they experienced, that would then need to be documented. Quincy laid off 13 percent of its staff and “a year and a half later, in November 2016, FDA inspectors observed a “noticeable decrease” in the number of adverse event reports Quincy received after they stopped the calls” (Wired) leaving them with over 4,000 reports of health complications expressed by their customers.

With all these issues cited in this case, lawsuits have become a powerful tool to combat and regulate companies like Quincy Bioscience. Prevagen has been specifically targeted in multiple proceedings, mainly surrounding their false advertising claims. While the FTC’s false advertising case against Quincy Bioscience is still ongoing, other settlements are flawed and keep the power in Quincy’s hands rather than the affected customers. This is due to customers not making any substantial compensation in these cases, and the ratio of awards to legal fees being opposite to how they should be. Ultimately, resulting in little to no individuals making a claim against the makers of Prevagen.

Madison Memory Study falsely advertised effects of 

Prevagen that are not scientifically proven.

 

Stakeholders

Quincy Bioscience relies on their relationship with its stakeholders to ensure they stay in business and continue making profit. The company will need to make reparations with its consumers after misleading and manipulating them into buying an unsafe and unregulated product. They would then have to mend the broken trust with other stakeholders, such as federal agencies in charge of regulating the industry. Quincy betrayed their trust by exploiting loopholes internally and not following regulations, even when instructed to. This relationship with these stakeholders will need to be repaired, especially if Quincy Bioscience wants to remain in the industry and get approval for future business actions.

Individualism

From an individualist perspective, the production and sale of Prevagen would be ethical. This is due to Milton Freedman theory that management was responsible for maximizing business profits and any action taken without considering profit is stealing from the owners of the company (Salazar 17), but to always do so within the law. Freedman would look at what Underwood did with Prevagen and see the loopholes that he took to ensure profit and approve of the steps taken. If Underwood classified Prevagen as a drug, it would have taken years of research and experiments just to not be released due to it not being effective. Instead, he knew the loophole around the FDA and classified Prevagen as a dietary supplement, ensuring a quick and profitable route with this new product. This tactic seemed to work because “from 2007 through the middle of 2015, sales of Prevagen totaled about $165 million and the company claims Prevagen is now a “best-selling branded memory supplement in chain drug stores across the United States”’ (Elemental). Taking this route for Prevagen is attractive for an individualist because the safety of the product and compliance needed are very loose in this industry, furthermore, leading to people taking advantage of areas that the FDA falls short in. Quincy profited drastically by how “the marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss” (elemental), it is not illegal to instill fear in consumers in order to sell a product, therefore, being ethical in an individualistic analysis. Also, by Quincy ending outbound sales calls, they were able to minimize their customer complaints and sell more Prevagen without having to document cases of adverse effects. This is ethical within individualism because it does not taint the companies records, it has less jobs since the direct sales department closed, and does not violate any laws. Eventually leading to increased profit in multiple areas. Although, with new changes to the FDA, including requirements for supplements to have experimental evidence and not mislead their customers, Quincy Bioscience will need to change their strategy to ensure they stay within the law.

Utilitarianism

On the other hand, a Utilitarian would analyze this case as unethical because of Quincy’s misleading advertising and lack of concern for the health and safety of their customers. The theory of utilitarianism states that “we can determine the ethical significance of any action by looking to the consequences of that act” (DesJardins 29). Using this as a basis of what is ethical, one would see that the actions of Underwood, who stole his mother’s idea to quickly sell a new product, without ensuring its safety and doing the proper experimentation just to make money, are all unethical actions.

For this to be ethical through the lens of a Utilitarian, Underwood would have classified Prevagen as a pharmaceutical drug, gone through the proper testing and regulations to ensure safety and effectiveness of the product. He then would have to not mislead his customers on the effects of the drug and report to the FDA the actual adverse effects that have been reported to the company. If he followed the regulations without exploiting, did not deceive his customers into purchasing a product that was not scientifically supported, and used his customers as an ends and not simply a mere means, then the business would “maximize happiness in the long run for all conscious beings that are affected by the business action” (Salazar 17). One of the fundamental regulations for Utilitarianism is to maximize pleasure and minimize pain with the focus being on the stakeholders. In this case, Underwood has more self-interest than the interest of the stakeholders. As seen from the business actions he took, it was all aimed at making profit and not aimed at creating a proven medical treatment. This directly goes against the ideals of a Utilitarian because they will “avoid short-sighted thinking that often boosts profits momentarily but leads to a quick demise” (Salazar 20), and that is the opposite of what Underwood did. Furthermore, being ethical from a utilitarian point of view is more important that just being just that. Being deemed unethical leads to more financial loss due to lawsuits from customers and agencies that report adverse effects, misleading advertising, and improper manufacturing procedures.

Kantianism

When analyzing this case as a Kantian theorist, the main deciding factor of whether the act was ethical or not depends on the will of the person behind the action. “Kantianism does not make decisions based on consequences” (Salazar 21), which is the major difference between that and utilitarian decision making. This can be applied in this situation because Underwood’s decision for Prevagen to be classified as a supplement rather than a pharmaceutical drug was expressing bad will. His reasoning was to make more money as fast as possible, instead of ensuring the safety and effectiveness of the product before introducing it. Along with that, another main concept to consider is that “Kant tells us that we should act only according to those maxims that could be universally accepted and acted on” (DesJardins 38). With that being said, the question would arise whether a universal law could be made to absolve supplement companies from providing evidence of their products safety and effectiveness and advertise dishonestly. This law cannot be made universal because if everyone was allowed to release a supplement without having to prove its effectiveness and is safe and can market it however they want, then that will cause a major health and safety risk for consumers. It would also not hold those companies legally liable if this kind of laxity were permitted. Furthermore, when creating universal laws one must consider that, “truth telling could, but lying could not, be made a universal law” (Salazar 38) and since Quincy Bioscience was accused of false and misleading advertising, they cannot say their actions are universally accepted.

When Quincy received warnings from the FDA, they would either deny them or make small changes that did not solve the issue at hand. When analyzing this using Kantianism, one would see that the company only made changes when they were demanded to, and their intent was to deter the FDA. Underwood is being unethical and practicing bad will because the reasoning behind making these changes should be for the betterment of his customers, not for his own self-interest.

Virtue Theory

From a Virtue Theorist perspective, a person’s character and how their actions reflect who they are as a person is much more important than the outcome. Virtue theory is based on 4 Cardinal Virtues including, prudence, courage, temperance/self-control, and justice/fairness. Virtue Theorists use these to analyze if people are ethical by seeing if they “act so as to embody a variety of virtuous or good character traits and so as to avoid vicious or bad character traits” (Salazar 22). When looking through this lens, Underwood’s decisions display a poor character that a Virtue Theorist would see as being unethical.

Quincy Bioscience has infringed on numerous virtues that are crucial to being deemed ethical. For example, through misleading and false advertising, Quincy has not expressed the virtues of justice/fairness, which also include honesty. With the FDA citing issues with the company’s manufacturing processes, complaint handling, and the quality control testing, along with the FTC’s complaints on false, deceptive advertising, nothing aligns with the virtues of justice/fairness. The lack of compliance to regulations and feedback from the FDA has led Quincy to lie to agencies and their customers and ultimately be regarded as unethical. When analyzing virtue theory, it is good to use the analogy of a table, the legs are each virtue that someone must have to be ethical. If one of the legs are missing (justice/fairness), and someone does not have that virtue, then the table will collapse, and the person is unethical.

Justified Ethics Evaluation

In my opinion, I believe that Quincy Bioscience’s actions were unethical in every sense. Even the foundation and creation of the company was based on an unethical action, taking the idea from his mother, and changing it from the course she hoped it would have gone. It has then followed that trend of unethical behavior at almost every decision made. Whether it be from classifying Prevagen as a supplement and not a pharmaceutical drug, to not listening to agencies regulations, and false advertising, there are multiple aspects of this company that are unprofessional and express negligence. Underwood’s main goal of profit is ethical through the lens of an Individualist but analyzing it using any of the other ethical theories, one would evaluate that Underwood and Quincy Bioscience is unethical.

Even when customers started to complain about adverse effects and the FDA questioned the safety and processes within the company, Quincy tried to sweep everything under the rug. They would either deny or not report adverse effects that were reported to them and they did not listen to the FDA’s feedback and recommendations for reform. This negligence led to more people experiencing negative side effects that were detrimental to their health, all while not being held accountable for it. Even when they were given opportunities to change for the better, they continued down the unethical road by persisting to misinform, take advantage of, and manipulate the public, along with the FDA. Overall, Quincy Bioscience acted on its own self-interests and used unethical motivations, that drove every decision away from ethical thinking.

Company Action Plan

Quincy Bioscience has numerous issues that need to be resolved to continue making profit and regain the trust of their customers and stakeholders. The company classified Prevagen as a supplement instead of a pharmaceutical drug to make quick profits and bypass important regulations. This would be the first issue that needs to be resolved. The company should reclassify Prevagen as a pharmaceutical drug and put it through rigorous tests to ensure its safety and effectiveness. Although this will take a long time and they might encounter issues along the way, it will prove to their stakeholders that they are serious about reform and will act ethically. Underwood did not want to take this route because he wanted quick profits, but this way of thinking is unethical and short term. This is true because rushing and taking short cuts leads more flaws in the products and eventually a decrease in profits, along with lawsuits in the future. Classifying Prevagen as a drug is more of an investment, it will take longer to get profits but the product is trusted and proven to work, so in the long run the company will make more money through credibility and proven facts.

Another issue that Quincy needs to solve is their relationship with the agencies like the FDA. Through the lifespan of the company, they continuously took advantage of loopholes and did not listen to warnings given by these agencies. Multiple times the FDA has requested to come do inspections, during them, they cited changes that need to be made. In these instances, the agency was met with opposition and a complete lack of self-responsibility, either being ignored by the company or denying the violations that were reported. If Quincy listened to the FDA, they would have a smoother manufacturing process, they would not have to worry about breaking any violations, and consequently make more money by having the support of the FDA. Underwood should apologize to the agency and promise to be compliant with past and future issues.

Quincy Bioscience has also received backlash due to their poor relationship with their customers. Agencies are calling for lawsuits for the misleading and false advertising expressed by the company. They would deceive their customers into ordering more of their product by relying on a noncredible study, taking advantage of peoples fears, and exaggerating the effects it has on the body. The Madison Memory study has been refuted multiple times as not showing any conclusive evidence into the effectiveness of Prevagen. The sales team would market Prevagen to older consumers and prey on their fear of age-related memory loss. Quincy also claimed that Prevagen improves memory by being able to cross the blood-brain. This claim is false because the main protein that is supposed to improve memory, gets broken down into amino acids during digestion, before reaching the brain. With all their claims “Quincy Bioscience failed to show that Prevagen works better than a placebo in any measure of cognitive function” (NBC). To resolve these issues and create a better relationship with customers, Quincy must first apologize and take responsibility for their deception, then they must pay reparations to those negatively impacted by their use of Prevagen. Once those steps are done Quincy should conduct a credible study, their marketers should not take advantages of people fear, and only make claims that are supported by multiple credible findings. This will take time and money, but in the long run, they will have a better relationship with customers and be trusted again.

Aside from issues within the company, one of the biggest issues in this case is the agencies lack of resources to combat companies that exploit regulations. The lack of funding to adequately police this industry is a large part of the problem and creates situations where agencies are not prepared to take regulatory action, instead they must resort to citing voluntary action to a company. This leads to companies taking advantage and not being held accountable to following the rules. With the FDA recently announcing plans to modernize its regulation of supplements, many companies will be forced to obey new rules to ensure the safety and validity of every aspect in the industry.

Quincy Bioscience needs to change their mission statement from being about making money any way possible, to making sure people see their growth and that they strive to be more ethical. My recommendation would be “Quincy Bioscience is a biotechnology company based in Madison, Wisconsin, that devotes new discoveries, developments and commercialization of novel technologies to support cognitive function while emphasizing factual evidence, trust, and transparency”. This mission statement stays true to the original vision while adding key elements that they were deficient in historically.

The core values that are expressed in that mission statement, if implemented, resolve the issues that the company faces, along with confirming their ethical status when analyzing the company using all the ethical theories.

Values:

·         Factual Evidence – Making sure every claim made is factual is crucial for every company. This was a shortcoming with Quincy Bioscience, so if they stress that all their statements are supported by evidence, the issue will be resolved.

·         Trust – Loyalty is vital when it comes to its stakeholders. Underwood lost the trust of these individuals by lying and deceiving. If they can regain this trust, then their customers will be loyal and business partners will be proud to be associated with them.

·         Transparency – Being transparent and honest with a company’s stakeholders is of the utmost importance. This was a major issue with Quincy Bioscience not being transparent with customers and the FDA on facts, figures, and reports. If they emphasize honesty, then they will be more ethical and resolve many issues.

To ensure ethical productivity and monitoring of ethics Quincy Bioscience can become more transparent with agencies and customers. This transparency will hold them accountable for their actions and keep their record clean. They can also implement ethical trainings with advocacy groups that can speak up if they see anything that is unethical. These groups can either be apart of the company or apart of an independent organization that solely monitors the ethical state of the company. They can promote employees that give ideas on how to be more ethical, along with firing individuals that were the leading cause of claims against the company for unethical behavior. Quincy Bioscience needs a completely new marketing strategy that showcases their reforms they have done and how they shed away their wrong, unethical past.

My plan will take time and be expensive, but it is worth the investment if the company wants to continue profiting and be ethical. If Quincy Bioscience does not change, then they will face financial ruin through lawsuits and violations of regulations. Since Underwood tried to take shortcuts in the beginning stages of this company, he is now facing the consequences of these unethical actions. If Quincy Bioscience implements these changes, they will profit from gaining back the trust of their stakeholders, become a reputable company that people can rely on, and ensures good ethics through maintaining their core values.

Conclusion

The supplement industry is very underregulated with a lot of opportunities for companies to take advantage for financial gain. This is exactly what Mark Underwood and Quincy Bioscience did with the memory loss “supplement” Prevagen. They took advantage of loopholes, preyed on the fear of their customers through false and misleading advertising, to sell them a drug that is not proven to be effective or safe. The only way they can comeback from this is to follow the correct regulations that are set in place by the FDA and have their main goal be to create a proven medical treatment. The product needs to be tested in multiple, reputable, studies, factually advertised, and held accountable in every facet of production and reports. Even though there are differences between the ethical theories, there are commonalities amongst them that, when used correctly, can ensure a company is acting ethical. Hopefully, Quincy Bioscience learns from their mistakes and are better able to effectively improve the health of the public in the future.

                                                                                                        Ethan Valdes

 

References

Carroll, Linda. “'Brain-Boosting' Supplements May Contain Unapproved Drugs, Study Says.” NBCNews, NBCUniversal News Group, 24 Sept. 2020, www.nbcnews.com/health/health-news/brain-boosting-supplements-may-contain-unapproved-drugs-study-says-n1240880.

DesJardins, Joseph. An Introduction to Business Ethics. New York City: The McGraw-Hill Companies Inc, 2014.

Eisner, Chiara. “Americans Took Prevagen for Years-as the FDA Questioned Its Safety.” Wired, Conde Nast, 21 Oct. 2020, www.wired.com/story/prevagen-made-millions-fda-questioned-safety/.

Janet, Howard A, et al. “Prevagen under FDA Investigation.” JJS Janet Janet & Suggs, LLC Attorneys at Law, Hotjar, 2020, www.jjsjustice.com/prevagen-fda-investigation/.

(Image) Katz, Mitchell  J, et al. “FTC, New York State Charge the Marketers of Prevagen With Making Deceptive Memory, Cognitive Improvement Claims.” Federal Trade Commission, 9 Jan. 2017, www.ftc.gov/news-events/press-releases/2017/01/ftc-new-york-state-charge-marketers-prevagen-making-deceptive.

Robert H. Shmerling, MD. “FDA Curbs Unfounded Memory Supplement Claims.” Harvard Health Blog, Harvard Health Publishing, 29 Sept. 2020, www.health.harvard.edu/blog/fda-curbs-unfounded-memory-supplement-claims-2019053116772.

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

(Image) “Prevagen Extra Strength Capsules.” Walgreens, 2020, www.walgreens.com/store/c/prevagen-extra-strength-capsules/ID=300402930-product.

Zaleski, Andrew. “The Predatory Scam of Memory Supplements.” Elemental, Medium, 14 Oct. 2020, elemental.medium.com/the-predatory-scam-of-memory-supplements-c49c8a17d14b.

Medek LLC, Resource Recovery&Trading LLC, and AJR Trading: Hand Sanitizer Recall (2020)

Ethics Case Controversy 

Consumers using hand sanitizer 

            What we are looking at is to see if Medek, LLC, Resource Recovery & Trading LLC and AJR Trading acted ethically when they were producing methanol contaminated hand sanitizer. Digging a little bit deeper, we know that the major increase of hand sanitizer demand caused companies to start producing a variety of hand sanitizer to distribute the product faster. So, was the use of methanol and accident because they were trying to work fast or was it purposely used to create a stronger disinfectant? We can see why there would be the need for a stronger disinfectant because of the COVID-19 outbreak. The desire for better hygiene and keeping hands clean made people desperate to try anything that killed the most bacteria. 

damaged hands from sanitizer

Medek LLC “voluntarily” began to recall their hand sanitizer nationwide when the FDA performed an analysis on the product and found “the M Hand Sanitizer to contain methanol and be sub-potent for ethanol.” Using any product comes with a risk but the side effects to methanol exposure became very dangerous very fast. “Substantial Methanol exposure can result in nausea, vomiting headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death.” A major concern was the exposure of the product to young kids who would very likely ingest said hand sanitizer which would increase the likelihood of methanol poisoning. Medek notified the customers and distributors about the recall on the methanol contaminated hand sanitizer and suggested that they all stop using, purchasing, or providing the product until they knew it was safe again. The FDA also gave a hotline number that provides information to those with questions about the product to help people fill in the blanks that came with the recall.
    Resource Recovery & Trading LLC also,  recalled their hand sanitizer when the question of a presence of methanol in the product came to surface. “The main concern with the use of hand sanitizer that is sub-potent for ethyl alcohol is the potential for decreases bactericidal and virucidal activity. The health consequences can result in the opposite effect, an increase in infections. The product is used to “decrease germs when soap and water is not available” but small children can ingest the product or adults/adolescents drink the product because of the alcohol, increasing the probability of poisoning. RR&T LLC put out a notice telling all consumers, buyers, and providers to stop using the product and return all hand sanitizer to the location in which it was purchased again, once the FDA came to the conclusion their hand sanitizer was dangerous. 

“According to the Food and Drug Administration (FDA), AJR Trading issued a recall on 2,004 units of Advance Hand Sanitizer currently in US distribution.” The lot of hand sanitizer based test and met all the appropriate specifications and requirements. That being said with a possibility of the presence of methanol in other lots of hand sanitizer that has been recently produced, they recalled everything. AJR classifies young children and teenagers as high risk to the problem as they are most likely the ones that will physically end up with the methanol substance in their bodies rather than adults who just use it on their hand. The FDA was taking no chances when the question of methanol surfaced with any company. With the safety of the consumers their main priority they wanted all potential harmful sanitizers recalled. 

COVID-19

With the outbreak of COVID, many hand sanitizer companies have been rushing and speeding up their production time to distribute hand sanitizer. “In these uncertain times of critical personal hygiene caused by the COVID-19 pandemic, some manufacturers have sought to profit by selling a variety of ‘hand sanitizer’ products containing dangerous amounts of a toxic and potentially lethal chemical.” Methanol is indeed a type of alcohol, it used to make industrial products such as solvents, antifreeze, and different types of fuels. That being said, all those products are not meant for humans to consistently apply to their skin like hand sanitizer. “Human exposure can occur through both ingestion and skin absorption” which can result in serious health consequences. The FDA came forward and said that methanol is not an acceptable ingredient for the use of making hand sanitizer and has found at least 75 hand sanitizer products that possibly contained methanol. “The FDA advises that these products should not be used and should be disposed of as a hazardous waste.” If a human has used a methanol contained hand sanitizer the FDA highly recommends that they seek medical attention, even if they are not showing poison symptoms, so they can reverse the damage before it is too late. 

FDA Logo

“The FDA continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol.” On top of that, the FDA has taken action to prevent particular hand sanitizer from entering the US by putting hand sanitizer on an import alert. “Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products.” The FDA made an 
announcement which overall concluded that hand hygiene is important but we need to be careful with what products we actually use. The list of dangerous hand sanitizers is constantly being updated because methanol doesn’t usually appear on product labels. If a hand sanitizer manufacturer fails to recall dangerous sanitizer that places consumers in danger they can be held responsible for the resulting health consequences of said consumer. When looking at the FDA provided list consumers need to look for Manufacturer name, product name, and national drug code to see if the sanitizer is safe. 

 

Stakeholders

            In this dilemma, there are three groups of stakeholders. The first group consists of Medek LLC, Resource Recovery & Trading LLC and AJR Trading. They are the ones providing the methanol hand sanitizer to the public ultimately putting all the consumers at risk. Then we have the FDA. The FDA made the companies recall their products because it was harmful to the people. Last are the consumers that used the product. By using the hand sanitizer they were put at risk of major health problems that could have been avoided. 

 

Individualism

            The overall goal of the Individualist Theory is to maximize a stakeholders profit/happiness and for everyone to act rationally/ in their best interest. All three companies maximized their happiness and profit by letting consumers buy their products as the demand for the hand sanitizers continued to rise. The companies were happy because they were bringing lots of money in. Although they were happy, they were not acting rationally/in their best interest. Medek, RR&T, and AJRT manipulated their consumers and let them buy a product that was dangerous.  

            If the companies had taken their time to produce safe hand sanitizers they wouldn’t be in the situation they are in now. Currently, they lost money by having to recall their hand sanitizer and start from scratch to make sure what they were producing is safe for their consumers. Both the producer and consumers were being hurt because of the loss of money on the business end and the health problems on the consumer side. If they acted rationally from the beginning they wouldn’t be out money and their consumers would have been safe. 

 

Utilitarianism

         When talking about the Utilitarian Theory, the goal we need to have in mind is to create or promote happiness to as many people as possible. As we have seen Medek, RR&T, and AJRT have done the complete opposite. Due to failure of producing safe sanitizer, many of their customers found themselves or a loved one in the hospital. Babies were ingesting said sanitizer and parents were watching their kid suffer from poisoning that they weren’t aware of. Adults were having extreme headaches and found themselves in coma’s, again, because of poisoning they were not aware of. Obviously, if someone is in the hospital for poisoning, there is no happiness. 

            That being said the sanitizer companies weren’t happy when their products were on recall. As the FDA made announcements telling consumers to throw out or bring the hand sanitizer back to the distributer, RR&T, AJRT, and Medek saw money going down the drain. Knowing they lost money and were the reason many people came down with Methanol Poisoning surely didn’t bring them happiness. 

 

Kantianism

            Ethical decisions that are motivated by the idea of a rational decisions is the idea behind the Kantianism Theory. The Kant Theory also is revolved around the idea of the “Formula of Humanity.” This idea tells us that we should treat others the way we want to be treated and not as means. If you treat someone as a mean you are not acting ethically because you are using them to amplify your own happiness without paying any attention to how others are affected. 

 When taking the actions of the three hand sanitizer companies into consideration we can see they are unethical under the Kantianism theory. These companies were motivated by self-interest (getting the sanitizer out quickly to stores and consumers) rather than their duty (making sure the product was safe to go out to the market). The rational decision for them to quickly produce hand sanitizer and ship it off knowing it contained methanol is not ethical. If the rational decision is not ethical it fails to meet the requirements of Kantianism. 

            If they had acted ethically, the result of this error would be different. For starters, the companies should have recalled the sanitizers not the FDA. When the FDA made the announcement it made the companies look like they were trying to cover their error. Ethically, Medek, RR&T, and AJRT should have taken responsibility for their error before the FDA. Also, if they had taken a second to look at what they were producing, they could have found how methanol was ending up in their product. Instead, they continued working without giving it a second thought. 

 

Virtue Theory 

         The Virtue Theory revolves around four characteristics: courage, honestly, self-control, and justice/fairness. The first aspect is Courage and what this basically is, is the willingness or willing to take a risk for the right actions or ideas. The companies took a risk by producing hand sanitizer that was dangerous to the consumers. By producing the methanol contaminated sanitizer and not giving the methanol problem a second thought they took a risk. The thought of the safety of the consumers who would use the produce was not a thought in the producers minds otherwise they would have checked over the sanitizer to make sure it was safe. 

            Honesty on the Virtue Theory is described as being truthful with the public. Obviously, we can tell that this was not the case. There was not honesty with the public because the companies let their customers use a dangerous product without giving a warning. Ethically, if the companies were going to continue to sell the hand sanitizers with methanol, there should be a warning on the bottle telling the consumers. If there is a warning, the consumers are buying the product at their own will BUT they are informed about the potential dangers of using the product. 

            Self-Interest (AKA Temperance) are the expectations and desires the employees have for their companies. We see here that those desires don’t line up with the society’s expectations. Although, our producers wanted to maximize their profit, they were taking the wrong steps. The goal in which they had, has two paths to get to it. One, caring about the people as much as they care about their company and two, doing whatever they need to do to get to the top. They got to their goal by taking the unethical path. 

            Finally, the hard work, ideas, and fair practice all fall under the last virtue, Justice. The companies were working to make good hand sanitizer to kill germs/virus’ like COVID-19. Even though they were trying to make a good product, they ended up doing more harm than good. They had the right idea by trying to kill germs but the lack of effort to make the product safe is where they fall short. 

Justified Ethics Evaluation: 

            After researching this problem. I believe that the companies could have prevented the recalls. If Medek, RR&T, and AJRT had a closer eye on their product all the health problems that were reported could have been prevented. Also, they shouldn’t have waited for the FDA to announce a recall, they should have done it themselves. With them waiting for the FDA, they made it seem as if it wasn’t as big of deal as it was. It is better if a company does their own recall I also feel that both of the companies didn’t have the consumers best interest when they were producing the hand sanitizer. If they did, there would have been a notice on the bottle so they aren’t taking the choice away from consumers to buy a safer product. Under the four ethical theories I had discussed, I believe that in every situation the actions that were observed in this study are ruled to be unethical. 

 

Company Action Plan

Currently, the FDA has published a list telling consumers what brands of hand sanitizers not to buy. They are aware of the health consequences that can result from methanol and are on high alert monitoring the producing companies, distributors, and consumers. This is best compared to the contact tracing we do for COVID positive patients. The FDA watches where the hand sanitizer goes so if someone gets methanol poisoning they can trace it to the right back to the production facility. The investigation to find more companies that use methanol in their hand sanitizers is still ongoing. The FDA is advising that anyone who has come down with symptoms to get medical treatment immediately and to report their symptoms so sanitizer can be traced back.

“FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. The agency is especially concerned with:

• The dangers of drinking any hand sanitizer under any conditions. While hand sanitizers with possible methanol contamination are more life-threatening than those that are not contaminated, FDA urges consumers not to drink any of these products. 
• Certain hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
• Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (e.g., for up to 24-hours).
• Products that are fraudulently marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
• Products packaged to appear as drinks, candy or liquor bottles, as well as products marketed as drinks or cocktails because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products since ingesting only a small amount of hand sanitizer may be lethal in a young child.
• Products labeled with harmful or poisonous ingredients, such as methanol.”

The above data comes straight from the FDA and their exact plan to limit the amount of hand sanitizers that contain methanol that get distributed to the public. That being said, the FDA is aware of the problem and are doing everything they can to make sure only safe hand sanitizers are in the market. They advise to keep an eye on their “Do-Not-Buy List” and to call them or your health providers with any questions you may have. 

    The FDA has a mission to get the methanol problem under control to keep the consumers safe and healthy. This mission shows that the FDA has the consumers best interest and is doing everything in their power to stop the production and purchasing of hand sanitizer that contains methanol. As the FDA is working extremely hard they are taking several core values into consideration as well. These values include: customer safety, integrity, and respect. As mentioned before the FDA is taken all these actions just to keep customers/consumers safe. They show integrity to the public by providing the “Do-Not-Buy” list. The FDA is aware of methanol coming from certain companies so, as they get that information they are reporting it out right away. With that, the FDA is also following the value of respect. They are telling the public honesty information out of respect for the consumers. The employees of the FDA sure wouldn’t want to use dangerous sanitizer themselves so they are making it known to the public. 

            To ensure ethical productivity and monitoring of ethics in the future to prevent this problem from reoccurring the FDA should push new training programs on all the companies that find themselves on the DO-NOT-BUY list. The new training should include extra supervisions of the production of the hand sanitizer and testing procedures that will show if there is a harmful chemical within said hand sanitizer. When it comes to the hiring, firing, and promotion system, the managers will really need to evaluate the employees. Hire those who are willing to give 110% and want to keep the public as safe as possible. Fire those who seem to be doing a careless job. With the promotions, give employees an incentive to strive to do their best work possible.

            As companies are recollecting themselves the FDA should promote or market an updated DO-NOT-BUY list. On top of that, said company should take it upon themselves to promote the new and improved hand sanitizer that will be coming to the market. These companies have to get back on their feet and regain consumer trust. In order to do that, they will need to be completely honest and open about their product. By taking these actions the companies will not only regain consumer trust but also begin to improve profits and productivity levels. If the FDA pushes the core values and new training system the consumers will start to be willing to buy products from those companies again. As the honesty of the companies grow, so will the loyalty of the consumers.

 

 

References

Center for Drug Evaluation and Research. “FDA Updates on Hand Sanitizers Consumers Should Not Use.” U.S. Food and Drug Administration, FDA, 2020, www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use. 

Center for Drug Evaluation and Research, Medek Company. “Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels.” U.S. Food and Drug Administration, FDA, Sept. 2020, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medek-llc-issues-voluntary-nationwide-recall-m-hand-sanitizer-due-potential-presence-methanol-wood. 

Center for Drug Evaluation and Research. “Resource Recovery & Trading, LLC.,Issues Nationwide Recall of Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotency Ethyl Alcohol Company Announcement.” U.S. Food and Drug Administration, FDA, July 2020, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resource-recovery-trading-llcissues-nationwide-recall-hand-sanitizer-due-potential-presence-methanol.

Commissioner, Office of the. “Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products.” U.S. Food and Drug Administration, FDA, Sept. 2020, www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-reiterates-warning-about-dangerous-alcohol-based-hand-sanitizers.  

FDA. Hand Sanitizer Lawsuit - Kazan Law, 2020,  www.handsanitizerattorneys.com/?gclid=Cj0KCQiA-rj9BRCAARIsANB_4AD-JoJPX3lTvtmdPQlMY7qWlhq6Uy1wt5DHDFc6QA79wGjn_Uq1EbcaAkInEALw_wcB. 

Impelli, Matthew. “Hand Sanitizer Recall Expanded to Include Another Brand Due to Possible Presence of Methanol.” Newsweek, Newsweek, 4 Sept. 2020, www.newsweek.com/hand-sanitizer-recall-expanded-include-another-brand-due-possible-presence-methanol-1529687.