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…

women are putting their health at risk by unknowingly ingesting harmful chemicals from their daily cosmetic products. In Europe, approximately 1,300 chemicals are prohibited for use in personal care products, while about only a dozen are banned or limited in the United States (Dennis). Studies have linked certain chemicals and ingredients contained in cosmetics to allergic reactions, environmental concerns, disruption of the endocrine system, developmental, reproductive and organ-system…

The Food and Drugs Act defines a cosmetic as “any substance or mixture of substances for use in cleaning, improving or altering the complexion, skin, hair or teeth”, which includes both beauty products and grooming aids, such as soap, shampoo, cream and deodorant (Health Canada, “Cosmetics Legislation”). This means that cosmetics are something that we all use and come in contact with our bodies every single day. For this reason, it is important that we are aware of the ingredients in these…

There are many reasons why the cosmetic industry has become a concern for the people of the United States. Many people have had diseases and cancers that can be linked to the chemicals that are placed in their personal care products and cosmetics. Little has been done for putting regulations on these chemicals being placed in personal care products until recently with the Personal Care Products Safety Act. The chemicals that are being put into cosmetics are affecting every person who uses any…

Tens of thousands of animals are tested on for the cosmetic industry every year. (Pro-Con) However, this cannot be accurate due to some animals not being protected -therefore unaccounted for in these numbers- by law: “95% of animals used in experiments are not protected by the federal Animal Welfare Act (AWA)” (Hastings Center) . The reasons vary for this; one of the most common excuses is for the benefit of humans who should be kept safe from faulty products. Such products range from medical to…