When products in your shipment violate or appear to violate FDA laws and regulations, FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice of Detention and Hearing.
The product may be detained because it appears to be:
■ adulterated, meaning the product is contaminated, is not safe, or does not otherwise meet applicable standards
■ misbranded, meaning the labels contain false or misleading information
■ an unapproved new drug
■ manufactured, processed, or packed under insanitary conditions
■ forbidden or restricted for sale in the country in which it was produced or from which it was exported.
Also, once on a Red List Import Alert, in which specific firms from certain countries have a pattern of non-compliance, any future products imported from these firms will be detained without physical examination (DWPE) until it can be shown that they are safe and meet pre-approved standards.
Here are some key Alerts for Detention without Physical Examination:
- aflatoxin in food products
- pesticides in raw agricultural commodities and in processed foods
- Salmonella in food products
- sulfites in food products
If FDA detains your product, your options include:
- Submitting evidence to overcome the appearance of a violation.
- Submitting a request to recondition the product to correct the violation.
The compliance officer can issue a refusal of admission if FDA does not receive a response by the “respond by” date listed on the Notice of FDA Action. Typically, the “respond by” date is 10 business days but can be up to 20 calendar days to allow for weekends, holidays, and mailing time.
When you are unable to overcome the appearance of a violation, your product will be refused admission and you can work with U.S. Customs and Border Protection (CBP) and FDA to destroy the product or export it from the U.S within 90 days of the refusal.
U.S. Agents can always help. Some are better at it than others. ITB HOLDINGS LLC is one of them. Keep that in mind.
The most common problem is delay in contacting a U.S. Agent soon enough when FDA Notice is received, resulting in insufficient time to assemble all the evidence and triggering a panicked request for an extension.
Indicate exactly what you have found out from the FDA in order to determine how to clear your product. It is critical that the correct steps are taken when sampling and testing or the data will be rejected.
Count on U.S. Agents to walk you through the process, and stop worrying.
Also, remember that FedEx, UPS, DHL and other companies will not be able to provide the much needed assistance.