Many people have heard of this great institution, but just between you and me FDA what is it? How does it work? What are its responsibilities for the United States and the world? These and other questions will be answered in this publication. Follow along now.
FDA what is it?
The giant former USFDA (as it is also known) is an institution, an agency belonging to the American government.
It is part of the US Department of Health and Human Services. This, the HHS, is only one of the federal executive departments in the US.
The role of the Food and Drug Administration (FDA) is broad and encompassing, and its relationship with other federal institutions is very close and necessary to its work.
In general, the FDA aims to protect public health by working (primarily) on food. More about this will follow.
There is also another department, which is the Department of Agriculture, and it regulates the guidelines on beef, some egg products and also poultry. This responsibility, therefore, does not lie with the FDA.
The FDA has grown and had so much global prestige that it has sent employees to various countries, such as the United Kingdom, Chile, China, India and others. This started in 2008.
What is the function and mission of the FDA?
One of the major efforts of the FDA agency is to ensure that products (food or otherwise) are properly labeled and safe, as well as healthy and compliant with health regulations.
Things like blood transfusions, vaccines, and biopharmaceuticals also come under the regulation of the institution.
In addition, the FDA also acts on issues related to the radiation of electronic products, medical devices, biochemical products, as well as drugs for animals and humans, seeking maximum effectiveness and safety for the population.
Dermocosmetic products, as well as some supplements (dietetics, for example), products made of or derived from tobacco are also “jurisdictions” of the FDA.
It handles regulations for labeling, manufacturing, marketing, and distribution. It also spearheads various related research and innovation.
If you want to do business in the USA, be aware of the regulations if your product is one of the types listed above.
Some other functions of FDA
Few people know, but the FDA was authorized by the US Congress to enforce the “Federal Food, Drug, and Cosmetic Act”, which is a set of laws passed by Congress in 1938.
Since the authorization, the FDA has the authority to oversee and regulate various other issues, and today this is the main focus for the institution.
There are also other laws that are enforced by the FDA, such as Section 361 of the Public Health Service Act and associated regulations, for example.
Many of these services are not linked to drug or food related issues, as everyone hitches to the FDA. These include:
- cell phones,
- disease control in products ranging from certain household pets to sperm donation for assisted reproduction,
- regulation of lasers, among others.
Products that are imported to be sold on the market in the United States also go to the FDA for technical and thorough analysis.
Only after approval can these products be legally marketed in the country.
FDA and its importance in food issues
The area of food is a critical point in any nation, and there is a controversy over whether or not the FDA gives approval (or not) in the form of a seal of approval for food and beverages.
The truth is that there is no such seal of approval for this category.
The FDA has a standardized process by which any company that wants to sell products in this area in the USA must register with the FDA.
This registration does not mean approval of anything, it only demonstrates the willingness of a business to sell its product items within the country.
It happens that many products have substances that are prohibited in the United States, and therefore their permission to sell is denied.
In other cases, there are new substances in the product, making FDA approval necessary (the institution needs to guarantee that it is safe and does not harm people).
Usually the FDA charges the company that wants to bring in its product with all the information and conditions for the necessary testing.
This causes many companies to stop trying to do business in the USA, due to the cost of these processes, the need for registration, and the rigidity of the FDA regulatory agency.
Still on this “FDA approved” issue
Not all products are eligible for FDA approval (or non-approval) for marketing.
It turns out that some companies maliciously tend to use the term “FDA approved” as a way to endorse their own product.
But you need to understand that not all products go through this process.
Yet even in cases where FDA approval is not required before the product goes to market, the FDA still has regulatory authority to take action if public safety issues arise with that product.
In many cases, the FDA’s focus is on putting effort into products when they are already on the market (for sale).
And another important thing to know is that the authority that determines these issues is the Congress, through the approvals given to the FDA.
According to their own website:
“FDA also plays a significant role in the Nation’s counterterrorism capabilities. FDA fulfills this responsibility by ensuring the safety of the food supply and promoting the development of medical products to respond to deliberate and naturally emerging threats to public health.”
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