Legislation & regulations Essay Example for Free

Legislation regulations Essay Until the passage of the Food, Drug and Cosmetics Act of 1938, which for the first time imposed penalties for products that contains dangerous or impure substances, the production and sale of cosmetics in the United States was then regulated. Grolier (2005:220). Clear and accurate labeling of all ingredients was now required. The food and drug laws are administered by the Food and Drug Administration (FDA), sometimes in conjunction with the Department of Agriculture. With regard to cosmetics, the laws hold the manufacturers responsible for selling products that are in compliance with the regulations. Manufacturers, however, are not required to register their companies, their products, or their product ingredients with the FDA. They need not report adverse reactions, if they occur among their customers. The FDA may investigate a product , but bears the responsibility for proving that a substance used in that product is harmful. The industry, however, has been largely self-policing in the recent years. Reputable manufacturers conduct their own product-safety tests. In this table, the functions of FDA are enumerated, although not limited only to these: Source: Passiment (2006:38) Prue (2007:349) As part of the screening procedures and safety measures in adapting these products and selling cross-regions, the question on quality control assessment should never be compromised nor put into secondary importance. The degree of the quality measures will directly impact product performance, societal consumption, customer loyalty and market survival of the firm. Thus, the evaluating board should minimally possess the strictest procedures or methodologies of testing and evaluating these bio-products, as per the illustration or flowchart below: Source: Akoh (2004:39) Regulatory and Safety Conditions More than cosmetics, the government also oversees regulatory policies for any agents intended for use in the processing of foods or synthesis of compounds or ingredients for food use. According to the Food Chemical Codex, enzymes as listed must have a GRAS status or undergo the regulatory process of approval. However, the controversy over genetically modified organisms should be taken into consideration by molecular biotechnologists and applied biotechnologists as they design new lipases for new uses. These regulatory polices were established by the U. S. Food and Drug Administration (FDA) for substances that will be present in the diet at low levels. Neither the enzyme preparation nor the production organism has any health-related hazard, and both lack any oral toxicity and genotoxicity. Imposing and implementing policies affecting human subjects are the main functions of the FDA. Being a federal regulatory agency that monitors the safety and effectiveness of food and beverages and even of medical devices. The FDA is broken down into centers:   Center for Devices and Radiological Health with its Office of In Vitro Diagnostics Device Evaluation   Center for the Biological Evaluation and Research FDA classification are designated into several classes: Class I, Class II or Class III, with Class I being the least regulation. Devices are classified by the risk of harming the user and design. The simpler the design, the higher the probability that it will be categorized as Class I. FDA’s decisions can be very controversial for the industry and for the company or the manufacturer. It should be noted however that this decision-making process is not a rule-making game, so neither the affected company be able to comment on FDA’s decisions. The FDA has been commonly viewed as an obstructionist to a new innovation. , especially in new products and medication.