What is FDA registration (Food and Drug Administration)
FDA registration (Food and Drug Administration) is responsible for the safety of the food, medical products, and devices for humans and animals. It is under the US department of health and human services. Among the things that are regulated by the FDA includes; food safety, tobacco products, medications, vaccines, blood transfusions, dietary supplements, medical devices, electromagnetic radiation emitting devices, veterinary products, and cosmetics.
Registration of food
The most of the US food supply is being monitored by the FDA. It is the responsibility of the FDA to protect the health of the public by ensuring the safety of the food supply. Apart from food, FDA also regulates food additives, dietary supplements, and added substances. It oversees whether food is hygienic, properly labeled, safe and wholesome for human consumption. FDA regulates all types of food except meat, poultry, and eggs which are regulated by the US Department of agriculture. All imported food to the United States is also subjected to FDA regulation. Their labels must be truthful and stated in English. FDA should also be given prior notice before shipping imported food.
Registration of food facilities
If someone wants to start a food establishment, one has to fulfill many requirements. All the facilities that are involved in the manufacturing, processing, packaging and holding food for human or animal consumption are required to be registered in the FDA (Food and Drug Administration). Some of the special regulatory requirements may be needed in some of the food items such as seafood, juice or low acid canned food. It is recommended to discuss the specific food products with the FDA district office and state and local regulatory bodies in order to identify the regulations regarding the food before applying for registration. If the food establishment is only catering to the local area (home based business) and not importing food across the states, it may not need registration. But if it sells products online and shipping products across states, it needs FDA registration.
Dietary supplements are regulated according to the Dietary Supplement Health and Education Act of 1994. Although FDA regulates both supplements and their ingredients, the manufacturers and distributors are not required to obtain prior approval from the FDA before marketing these products. However, the firm that markets these products are responsible for its safety and they may be liable if any claims were made against the product by a consumer.
Registration of drugs
All the drugs including over the counter, generic drugs, and prescription drugs are regulated by the Centre for Drug Evaluation and Research (CDER) of FDA (Food and Drug Administration). Kinds of toothpaste, antiperspirants, and dandruff shampoos are also regarded as drugs and included in this section. The registration of these different types of drugs is different. The following section gives an overview of how they are being registered through different pathways.
New prescription drugs
The new drugs must be tested thoroughly before applying for FDA registration (Food and Drug Administration) use laboratory, animal, and human models. A new drug is something made by a different manufacturer, uses different ingredients or if used for a different purpose. If the drug is a completely new one, the molecular basis of the drug also has to be established. Its efficacy and safety must be clearly defined for the disease that the drug is aimed to treat. The new drug is accepted through an application called New Drug Application or a Biologics License Application if the drug is made of biologic materials. The application usually includes the test results of the drug, manufacturing information and the proposed label including possible risks and how to use it. A drug is approved if it is effective and safe when used as instructed. However, there are some exceptions to this procedure if the condition that is being treated has no other effective treatments. This is seen in rare diseases when clinical trials take more time.
Generic drugs are the approved brand-name drugs’ chemical equivalents. Because the brand name drugs have already shown the safety and effectiveness, generic drugs do not have to be tested for their effectiveness and safety. But the generic drug should be the same as an already approved drug. These generic drugs are approved under the ANDA (Abbreviated New Drug Application).
Over the counter drugs
These drugs can be purchased by a person without a prescription. They have been found to be safe and appropriate to be taken without a doctor’s supervision. These drugs can be legally marketed without FDA application following OTC drug monograph which contains the ingredients and formulations that should be included in the drug.