The Food And Drug Administration

- The FDA determined that genetically engineered foods should be regulated the same as regular foods. There are no regulations to date that have been determined that are specific to genetically engineered foods.

Food and drug administration is a department of U.S health and human services. It’s responsibility is to test the safety and efficacy of new drugs entering the market as well as to make sure that these medicines are quickly accessible to people. The Food, Drug, and Cosmetic Act has been passed in 1938 to ensure that foods other than meat, poultry and fish are clinically hygienic and safe to eat. This act also requires that the food should be labelled according to its content. (FDA.org) Drugs and tobacco are also regulated by FDA and in 1996, FDA strictly regulated the use of tobacco products like nicotine, cigarettes and smokeless tobacco, by children and adolescents because of the increase in diseases prevalence and tobacco addiction. Annually 40000 deaths are attributable to its use and most of them are of premature. Therefore the goal of FDA is to stop the tobacco addiction by minors and prevent the deaths and diseases due to nicotine addiction. (FDA vs Brown, n.d) This essay will cover the food and drug administration’s role in under and over regulating drugs and medicines and how it effects our economy, health care system and patients health and safety.

Whether or not to require labeling of GM foods is a major issue in the persistent debate over the risks and benefits of foods crops that are produced using biotechnology. Bills requiring compulsory labeling have been introduced and proposed in different levels, but not evenly implemented. Some of the common genetically engineered crops include soya beans, canola, corn and cotton. The US Food and Drug Administration policy on the labeling of GM food requires labeling is the food has significantly distinct nutritional property (US FDA par 2). Further, labeling is required if the GM food product includes an allergen that consumers may not expect to find in such a product, or if the product contains a toxicant that is beyond acceptable limits (US FDA par 3).

After conducting some research I found that “The United States does not have any federal legislation that is specific to genetically modified organisms (GMOs)” . Along with this I discovered that, “The US approach to regulating GMOs is premised on the assumption that regulation should focus on the nature of the products, rather than the process in which they were produced” . I found this to be alarming. After finding this information I decided to investigate further, specifically, into the regulation of genetically modified foods. All things related to food must go through the Food and Dug Administration (FDA). Essentially the FDA regulates if foods are safe or not for a consumer. After searching high and low for any information regarding the FDA regulations for genetically modified foods, I found nothing. I found no information about what is allowed and what is not with genetically modified foods and nothing about labeling genetically modified foods, besides when allergens are present in a food. The only information I found was that “The FDA encourages developers of new plant varieties intended for food use, including GMOs, to engage in a consultation procedure with the FDA, in order ‘to ensure that human food and animal feed safety issues or other regulatory issues (e.g. labeling) are resolved prior to commercial

GM plants that are destined to be eaten are checked for possible dangers, and the results are evaluated by multiple agencies. The three main agencies involved in regulating GMOs are the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA) (Library of Congress, 2015). The FDA regulates GMOs in conjunction with the US Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). The USDA’s Animal and Plant Health Inspection Service is responsible for protecting agriculture from pests and disease, including making sure that all new genetically engineered plant varieties

Individuals with severe allergies need to be informed if the genetically modified food appears to be something they can eat without going into anaphylactic shock, is actually injected with a gene that can cause them an allergic reaction or death (GEF). This alone demonstrates a need for further testing requirements and labeling laws. The fact that labeling is not required on these products seems inhumane, as consumers have a right to know all ingredients in the food they are purchasing. If processed foods require labeling, then GMOs should be required to label as well. This puts a sense of suspicion and doubt over the GMO products, because if the safety is not compromised.

The Food and Drug Administration, Environmental Protection Agency, and the US Department of Agriculture's Animal and Plant Health Inspection Services are all different entry points for the approval of GM crops or GMOs. The EPA largely deals with the regulation of bio-pesticides. For the EPA approval of a GM crop, there must be sufficient proof from the developer that the crop is environmentally safe and the protein does not cause food allergy. The FDA regulates the safety of GMOs consumed by humans and animals. A 1992 policy by the FDA established that most GM crops are "Substantially equivalent" to non-GM crops. This means that crops that are "Generally Recognized as Safe" do not require approval before being sold at market. APHIS regulates GM crops under a permit of notification

The first position of the federal government on GM crops, is the department of the EPA, FDA, USDA biochemist scientists to experiment and record GMO foods are safe for the consumer to eat without any severe risk. The government department American Association for the Advancement of Science (AAAS) approves that consuming foods from modified genetic ingredients obtained from GM crops pose no greater danger than consuming from Non-GMO foods. Therefore, the different characteristic of GM foods was altered will stay fresh for an extended amount of time, significantly delaying its expiration, for a longer period of freshens in the local grocery store. The FDA has approved that GMO is safe to consume, and there is no need to test or labeling supplements containing material made from genetically modified organisms. However, the federal government departments of the EPA, USDA, FDA does not inform the customer of the harmful ingredient injected into a seed that may cause unfavorable proteins. (Food and Drug Administration. 2013). Secondly, the government agencies and biotech company are keeping the public in the dark about the hazardous proteins in GMO foods. The federal government has assigned specific departments to safeguard the public, from the dangerous ingredients that generated from GM crops. Even though, the public is unaware about how the biotech industries have concealed the adverse results from the pubic though threatening genetic

There are no conclusive evidence that Genetically Modified Organisms are harmful or have done harm to humans. There is no proof of Genetically Modified Organisms causing allergies in humans. The safety of Genetically Modified Organisms are not fully determined, more study is needed to be positive. The FDA does not get all data to perform a very safe review. Plenty of scientists feel that Genetically Modified Organisms safety has not yet been established. An ominous sign is that in Washington State University found out that weeds are developing resistance is at an all time high up by twenty five percent,with increasing weed killer usage water can become contaminated. Genetically Modified Organisms have to be marked in 64 countries not including the US (Harrar).

People all over the world have a right to know what they are purchasing and consuming. The US government thinks otherwise. There have been no conclusive studies that show that genetically modified foods are safe to consume. The US Food and Drug Administration does not think it’s necessary to require safety studies for genetically engineered foods. The article “About GE Food Labeling”,

Genetic modified organisms (GMO) have been around for years this method is used to supply more food. Farmers have adapted the method of GM technology to increase the production. The regulation of genetic engineering concerns the approaches taken by the government’s access to manage the risks that such organisms can have on a person’s health. Many may concern about their health and the increasing usage of additives in their food. The federal government should make the Food and Drug Administration (FDA) label GM food so that the consumers can be aware of what they are consuming.

GMOs are not properly regulated in terms of safety measures as it pertains to food. As it pertains to risks to human health, concerns continue to mount regarding US governmental agencies due diligence in safety analysis of GMOs. For example, the FDA’s policy has been minimal based on their reliance of GMO producers

“Genetically modified organisms”, or more commonly known as GMOs, are “organisms that have been created through application of transgenic, gene-splicing techniques that are part of biotechnology.” (www.justlabelit.org/). GMOs entered the market about twenty years ago, and people are still in the dark about if the food we feed our families contain GMOs. “In 1992 the FDA’s policy statement defined “material” as the ability to be sensed by taste, smell, or other senses.” (www.justlabelit.org/) According to the FDA genetically modified foods are “substantially equivalent” to conventionally produced foods. So, because the FDA deemed them the same, no labeling was required. Twenty years later, the policy remains unchanged. Agriculture

     Critics believe that using biotechnology in agriculture will pose human health and safety risks such as allergic reactions and biological contamination. This is a reasonable concern, but it isn't likely to happen. Several agencies have developed laws and regulations to ensure that genetically altered foods are safe. The Federal Food and Drug Administration (FDA) has developed strict regulatory requirements to make sure genetically engineered foods are safe. Genetically altered foods will be judged based on their individual safety, allergenicity, toxicity, etc. Under the Drug and Cosmetic Act, the FDA has control over genetically altered products and drugs for humans and animals. Before a new genetically altered food can be accepted, companies must follow a set of seven questions developed by the FDA. To name a few, companies have to ask, "Does the genetically-modified plant have a history of safe

Are Genetically Engineered Foods (GM foods) harmful? Can we trust the Food and Drug Administration (FDA) to make a safe call on rather these foods should be offered to the general public? Should a consumer be knowledgeable of their purchase? I believe so. In my opinion, we have a right to know what we are putting into our bodies. Genetically Engineered Foods should be labeled considering the potential risk to the consumer, the risk to our wild life, and the permanent affects that are sure to follow the development of future generations. GM foods have actually been around quite a long time. The history can be traced back to the 19th century when Gregor Mendel - an Austrian monk and botanist, carried out an experiment wherein he crossbred tall pea species with short pea species to show that certain traits in one species were inherited by other in this process (Nodoushani, Sintay, and Stewart 136). Therefore, the evolution of GM foods was bound to happen; we just need to determine if it is really worth the potential harm it could cause.