What is FDA?

FDA stands for Food & Drug Administration (US Food and Drug Administration). The FDA is part of the United States Department of Health and Human Services, established in 1906, and is headquartered in Washington DC. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

The roles of FDA

FDA is responsible for

• Protect public health by ensuring that food (with the exception of livestock, poultry, and certain egg products regulated by the United States Department of Agriculture) is safe, healthy, hygienic, and properly labeled; ensure that drugs, vaccines and other biological products and medical devices are used safely and effectively.

• Protect people from electronic product radiation

• Ensure cosmetics and dietary supplements are safe and properly labeled

• Managing tobacco products

• Enhance public health by helping to accelerate product innovation

FDA's responsibility extends up to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, U.S. Samoa, as well as other U.S territories and properties.

FDA regulations on food products imported into the US

Food imported into the US market, it is necessary to comply with the principles and meet the standards set by this market.


The Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act, requires most foods to be labeled with nutrition facts and requires food labels to have a nutrient content claim and a certain health messages to comply with specific requirements.

Packaging and ingredients

The Nutrition Labeling and Education Act (NLEA) requires most foods to have special nutrition, ingredients labels and requires food, drink, dietary supplements to contain warnings about Certain nutrition and health messages must meet the special requirements of the FFDCA. Pay special attention to functional foods.

Other notes

• Food establishments must be registered with the FDA, and FDA has the authority to inspect facilities or incoming shipments: FDA requires domestic and foreign facilities that manufacture, process, pack, or store food for Humans or animals consumed in the United States must be registered with the FDA. U.S.-based farms, retail establishments, restaurants, and non-profit food establishments where food is prepared or served directly to consumers are exempt from these requirements.

• FDA is notified in advance of imported food shipments: FDA requires that US buyers or importers or their representatives submit to FDA prior notice of importation of food. This notice must be submitted no less than four hours before the flight's arrival but no more than five days before the arrival of the shipment.

• Comply with the Food Safety Modernization Act (FSMA): with the aim of making the food supply in the US market safe, by meeting comprehensive precautions from the production of ingredients , processing, packaging, labeling, transportation until the goods reach the consumer. Instead of just inspecting the final product at a US port.

GOL provides FDA related solutions to support businesses to export to the US market, including: 

- FDA registration service for food products, cosmetics and medical devices 

- Consulting service on packaging and labeling to stay compliant with FDA standards 

- Training and consultation of FSMA standards to factories (for food) 

- FDA mock inspection service, FDA inspection assistance 

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