This paper intends to highlight the past and present measures are taken to properly administer the food and drugs issues. The key notion is to identify any advances reached. For this purpose initially, the topic is introduced so that it becomes easy to get an idea of the perspective of this research. Further is tries to introduce some basic food and drug laws and then the types of drugs currently available. It also points out the role played by the Food and Drug Administration (FDA) and the Federal Food, Drug, and Cosmetic Act. It provides a brief introduction, background, and history of the FDA and how it operates, and the practices implemented. In the end, this paper discusses a relevant case of the Green Hornet, and the FDA’s reaction to this event.
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Introduction and background
Before starting the discussion about food and drug administration in the USA I feel likely to present a brief overview of pure food and drug laws so that we can precede our study towards the significance of the Food and Drug Administration.
Pure food and drug laws
These laws are meant to ascertain safety and healthiness criteria for foodstuff, medicines, medicinal appliances, and cosmetic products. The Federal Food, Drug, and Cosmetic Act, approved in 1938, is the fundamental food and drug law of the state. It forbids the circulation of contaminated foodstuffs, medicines, or cosmetics in the United States. It also prohibits fake or deceptive tagging on these items.
FDA-The Food and Drug Administration is an organization in the Department of Health and Human Services which implements the Federal Food, Drug, and Cosmetic Act. The FDA ensures food and drug artifacts to ascertain they meet federal paradigms. If the FDA discovers confirmation of desecrations, it provides the proof to a federal court. Federal courts annually accept hundreds of new cases which handle these contraventions (Pure food and drug laws, 2008).
The main segment of the Federal Food, Drug, and Cosmetic Act confers the FDA authority to put criteria for all kinds of edibles being produced for both humans and animals. Food standards define what ingredients a food must contain and how the food should be labeled. The FDA sets standards for only the most common food products. The food section of the federal act contains provisions that cover (1) impurities in foods, (2) food additives, and (3) labeling of foods.
- Impure foods are foods that do not meet the safety, purity, or cleanliness standards of the Federal Food, Drug, and Cosmetic Act. They include foods that have dirty or rotten contents or have been prepared or packaged under unsanitary conditions. The most frequent sources of impurities found in food are insects, mice, and rats.
In addition, harmful chemicals may be the cause of impurities. Such chemicals may be present in food on which producers have used a poisonous spray. Harmful chemicals also may be found in fish that have lived in polluted water.
- Food additives are substances that food producers can legally add to their products. They include spices and many other substances used to flavor or preserve food. The Federal Food, Drug, and Cosmetic Act requires that these substances be proved safe by scientific tests before they are put on the market. More than 3,000 food additives have been approved. Permitted additions to foods also include color additives. The FDA must approve every batch of color that is used in the preparation of foods, drugs, and cosmetics. (Pure food and drug laws, 2008)
The safe use of pesticides is also permitted. Food growers often use pesticides on or around food. The Environmental Protection Agency determines how much pesticide may remain on a food crop. It sets these levels far below those that would make the food dangerous to eat. The FDA tests food products for pesticides and takes them off the market if too much remains on them.
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- Labeling of foods The Federal Food, Drug, and Cosmetic Act requires food producers to provide certain information on the labels of their products. This information includes the name of the product and its manufacturer, packer, or distributor; the amount of food in the package or container; a complete list of ingredients, except for some standardized foods; and the name of any chemical substance added. In addition, a food label must tell if artificial color or flavor has been used, except for some colors that are added to butter, cheese, and ice cream. The Nutrition Labeling and Education Act of 1990 require that all packaged and processed foods sold in the United States also carry labels with nutritional information. (Pure food and drug laws, 2008)
Drugs and devices
The Federal Food, Drug, and Cosmetic Act define drugs as products intended for use in the medical care of people or animals. The act covers several kinds of drugs, including (1) prescription drugs, (2) over-the-counter drugs, (3) biological drugs; it also covers medical and other devices.
Before a producer can sell a new drug, the drug must be tested thoroughly to find out if it is safe and effective when used as directed. The producer must give the FDA a report on all tests and on all the ingredients of the drug and the methods for testing their strength and purity. The the producer must submit the proposed label directions and any needed warnings. The FDA, after approving a new drug, keeps watching on its use and effects (Pure food and drug laws, 2008).
- Prescription drugs are dangerous to use except under medical supervision. The Federal Food, Drug, and Cosmetic Act define the kinds of drugs that should be in this group. The act forbids the sale of such drugs unless a physician or a dentist has prescribed them. The act also prohibits the sale of a prescription drug for an animal unless a veterinarian has prescribed it.
- Over-the-counter drugs may be sold without a prescription. Such drugs must be safe for use without medical supervision. Label directions and warnings on over-the-counter drugs must be clear and easily seen so that consumers can use the drugs safely and effectively.
- Biological drugs are made from animal or human substances. These drugs include serums and vaccines, and drug products made from human blood. A manufacturer may not sell such a drug unless the FDA has licensed it. An FDA license assures the purity, safety, and strength of the drug.
- Medical devises Medical devices are products used in the control or treatment of disease. The Federal Food, Drug, and Cosmetic Act require them to be safe and effective. Such devices include artificial parts for the human body, fever thermometers, and sun lamps. Many medical devices need FDA approval before they go on the market. The FDA also tests radiation-emitting devices such as X-ray machines, televisions, and microwave ovens to ensure that they do not endanger health. (Pure food and drug laws, 2008)
Cosmetics include such products as deodorants, lipsticks, perfumes, shampoos, and toothpaste. The Federal Food, Drug, and Cosmetic Act requires cosmetics to be safe and properly labeled. It also requires cosmetic producers to make and package their products under sanitary conditions. The ingredients used in a cosmetic must be listed on the label. The labels must include the manufacturer’s name and address. Labels of coal tar hair dyes must warn that the product should be tested for possible skin irritation before being used. (Pure food and drug laws, 2008)
The Food and Drug Administration publishes regulations that explain the Federal Food, Drug, and Cosmetic Act. However, manufacturers sometimes violate the act, accidentally or intentionally. In most cases, the FDA does not prosecute if the manufacturer voluntarily stops shipping an illegal product. If an illegal product has already been sold, the manufacturer may be required to notify the people who bought it and arrange to take the unsold stocks of the product off the market. This procedure is called a recall.
Evidence of violations of the act is gathered by hundreds of FDA field investigators and inspectors. These employees inspect factories and warehouses and investigate complaints of illness or injury caused by impure or mislabeled foods, drugs, or cosmetics. In addition, FDA inspectors supervise the enforcement of court rulings on violations (Pure food and drug laws, 2008).
The FDA also employs hundreds of scientists in field jobs, including microbiologists, chemists, and veterinarians. These experts use laboratory tests to check the purity, safety, and effectiveness of foods, drugs, cosmetics, and devices. In addition, the agency employs hundreds of other scientists and physicians who review and approve new drugs and serve as experts in other scientific areas.
Three kinds of legal action can be taken if the FDA finds that a producer has violated the federal food and drug laws: (1) A federal court may issue an injunction (court order) directing the manufacturer to stop. (2) The court, acting on evidence from the FDA, may seize a product that violates the law. (3) Prosecution for such violations can result in a fine or imprisonment or both.
Since ancient times, there have been food and drug laws regulating the quality of meat, milk, and flour products. By about A.D. 1300, European merchants had set up powerful trade organizations to inspect food and drugs. During the Industrial Revolution, which occurred in the 1700s and early 1800s, food producers began using chemicals to preserve and color food.
In 1784, Massachusetts passed the first general pure food and drug law in the United States. Early state laws were difficult to enforce, however, because they often did not define pure, and what was considered pure in one state could be ruled impure in another. Also, some people felt it was unfair to punish a merchant for selling foods or drugs that the merchant did not know were considered impure in a particular state (Pure food and drug laws, 2008).
In 1848, Congress passed the first federal drug law, the Import Drug Act, to stop drugs of poor quality from coming into the country. Beginning in 1883, Harvey W. Wiley, chief of the Bureau of Chemistry in the U.S. Department of Agriculture, began studies of food purity. He favored the passage of a federal law that would define impure and misnamed foods and drugs for all states. Public support for the passage of such a law grew as journalists wrote about certain chemical preservatives and other harmful substances in foods and about dangerous ingredients, such as alcohol and opium, in drugs. As a result, Congress passed two food and drug acts in 1906—the Meat Inspection Act and the federal Food and Drugs Act. Stronger legislation—the Federal Food, Drug, and Cosmetic Act—was passed in 1938. The act has been revised many times since then.
In 1995, the FDA declared that nicotine was a drug and that cigarettes and other tobacco products were nicotine “delivery devices.” As a result, the FDA introduced restrictions on the marketing and sale of tobacco products to young people. In 2000, however, the Supreme Court of the United States ruled that the FDA does not have the authority to regulate tobacco products (Pure food and drug laws, 2008).
Food and drug administration
Food and Drug Administration (FDA) is the agency of the U.S. Department of Health and Human Services that oversees the safety of foods, drugs, cosmetics, and medical devices and operates the National Center for Toxicological Research. The FDA oversees the review and approval of new medicines and medical devices. It also monitors the safety of dietary supplements, though it does not review and approve the supplements before they are sold.
The FDA helps to ensure that people receive accurate information about the foods and drugs that they use. The agency calls for the truthful description of product benefits and risks and for safety and honesty in packaging. The FDA designed the “nutrition facts” panel that appears on packaged foods in the United States (Olson, 2008).
The FDA originated in the late 1800’s as the Division of Chemistry (later called the Bureau of Chemistry). The agency adopted its present name in 1930. Laws administered by the agency include the Federal Food, Drug, and Cosmetic Act of 1938, the Drug Amendments of 1962, and the Medical Devices Amendments of 1976 (Olson, 2008).
Congress passed the Pure Food and Drug Act, in response to the complaints against the unproven chemical additives in foodstuff in 1906, which established this agency. A number of consequents expanded the perspective of its authority, as in the beginning the FDA had only reacted on the eatable preservatives and the drugs which were though already in use but had been proven to be detrimental. And it was in the year 1938 act of The Food, Drug and Cosmetic Act (1938) required the producers to have tested their products on both the animals and human beings before they intend to market their products. Moreover in 1957 for newer or modern food preservatives testing was necessary, following this Delaney Clause (1958) proscribed the addition of materials into the foodstuff if they were of some aid to initiate cancers in the laboratory animals. Although, the scrutiny of the Delaney Clause was replaced with the law that low levels of remnants to be allowed in processed or fresh foods which were presumed to be harmless (Food and Drug Administration, 2008).
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In 1962, having averted disaster by delaying approval of thalidomide, the FDA issued new regulations that made the drug-review process far more stringent, and FDA approval for many new drugs now required up to three years of testing. The Orphan Drug Act of 1983 offered tax credits and other inducements to encourage pharmaceutical companies to develop drugs for rare diseases that affect small populations Controversial “fast-track” approval procedures for these drugs have been instituted in some cases, causing concern about the potential for new drug hazards. The use of antibiotics in animal feed is another unresolved issue. However, regulations to improve the nutritional labeling on foods, an issue that had long been an FDA concern, were finally adopted in 1992 (Nash, 2008).
In the 1990s, the FDA accelerated its review and approval processes for new drugs. In the years that followed, some widely used drugs were withdrawn from the market for safety reasons. Many people argued that in speeding up its review process the FDA failed to protect the public from unsafe drugs. In 2004, the FDA announced plans to establish a new Drug Safety Oversight Board (Olson, 2008).
In recent years the FDA has confronted highly sensitive issues. It entered the smoking controversy in 1996 with its most far-reaching regulation, which treats cigarettes as a “drug delivery device” and therefore restricts their advertising, sales, and promotion to children. In 2000, however, the U.S. Supreme Court ruled that the FDA does not have the power to regulate tobacco and tobacco products. The FDA has also involved itself in the abortion controversy, with its 1996 approval for the U.S. marketing of the abortion-inducing pill Mifepristone (known as RU-486); the agency has also promoted the use of certain oral contraceptives as “morning after” pills. In 1997 the FDA Modernization Act was signed into law. This act speeds up the approval process for drugs and medical devices, as well as providing patients access to unapproved drugs that are very effective in clinical trials (Food and Drug Administration, 2008).
Background of the organization
The Food and Drug Administration (FDA) originated in the movement, early in the 20th century, to secure federal controls over the adulteration of food and patent medicine frauds. A key figure in this campaign was Dr. Harvey Wiley, chief chemist of the U.S. Department of Agriculture from 1883 to 1912, who formed a famous “poison squad” to test suspected foods. Wiley’s agitation for federal controls received a boost from muckraking journalists, especially Upton Sinclair, whose novel The Jungle (1906) dramatized unsanitary conditions prevailing in the Chicago stockyards.
With President Theodore Roosevelt’s prodding, Congress enacted the Pure Food and Drug Act of 1906, which prohibited the movement of adulterated foods and drugs in interstate commerce and required honest labeling (Nash, 2008).
Between 1906 and 1927 responsibility for the act’s enforcement was placed in the Bureau of Chemistry in the Department of Agriculture. Then, in 1928, Congress authorized the organization of the Food, Drug, and Insecticide Administration as a separate unit to engage in research and technical work associated with the execution of the Pure Food and Drug Act. The Agricultural Appropriation Act of 1931 changed the unit’s name to Food and Drug Administration. Its jurisdiction was expanded in the era of Franklin D. Roosevelt, who fostered the passage of the Food, Drug, and Cosmetics Act of 1938. This greatly extended the range of commodities coming under federal control and increased penalties for violators. To lessen pressures from outside groups, the FDA was placed in the Federal Security Agency in 1940; in the Department of Health, Education, and Welfare in 1953; and in the Department of Health and Human Services in 1980 (Nash, 2008).
The FDA’s methods
The FDA uses a variety of methods to execute its responsibilities. It relies on factory inspection by its field staff, which are its eyes and ears. Trained inspectors examine manufacturing facilities as well as products falling in their jurisdiction. A related method is the scientific testing of foods and drugs to determine whether they meet federal specifications.
The Food and Drug Administration also utilizes informal advice. By disseminating legal requirements, for example, it hopes often to prevent violations of the law before they occur. The agency in addition has effectively used publicity to deter would-be violators or to focus public attention on irresponsible manufacturers. When all other means fail, the FDA can issue “desist” orders that are enforceable in courts of law.
In practice, the FDA does not closely regulate the more than 100,000 manufacturers under its jurisdiction because most of them are law-abiding. Instead, its staff, which is surprisingly small—just several thousand employees—considering its responsibilities, concentrate on fringe groups of violators. With the expansion of federal activities in the field of health care and consumer protection, the FDA’s responsibilities have increased. (Nash, 2008)
- The job of the FDA can be portrayed as five kinds of activities or jobs. Let us take a concise view of what the FDA does:
- FDA examines the outcomes of the laboratory; it examines all the animal and human medical processes done by companies to make sure if the good they want to sell in the market is harmless and useful. However, products are not being made or tested by FDA itself. FDA conducts this pre-market examination for new human medicines and biologics, composite medicinal procedures, food and dye preservatives, and animal medicines. Baby formulas are checked for requisite nutrient substance and protection in built-up practices.
- When the product reaches the market the FDA keeps in touch with how the product is manufactured and takes action to news of harms or recently acknowledged dangers.
- To guarantee the well-being of marketed goods, FDA employees check local and overseas producers inspect consignments of imported goods, and gather and examine product models for signs of contagion.
- More than sixteen thousand visits are being made to the amenities that hold FDA-examined goods. Several state governments are supportive of FDA to enhance the number of amenities that are examined. Since primary examination of goods is based on a comparatively little quantity of consumers, and as the disparity in quality can occur in making, FDA maintains vigilant observation on the information of unfavorable incidents with goods after they are sold. The organization entertains more than 400,000 difficult news per annum.
- If this supervision becomes trouble that desires to be solved, FDA can request the producer to recollect the good, depart authorization (of a drug, for example), and entail labeling amendments, or send caution to doctors or other healthiness practitioners.
- FDA utilize rules and manufactured goods standards like the “yardsticks” to describe particular necessities producers have to pursue to guarantee product wellbeing and to give the precise report to fitness professionals and customers.
- FDA works with overseas governments to support the protection and superiority of imported goods by ensuring that foreign principles are comparable to those imposed by the FDA.
- FDA’s investigation works give the methodical foundation for its authoritarian judgments and the tools required to recognize and evaluate dangers.
- The organization utilizes its investigation outcomes to direct standard situations, assess new goods, widen test processes and other help for product checking, and learn up-and-coming dangers. When a difficulty occurs, FDA can take several measures to defend the community health. At first, the organization works with the producer to solve the difficulty willingly.
- If that be unsuccessful, lawful remedies comprise inquiring the producer to recollect a product, having centralized marshals grab goods if a controlled recollects is not finished, and restraining imports at the docks of entrance until troubles are solved. If necessary, FDA s able to ask the courts to concern sanctions or take legal action against those that intentionally disobey the regulation
FDA’s reactions to relevant cases
The Green Hornet Case
A new liquid is recently seen among the young, about which the Food and Drug Administration (FDA) is growing concerns, the FDA has been involved in prohibit the use of these products. The product is easily available on the internet, local stores, and the market as an herbal solution or version of the “Ecstasy” the banned street drug (FDA News Release, 2004).
The FDA has declared this product to be an unapproved new drug as it contains some other illegal addictives among which the most active and prohibited ones are the dextromethorphan and the diphenhydramine which are actively found in the over-the-counter (OTC) drugs.
Recently the FDA’s concerns grew, when they received the reports of the adverse effects of the consumption of the Green Hornet, by four teenagers. All four of these teenagers has similar effects and were immediately rushed to the hospital as they showed clear signs of high blood pressure, seizure, intense body rashes, and unusual excessive heartbeat. Therefore the doubts of the FDA about the Green Hornet have realized some truth and FDA is investigating that whether alone the Green Hornet or its consumption with some other substances could be responsible for such intense adverse effects. (FDA News Release, 2004)
The FDA Commissioner Mark B. McClellan, M.D., Ph.D. expressed that “We are currently trying to get hold of some evidence that, the seizure and other effects experienced by the four teenagers, were due to the consumption of this product. We still advise the same about the “so-called” secure substitute to the illegal street drugs i.e. they aren’t safe, try not to buy and use them. FDA is responsible to carry out any prompted legal action to enforce to drive out these products from the market and will try its level best to get hold of the individual responsible for the provision of such products and make them be tried by the court of law.
In this particular case, the products Green Hornet was sold by Kekio, Inc., Colorado Springs, Colo. This operates as a general store known as the Mind Excursion. The store is also said to be operating a website and has stopped selling this so-called alternative to street drugs.
In another case, FDA is warning consumers to abstain from such products which proclaim to provide “safe legal highs” and are marketed as the substitute to street drugs, another company Cytotec Solutions, Inc., of Tampa, Fla is also said to be involved in the production of such products, which also involved in the distribution of the Green Hornet. Similarly, products by Cytotec Solutions are sold on the internet and the local market as the legal versions of illegal street drugs (Longley, 2004).
After the analysis of the other drugs manufactured or distributed by Cytotec Solutions, by the FDA, they have proclaimed that they have not only found the drug, diphenhydramine HCl and dextromethorphan, but also the ephedrine and the illegal substances of GHB and GBL as well. However such products are no longer manufactured or marketed by the company, it remains under the investigation of the FDA so that any other potential and current manufacturers and distributors of such products could be traced. The FDA finds it necessary to issue such warnings as still consumers may be able to buy and consume them (Longley, 2004).
Other products which are under FDA’s warning are Liquid Speed, Schoomz, Orange Butterfly, Solar Water, Snuffadelic, Invigorate II, and Trip2Night. Similarly to the Green Hornet, the packing of these products are printed with some herbal ingredients but there is no name of the manufactures or the statement that they contain such illegal and unapproved ingredients and drugs as well (Longley, 2004).
The product is widely available in the market of 4 and 16oz bottles and it is quite doubtful that they are printed with the name of the manufacturer. Although a number of herbal ingredients are printed on the packing, however, FDA claims that they have found two active ingredients in this product, as discussed already the dextromethorphan and diphenhydramine, they say that these ingredients are usually found in the number of cold products or the OTC’s (FDA News Release, 2004).
It’s not new to state that FDA has been continuously involved in posing actions against the various products which are marketed and manufactured and sold as substitutes to the illegal street drugs. FDA states an alarming concern that increasingly these products are being actively used by individuals especially minors and perceived as a potential threat to the consumers (FDA News Release, 2004).
According to the FDA any such products that are encouraged as a substitute to the street drug to be newer unapproved one and marketed illegally against the principles of the Federal Food, Drug, and Cosmetic Act. Furthermore, that and products that contain undeclared or unapproved drug ingredients are against the law and therefore legal action against such practices would be undertaken which may result in heavy penalties, seizure of assets, and injunction.
- FDA News Release. 2004.
- Food and Drug Administration. (2008). Grolier Multimedia Encyclopedia.
- Longley, R. 2004. Don’t Let Green Hornet Sting Your Kids.
- Nash, G. D. (2008). Food and Drug Administration. Encyclopedia Americana.
- Olson, Mary K. “Food and Drug Administration (FDA).” World Book Online Reference Center. 2008. [Place of access.]
- “Pure food and drug laws.” World Book Online Reference Center. 2008.