Regulatory Requirements to Enter U.S. Market

The United States (U.S.) is the largest economy in the world and a leading global trader. In 2022, the U.S. was Malaysia’s third largest export destination and trading partner. Total trade between Malaysia and the U.S. in that year was recorded at USD 60.71 billion. Malaysia’s major exports to the U.S. includes electrical and electronics, machinery, optical and scientific equipment, furniture and rubber products.

With a market size of approximately USD 2.8 trillion, the U.S. holds the position as the largest market for food and beverages in the world. E-commerce is the main factor contributing to the growth of the U.S. F&B market as more consumers are shopping for groceries and prepared meals online. Another factor is the demand for healthy F&B products, as consumers are becoming more aware of the importance of health and wellness. The F&B market is also expected to grow in the coming years, due to increased consumer spending, rising income and growing demand for convenience and healthy F&B products.

Companies seeking to expand their business to the U.S. need to ensure they have met the country’s regulatory requirements. The U.S. Food and Drug Administration (FDA) is responsible for protecting public health and develops regulations to enforce the Federal Food, Drug and Cosmetic Act. Under the FDA, registration is required for food facilities that manufacture, process, pack or store food. The registration has to be renewed every two years, on even numbered years.

The labelling of foods as “Organic” is regulated by the United States Department of Agriculture (USDA). Only products made with 100 percent organic ingredients may use the USDA Organic seal or the term “100 percent organic.” Products made with at least 95 percent organic ingredients may use the USDA Organic seal or the term “organic.” However, products made with 70 to 95 percent organic ingredients may only use the phrase “made with organic….” Products made with less than 70 percent organic ingredients may only disclose individual organic ingredients in the ingredient statement.

The FDA Food Safety Modernization Act (FSMA) focuses on preventing food contamination through Hazard Analysis and Critical Control Points (HACCP) and Hazard Analysis and Preventive Controls (HARPC).  HACCP and HARPC are food safety standards that requires food facilities to conduct a hazard analysis and implement controls, monitoring and corrective actions.

Malaysian companies who are interested in exporting to the U.S. can reach out to MATRADE for enquiries and assistance. Matrade will assist with connect U.S. importers with Malaysian exporters, as well as coordinating and facilitating business networking with U.S. buyers.

For enquiries, please contact:

T: +1-(305) 267-8779

Registrar Corp (Malaysian Office)
Theva Ganesh

Matrade Webinar (Regulatory Requirements for Exporting to the U.S. Market)