Sabrina Schramm
U.S. History
Marcotte
Food and Drug Administration Before 1906, the working conditions and practices of the meatpacking industry were horrendous and caused lots of health issues for many Americans. A book published by Upton Sinclair called “The Jungle” called attention to these issues to the White House when President Teddy Roosevelt read it (Oakes, McGerr and Lewis). Thus, the Pure Food and Drug Act of 1906 and the Federal Meat Inspection Act of 1906 was created (Oakes, McGerr and Lewis). This expanded the mission of the Bureau of Chemistry which was now responsible for regulation of these new acts (FDA's Origin & Functions - FDA History). The Bureau of Chemistry was later changed to the Food, Drug and Insecticide Administration
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A terrible incident happened in Tennessee in 1937 when a drug called Elixir Sulfanilamide was mislabeled and contained toxic quantities of antifreeze that killed over 100 people (FDA's Origin & Functions - FDA History). Before this event, Congress debated substituting the 1906 Act and this instance in Tennessee drove Congress to approve the Food, Drug and Cosmetic Act of 1938 that provided an updated set of standards. Unlike before when the government had to disprove a drug was effective, the new act stated that drugs had to be proven effective before being sold. It not only replaced the Pure Food and Durg Act, but the Sherley Amendment as well (Centennial Edition of FDA Consumer).
From the 40s to the 60s, the FDA required more guidance over the abuse of amphetamines and barbiturates than any other drugs in combination. The Durham-Humphrey Amendment of 1951 concluded the debate against what was considered to be an over the counter drug and a prescription drug (FDA's Origin & Functions - FDA History). The Kefauver-Harris Drug Amendments were added to the FD&C Act in 1962 to ensure FDA approval of drugs preceding the commerce of the drug (Centennial Edition of FDA
This book was called The Jungle and its purpose was to bring attention to the hardships of plant workers (Constitutional Rights Foundation). However, when the public read his book, they were more appalled at the possibility of consuming contaminated meat than the hardships of plant workers, and so demanded that President Theodore Roosevelt and Congress do something about it (Laws.com). In response, President Roosevelt commissioned labor commissioner Charles P. Neill and social worker James Bronson Reynolds to investigate Sinclair's claims. What they found was exactly what Sinclair had described (Constitutional Rights Foundation). After the President and Congress heard of these deplorable conditions, they went to work creating a law to improve the working conditions in both slaughterhouses and meat processing plants. What they came up with was the Federal Meat Inspection Act (Constitutional Rights Foundation). The act improved conditions in slaughterhouses and meat processing plants by forcing slaughterhouses and meat processing plants to practice clean and sanitary handling and preparation of meat. It also required inspections of livestock and animal carcasses, as well as monitoring of slaughterhouses and meat processing plants, among other things (USLegal, Incorporated). All this helped to put an end to the dangerous and unsanitary conditions of
The lack of oversight in politics allowed industries to circumvent controversy and take advantage of the american people. Furthermore businesses such as the meat industry were able to sell unhealthy meat to the people. As well the meat industry provided unsanitary and harsh working conditions in which nobody could work in. For example in “The Jungle” Sinclair describes the horrific process in the meat industry and the reality of the business. In a meat packing factory a family has to deal with the harsh working conditions: “And yet, in spite of this, there would be hams found spoiled, some of them with an odor so bad that a man could hardly bear to be in the room with them” (160 Sinclair). The meatpackers revolting and toxic hygiene practice serves as a metaphor for the exploitive labor
Everyday you consume things may it be food, drinks, or prescription drugs. Most people will just absent mindedly intake these products subconsciously knowing that they are monitored by government organizations ensuring your safety. It has not always been that was and has progressed greatly throughout the years. although all consumer safety organizations may not be reputable, they do much more good than harm. Consumer safety is something that is extremely important to the American family, and has help thousands of people survive. Consumer safety is something that has allowed America to progress to where it is today.
The claims found in “The Jungle,” were confirmed in The Neill-Reynolds Report [Doc B] which had been commissioned by then-president Theodore Roosevelt. Following the release of the report, Theodore Roosevelt, a known progressive, would sign the Meat Inspection Act of 1906. The Meat Inspection Act of 1906 would lead to stronger regulation for cleanliness in the meatpacking industry but didn’t take into account the proper labeling of food products. The Pure Food and Drug Act, passed in the same year, would, “prohibit interstate commerce in adulterated and misbranded food and drugs (fda.org).” With both acts passed, consumer protection was ensured throughout the nation and was seen as a victory for reformers. However, the main issue that was meant to be addressed in “The Jungle,” was that of harsh working condition and unfortunately reformers were not able to cause much change on the national level in regards to harsh working
In 1906, the Pure Food and Drug Act, that was years in the making was finally passed under President Roosevelt. This law reflected a sea change in medicine-- an unprecedented wave of regulations. No longer could drug companies have a secret formula and hide potentially toxic substances such as heroin under their patent. The law required drug companies to specify the ingredients of medications on the label. It also regulated the purity and dosage of substances. Not by mere coincidence was the law passed only about five years after Bayer, a German based drug company began selling the morphine derivative, heroin. Thought to be a safe, non-habit forming alternative to morphine, heroin quickly became the “cure-all drug” that was used to treat
Back in the 1900?s, the food was not the healthiest or cleanest you would see nowadays. From Upton Sinclair?s book entitled ?The Jungle? written in the 1906, had called the nation?s concentration to abuses by the meat-packing industry. Sinclair disguised himself as a worker in a Chicago meat-packing plant to observe harmful and unsanitary practices. In the factory, to kill rats, Sinclair wrote, ?the packers would put poisoned bread out for them, they would die, and then rats, bread, and meat would go into the hoppers together.? Hence, that would be the meat made for the public to eat. Many people did not consider that the meat industries actually did this, for example, former President Roosevelt doubted Sinclair?s viewpoints, and however, he ordered an investigation of meatpacking practices. The investigation report shocked him that he demanded more health and sanitary laws. In June 1906,
This act, under the direct administration of the Bureau of Chemistry, forbade the interstate transport of illegal food and drugs, and exposed any responsible parties, that dare to violate the law, to penalty of seizure of the questionable products and/or prosecution. In fact, the foundation of the law relies on the regulation of product labeling rather than pre-market approval. The selling of Drugs, which are defined according to the standards of strength, quality, and purity in the United States Pharmacopoeia and the National Formulary, is denied under any other condition except that the specific variations from the applicable standards were clearly stated on the label. However, there were different standards that defined foods, but the law outlawed the addition of any ingredients that would alternate for the food, hide damage, generate a health danger, or constitute a filthy or decomposed substance. The controversial interpretations of the food provisions in the law engendered many, sometimes prolonged, court battles. In case the manufacturer decided to list the weight or measure of a food, this had to be done accurately. Also, the food or drug label could not be false or misleading in any particular, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine, had to be listed (Nash 276-77).
The Controlled Substances Act (CSA) gives certain bodies or individuals such as research scientists, pharmacies, doctors and manufacturers the legal right to access controlled substances.
The history of drug use dates back for thousands of years with diverse purposes throughout humanity. According to Levinthal (2012), the drug-taking behavior gained federal awareness in the early 1900s, due to the lack of drug control regulations. Moreover, Levinthal (2012) mentions four major drug control laws which were established, including: (1) The Harrison Narcotic Act 1914, (2) The Marijuana Tax Act 1937, (3) The Boggs Act 1951, and (4) The Controlled Substance Act 1970. The drug control laws formed help regulate importation, manufacture, selling, or distribution of drugs within the United States (Levinthal, 2012).
In the decade of 1950 there took place the sadly crisis of the thalidomide that was motivated by the prescription of this agent to pregnant women as treatment to relieve the morning vomits. The drug was sold either directly or under license, in over 46 countries. What caused a considerable number of alterations in the extremities of many newborn children. Countless children died at birth or in the womb. In spite of the fact that when the drug was tested on rats, it appeared to have no toxic side effects. In response to this crisis, the United States congress improves the procedures to increase the safety of medicines and in 1962 Senator Estes Kefauver, of Tennessee and the representative Oren Harris, of Arkansas, realized a very important amendment.
In 1938, the Federal Food, Drug, and Cosmetic Act was passed and gave the right to the FDA to approve pharmaceutical advertising. Congress gave permission to the FDA to specifically regulate prescription drug advertising and labeling in 1962. Seven years later, the FDA released
In 1985 a small group of people sued the DEA to try and prevent them from doing so. This small group of people failed due to an incident that had happened the year before. China White, a drug sold to heroin addicts as a legal substitute, contained a poisonous impurity that caused a form of severe brain damage. This caused the US Congress to pass a law allowing the DEA to place an emergency ban on any drug that it felt might cause any danger to the public. MDMA was one of the drugs banned on July 1, 1985. (Saunders p.8) The temporary ban lasted for one year only. There was a hearing set up to decide what the final word would be on Ecstasy. At the end of the case, the Judge recommended MDMA to be placed in a category that was not as restrictive. The DEA would not back down from their decision, and ignored the recommendation given by the judge. By placing MDMA in a less restrictive category it would have allowed the drug to be manufactured and to be used for research.
Initially, as the pharmaceutical industry was growing and rapidly developing, it was also unmonitored, and the claims they made about the products they advertised posed a risk for the consumers given the freedom they had to promote them. For example, the Pure Food and Drug Act was signed in 1906, but it was not stringent enough to prevent the sale of harmful substances: it was directed towards product labeling, and did not have any restrictions about advertising. This evidently created a loophole because it addressed only the topic of misbranding and label content, while false claims that were not included in the label were not prohibited. The tremendous growth experienced by advertising for food, drugs and cosmetics created a demand for the legislation that took place in 1938, the Federal Food, Drug and Cosmetics Act, where FDA was granted greater powers to regulate the industry. This was sharpened by the Sulfanilamide disaster that occurred in 1937: again, "law of action-reaction" manifested, and this is exactly what I find the most interesting, how regulations have been made as a result or response to particular events. More than a preventive strategy, it has always been a reactive one. But
Dating back to 1906, the U.S. Food and Drugs Act spearheaded the regulatory functions of the Bureau of Chemistry (predating the FDA), to regulate drugs and medical devices in order to prevent consumer harm (Shi and Singh, 2013). As regulatory functions evolved, manufacturers conducted safety tests on products before they were marketed, and the FDA would intervene only if someone was harmed from a drug or medical device (Shi and Singh, 2013). The purpose of this paper is to analyze two FDA drug and/or medical device legislations during the 1900’s, and discuss their impact today. Chosen from a summary of FDA legislation from Shi and Singh (2013), I have chosen to discuss The Safe Medical Devices Act of 1990,
THE 1930s and 1970s: In 1941 nearly 300 people were killed or injured by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative, phenobarbital. That incident caused FDA to revise manufacturing and quality control