US FDA Roles, Responsibilities and Guidance

Running head: US FDA ROLES, RESPONSIBILITIES AND GUIDANCE
US FDA, ROLES, RESPONSIBILIES AND GUIDANCE
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1US FDA ROLES, RESPONSIBILITES AND GUIDANCE
Roles and Responsibilities
The Food and Drug Administration (FDA) of the United States, is an organization of the
government which plays a key role in the regulation of food and associated products like drugs,
nutritional supplements, and cosmetics, equipment used for medical equipment, biological items
and blood based products. The primary responsibility of the FDA is to ensure that the health of
the public is protected by conducting regulatory practices which ensure that drugs, for human
and veterinary purposes, along with medical equipment and biological items are safe, efficient
and secure (Zhou et al. 2018). An additional responsibility of the UD FDA is to ensure that the
nation is adequately supplied with essential food products, radiation producing items and
cosmetics, which are safe for usage and consumption by the citizens. In addition to the above,
the responsibility of the FDA is also associated with the regulation of the processes of
manufacture, marketing and distribution of tobacco and products containing tobacco along with
ensuring reductions in the usage of the same in the nation, especially among minor populations
(Downing et al. 2017). The FDA also has a salient responsibility in ensuring that optimum
standards of public health are met by regulating, guiding and establishing directives for
healthcare organizations to engage in manufacturing of healthcare products which are innovative,
efficient, safe and affordable. The FDA also engages in the provision of evidence based, high
quality scientific information to the public in the form of instructions for purchasing medicinal
items aimed at improvement and maintenance of public health. Lastly, the FDA is also
responsible for ensuring that the public is protected from threats to healthcare and safety,
especially in the face of crisis, by ensuring that adequate rates food supply in the nation are

2US FDA ROLES, RESPONSIBILITES AND GUIDANCE
maintained and that by ensuring the manufacturing of products which can protect the public from
harmful diseases (U.S. Food and Drug Administration 2019).
Code of Federal Regulations
The Code of Federal Regulations (CFR) comprise of a set of codes applied to rules and
regulations which are permanent as well as general, and are established by the United States
federal government’s executive agencies and departments, and is also known as the
administrative law. CFRs are categorized into a total of 50 titles – each of them representing a
subject or area of study regulated by the federal law (Naci, Smalley and Kesselheim 2017). Of
the 50 titles of CFR, Title 21 is the CFR which is responsible for the governance of drugs and
food products circulating within the United States, for associated organizations such as the
Office of National Drug Control Policy (ONDCP), the Drug Enforcement Administration (DEA)
and the Food and Drug Administration (FDA). The title is divided into three chapters, the first
chapter is associated with the FDA, the second chapter is associated with the DEA and the third
chapter is associated with the ONDCP (Ghazala 2016). The first chapter associated with the
FDA is based primarily on the Federal Food, Drug and Cosmetic Act and deals with regulation
of human participants within clinical trials and quality practices to be conducted in the
laboratory. The series of 100 is primarily concerned with food products such as regulation of
labelling of nutrition facts in food products, dietary supplements, trans fats, minerals and
vitamins. The series of 200 and 300 deal with pharmaceuticals especially marketing and
advertising and requirements of novel and over the counter drugs (Ma, Marinovic and Karaca-
Mandic 2015).