Importing food and health products from China: FDA, SGS certification and import restrictions guideI. FDA certification requirements

1. Food FDA registration
   Mandatory requirements: All Chinese companies exporting food to the United States must register with the FDA

Registration process:

Obtain a DUNS Number

Submit registration through the FDA FURLS system

Update every two years (October 1 to December 31 of even-numbered years)

Required documents:

Basic company information

Product ingredient list

Production process flow

2. Special regulations for health products (dietary supplements)

Must comply with 21 CFR 111 regulations

New dietary ingredients (NDI) must be notified to the FDA 75 days in advance

Prohibit the presence of drug ingredients or unapproved medical claims

II. SGS certification services

1. SGS common test items

Microbiological testing (total colony count, E. coli, etc.)

Heavy metal content (lead, mercury, arsenic, cadmium)

Pesticide residues

Food additive compliance

Nutritional analysis

2. Certification process
   Submit samples and product information

SGS laboratory testing

Issue test reports and certificates

Optional factory audit (for long-term suppliers)

III. Main import restrictions

1. US import restrictions
   Import ban:

Products containing ephedrine ingredients

Certain animal-derived foods (such as poultry products subject to regional restrictions)

Undeclared new food ingredients

Special restrictions:

Infant formula requires advance notification to FDA

Alcoholic beverages require TTB approval

2. Common restrictions in the EU
   Genetically modified ingredients must be clearly labeled

Fortified foods require prior authorization

Traditional herbal products require TMHPD registration

IV. Practical suggestions
Plan certification in advance: FDA registration usually takes 4-6 weeks, SGS testing 2-4 weeks

Label compliance: Ensure that the Chinese and English labels contain all required information (ingredients, net content, allergens, etc.)

Record retention: FDA requires importers to keep records for at least 2 years

Professional support: Consider hiring a local compliance consultant to handle complex cases

Regular updates: Regulations often change, and it is recommended to check and update every quarter

V. Solutions to common problems
Detained by FDA: You can apply for release by submitting a third-party test report

SGS test failure: You can apply for re-inspection or adjust the formula and re-submit for inspection

Delayed customs clearance: Ensure the HS code is accurate and prepare electronic versions of all certificates in advance

It is recommended that importers declare in advance through the FDA’s “Prior Notice” system before the first import from China, and consult a professional customs clearance agent to handle specific matters.