FDA registration is mandatory for all companies involved in the manufacturing, processing, packaging, or distribution of food, drugs, medical devices, or cosmetics in the United States. Registering with the FDA can be a complex and time-consuming process. However, it is essential to ensure that your products comply with FDA regulations and are safe for consumers. So, how do you register with the FDA? Let’s refer to the article below with GOL for more information.

1. The concept of FDA (Food and Drug Administration)

The Food and Drug Administration (FDA), is the regulatory body for food and pharmaceuticals in the United States. They are responsible for safeguarding public health by ensuring the safety, efficacy, and security of food, drugs, medical devices, and cosmetics.

Recognition by the FDA is a registration granted by the U.S. Food and Drug Administration for products identified as safe, effective, and suitable for American consumers. It’s mandatory to obtain FDA registration for the sale of all food, drugs, medical devices, and cosmetics in the United States.

2. The role of FDA registration

• Food: FDA ensures that food, excluding meat, poultry, and some egg products regulated by the U.S. Department of Agriculture, is safe, wholesome, sanitary, and properly labeled. This includes inspecting imported foods, conducting inspections at facilities, and collecting data on food safety.
• Drugs: To ensure the safety and effectiveness of human and animal drugs, vaccines, as well as other biologics and medical devices, the FDA evaluates clinical research, approves new drugs and medical devices, and monitors their use.
• Radiation: FDA protects humans from electronic product radiation, such as MRI and X-ray machines. This involves establishing safety regulations for radiation and conducting tests to ensure compliance with regulations.
• Cosmetics and Dietary Supplements: FDA ensures that cosmetics and dietary supplements are safe and properly labeled. This includes inspecting imported products, conducting inspections at facilities, and collecting data on product safety.
• Tobacco: FDA regulates tobacco products, including cigarettes, electronic cigarettes, and heated tobacco products. This includes establishing packaging and labeling regulations, banning tobacco advertising, and conducting community health education campaigns.
• Promoting community health by accelerating product innovation: FDA supports research and development of new products and improvements to existing products. This support includes funding for research, providing information, and expertise.

In summary, the FDA plays a crucial role in safeguarding community health. FDA regulations and activities ensure that food, drugs, medical devices, and cosmetics are safe and effective for consumers.

Read more: FDA approved vs FDA cleared: The differences you need to know

3. The consequences of not registering with the FDA

The consequences of not registering with the FDA can be severe, both legally and financially.

In terms of Legal, companies failing to register with the FDA may face fines, and in some cases, criminal prosecution. Fines can reach up to millions of dollars. In cases of criminal prosecution, individuals may face imprisonment and be prohibited from participating in related industries.

In terms of Financial, non-registered companies may encounter difficulties accessing the U.S. market. Many retailers and distributors refuse products without FDA, potentially leading to missed business opportunities and revenue loss.

Here are some specific consequences of not registering with the FDA:

• Products not registered with the FDA may be detained at the U.S. borders and prohibited from importation.
• Non-registered companies may be required to recall their products from the U.S. market.
• Companies failing to register with the FDA may be obligated to compensate consumers who suffer injuries from using their products.

4. The expiration date of FDA

The validity of an FDA depends on the type of product. For food products, it has a duration of 2 years. In the case of pharmaceuticals, medical devices, and cosmetics, the registration is valid for 1 year.

The duration of the FDA registration is determined by the FDA from the date of approval of the FDA registration. Companies are obligated to renew their FDA registration before it reaches expiration. To initiate the renewal process, companies must actively engage and submit a renewal application online or via postal mail. The FDA registration renewal process generally involves several steps and typically takes a few weeks to complete.

5. The most detailed procedure for obtaining FDA

Registering with the FDA is a mandatory procedure for products looking to circulate in the U.S. market. This process is carried out by the U.S. Food and Drug Administration (FDA) to ensure the safety and quality of products for consumers.

The FDA registration steps include:

Step 1: Prepare the documentation

Businesses need to prepare a complete set of documents according to FDA regulations to register their products. The registration dossier includes information such as:

• Business registration certificate
• Manufacturing facility address
• HACCP/ISO 22000 certification (if applicable)
• Contact information for the U.S. representative office
• Information on personnel responsible for FDA compliance
• Other specific information depending on the case

Step 2: Appoint a U.S. Agent

Businesses need to appoint a U.S. agent to receive information and handle issues related to the FDA. The U.S. agent can be a consulting company with sufficient capability to carry out FDA-related procedures.

Step 3: Register manufacturing facility, obtain code, and create an account

Businesses need to register their manufacturing facility, obtain a code, and create an account on the FDA system. The registration information includes:

• Manufacturing facility name
• Manufacturing facility address
• FDA registration number
• Account name and password

Step 4: FDA registration

The FDA will review the registration dossier and inspect the manufacturing facility. If the registration dossier is complete and the facility meets FDA requirements, the FDA will issue an FDA certificate for the product.

The time to complete the FDA registration process can range from 10 to 30 days, depending on the type of product and FDA requirements.

Here are some notes to consider when registering with the FDA:

Businesses should seek the advice of consultants to ensure the registration dossier is complete and accurate.

Businesses need to prepare all necessary documents according to FDA regulations.

Businesses must adhere to FDA requirements for product safety and quality.

FDA registration is an essential procedure that helps businesses ensure their products meet the requirements of the U.S. market and are legally circulated in this market

Read more: How to get FDA approval? Tips for a Successful Application

Read more: The process of registering medical devices with the FDA

6. Reliable FDA registration service

GOL is a consulting company specializing in providing FDA registration services for businesses looking to sell their products in the United States. With over 20 years of experience in FDA registration, GOL has successfully assisted thousands of businesses.

GOL offers a range of FDA registration services, including:

• Food Registration: GOL helps businesses meet FDA requirements for food products, including canned foods, frozen foods, fresh produce, and more.
• Cosmetic Registration: GOL assists businesses in meeting FDA requirements for cosmetic products, including makeup, skincare products, and more.
• Medical Device Registration: GOL helps businesses comply with FDA requirements for medical devices, including diagnostic medical devices, therapeutic medical devices, and more.

With a team of experienced experts possessing specialized knowledge in FDA regulations, we will collaborate with you to comprehend the specific requirements of your business and assist you in meeting all FDA regulations.

GOL provides FDA registration services with competitive pricing and flexible service packages tailored to meet the needs of your business.

7. Considerations when registering with the FDA

7.1 FDA Registration Requirements for Goods Exported to the United States

FDA registration is a challenging task for manufacturers and researchers, as the agency’s requirements are very stringent. The specific requirements are as follows:

• The product (fresh food, dietary supplements, etc.) must be assessed for the essential nutrients and permitted levels.
• The manufacturer must demonstrate that the production facility, machinery, equipment, and technology meet international standards.
• The product packaging must clearly display information such as nutritional information, manufacturer information, and instructions for use. Each type of product has its own packaging regulations that businesses must follow. If the packaging does not fully disclose the information, it will be considered a violation of advertising and may be required to be destroyed or recalled from the market.
• The professional team must have the expertise and ability to control the quality of the products produced.
• For defective products, which is an unavoidable situation, the manufacturer must propose a convincing plan or measure to address the situation.

7.2 Cases in which FDA registration for goods exported to the United States cannot be obtained

According to FDA regulations, there are two types of imports into the United States: commercial imports and personal use imports. In many cases, goods may be held if they do not meet FDA standards and are not allowed to be commercially distributed into the US market.

For example:

• Mixed goods, unsafe, not meeting applicable standards
• Products with incorrect labeling (labels with incorrect information) or products that have not been registered as required
• Products on the list of restricted products for consumption in the US market

Related articles:

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