Successfully importing food, beverages, dietary supplements, cosmetics, and OTC products into the U.S. requires strict adherence to FDA import compliance and U.S. Customs clearance regulations. Failure to meet these requirements can result in costly delays, product detentions, or even refusals at the port of entry.

The FDA, in coordination with U.S. Customs and Border Protection (CBP), carefully monitors shipments to ensure only compliant products enter the country. Importers must provide complete and accurate documentation, including Prior Notice for food shipments, product facility registration, and labeling compliance. For hybrid products (such as cosmetics with OTC drug claims), additional FDA entry requirements may apply.

Key aspects of FDA import compliance and customs clearance include:

• FDA Facility Registration & Product Listing – Ensuring the foreign manufacturer or facility is properly registered with the FDA.
• Prior Notice Filing – Mandatory for food and beverage shipments to notify the FDA before arrival.
• Accurate Product Labeling – Meeting FDA standards for nutrition facts, ingredients, warnings, and claims.
• Customs Documentation – Including invoices, packing lists, and certificates of analysis where applicable.
• Detention Avoidance – Preventing common issues such as mislabeling, unregistered facilities, or incomplete Prior Notice filings.
• Special Oversight for Hybrids – OTC/cosmetic combination products must comply with both FDA and Customs rules.

At XPRO America, we specialize in helping global exporters, distributors, and importers achieve smooth U.S. market entry. Our services include Prior Notice filing, FDA entry submissions, customs broker coordination, and compliance documentation review. We also provide corrective guidance in case of detention, ensuring faster resolution and minimizing losses.

With increasing FDA oversight under programs like PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting), importers must take proactive measures to ensure their shipments meet all regulatory requirements. XPRO America’s expertise helps businesses avoid costly delays and gain reliable access to the U.S. marketplace.

XPRO America helps businesses with FDA import compliance & customs clearance, Prior Notice filing, detention avoidance, and smooth U.S. market entry.