Food Drug And Cosmetic Act 1938

According to, http://www.toxicology.org/gp/fda.asp, the Society of Toxicology website, in 1937 the Massengill pharmaceutical company dispersed Elixir Sulfanilamide. This drug was prescribed generally to anyone who had symptoms of strep throat. Elixir Sulfanilamide contains diethylene glycol, which is a chemical equivalent of antifreeze. There were 107 documented deaths, involving many children, because of the lack in regulations. The Pure Food and Drug Act was deemed to insufficient to protect the public. This tragedy was the critical motivation for the creation of the Federal Food, Drug, and Cosmetic Act.

The purpose of the Pure Food and Drug Act was to protect the public against contamination of food and from products identified as healthful without scientific support. The muckrakers had successfully heightened public awareness of safety issues develop from careless food preparation procedures and the increasing number of drug addiction from patent medicines, both accidental and conscious. President Theodore Roosevelt began the process by ensuring the passage of the Meat Inspection Act of 1906, which was followed by the Pure Food and Drug Act, passed in 1906 to become effective at the start of 1907. (Us

The first Pure Food and Drug Act was put into action by Theodore Roosevelt in 1906. The act was passed to prevent the manufacture, sale, or transportation of misbranded or harmful food, drugs, medicines, and liquors. Due to this act the Food and Drug Administration (FDA) came to be. The FDA is now responsible for the testing of all foods and drugs for human consumption and the label warnings on them as well.

As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen (1981), it was hoped that the enactment of this law would eliminate adulterations and poisons sometimes found in foods, sometimes in drugs and often in both. The foundation of food and drug protection came from the development of scientific methods of analysis by the Federal Bureau of Chemistry,

The Food, Drug, and Cosmetic Act of 1938: Sulfonamide tested for flavor and fragrance but not safety, children died and 350 more were poisoned. This act made it so the sale of unsafe drugs could be stopped, that toxic drugs could be seized, and the burden of proof was given to the manufactures to show data of safety experiments.

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

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).

Barkan, Ilyse D. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906. American Journal of Public Health January 1985: Vol. 75, No. 1, pp.

The Pure Food and Drugs Act was passed, authorizing the government to monitor the purity of foods and the safety of medicines, now a responsibility of the FDA.

On June 30, 1906, President Theodore Roosevelt signed the Pure Food and Drug Act. He began to enforce this act by also passing the Meat Inspection Act of 1906. The person responsible for introducing the act is Sen. Weldon Heyburn. The act is sure to benefit the health of Americans in the present and future.

The Prescription Drug Marketing Act of 1987 was signed into law on April 22nd 1988. The law was made to protect people from the purchasing and consuming tampered products. This includes counterfeit, adulterated, misbranded, or expired drugs. The FDA takes a special point to monitor counterfeit medication. Lately there are many serious counterfeit drugs that have been killing people. One example is that they have been finding many counterfeit drugs that contain fentanyl. Because this is such a potent pain killer people are accidentally overdosing.

This put pressure on congress and finally the Pure Food and Drug Act law was

The Pure Food and Drug Act of 1906 was passed by Congress – along with the Meat Inspection Act – on June 30, 1906, then took effect on January 7, 1907 (Lerner 670). This act prevented manufacturers from selling mislabeled products, contaminated food with unsafe ingredients, and fixes dirty conditions in the food industry that was brought to the attention by journalists and authors (Lerner 670; “Pure Food” 1081). This regulation strongly enforces how food and drug products “were packaged, labeled, sold…in the United States” (“Pure Food”

Standard 1.2.7 became law on 18 January 2013 to regulate nutrient content claims and health claims on food labels and in advertisements. It was introduced to reduce the risk of misleading and deceptive claims about food. Nutrition content claims and health claims are voluntary statements made by food businesses on labels and in advertising about a food. Food businesses must comply with the new standard (Standard 1.2.7) from 18 January 2016. A product must meet certain strict criteria for energy, sugars, sodium and other key nutrients in order to carry a health claim.

M. Markel, author of the article Histories of Product Regulations: Food Standards Under the 1938 Food, Drug, and C. A.: Bread and Jam supports the use of standards for product regulation, shelf-life and food storage expectations. He explains that “By 1957, Standards had been set for many varieties of products, yet in 1954, hearing procedures were modified to waive hearings in undisputed cases. The hearings to set standards best illustrates the new complexities. FDA officials had a saying based on years of regulatory work that anyone with a new food additive of ingredients tried it first in bread.” Although the FDA continues to regulate all food productions, specific food storage methods that provide additional shelf life remain the most