Reassessing Regulatory Oversight and Manufacturer Responsibility in E-Cigarette Safety

This simulation will take place during class. Teams will be given time during the session to prepare calculations and produce a Business Recommendation Report requested by the General Manager of the company in question.

In your assigned team of four (or three) partake in the "Dye me Red or Not" simulation and prepare a report of no more than 600 words that includes AT LEAST the following:

Recommendation of whether you will recall or not

Sampling plan and justification:

Why did the team choose that sampling plan?

Why that sample size? Why not larger or smaller?

The Team must submit an Excel Spreadsheet that contains the items that were sampled and the amount of the chemical measured on each sample.

The instructors for the course will double-check that teams have accurately obtained the quantities of the chemical for every item on their chosen samples

Confidence intervals for the content of chemicals that support/are in line with the recommendation of recall or not.

Control charts that are referred to and explained in business non-statistics terms in the document:

Ensure to talk about UCL and why is it relevant in your decision

Ensure to talk about the variability of the process and make relevant recommendations to the company

On top of statistics and quantitative techniques, which other considerations should the company take into account? This is a non-comprehensive list of business elements you may want to address in your report: PR, brand reputation, legal and regulation considerations, customers and consumers, and competition.

E-Cigarette Battery Exploding, but No Recall

Download and read a follow-up article Download read a follow-up articleby Azad (2019) on the same topic, also from CNN.

A study led by Rossheim (2020) using Text Analytics from the National Electronic Injury Surveillance System produced the following estimates on the number of injuries due to E-cigarettes:

PubMed Image Around Estimated Number of Explosions from eCigaretters 2020.png

The FDA -which has not issued a recall due to exploding batteries- last updated its website on Feb 2022. The FDA (2022) issued guidance reads "These issues [exploding E-cigarettes] appear uncommon". The same publication reads: "Until all vapes and vape batteries conform to strong and consistent safety standards" without stating what is being done for the manufacturers to comply with such standards. Read the full article hereLinks to an external site..

After having reviewed the material above, think critically about the following question and statement. Include a mention of the E-Cigarettes in your written report to contextualize your decision:

How is your decision different or similar to the [lack of] actions taken by the FDA on mandating a recall, and the [lack of] actions from the e-cigarette companies on executing a voluntary recall?

Consider this statement and discuss it in your paper: "All products, including e-cigarettes, are bound to have defects and occasionally malfunction. This is the cost of doing business."

DO NOT STRUCTURE YOUR PAPER LIKE Q&A. Write a business report aimed at the General Manager with your clear and succinct recommendation(s) well supported by your analysis.

References:

Azad, A. (2019). This teen’s vape exploded, shattering his jaw. CNN. 

[CNN] (Dec 22, 2016). E-cigarette explosions raise safety concerns. 

FDA (Feb 16, 2022). Tips to Help Avoid Vape Battery or Fire Explosions. Retrieved on Oct 4, 2022. 

Rossheim, M. E., McDonald, K. K., Soule, E. K., Gimm, G. W., Livingston, M. D., Barnett, T. E., Jernigan, D. H., & Thombs, D. L. (2020). Electronic cigarette explosion/burn and poisoning-related emergency department visits, 2018-2019. The American journal of emergency medicine, 38(12), 2637–2640.

*ERS stands for Ethics, Responsibility, and Sustainability