This is the first post in a three-part series of discussions on import detention by the FDA. In this post, I discuss some of the preventative steps that an importer can take to avoid an import detention and help to familiarize importers with available resources regarding import detention so proactive measures can be taken.
An import detention notice from the FDA is received by many importers of foreign goods with mixed feelings of surprise, confusion, and anxiety. There can be several reasons why a product that is generally not regulated by the FDA falls within its jurisdiction when reviewed at the time of import, though the FDA detains imports primarily for two reasons: adulteration or mislabeling. Often, broad product claims in labeling are all that is needed to trigger FDA detention.
The FDA does not recognize regulatory approvals from foreign countries/areas. All imported products are required to meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe for their intended use and properly labeled; radiation-emitting devises must meet established standards; and all products must contain informative and truthful labeling in English.
One can view the country- and industry-specific detentions on the FDA’s website. So far this year, the three countries with the highest import detentions have been China, Canada, and Mexico, perhaps because the highest volume imports come from these countries as well. Unfortunately, the FDA does not publish information about which industry is subjected to the most import detentions. Based on the information from the import detentions in 2011, our analysis indicates the food industry might be leading this year in industry-wide import detentions.
The FDA uses its automated Operational and Administrative System for Import Support (OASIS) to make admissibility determinations to ensure the safety, efficacy, and quality of foreign-origin products. The purpose of this system is to centralize the operations data and information at various ports of entry into the U.S. It also allows the FDA to leverage resources of other government agencies, such as the United States Department of Agriculture (USDA), to render expert import decisions.
Following are some of the preventive steps that we recommend importers take before importing a foreign product for distribution in U.S. commerce.
Understand one’s role in the distribution chain. All foreign firms are required to register their establishments, identify a U.S. agent, and individually list their devices before they may import them into the United States. Complete information on registrations and listing requirements and processes can be obtained from the FDA’s registrations and listing website. A failure in the registration process can trigger a detention.
Conduct a full legal analysis of the product. This analysis will help determine whether a product is exempt from or is required to comply with certain FDA requirements when distributed in the U.S., such as Pre-Market Notification (510k) or Pre-Market Approval (PMA) in the case of medical devices. Any product brought into the United States from a foreign country is considered imported. Thus, all importers, including those filing warehouse entries, are subject to the import provisions set forth in section 801 of the Federal Food, Drug, and Cosmetic Act.
Make sure the information about the manufacturer of the product is provided in the import documents. Sometimes, importers provide the shipper’s information instead of the manufacturer’s information. Technically, when a product is exempt from the FDA’s registration and listing requirements, the shipper’s information may be substituted for the manufacturer’s information, but it is advisable that importers provide the actual manufacturer’s information because substitution can result in a firm’s incorrect placement on the FDA’s import alert list.
Investigate the relationship between the country of origin and the United States. There may be special requirements or exemptions based on a memorandum of understanding between the country of origin and the United States.
Check to be sure the manufacturer’s facility is in compliance. Facility inspections of foreign manufacturers of FDA-regulated products that reveal significant deviations from GMP, unsanitary conditions, or practices that result in the articles manufactured at such facilities appearing to be misbranded, adulterated, or otherwise in violation of the Federal Food, Drug, and Cosmetic Act may result in the recommendation of detention without physical examination of the actual articles offered for import.
Make sure the actual product is properly labeled. The product labeling, its promotional material, and any affiliated websites must be carefully vetted by an expert to make sure product claims are not unnecessarily broad.
In addition to the loss of business due to the failed delivery of a product, the process of removing a product from FDA import detention can get very costly. In order to avoid detention of an imported product, it pays to do some planning up front and consult with those who are familiar with the FDA’s regulatory practices and procedures. Brokerage firms will usually not address these issues proactively, so engaging a broker will not necessarily prevent problems.
Stay tuned for my next discussion on the FDA’s practices and procedures for import detention.