The Food and Drug Administration (FDA) is a branch of the U.S. Department of Health and Human Services that is based in Washington, D.C. Its main job is to check the safety and quality of food, drugs, and other related goods to make sure they meet U.S. standards before they can be sold.
It’s hard to explain the FDA in simple terms because it has a lot of different jobs, like making sure food is safe and regulating drugs and medical devices. If you want to send goods to the US, though, you need to follow FDA rules.
What is the FDA?
The FDA was established in June 1906 when President Theodore Roosevelt signed the Food and Drug Act. The bill was drafted by Dr. Harvey Washington Wiley, whose public health demonstrations drew national and congressional attention.
The agency was initially named the U.S. Food, Drug, and Pesticide Administration (USDA) and later abbreviated to the U.S. Food and Drug Administration (FDA).
To date, the FDA has 223 offices and 13 laboratories in the United States, the Virgin Islands, and Puerto Rico. Since 2008, the FDA has established offices in various countries, including China, India, Costa Rica, Belgium, and the United Kingdom.
Key Responsibilities of the FDA:
The FDA is the agency that is primarily responsible for protecting and promoting public health. They are responsible for regulating and overseeing the safety of food and drugs in the countries in which they operate. Products regulated by the FDA include:
- Foods
- Cigarettes
- Functional foods
- Dietary supplements
- Prescription or over-the-counter drugs
- Vaccines
- Blood transfusions
- Medical devices
- Electromagnetic radiation emitting devices
- Veterinary-related products
In addition, the FDA regulates a number of laws that are not directly related to food and drugs. These include:
- Interstate travel health regulations
- Disease control for different types of products
- Control of household and business pet diseases
- Or they monitor and evaluate sperm donations for assisted reproduction ……
FDA Certification Requirements for Shipping to the USA
When shipping goods to the United States, the FDA certificate is one of the most important documents in the process. Goods such as dried shrimp, dried fish, cakes, candies, jams, medicines, teas, etc. require this certificate. This serves as proof of customs clearance for importing your goods into the United States.
All products regulated by the FDA must meet the organization’s strict rules in order to obtain FDA certification.FDA certification is issued for each product type and is not limited by quantity or weight.
For example, if you send 1kg of dried shrimp and 100kg of dried fish to the United States, you will still need to apply for 2 FDA certificates for the shrimp and dried fish.
What are FDA Standards?
FDA standards are strict regulations set by the U.S. Food and Drug Administration (FDA) to monitor the safety of products regulated by the FDA for distribution in the U.S. market. Any exporter wishing to bring products into the U.S. must comply with FDA regulations and obtain an FDA certificate. Even if you use a service that sends goods to the United States, you should pay attention to this certificate in addition to knowing the U.S. import duties.
Criteria for obtaining FDA approval for each product type
1. food and beverages:
- FDA compliance
- HACCP standards for seafood and juices
- Low-acid canned foods
- Product labeling
- Claims on food labels regarding health or ingredients, uses
- GRAS (Generally Recognized As Safe) assessments, including product ingredients and FDA notifications
- cGMP requirements consultation
- FDA color certification requirements review
- Determination of EPA and FDA allowable limits for pesticides
2. Functional foods, drugs & functional medicines
- Compliance: product labeling requirements
- Safety: ingredient details
- Manufacturing facility registration and cGMP compliance
- Product structure, function information. Submission of notifications to the FDA
3. Cosmetics/cosmetic drugs
- Compliance: FDA product labeling rules
- Safety: ingredient review
4. Electronic, electromagnetic, and radiological emitting devices
- Development of FDA performance standards, certification, and reporting requirements
- Compliance with FDA electronic product reporting; application for an FDA access number
Benefits of the FDA
As Hongocean describes, the FDA is the agency responsible for protecting and promoting public health. As such, the FDA’s standards are extremely stringent. It is dedicated to helping users of food and beverage products maintain their health and safety. In addition, the FDA protects products such as cosmetics/drugs, and electronic devices.
To be certified by the FDA, manufacturing facilities must comply with Current Good Manufacturing Practice (cGMP) regulations. cGMP is a generalized manufacturing practice that includes:
- Technology
- Manufacturing Processes
- Manufacturing equipment and product standards must meet industry standards.
- New inventions in the field of technology at the time of application.
For example, in terms of product labeling regulations, the label will list detailed information about each nutrient in the product without any description or instructions for use. This will help users proactively choose the right product for their health more quickly and easily.
Thus, the primary advantage of the FDA is to help protect the user’s health, and FDA approval ensures the absolute safety of the product’s ingredients and the user. American products with FDA approval are well known worldwide. Therefore, Vietnam is also responding to the growing trend of importing American goods.
Exempt goods do not require FDA approval
- Foods prepared by individuals
- Merchandise sent to the U.S. as a personal gift
- Personal items sent to individuals on a non-commercial basis
- Samples of non-edible food items that cost less than $200.
You need to certify that these items are samples and send them to a food manufacturer or laboratory.
The information above is important for understanding the FDA certification, which we have gathered and organized to help you better comprehend this process. FDA certification is one of the most important documents required when shipping goods to the United States. Therefore, if you need any support regarding the FDA, please contact us at
