What FDA import and labeling requirements apply when exporting a Panama-made food supplement to the United States?

To export a dietary supplement from Panama to the United States, the FDA requires facility registration, compliance with supplement-specific Good Manufacturing Practices, proper labeling with a complete Supplement Facts panel and mandatory warnings, and a premarket notification only if the product contains a new dietary ingredient. If no new ingredients are included, no prior FDA approval is required. All requirements must be met before importation. If you have any questions, feel free to contact me:

To export a dietary supplement from Panama to the United States, the FDA requires facility registration, compliance with supplement-specific Good Manufacturing Practices, proper labeling with a complete Supplement Facts panel and mandatory warnings, and a premarket notification only if the product contains a new dietary ingredient. If no new ingredients are included, no prior FDA approval is required. All requirements must be met before importation. If you have any questions, feel free to contact me:

When exporting a Panama-made dietary supplement to the United States, the product falls under FDA regulation via DSHEA (Dietary Supplement Health and Education Act).

 

Facility & manufacturing

Your manufacturing facility must be registered with the FDA (Food Facility Registration) and comply with cGMP for dietary supplements (21 CFR Part 111). The FDA does not “approve” facilities in advance but can inspect them, including foreign sites.

 

Premarket notification

No FDA pre-approval is required unless the product contains a New Dietary Ingredient (NDI) not marketed in the U.S. before October 15, 1994. In that case, an NDI notification must be submitted at least 75 days before marketing.

 

Labeling requirements

Labels must comply with 21 CFR 101 and include: statement of identity, net quantity, Supplement Facts panel, ingredient list, directions for use, manufacturer/distributor info, and mandatory disclaimers for structure/function claims. Disease claims are prohibited.

 

Import & compliance

Each shipment is subject to FDA import screening. Non-compliance can result in detention, refusal of entry, or import alerts. Proper documentation, compliant labeling, and GMP readiness are critical before exporting.