United States Food and Drug Administration (USFDA) Requirements for Malaysian Exporters

The United States is Malaysia’s seventh largest export destination for processed foods. The major food products exported to the United States includes cocoa products, edible products, vegetables and fruits, preserved seafood, cereal, flour, starch, coffee, tea, dairy products and others.

Prior to exporting to the United States, Malaysian businesses must ensure that they have complied with the United States Food and Drug Administration (USFDA) regulations. The Food and Drug Administration (FDA) is responsible for guarding public health by verifying the safety, efficacy and security of human and veterinary drugs, biological products and medical devices. The FDA also ensures the safety of food products, cosmetics and products that emit radiation.

Facilities that manufacture, process, pack or store food, including beverages and dietary supplements, are required to register under the FDA. The FDA has also listed several exemptions for FDA registration, such as trading companies, personal residences, farms, retail food, fishing vessels and USDA-regulated facilities. However, MATRADE has advised Malaysian exporters to reach out to the FDA for confirmation of exemption. 

FDA registration renewal is applied every two years, on even-numbered years. Business facilities must also consent to FDA inspection to renew their registration. Failure to renew would result in an invalidated registration, and the FDA would consider the food facility as having failed to meet their registration requirements.

After registering with the FDA, businesses will have to designate a U.S. agent for FDA communications, which serves as a point of contact for any matters related to the FDA. This includes the scheduling of inspections, complications in port and other regulatory matters. Businesses should also verify that their labeling is compliant with the FDA, as labelling mistakes is one of the leading causes for food to be denied entry into the USA. On top of that, businesses should ensure that their product ingredients are not prohibited by the FDA.

The FDA also requires companies that produce certain shelf-stable, hermetically-sealed acidified or low-acid foods to obtain a Food Canning Establishment (FCE) registration. Manufacturers must also submit documentation for each process used in the production of foods subject to these requirements. Finally, businesses should ensure they have complied with the new Food Safety Modernization Act (FSMA) requirements.

Malaysian businesses who are interested in exporting to the United States can reach out to MATRADE or Registrar Corp for enquiries and assistance. Registrar Corp is a provider of FDA compliance assistance, and would assist businesses in FDA registration, labelling compliance or detention assistance.

For enquiries, please contact:
F&B, Halal and Agro Based Section
Mr. Harulnizam Kassim
E: nizam@matrade.gov.my
T: +603-6207 7265

Registrar Corp Malaysia
Theva Ganesh Palanisamy
T: +6011-1199 6621

Registrar Corp:

FDA Guidance:

MATRADE webinar (Export Opportunities of F&B in USA & Beyond: Understanding the United States Food and Drug Administration (USFDA) Product Requirements)