I am back with part II of my analysis on detention of imported products by the FDA. In part I, I discussed some of the precautionary measures that an importer can take to prevent import detention by the FDA.

Importers bear the primary responsibility for ensuring products they import comply with all provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), and may be required to pay the entire expense incurred by the FDA relating to a product detention, which includes among other expenses, payment for the time, travel, and per diem allowance of inspectors, analysts, and other staff, and all administrative support expenses.

If detention is unavoidable, understanding the elements of detention will help an importer better navigate the cumbersome and often expensive process of releasing a detained product. Some of the actions the FDA takes on a regular basis with respect to detained products are:

Notice of sampling. The FDA issues a notice of sampling before obtaining samples of a product for examination to determine whether an article offered for import may be subject to refusal of admission.

Notice of detention and hearing. If after the examination of a product sample the FDA determines to detain a product, a notice of detention and hearing is required to specify the nature of the violation charged. The importer has 10 days to respond to this notice and is entitled to an informal hearing before the FDA in order to provide testimony in support of admissibility of the article.

Application for authorization to relabel and recondition. In order to obtain permission from the FDA to relabel and recondition a detained product, an importer must submit Form FD-766 or another appropriately notice of completion (such as a letter) and execute a bond.  

Importer's certificate (Form FD-766). After the relabeling or reconditioning operation is complete, the applicant must submit a notice of completion. The FDA may accept the statement or conduct a follow-up inspection.

An importer must diligently keep all records and make sure that a violation that resulted in the detention of a product is not repeated. Repeated violations may lead to import alerts and detention without physical examination of a product, both of which will be discussed in part III of my analysis of import detention. Stay tuned.