There is Nothing Simple About Importing Products into the United States

Here at FDA Compliance Simplified we frequently work with companies that wish to import products into the U.S.  While we can help those companies comply with the U.S. Food and Drug Administration import requirements, those are only part of the regulatory pathway that must be navigated in order to import products into the U.S.  You can find our post about FDA import requirements here.  Below is a description of the import process from the perspective of Customs and Border Protection (CBP) provided by one of our partners, Sean Scarbrough of Taggart International, Ltd., a U.S. Customs Brokerage and freight forwarding firm that specializes in U.S. Customs regulations.

There is nothing simple or easy about importing product legally and properly into the United States, especially if your company has never done it before. This is even more so when the products being imported have U.S. Food & Drug Administration (U.S. FDA) oversight. As background, there is no unalienable right to import products into the U.S., even for U.S. citizens. It is a privilege granted those that agree to do so compliantly – whether the importer understands the rules or not. However, it is the importer’s responsibility to understand the U.S. import regulations and to abide by them. Failure to do either can result in significant fines or penalties and in some cases, criminal prosecution for those involved.

The U.S. Customs Informed Compliance publication entitled, “Reasonable Care” provides some insight into the extent to which CBP holds importers accountable for what they do or is done in their name. Other Customs publications that will help you look further into what is required should you choose to be a U.S. importer can be found here and here.

Required Information for FDA-Regulated Imports

It is best to have an experienced Customs broker help your firm with the process. The information below is required to have a meaningful and specific conversation with your broker about importing goods into the U.S.A.  All of this information is necessary if your firm is ever to either ship commercial quantities to the U.S.A or act as the U.S. importer of record.

  1. Names of all contract manufactures, their full addresses and the manufacturer’s U.S. FDA registration numbers.
  2. Your company’s FDA Registration number, if required.
  3. If the products are going to be held at another facility prior to export to the U.S.A, those facility registration numbers as well.
  4. U.S. service of process agent for FDA purposes, if your company is not setting up a U.S. operation that will have a person that can fulfill that responsibility.
  5. Confirm your product packaging and/or labeling has been approved or registered, or that it is not necessary by a qualified expert.

Information Required by Customs

Once the above preliminary information is in place, there is a set of Customs-related questions or areas of exploration that will need to be addressed including:

  1. What is the Harmonized Tariff Schedule of the United States (HTSUS) of the product(s)?
  2. What are the relevant duty rates?
  3. Are there other Customs-related Harmonized Tariff Schedule matters?
  4. Who will be the U.S. Importer of Record (U.S. IOR)?
  5. If you are shipping in commercial quantities, someone must be the U.S. importer of record.
  6. The U.S. IOR can be a foreign company, but additional requirements and considerations impact.
  7. Will a U.S. Customs continuous bond be purchased or will single transaction bonds be used? This is based upon a number of factors, including estimated import value of the good(s) and the duties, taxes and fees.
  8. What will be the reported value of the merchandise at the time of importation and are those values proper or correct?

Based upon the answers to the above, additional questions or issues will surface that will need to be addressed. Likewise, this is all before discussing the physical movement of the goods from origin location(s) to destination(s). There will likely be questions about those, particularly with the costs for doing it all with providers that satisfy FDA requirements. As stated earlier, there is nothing easy or simple about the process. It is a complicated, exacting and tedious process even with the most mundane of products, which is very time consuming for all parties involved. We understand it is a necessary part of the business case buildout for companies that are entertaining the idea of selling products in the U.S.A and we at Taggart International, Ltd. are happy to help.

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