and Cosmetic Act

In order to comply with the Federal Food, Drug, and Cosmetic Act (FDCA), it is a requirement that manufacturers obtain Food and Drug Administration(FDA) approval before proceeding to market any brand-name or generic drug in interstate commerce. The generic drug must have the same chemical counterparts as the approved brand-name drug. Once the drug is approved, the manufacturer is not allowed to make any vital changes to the overall quantifiable formulation of the drug product such as the active ingredients and the detailing provided in the approved application(). In the year 2004, the respondent Karen Bartlett, a resident of New Hampshire was prescribed a brand-named drug known as Clinoril also known as Sulindac. This drug is a nonsteroidal…

horror story with acts such as the Federal Food, Drug, and Cosmetic Act, horror stories are what sparked the public outcry for such a legislative lien. The story of the Federal Food, Drug, and Cosmetic Act traces its lineage…

as Hughes presented enough evidence to prove Boston Scientific’s failure to report serious injuries and device malfunction1. Legal Issue The district court preempted all the claims of Jan Hughes and granted a summary judgement to Boston Scientific Corporation as construed by Reigel v. Medtronic, Inc. 552U.S. 312 (2008) and Buckman v. Plaintiff’s Legal Comm., 531 U.S. 341(2001). Due to the district court doctrine of preemption Hughes applied to the Court of Appeals for the Fifth Circuit to…

Price of Beauty When one walks into any Target, Macy’s, or Sephora they see a wide variety of cosmetics. There is mascara that promises to make one’s eyelashes look 300 times fuller and perfume that smells like a fresh garden. However, there is hardly any thought on whether these products will burn one’s eyes or cause a rash; this is because animals are taking the pain for the price of beauty. In the cosmetics industry alone, it is estimated that 100,000-200,000 animals suffer and die every…

Although there had been some earlier calls to require pre-market safety testing, it was due in large measure to the public outcry over the Elixir Sulfanilamide incident that Congress passed the Food, Drug, and Cosmetic Act of 1938 (FDCA). The previous year, Elixir Sulfanilamide, a drug which had been used for years in tablet and powder form to treat streptococcal infections, was converted to a liquid form. The new liquid version of Elixir Sulfanilamide used diethylene glycol as a solvent, a…

On the side of the Department of Health and Human Services, one would dispute in defense of the Federal Cosmetic Surgery Protection Act (FCSPA). Their primary focus would be to defend the decision to have cosmetic surgery as an economic activity, since the individual is the one deciding to purchase this medical service and pay the particular amount of money, which articulates a commercial exchange. Since the Court Case of U.S. v. Lopez, the substantial effect test was divided into two…

Corkill, Katherine. "Are Cosmetic or Skincare Products FDA Approved or Certified?" Personal Care Truth or Scare. Personal Care Truth, 16 July 2013. Web. 16 Nov. 2016. In this article, Corkill explains why a lot of cosmetic companies are not actually FDA Approved or even FDA Certified. She explained how the labeling on these products may be misleading to the customers. Instead, she gave information on what the FDA actually approves. She notes that having that label isn’t approving the cosmetic…

The Food and Drug Administration, established June 30th 1906 by Theodore Roosevelt and Harvey Washington Wiley, is an essential part of our federal government. It began after the Food and Drug act was passed in 1906. It was intended to regulate misbranded food and drugs (The History of FDA's Fight for Consumer Protection and Public Health) and has evolved into what it is now, regulating everything from food to supplements to cosmetics to pacemakers. The FDA consists of one commissioner and…

Before the Toxic Substances Control Act was passed by the United States law in 1976, the human population was believed to have been exposed to a multitude of chemical substances and mixtures. These chemicals were beginning to cause a lot of health problems to humans. This caused the lawmakers to believe that among the substances that are being constantly developed and produced, there are some whose manufacture, processing, distribution in commerce, use or disposal may present an unreasonable…

In my opinion, I believe that the Food and Drug Administration (FDA) should have mentioned the EpiPen characteristics that made the product unsafe. For example, instead of broadly saying that the company didn’t follow the guidelines and had product failures, they could have explained in more detail the exact thing that wasn’t right. I would have also liked to see some visual representations of the EpiPen to see the differences of how Mylan was selling the product in comparison to how it should…