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Food, Drug, and Cosmetic Act


The Food, Drug, and Cosmetic (FD&C) Act is a federal regulation policy that aims at ensuring the efficiency and safety of food, drugs, and cosmetics by providing good quality, safety, and labelling authorization protocols associated with the various implementation directives. The process aims to eliminate potential misuse cases that might cause substantial health complications due to increased awareness and care in their utilization. Moreover, it helps limit the manufacturing of low-quality products that might need to be more effective and secure for consumption among individuals. The regulation was approved in 1938, before which substantial accidents involved the need for more informational awareness and quality adherence. The policy provides the guidelines for all new entries in the market under the three categories to undergo an approval process before market availability, allowing the Food and Drugs Administration (FDA) to authorize their safety and public use. The Act holds individuals or organizations who might be responsible for making false advertisements, providing them with an opportunity to face legal repercussions.

The Act has undergone various amendment processes to identify its maximum efficiency in preventing healthcare cases associated with the product’s safety, raising the need for its application within multiple settings. It examines its impact on operational environments while defining the various elements under its directives, making it easy for people to assert a practical understanding. The Act applies to different clinical practices in multiple ways. For example, it aids in ensuring that there is proper evaluation of manufactured drugs before subjecting them to human consumption; thus, allowing professionals to conduct experiments to deduce their safety. Moreover, it focuses on promoting the quality of the products and raising standards in their products that can positively impact clinical operations. The Act also highlights any inefficiency involved with the products, prompting the need and identification of corrective areas to improve their competence, thus, maintaining people’s protection. The assessment examines the FD&C Act and provides a compelling analysis while deducing the various clinical application procedures to understand its role in enhancing healthcare standards.

Analysis and Evaluation

FD&C Act incorporates regulatory guidelines to assess various foods, medical drugs, and cosmetics before entering the market by ensuring they acquire specific standards that are safe and effective for individuals’ consumption. The policy aims at establishing a partnership with the FDA guidelines eliminating cases of sub-quality products venturing into the market and certifying them as proper for use among individuals. Before the FD&C Act, minimal assessment processes were involved with the products, with substantial effects associated with contamination. For example, there was a considerable poisoning incident within the country involving unprocessed antibiotics containing the deadly diethylene glycol, resulting in significant health impacts and deaths of more than 100 individuals in different states (Lam & Patel, 2022). Such effects raised the implementation of protective measures among national officials, raising the need to devise ways to enhance the products and acquire specific operational standards that are safe for human use.

FD&C Act highlights the need to instill guidelines in specific products since the lack of proper authorization contributes to people taking advantage of the freedom and processing sub-quality products. The industry involved in the goods within different states is substantial, with a significant demand, which may foster various manufacturers to overlook various protocols while operating on a profit-minded regime. Therefore, President Roosevelt’s introduction of the Act served as a national awareness of the extent the lack of proper control could have on people’s well-being, creating a substantial milestone in enhancing citizens’ protection (Lam & Patel, 2022). Moreover, the movement formed the basis of introducing changes focused on ensuring healthcare protection among citizens, which in some cases, may be without their knowledge. For example, it is challenging for individuals to differentiate products that have attained the quality consumption standards and counterfeit or ineffective, raising the need to acquire protection support from the administration.

The primary concern in establishing FD&C Act was the level of foods, medical tools and drugs, and cosmetics that was below par and available for purchase in various markets. Therefore, the administration’s main aim was to ensure a thorough evaluation process to ensure optimum quality levels, eliminating healthcare insecurity involved in their purchase and consumption. Another critical trigger in creating the policy was the lack of proper product identification and differentiation. The Act aimed at ensuring clear labels would allow people with minimal healthcare awareness to differentiate the products; thus, in the case of prescriptions, it would be easy to self-administer (U.S.F.D., 2018). The lack of knowledge can be detrimental, especially in cases of medicine, due to adverse side effects, which can be life-threatening. The administration understood the need to eliminate instances of undertaking false drugs, sub-quality foods, and ineffective cosmetics, prompting it to enact the bill and enhance citizens’ protection.

Drug manufacturers can often take advantage of their operating guidelines to produce drugs that fail to meet set standards for various reasons, such as lack of enough resources or operating on a profit-oriented strategy. Close monitoring is crucial in understanding the procedures involved in the process and ensuring they are of high quality, which aids in eliminating safety concerns in use when dealing with various healthcare challenges (Quinn et al., 2020). The policy demonstrates efficiency in such aspects, acting as a consumer protective module, legitimizing its development and application as a federal law. In some cases, various manufacturing institutions involved in foods, drugs, and cosmetics may implement illegal operational procedures; thus, the monitoring process aids in eliminating such probabilities since they would negatively impact residents’ health conditions.

FD&C Act is a crucial policy within the various states as it ensures the regulation of multiple products, such as drugs, limiting their incorporation into the market and eliminating chances of ineffective products. Drugs are highly demanded and abused among individuals. Thus, the lack of control provides opportunities for inefficient utilization that can negatively impact health standards. On the other hand, the Act maintains organizations giving adequate information, such as nutritional data, that can be crucial in purchasing decisions among people (Lam & Patel, 2022). Moreover, it ensures that the packaging is per the guidelines, allowing people to make accurate projections in their choices and eliminating cases of misuse. A thorough health evaluation contributes to the policy’s effectiveness in protecting individuals, demonstrating the reasons for establishing the regulative guidelines.

Application into Clinical Practice

FD&C Act is a policy that can substantially impact clinical procedures as practitioners devise ways of enhancing healthcare outcomes among patients. One way in which its application to clinical practice is it contributes to eliminating the selling of misbranded or unlabeled drugs, which can have substantial health effects. Misbranded drugs also contribute to illegal actions, such as pharmaceutical fraud, aiming to maximize income by deceiving patients requiring various prescriptions (Timofeyev et al., 2022). Drug users are often unaware of the components involved in multiple medications; thus, they are unlikely to protect themselves from the wrong medication due to information misguidance. The Act ascertains that indulging in such measures would be a criminal offence, enhancing community protection and presenting safe healthcare environments.

The policy also enhances the production of quality medicine that can help eliminate healthcare issues and health concerns involving producing low-quality drugs. Prior to the procedure, there were minimal assessment criteria to ensure the drugs met the required standards to assert the intended impact among patients. In order to acquire authorization, there are critical protocols involved to ascertain the standards, eliminating any room for incompetency among the manufacturers. The regulations have enhanced using evidence-based modules in improving drugs’ efficiency. Using evidence-based medicine aids in ensuring all the components are government-mandated and lower the risk of acquiring potential side effects, highlighting proper application protocols (Seppi et al., 2019). The Act maintains top-quality in medicine and medical tools manufacturing, presenting practitioners with the ability to effectively cater to patients experiencing various complications.

Moreover, the Act contributes to enhancing drug safety and effectiveness. The lack of proper evaluations may contribute to practitioners employing drugs that offer minimal impact on health standards among patients. Efficient medication establishes a positive response from the body, demonstrating reliability in handling the existing healthcare complication upon intake while illustrating positive effects upon after-drug monitoring (Fozoonmayeh et al., 2020). Drug purification is crucial in enhancing patient safety since other elements might cause adverse responses among individuals, such as body defects. The Act ensures that the producers undertake all the necessary steps to provide medication per the set standards. Therefore, the Act provided the basis for reforms focused on ensuring healthcare progress by providing applicable drugs in clinical practices.

FD&C Act forms the basis of guiding and regulating the entry of new drugs into the market. The modules help manage the pharmaceutical environment by ensuring the operations meet the regulatory requirements. In the case of manufacturers intending to utilize their resources in making the medication, they go through the approval strategies, which examine the benefits and risks associated with their use, helping assert a positive impact on healthcare operations (Lam & Patel, 2022). Developing drugs for new healthcare challenges becomes easy by using legal and ethical guidelines while focusing on efficiency and quality.


FD&C Act is a federal reform that aims at regulating the production and provision of foods, drugs, and cosmetics among individuals for use. The policy seeks to assert safety, efficiency, and quality to ensure positive influence in clinical operations. Since its development, the policy’s various amendments have enhanced its positive impact on care operations, raising operational standards among manufacturers and maintaining healthcare progress. Incorporating the guidelines played a crucial role in asserting healthcare reforms, eliminating previous issues associated with unawareness, such as lack of labelling. FD&C Act has made a substantial impact on clinic operations through various measures. For example, it contributes to eliminating misbranding and mislabeling issues associated with poor medical utilization.

Moreover, it contributes to eliminating the provision of low-quality drugs by incorporating a critical evaluation process, ensuring they meet the various specifications. The policy ensures drug safety and efficiency, allowing them to assert positive impacts in clinical operations. FD&C Act is critical in limiting the entry of new drugs into the market and ensuring the incorporation of top-quality tools that will enhance healthcare progress within settings. Therefore, establishing FD&C Act as a federal policy has provided an opportunity to improve the safety and quality standards of foods, drugs, and cosmetics by implementing an authorization process that ensures the protection of citizens’ health.


Fozoonmayeh, D., Le, H. V., Wittfoth, E., Geng, C., Ha, N., Wang, J., … & Woodbridge, D. M. K. (2020). A scalable smartwatch-based medication intake detection system using distributed machine learning. Journal of medical systems44, 1-14.

Lam & Patel. (2022, August 4). Food, drug, and cosmetic act – StatPearls – NCBI bookshelf. National Center for Biotechnology Information.

Quinn, S. C., Jamison, A. M., & Freimuth, V. (2020). Communicating effectively about emergency use authorization and vaccines in the COVID-19 pandemic. American Journal of Public Health111(3), 355-358.

Seppi, K., Ray Chaudhuri, K., Coelho, M., Fox, S. H., Katzenschlager, R., Perez Lloret, S., … & Djamshidian‐Tehrani, A. (2019). Update on treatments for nonmotor symptoms of Parkinson’s disease—an evidence‐based medicine review. Movement Disorders34(2), 180-198.

Timofeyev, Y., Hayes, S. A., & Jakovljevic, M. B. (2022). Predictors of loss due to pharmaceutical fraud: evidence from the US. Cost Effectiveness and Resource Allocation20(1), 6.

U.S.F.D. (2018, November 27). Part II: 1938, food, drug, cosmetic act. U.S. Food and Drug Administration.


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