FDA Approvals and Regulations
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People’s health starts with the food they take and drugs they are administered in case of a disease. In this case, the food needs to be protected from poisoning and contamination and drugs from lousy quality. In the wake of the industrial revolution, the production of medicine and food material increased, where firms started producing on a large scale. A lot of inventions come along with increased production like food canning, which increased food stay for a longer period to be shipped or be used in the future. On the other hand, medicines were sold in large quantities to cater for a variety of ailments. Due to this, a new veil existed between consumers and producers where producers branded their products with hyped slogans and artful labels, which made it had to tell genuine food products and medicines/drugs. It is due to this that the American government decided to introduce a new Act to look upon food and drugs. In 1906, America passed its major bill on food and drug, which was the pure Food and Drug Act (Panko). The Act was aimed at enhancing the safety of food and drugs. To strengthen its applicability, the law operates under approvals and regulations. This essay gives various approvals and Regulations of the FDA.
Food and Drug Administration Approvals
Before producers and manufacturers releases drugs or food products in the market, the Food and Drug Administration Agency has to do a scan on them to approve and allow them to be sold in the market. No new food or drug can be allowed to enter into the market without necessary approvals and certification by FDA (Fang et al.). Not all foods and drugs require approval by the FDA. There is a systematic procedure that he manufactures need to follow to get approved by the FDA.
Process of FDA Approval
Approval of drugs and food by the FDA means that the effect of the respective product has been reviewed and proven to pose minimal or zero side effects to the consumers. The approval process of food and drugs is structured in the following format.
Analysis of the target consumers and available satisfaction.
For drugs, the FDA reviews the condition of the patient for which the drug will be used to weigh the benefits of the drug and related risks. If the drug has less risk to the user compared to the benefits, the FDA approves it (Mantus). FDA has less control on food.
Assessing available data about the benefits and risks of people’s health.
The FDA team analysis available data to confirm that the benefits associated with the drug or food products will be beneficial to the customers. This includes performing prior tests, especially for drugs, to test their compatibility with the human body. After confirming that they are functional, the FDA goes to the last step of the approval process.
Strategizing on how to manage risks
The introduction of new drugs and food substances is associated with risks. Therefore, before approval, FDA strategizes on how to manage any risks afterward. Some of these management include labeling using FDA-approved labels, which highlights major benefits and risks of the drug or food substance. From here, the FDA can clearly approve the release of drugs and food to the market for human consumption.
Getting FDA approval largely depends on the type of food a company is marketing in America. Despite being heavily involved in most food and drug products, the FDA does not approve of all products.
FDA Approval of Beverages, Food, and Dietary Supplements
Approval of food, dietary supplements, and beverages are not done by the FDA. No certification is required for the distribution and selling of food in America. Food producing facilities are obliged to register with food facilities, but this doesn’t mean they are approved by FDA (Dodge and Kaufman). However, there are those food products that require direct approval from the FDA. New food additives that introduced in the market require FDA approval. Since FDA is mostly concerned with the testing of the suitability of food and drugs in the market, manufactures of new food additives are required to submit samples to the FDA for testing their safety before being approved.
FDA Drug products Approval
New drug products must undergo FDA approval even if they conform to the Over-the-Counter (OTC) monograph. OTC gives conditions, which the FDA has pre-determined a drug to be safe for use. If a drug conforms to OTC conditions, it can be released to the consumers without FDA approval (Panko). However, if the new drug differs with monograph conditions, it must be approved by FDA before releasing them to the market. To be approved, manufactures must submit extensive lab and animal clinical testing and submit that data to the FDA so that the FDA can approve it.
FDA Approval of Color Additives
All color additives used in drugs, food, medical devices, and cosmetics require FDA approval. Some colors contain high-risk levels that require FDA certification for the individual batch.
Apart from approval, FDA play another essential task in food and drug distribution, which is regulations of these products. For instance, the FDA continuously informs the tobacco industry about regulations, pathways for legal tobacco, and restrictions of promotion and labeling (Fang et al.). FDA also gives guidance on how to use these drugs and food products. The following is among the major regulations that are bounded to the FDA.
Food and Drug Administration Regulations.
FDA develops essential regulations that are based on laws that relate to Food, Drug, and Cosmetic Act (FD&C Act) or other wider laws. FDA gives regulations pertaining to tobacco smoking. To regulate this, FDA passed the Family Smoking Prevention and Tobacco Act that operates under the Food and Drugs Administration Act (FDA Center). The act was passed to control the use of harmful tobacco in public places. FDA regulates the use of premium cigars. FDA also regulates the sale and subsequent distribution of smokeless tobacco and cigarettes. Finally, regulate the advertisement and promotion of food and drug products by ensuring that there are no exaggerations on slogans and labels.
Apart from Approving and regulating food and drugs, the FDA has other responsibilities that are extended beyond US borders. Some of these responsibilities include;
- FDA protects the health of the general public by making sure that manufactured foods are safe sanitized, wholesome, and properly sealed and labeled.
- FDA protects the public from being affected by electronic radiated products.
- FDA has the responsibility to make sure that dietary supplements and cosmetics are safe and clearly labeled.
- FDA plays a huge role in regulating the sale and distribution of tobacco products.
- FDA also has a crucial role in the advancement of public health through stimulating the rate of product innovations.
Since its establishment, the FDA has accounted for major successes since its establishment. Some of the incredible accomplishments for FDA include;
The major accomplishment for FIDA was its undisputed rejection of thalidomide, a drug that was later found to cause major birth defects. The drug was distributed in major parts of Europe as a curb to morning sicknesses for expectant mothers (Dodge and Kaufman). This accomplishment was largely applauded by then-president John. F. Kennedy, citing it as a good move to stop a tragedy that could cause birth deformities in America.
To sum up, individual health is one of the sectors that world governments try to look at and ensure it is at top-notch. Food and drugs are produced to ensure people’s health is in a good state. However, they need correct testing to ensure they are in a good state so that they can be beneficial to the people. To ensure this, Americans enacted the laws and implemented the start of the FDA as the agency to oversee the manufacture and distribution of healthy food and drugs. The agency is involved in approving a number of products. The agency also has a variety of roles and regulations that are all aimed at enhancing the safety of food and drugs for American people at the world at large.
Work cited
Center, FDA. “Development & Approval Process (Drugs).” U.S. Food and Drug Administration, 2019, www.fda.gov/drugs/development-approval-process-drugs.
Dodge, Tonya, and Annette Kaufman. “What Makes Consumers Think Dietary Supplements Are Safe and Effective? The Role of Disclaimers and FDA Approval.” Health Psychology, vol. 26, no. 4, 2016, pp. 513–517, 10.1037/0278-6133.26.4.513. Accessed 2 Sept. 2019.
Fang, Hong, et al. “FDA Drug Labeling: Rich Resources to Facilitate Precision Medicine, Drug Safety, and Regulatory Science.” Drug Discovery Today, vol. 21, no. 10, Oct. 2016, pp. 1566–1570, 10.1016/j.drudis.2016.06.006. Accessed 3 Sept. 2019.
Mantus, David. Fda Regulatory Affairs. Crc Press Inc, 2014.
Panko, Ben. “Where Did the FDA Come From, And What Does It Do?” Smithsonian, Smithsonian.com, 8 Feb. 2017, www.smithsonianmag.com/science-nature/origins-FDA-what-does-it-do-180962054/.