Food and Drug Administration (FDA - Food and Drug Administration) is a subsidiary of the Ministry of Health in the United States (USA). The FDA is the oldest and most comprehensive comprehensive consumer protection agency in the U.S. federal government. Since 1848, the federal government has used chemical analyzes to monitor the safety of agricultural products, and these studies were left to the Ministry of Agriculture in 1862 and later to the FDA.
While it is not known by its current name until 1930, the FDA´s modern regulatory functions began with the Pure Food and Drugs Act, which came into force in 1906. The FDA has been the driving force behind this law and has pioneered its implementation in the early years, providing essential protection elements that consumers have never known before. Since then, the FDA has changed and evolved through social, economic, political and legal changes in the U.S. Today its impact has spread to the US borders and has become a company that is followed, adopted and referred to its publications worldwide.
FDA Working Areas
The FDA is responsible for protecting public health by ensuring the safety, effectiveness and safety of human and veterinary medicines, biological products and medical devices. It works to ensure the safety of food, cosmetics and radiation emitting products. The FDA also works to regulate the production, marketing and distribution of tobacco products to protect public health and to reduce the use of tobacco, especially for young people.
Improving public health is among the core tasks of the FDA by helping to speed up innovations that make medical products more effective, safer and more affordable. In doing so, it aims to use medical products and foods to help the community apply accurate and scientific information, and to protect and improve their health. The FDA also plays an important role in anti-terrorism efforts. It fulfills this responsibility by ensuring the security of the food supply and by promoting the development of medicinal products to respond to deliberate and naturally emerging public health threats.
FDA Regulations and Scope
The FDA is one of the largest authorities in the food and pharmaceutical industry, not only in the US, but all over the world. His studies, research results, standards and regulations are accepted as reference all over the world. In this context, we can say that the scope of the subjects he is an authority is very wide. The FDA´s responsibilities are closely related to that of many other government agencies. Below is a list of traditionally recognized product categories that fall under the regulatory authority of the FDA:
o Other food products (Although the US Department of Agriculture plays a leading role in the regulation of some meat, poultry and egg products, the FDA is also working on these products.)
o Prescription drugs
• Biological products
Blood and blood products
o Tissue and tissue products
Vaccines for humans
Cellular and gene therapy products
• Medical devices
Simple essential products such as tongue forceps and potty
o Complex technology products such as pacemakers
Surgical implant and prosthesis
• Radiation-emitting electronic products
Ultrasonic therapy equipment
Mercury vapor lamps
• Makeup supplies
Color additives in make-up and other personal care products
Skin moisturizers and cleansers
Perfumes and nail polishes
• Veterinary Products
o Animal feeds
o Veterinary drugs and devices
• Tobacco products
Smokeless tobacco products
FDA Certificate and Registration Consultancy
The sale of the above-mentioned products in the USA requires certain procedures to be followed. Production, packaging, storage, transportation etc. of these products. Institutions working in the processes must be FDA registered. Likewise, products shipped to the U.S. must have an FDA registration. Therefore, companies exporting the above-mentioned products or product groups to the USA are required to register and obtain an FDA Certificate.
FDA registration is a difficult and lengthy process. Because for these transactions, it is necessary to negotiate and negotiate with representative companies in the USA. Therefore, it is beneficial for companies that want to get FDA Certificate to work with a consultancy firm for these studies. At this point, Aşan Danışmanlık provides you with all kinds of support for fast and accurate tracking and completion of FDA processes. You can get training and consultancy from Asan Consultancy for mandatory and complex procedures that must be followed when exporting food and pharmaceutical products to the USA. With Aşan Danışmanlık, who has knowledge and experience about FDA processes, your registration and document procedures can be completed in the shortest time possible.