Food and Drug Administration

The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency/office in the U.S. federal government. Since 1848, the U.S. government has used chemical analysis to monitor the safety of agricultural products. Initially taken over by the U.S. Department of Agriculture in 1862, this responsibility was later assumed by the FDA. The modern regulatory functions of the FDA, unknown by its current name until 1930, began with the passage of the 1906 Pure Food and Drug Act, prohibiting interstate commerce of adulterated/naturally altered and misbranded foods and drugs. The FDA pioneered the enforcement of this law, providing consumers with fundamental protection elements previously unknown. Since then, the FDA has undergone changes alongside social, economic, political, and legal developments in the U.S. Understanding the history of these changes illuminates the importance of the FDA’s role in preserving public health and the emergence of current regulatory laws/rules.

The FDA is responsible for ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices. Additionally, it safeguards public health by regulating the safety of the U.S. food supply, cosmetic products, and products emitting radiation. Furthermore, the FDA is responsible for regulating the production, marketing, and distribution of tobacco products to protect public health and reduce tobacco use among young people. The products regulated by the FDA include food products, drugs, medical devices, radiation-emitting products, vaccines, blood and blood products, biologics, products related to animals (including animal feed), veterinary products, cosmetic products, and tobacco products. In this article, we will explore frequently asked questions about the FDA under the following headings.

FDA Product Approval and FDA Certificate: What Are They?

The regulatory approaches for marketing approval of products regulated by the FDA are as diverse as the products themselves. The differences are determined by laws enacted by the FDA and the relative risks posed by the products to consumers. Some products, such as new drugs and complex medical devices, must demonstrate their safety and effectiveness before being marketed by companies. Additionally, the FDA must approve new food additives before they are used in foods. Performance standards for other products, like X-ray machines and microwave ovens, must be measured. Certain products, like cosmetics and dietary supplements, can often be marketed without prior approval. At the heart of the FDA’s medical product evaluation decisions lies the judgment of whether the benefits of a new product outweigh its risks to users. No regulated (scrutinized) product is entirely risk-free, making these decisions crucial. When a product’s potential benefit is substantial, especially for products used to treat serious, life-threatening conditions, the FDA may allow its marketing despite the associated risks. The FDA reviews/approves products by evaluating laboratory tests conducted by companies, as well as the results of animal and human clinical trials. It’s essential to note that the FDA does not develop or test products itself.

Pre-market reviews by the FDA are conducted for new drugs and biologics (such as vaccines, blood products, and biotechnology products), complex medical devices, food and color additives, certain infant foods, and animal drugs. In recent years, the FDA has facilitated the review process for medical products to accelerate the introduction of important new treatments for patients. For example, the average review time for an innovative new drug is only six months, and some can be approved even faster.

The approval given through the pre-market review by the FDA before a product is introduced is called FDA Approval.

What Products Does the FDA Certificate Cover?

The FDA regulates a wide range of products, including food products, drugs, medical devices, radiation-emitting products, vaccines, blood and blood products, biologics, animal-related products (including animal feed), veterinary products, cosmetic products, and tobacco products. Normally, FDA approval is required for the introduction of these products to the market. However, in some cases, some of these products may not undergo approval before being launched. This situation is determined by Congress in establishing the FDA’s powers. Additionally, even if FDA approval is not required before a product is sold, the FDA can use its regulatory authority when safety issues arise. As a result, companies wishing to trade any of these products in the U.S. must obtain FDA Approval and FDA Certificate, fulfilling crucial legal requirements for their commercial transactions. Obtaining this documentation and registering with the FDA is crucial for companies to ensure the smooth passage of their goods through customs and to avoid seizure of these goods.

For example, cosmetic products and their components, excluding color additives (except for those intended for use as coal-tar hair dye), are not subject to pre-market approval by the FDA. Additionally, there are banned and restricted cosmetic ingredients regulated by the FDA. Companies and individuals marketing cosmetic products bear legal responsibility for the safety of their products and components. The FDA’s authority over cosmetic products is post-market. If the FDA has information supporting that a cosmetic product is adulterated (mixed with a foreign substance) or misbranded, it can take regulatory action. Therefore, cosmetic products are somewhat exceptional in this regard.

How to Register with the FDA?

Unless waived by the FDA, all registration and listing information (annual, initial, or updates) must be submitted electronically. The FDA’s official website provides guidance on registration procedures and listings; it covers products regulated by the FDA such as animal products, cosmetic products, drugs, food products, medical products, radiation-emitting products, tobacco products, vaccines, blood products, and biologics. Guidance on how to perform registration for different products or facilities is shared during our consulting process.

Documents/Information Required for FDA Registration

Information that may be requested under FDA Registration includes the name, address, and phone number of the company (and, if applicable, the parent company), the name, address, and phone number of the owner or authorized representative of the company, all trade names used by the company, and a declaration that the information provided by the form filler is true and accurate. For foreign companies, the name, address, and phone number of the U.S. agent, and, in case of emergency, the phone number of the U.S. agent or another designated person are required.

What Does an FDA Registration Consultant Do?

Some firms in our country provide consultancy services for FDA registration processes. Under this consultancy, the relevant company or FDA Registration Consultant may:

• Obtain and translate necessary documents and regulations related to the FDA.
• Assist in fulfilling legal requirements for the swift export of products.
• Facilitate dealings with the established representative firm in the U.S.

How Long Does FDA Registration Take?

FDA registration processes can be done in three different ways: initial registration, annual registration, and registration updates. The FDA’s official site provides guides for the products to be registered. When these guides are reviewed, it will be observed that different registration times are specified for different products or facilities. For example, for drugs, the registration time is stated as „registration is required within 5 days of the product being included in commercial distribution.“ Additionally, annual registration renewal for these products should be done between October 1st and December 31st each year. For the initial registration of food facilities, it is stated that „you must register before your facility engages in the manufacturing/processing, packing, or holding (interpreted as storage) of