Suggestion: Watch the 10 minutes video tutorial before reading this article

Click Here to Get the
Starter Package: All Categories

Planning to import kitchen utensils, food products or medical devices from China, and sell in the United States? Then you need to ensure compliance with all mandatory FDA administered regulations.

In this comprehensive guide to FDA regulations and requirements for importers, you will learn what you must know about FDA labeling requirements, premarket approvals, documentation and lab testing.

In addition, you will also learn how Amazon.com is enforcing FDA regulations, such as 21 CFR, and why you should not rely on your manufacturer in China to manage the process for you.

Which products are regulated by the FDA?

FDA, standing for the Food and Drug Administration, is a government agency, not a standard or regulation in itself. The FDA administers regulations that affect various product categories.

a. Food Contact Materials / Kitchen Utensils

The FDA administers 21 CFR, which regulates all types of materials made to be in contact with food and beverages.

21 CFR covers plastics, ceramics, coatings, glass and metal used in both food packaging and all types of kitchen utensils.

For example, food packaging and kitchen utensils may not contain toxic or harmful chemicals and heavy metals – or affect the taste and smell of the food or beverage.

21 CFR mainly concerns the substances used in kitchen utensils (both electrical and non-electrical) and food packaging. Continue reading FDA Certification & Labels When Importing from China: A Complete Guide