United States Food & Drug Administration: Overview, Structure, and Importance

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United States Food & Drug Administration
The United States Food and Drug Administration is considered to be a federal agency in
the Department of Health and Human Services in the United States. It is mainly tasked with
the protection of public health through the supervision and control of food safety, dietary
supplements, tobacco products, over the counter and subscription drugs as well as medical
devices and blood transfusion, (Olutoye 99). For it to be effective and independent, it was
empowered by the American Congress so that it can enforce Drug, Federal Food, and
Cosmetic Act.
1. Foreword of the US Food and Drug Administration
i) Mission Statement
The agency aims at protecting consumers as well as enhancing the entire public health
system through the maximization of products that are regulated by FDA as well as r3educing
risks that may be or are associated with the products.
ii) Vision
The Food and Drug Administration ensures that all food in America is safe and all
medical products administered are effective and safe for consumption. As a result, the entire
public health system is protected and advanced, (Singh 06).

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2. Delegation authority
The authority provides for the delegation of power and authority. This is guided by the
Staff Manual Guide 1401.1 which came into effect in 2011. In addition, a delegation of
authority is provided by the FDA staff manual guide volume 2. Its purpose is the setting out
of procedures relating to the delegation, (Welch, John and Sandra). As a result of the
delegation, legal importance is realized with particular attention being directed on how the
agency operates. The Food and Drugs Administration officers are given the opportunity to
convey authority to members of the subordinate staff so that activities are carried according
to law. On the other hand, officers how to go against the law are held accountable for their
actions.
Secretaries have certain authorities which include making and issuance of reports to the
Congress and the President. Secondly, they approve and issue various regulations. Lastly,
secretaries establish committees and advisory councils as well as appointing their members
too. Commissioners also have authorities. A secretary to the Agency as well as an official
from the Administrative program gives Commissioners authority. Re-delegation of these
powers is restricted by law. In re-delegation, the Secretary empowers the Commissioner with
authority to perform duties such as described under the Drug, Federal Food and Cosmetic Act
21, International Cooperation section 307 and authorization of individuals undertaking
research. Other activities include the recording and reporting of essential information.
Providing mandates that relate to safer vaccines, manufacturers recordkeeping as well as
reporting and review warnings, precautionary information and user instructions. During the
delegation of authority, power is transferred from one person to the other and as such, duties
and responsibilities that have been delegated must be done accordingly and lawfully. In that

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regard, liability falls on the individual when he or she goes against certain laws and
procedures governing the authority bestowed upon him or her.
3. History of the Food and Drug Administration
The Food and Drug Administration began its journey in 1906 under the establishment
of the first food and drug safety bill called the 1906 Pure Food and Drug Act. This was done
so that food could be regulated in the country. During the Industrial Revolution, medical and
food production was on the rise hence the need for a law that could regulate the sector.
Medicines and medical equipment being invented needed regulation and patenting hence the
establishment of this body. Harvey Wiley is known to be one of the first advocates for
regulation of foods and drugs. By uncovering harsh work conditions and poor production
conditions of food in many industries across eh United States, the Pure Food and Drug Bill
was signed into law in 1906. Being called the Willey Act, amendments were made to it and
this was later transformed into the Food and Drug Administration as it is called today.
4. The organizational structure of FDA
The organization is made up of an office of the Commissioner as well as other four
directorates, the directorates oversee the core functions allocated to the agency which include
overseeing medical productions, tobacco, Global Regulatory Operations and Policy, Foods as
well as Operations, (Olorunfemi 2491).
5. Personnel statistics (number of people employed, positions included)
In the Agency, there are 1, 082 employees under the Centre for Food and Applied
Nutrition, 3, 603 in Drug Evaluation and Research, the Centre for Biologics Evaluation and
Research has 1, 074 whereas the Office of Regulatory Affairs has 5, 068 employees.