The United States Food and Drug Administration (FDA) has released import detention and refusal statistics pertaining to fiscal year 2011 (October 1, 2010-September 30, 2011). These statistics may be enlightening for importers and exporters of FDA-regulated products.
This data shows that Drugs, Biologics and Tobacco Products have the highest number of exams per line entry when entering the United States. It is not surprising, therefore, that Drugs and Biologics are also the most likely to be detained by FDA. What is surprising, however, is that Tobacco Products are disproportionately more likely to be released after examination.
Additionally, although Medical Devices have the second lowest examination rate among all FDA categories, Medical Devices have the second highest detention rate. Products within the Medical Device category are also the most likely to be refused entrance into the United States. This past fiscal year alone, FDA refused admission to 62,498 medical device line entries (more than 80% of all FDA refusals).
Important conclusions may be drawn from the recently released data:
The data could be interpreted as a stark warning for the medical device industry. Products regulated as medical devices are at a greater risk for refusal of entry with nearly half of medical devices detained for further examination being ultimately refused entry. The message is clear and the lesson is in the details: before shipping to the U.S. exporters and importers of medical devices must be certain that they have met all FDA requirements and their products are 100% compliant, including registration, listing and labeling!
Exporters and importers of other FDA-regulated products, also, should note important warnings from the data. Drugs, biologics and tobacco products are likeliest to be examined on entry, and drugs and biologics also are most likely to be detained by FDA for further examination. Exporters of these products should be aware of the heightened risks of their products being examined.
The food industry should not breathe easy either, despite the statistics. The Food Safety Modernization Act mandates increased inspections of imported foods and provides FDA with additional resources for such inspections. In the case of food and dietary supplements, the past may not be prologue.
FDA does not examine every product imported to the United States; the agency simply does not have the resources to physically review all imported foods, dietary supplements, drugs, medical devices, cosmetics, biologics, electronics, and tobacco products. Instead, FDA examines a portion of those products, some at random, and some based on the level of perceived risk.
For companies faced with a detention, it is critical to act quickly:
1) Get a copy of the Notice of Action (NOA) as soon as possible. These are written notices provided by FDA that indicate the exact nature and quantity of the detention, time frame requirements and FDA contact information. Notices of Action are provided by FDA to the importer’s customs broker and to the importer of record only, so you may need to inquire if the importer has received the Notice of Action.
2) Contact Registrar Corp for immediate assistance. Simply phone: +1-757-224-0177 or contact via Live Help: https://www.registrarcorp.com/livehelp