...Food safety is a growing concern globally. With the innovations in the processing technologies, packaging techniques, agricultural practices, and change in food habits, industry and enforcement authorities are facing new challenges every day. Currently there are more than twenty Indian laws relating to food, which are administered by a number of different Ministries and Departments. Food processors have to comply with these rules. Among the more important food laws are: • Prevention of Food Adulteration Act (PFA) of 1954 and the PFA Rules of 1955. Covers specifications related to food colour, preservatives, pesticide residues, packaging and labelling, and regulation of sales. • The Standards of Weights and Measures Act, 1976, and the Standards of Weights and Measures (Packaged Commodities) Rule, 1977. Designed to establish fair trade practices with respect to packaged commodities. • The Fruit Products Order, 1955. Specifications and quality control requirements regarding the production and marketing of processed fruits and vegetables, sweetened aerated water, vinegar, and synthetic syrups. • Meat Food Products Order, 1992. Administers the permissible quantity of heavy metals, preservatives, and insecticide residues for meat products. • Milk and Milk Products Order, 1992. Regulates the production, distribution, and supply of milk products; establishes sanitary requirements for dairies, machinery, and premises; and sets quality control standards for milk and milk products. ...
Words: 555 - Pages: 3
...Food and Drug Administration Almost Everyday grocery stores all around the world are filled with many customers looking to buy goods. Is the FDA administering food unhealthy to humans? The answer to this question varies among so many people, as all of us have different views on how the FDA system works. The FDA is allowing these foods to be sold. In my opinion, the food is very unhealthy. Although, many people like anything they can get their hands on and sometimes that is always not the best choice. People have so many concerns whether food is unhealthy or not, it is always hard to find good and healthy food, but FDA is not one of them. Most of the food is non-organic and has GMO in it. That is why a lot of people get sick more than usual ,because of the chemicals that the individual is putting in their body....
Words: 446 - Pages: 2
...The Food And Drug Administration has made a rule that requires motor carriers and shippers to make sure that vehicles are cleaned and properly-refrigerated when they are transporting food. Doug Morris is the OOIDA Director Of Safety And Security Operations. He has stated that the changes are something that they have been working on since January 2013. He also stated that these are major changes dealing with the housing, shipping and production of food. The Food And Drug Administration Modernization Act sets requirements for carriers, loaders and shippers who are involved in transporting both human and animal food. People are required to use the proper sanitary practices in order to ensure that food is safely transported. The rule specifically...
Words: 518 - Pages: 3
...he United States Food and Drug Administration (FDA) is a regulatory body vetted by the US Federal Government. It is responsible for securing the safety of its citizens and livestock in the realm of consumables like food, medicines, chemicals and all of their biological delivery methods. The FDA charter, by default, makes it intimately tied to various industrial and economic entities within the United States. Since the United States is the principal world leader in economics, the FDA is often viewed as the most efficient, thorough, and authoritative food and drug organization in the world. While the US FDA oversees the majority of food and medical innovation internationally, it is not the only world class regulatory department actively engaged in the safety of the world’s population. Comparable government committees throughout the industrialized world have matching, if not higher, standards than the US FDA. Without the “red tape” associated with...
Words: 595 - Pages: 3
...Organizations should have moral obligations to each of their stakeholders, both internally and externally, as well as a moral obligation to the community in which it serves. Generally, moral obligations require others to have a sense responsibility to others; however, moral actions cannot be legally enforced by companies. As firms seek to create economic stability, a financial approach to moral obligation stresses that any obligations one has to self will automatically include obligations to others (Wolfe, 1989). The United States Food and Drug Administration has the responsibility to assure the public at large that products produced by companies are safe (“What We Do,” n.d.). The Monsanto company is an organization that produces consumer products...
Words: 418 - Pages: 2
...Professor Lodge UNIV 200 14 April 2011 Ensuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of foods, medical devices, and prescription and over-the-counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturing, process of approval, marketing, and post marketing stages. When a drug or medical device is granted approval by the FDA, it will shortly become marketed in the United States and available for public use. The FDA responsibility during this post marketing stage consists of ensuring product safety and efficacy through continued research and testing of the product. If the FDA discovers safety or efficacy problems with the medical device or drug, they are also responsible for removing the product off the market and informing the public of their findings. The FDA is a very powerful United States government agency, who plays a crucial role in American citizen’s health and well-being. Through their legal authority established by the United States government, the FDA is chiefly responsible for ensuring the American public’s health and safety in the foods we eat, to the medicines we take to cure a common cold, to the treatment choices we use to help...
Words: 4122 - Pages: 17
...sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval. (FDA U.S. Food and Drug Administration, 2013). 2. Post-marketing control- According to "FDA U.S. Food and Drug Administration" (2013), Post-market surveillance is an assortment of processes and activities the FDA uses to screen the safety and efficiency of medical devices once they are on the market. These actions are designed to produce information to rapidly identify below par performing devices and other safety glitches, precisely characterize real-world device performance, clinical outcomes, and facilitate the development of new devices, or new uses for existing devices. 3. Consumer Education- According to "Direct-To-Consumers Prescription Drug Advertising" (March 2010), The FDA identifies three types of DTC ads: 1) reminder ads that include no reference to the drug’s purpose, benefits, or risks, and that refer to the drug’s brand name only, 2) help-seeking ads that contain information about a disease or medical condition without mentioning the drug’s brand name, and 3) product-claim ads that include both the drug’s...
Words: 474 - Pages: 2
...by Fred Sand Professor Newcomb, Legal – 500 February 27, 2014 compared The remainder of the document will discuss and examine law suites held against PharmaCARE and various ethical dilemmas the company may encounter. On August 17, 1997, executives around northern New Jersey’s drug corridor, where most of the international Pharmaceutical companies have their headquarters, mobilized for action” (Aitken & Holt, 2000, p. 82). According to Aitken and Holt (2000), this was the day that the US Food and Drug Administration issued temporary guidelines the, for the first time, permitting the drug makers to specify the uses of their prescription remedies in their radio and television advertisements (p. 82). Marketing and advertisement has been around almost since the beginning of time. One of the ethical dilemmas concerning television and radio advertisements for prescription drugs is the potential for the consumer to self-prescribe or evaluate their symptoms. According to the U.S. Food and Drug Administration (2013), doctors believe that patients understand that they need to consult a health care professional about appropriate treatment (p.1). On the other hand, it could be possible for the patient to adapt their own symptoms for the sake of obtaining a desired medication. “Intellectual property (IP) is the work product of the human mind. Novels, paintings, computer programs, songs and inventions are all examples” (Halbert & Ingulli, 2012, p. 316). “Activist...
Words: 1850 - Pages: 8
...Drug and alcohol control Name Course Institution Tutor Date Drug and alcohol control The pure food and drug act of 1906 The pure food and drugs act of 1906 was an important piece of the progressive Era registration. This act was enacted to safeguard the public against the adulteration of food and also from the products which were identified to be healthful without the scientific support. It was applied to the goods that were shipped in the foreign commerce. The main reason was to safeguard against misbranding or adulteration. The adulteration was as a result of poisonous color or flavor in food or even various ingredients that which would be harmful to the health of humans. The provisions included development of the food and drug administration that was entrusted on with the charge of testing of all drugs and foods that was meant for human consumption (Curtis, 2013). The provisions required that there be prescriptions from the licensed physicians prior to purchasing certain drugs by the patients. There were also requirements for the label caution for drugs that are addictive. In case a distributor or a manufacturer were caught offending this enforcement they were liable for prosecution by the central government. However distributors were not entirely liable to this action if they could show a sufficient guarantee from the vendors (Curtis, 2013). The pure food and drug act also required that certain drugs inclusive of alcohol, heroin, cocaine, cannabis and morphine...
Words: 1880 - Pages: 8
...box’’ 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk Shirley Murphy, MD, and Rosemary Roberts, MD Silver Spring, Md A prominently displayed boxed warning, the so-called ‘‘black box,’’ is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these ‘‘black box’’ warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. (J Allergy Clin Immunol 2006;117:34-9.) Key words: Food and Drug Administration, adverse drug reactions, MedWatch, ‘‘black box’’ warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development Abbreviations used AERS: Adverse Event Reporting System CDER: Center for Drug Evaluation and...
Words: 5617 - Pages: 23
...1010 Introduction – * What is caffeine? * The effects of caffeine intake * Tips for caffeine consumption * Within my discussion, I will weigh both the benefits and detrimental effects of how caffeine can alter the senses, as well as discuss how to assess your caffeine intake against the daily recommended amount of the drug. Body - * Caffeine is a huge part of our daily lives and our intake often reflects our health status. * The drug can often be found in many products throughout our society. * It can often be used in moderation in order to prevent Alzheimer’s disease, Parkinson’s, and even asthma. (Hensrud, 2010) * This is a major source of alertness, altering mood, and improving concentration. * While safe to use in moderation, the consumption levels of most Americans is often dangerous and can be detrimental to their health. * Insomnia, dizziness, and anxiety are often signs of over-consumption of caffeine. * Those who consume large amounts frequently become addicted and dependent on the drug. * Overdose has been reported from the drug and is a rising concern. * Monitoring and implementing a caffeine-regulating diet is essential through reading nutritional labels and knowing ingredients within the products you consume on a daily basis. * Recommended amount by the FDA of caffeine intake is 200-300 mg of caffeine per day. (Somogyi, 2009) * Searching...
Words: 808 - Pages: 4
...Government Regulations Laws in the United States for mass production and commercial use of a drug are amongst the strictest and most costly to develop in the world. US demands for prescription drugs in 2009 was $300 billion, which was a massive 40% of the world population. In terms of strictness, drugs have to go through many tests by numerous regulatory agencies before getting approved for mass production. The self-diagnostic kit that tests for Influenza, Pink eye and Respiratory Syncytial Virus (RSV) has to be approved by the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC) and the Environmental Protection Agency (EPA). FDA; The obvious government regulation needed is the one from the Food and Drug Administration (FDA). Before any drug, or in our case a drug diagnostic kit, hits the market, it has to go through many trials and tests before it is approved. “As with all products regulated by FDA, rigorous reviews of laboratory and clinical data are needed to ensure the safety, efficacy, purity and potency of these products.” CLIA; Due to the fact that the self-diagnostic test is going to be a commercially used product for humans, it has to be approved by the Clinical Laboratory Improvement Amendments (CLIA), which are a part of the FDA. CLIA are federal regulatory standards in the United States created in 1988 for any laboratory tests that are performed on humans. One major competitor, QuickVue, which is a diagnostic for influenza A and...
Words: 865 - Pages: 4
...One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways. The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the scientific...
Words: 3299 - Pages: 14
...The United States department of labor is the department that oversees my job. It regulates the amount of work hours before I am due a break, and or a lunch break. They also regulate the amount of minimum wage for jobs in the United States. The United States department of labors also constitutes what is considered overtime and the wage we receive. The Department of Labor fosters and promotes the welfare of the job seekers, wage earners, and retirees of the United States by improving their working conditions, advancing their opportunities for profitable employment, protecting their retirement and health care benefits, helping employers find workers, strengthening free collective bargaining, and tracking changes in employment, prices, and other national economic measurements. In carrying out this mission, the department administers a variety of federal labor laws including those that guarantee workers’ rights to safe and healthful working conditions; a minimum hourly wage and overtime pay; freedom from employment discrimination; unemployment insurance; and other income support. ("United States Department Of Labor", 2012). United States Department of Labor’s mission is: To foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States; improve working conditions; advance opportunities for profitable employment; and assure work-related benefits and rights. ("United States Department Of Labor", 2012). The Federal Communications...
Words: 1173 - Pages: 5
...ethics as: * Ethics is the systematic study of what is right and good with respect to conduct and character. * The beliefs and behaviors to which members of the profession subscribe. * A critical evaluation of assumptions and arguments. * A discussion about what ought to be done or ought not to be done. Using Merrill’s’ definitions as a rough guide we can evaluate the legal and ethical decisions of PharmaCARE’s use of the diabetic drug AD23 in slowing the progression of Alzheimer’s disease. The drug was reformulated to maximize its effect on Alzheimer’s treatment however, PharmaCARE took actions to avoid the Food and Drug Administration in the reformulated drug for Alzheimer. PharmaCARE setup its own pharmacy company CompCARE to sell the new formulation to the public. CompCARE was able to take advantage of PharmaCARE’s databases, networks, and sales and marketing expertise to create a high demand of the product. Once the high demand was there, CompCARE started to advertise AD23 directly to consumers and marketing the drug directly to hospitals, clinics and physicians. After the success of AD23 CompCARE was sold to WellCO. Two weeks later AD23 was linked to 200 cardiac deaths. Research three to five (3-5) ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety and examine whether PharmaCARE violated any of the issues in question. Multinational Corporations have grown to the point where their wealth can...
Words: 2197 - Pages: 9
