Company X manufactures products known as FlowerPower which is used to cure Acne by breathing in the product which is in liquid form. This product falls under cosmetics because it is used to cleanse and moisture the skin. However, the product plays a medicinal role thus the FDA has regulatory claim and authority over the company. When the company began to promote the product with the help of Ms Claire Alban who had been cured of acne, the manufacturer made medicinal claims. Whenever a company markets products and claims its use is to cure, prevent or treat a condition or particular disease, it stops being a consumer product and starts being a drug device which FDA has jurisdictions over.
It is the role of FDA to ensure that the company behaves with integrity throughout the lifecycle of the product. It expects Company X to ensure safety of the consumers by creating products that are safe and properly labeled. In this case, the company has violated almost all the rules regarding integrity of the product throughout its lifecycle. Ms Smith identified many issues such as wrong ratio of the mixture which is 70/30 instead of 80/20. On the other hand, the company used the whole forsythia which is not safe for people. There were also insects such as worm, spider and bee in the mixture. The other issue was cleanliness with rat droppings around the mixers.
It is the role of FDA to prevent the sale of products that are not safe to the public (FDA 1). It is evident that the integrity of manufacture of FlowerPower as a medicinal product is compromised thus FDA must have full jurisdiction over Company X regardless of its effectiveness. FDA has to determine the risk levels in the product and based on the fact that few people have died while others fainted from using FlowerPower; it has to ensure that the consumers are safe by looking at the root of the problem.
The pros of FDA having full jurisdictions over Company X is that it will regulate the manufacturing method by ensuring that they produce a product that is safe to the public. The law requires all companies to ensure that their products are safe and their ingredients are substantially mixed as per the labels (FDA1).
The cons of the FDA having full jurisdictions over Company X is that it will not be able to market its product until it meets the demands of FDA. However, FDA cannot persecute Company X with their evidence since FDCA holds the power to regulate the ways in which the company sells its products by requesting for premarket approval. The other mistake that the company made that also attracted FDA is wrong/poor labeling of the product. The company did not mention presence of insects such as worms and spider on the labeling of the drug. On the other hand, it did not mention that the product is being sold countrywide-in the labels, it was indicated that the destination for the product was Colorado Springs yet it is being sold countrywide. Company X will not be able to market its products or sell to the public if FDA takes actions against them until they use the right labeling method. The company will have to indicate in the label the prescriptions details or warnings on use of the product which may chase away many of the consumers leading to the company operating at a loss.
FDA. “Federal Food, Drug and Cosmetic Act (FD &C Act).” FDA.gov. Web. 10 May 2015.
FDA. “Selected Amendments to the Federal Food, Drug, and Cosmetic Act.” FDA.gov. Web. 05 Feb. 2015.