Low value e-commerce containing cosmetics, creams, lotions, supplements, food, and other U.S. Food and Drug Administration (FDA) regulated goods are now subject to full approval. All prior exemptions of certain low-value FDA-regulated products I've been rescinded All FDA-regulated goods are now subject to stringent approval and clearance processes, and critically, they cannot be cleared via the low-value Section 321 entry.
Importing FDA E-commerce Orders Without Section 321 Processes
For e-commerce businesses importing products regulated by the U.S. Food and Drug Administration (FDA) into the United States, it's crucial to understand that these shipments generally cannot utilize the simplified Section 321 clearance process. Regardless of their low value, FDA-regulated goods require a formal entry process to ensure compliance and public safety.
Types of imports regulated by the FDA
Contact our team and build a durable solution for your e-commerce orders of creams, lotions, supplements and other FDA items to the USA.
Here's how to navigate the import process for FDA e-commerce orders when Section 321 is not applicable:
1. Formal Entry and Importer of Record for FDA goods
FDA-regulated goods, including cosmetics, creams, lotions, supplements, and food products, must undergo a formal entry process. This means your shipment will be subject to a more detailed customs clearance procedure, even may otherwise qualify for Section 321.
2. FDA-Specific Requirements and Documentation
Prepare to meet all specific FDA requirements for your product category. This often includes:
- FDA Product Compliance: Ensure your products meet all U.S. FDA standards for ingredients, manufacturing, and safety.
- Accurate Product Labeling: Labels must comply with FDA regulations, providing accurate information about ingredients, nutritional facts (for food), and intended use.
- Prior Notice (for Food and Beverages): If you are importing food, beverages, or dietary supplements, you must submit "Prior Notice" to the FDA before the shipment arrives. This involves registering with the FDA and obtaining a confirmation number, which must accompany your shipping documentation.
- Required Permits or Certifications: Depending on the specific product, additional permits, certifications, or registrations with the FDA may be necessary.
3. Detailed Commercial Invoice and Packing List
Your commercial invoice must be comprehensive and accurate. It should clearly describe each item, its quantity, value, and the correct Harmonized System (HS) code. For FDA-regulated goods, including the FDA Prior Notice confirmation number (if applicable) and any other relevant FDA registration numbers on the invoice is essential. A detailed packing list is also crucial for efficient customs processing.
4. Utilize a Licensed Customs Broker with Express Consignment Experience
- Navigating FDA regulations and formal entry procedures can be complex. Partnering with an experienced and licensed U.S. customs broker is highly recommended. A customs broker can:
- Ensure Compliance: Help you understand and meet all FDA and U.S. Customs and Border Protection (CBP) requirements.
- Facilitate Formal Entry: Handle the necessary paperwork and declarations for formal customs clearance on your behalf.
- Expedite Clearance: Address any potential issues or requests from the FDA or CBP to help minimize delays.
- Advise on Duties and Taxes: Guide you on any applicable duties, taxes, and fees associated with the formal entry.
5. Be Prepared for Inspections and Holds
- FDA-regulated shipments are subject to inspection. Be prepared for your goods to be held at customs for examination by FDA officials. Having all your documentation in order and being responsive to any requests from the FDA or CBP will help expedite this process.
- By understanding and adhering to these requirements, e-commerce businesses can successfully import FDA-regulated products into the U.S. without relying on Section 321, ensuring compliance and a smoother customs experience.
- For more information, you can consult resources from Jet Worldwide:
- Importing Guide to the USA - Jet Worldwide
- Things to Consider when shipping USA from Canada - Jet Worldwide
- How to export foodstuffs to the USA - Jet Worldwide
Duty Free USA Section 321 Entry parcel Import - Jet Worldwide
The Evolution of Import Regulations for FDA-Regulated Products
Historically, many lower-value shipments, including some FDA-regulated items, might have slipped through customs with minimal intervention, often due to their declared value falling below certain thresholds. The focus was often on the commercial invoice and basic customs declarations, with less emphasis on specific agency approvals for smaller consignments.
However, in an era of heightened security and increased regulatory oversight, the U.S. Customs and Border Protection (CBP) and the FDA have reinforced their requirements. The emphasis has shifted to ensuring the safety and compliance of all imported goods, irrespective of their monetary value.
Why Section 321 No Longer Applies to FDA-Regulated Shipments
Section 321 allows for the duty-free entry of shipments valued at $800 USD or less by one person on one day, with simplified documentation. While this greatly benefits e-commerce and low-value imports, a crucial exception exists for goods regulated by Partner Government Agencies (PGAs), including the FDA.
Key points to understand:
- Formal Entry Required: Items requiring inspection or approval as a condition of release by agencies like the FDA must be entered using a formal entry process, regardless of their value. This means that even a single cosmetic item or a small food supplement valued under $800 cannot bypass the full FDA clearance process via Section 321.
- No Low-Value Exemption: The previous informal acceptance, often linked to a shipment's low value, is no longer applicable for FDA-regulated commodities. The nature of the goods, rather than their value, dictates the clearance procedure.
- Prior Notice for Foodstuffs: For foodstuffs, specific requirements such as registration with the FDA and obtaining a "Prior Notice" authorization number are mandatory before shipment. This number, along with a copy of the FDA confirmation, must accompany the commercial invoice. Failure to comply can lead to the destruction or return of the goods.
What This Means for Importers
For those shipping cosmetics, creams, lotions, supplements, and food to the USA, it is essential to:
- Understand FDA Requirements: Familiarize yourself with the specific FDA regulations pertinent to your product category. This may include ingredient compliance, labeling standards, and specific certifications.
- Prepare for Formal Entry: Be prepared for your shipments to undergo a formal entry process, which may require more detailed documentation, Harmonized System (HS) codes, and potentially a customs bond.
- Obtain Necessary Approvals in Advance: Do not assume low-value exemptions. Ensure all required FDA approvals, registrations (like FDA registration for food facilities), and prior notices are secured before shipping.
- Work with Knowledgeable Partners: Partnering with experienced logistics providers and customs brokers who specialize in FDA-regulated goods is crucial. They can help navigate the complexities of documentation, compliance, and clearance to avoid delays, penalties, or seizure of goods.
- The shift in FDA import regulations underscores a commitment to public safety and product integrity. By understanding and adhering to these updated requirements, importers can ensure a smoother and compliant shipping experience for their FDA-regulated goods.
For further information on shipping regulations and FDA requirements, you can refer to resources from Jet Worldwide:
- Importing Guide to the USA - Jet Worldwide
- Things to Consider when shipping USA from Canada - Jet Worldwide
- How to export foodstuffs to the USA - Jet Worldwide
- Duty Free USA Section 321 Entry parcel Import - Jet Worldwide
Types of Goods Regulated by the FDA
The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety, efficacy, and security of a broad range of products, including:
- Human and veterinary drugs
- Biological products (like vaccines and blood products)
- Medical devices
- Food and beverage items (except for meat, poultry, and certain egg products, which are mainly USDA-regulated)
- Cosmetics, creams and lotions
- Products that emit radiation (e.g., microwave ovens, X-ray equipment)
- Tobacco products
