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.
Detention without physical examination (DWPE), first used by FDA in 1974, is appropriate when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative.
DWPE may also be recommended on the basis of analyses performed by state or local agencies, where FDA has determined that the sampling and testing conducted by such agencies is accurate, acceptable and representative of the product on which the recommendation is based.
A recommendation for DWPE consideration may be based on the violative history of a product, manufacturer, shipper, grower, importer, geographic area, or country.
The information shows that product:
▪ offered for entry was harvested from polluted waters.
▪ was manufactured, processed, packed, or held under insanitary conditions or manufactured in a manner that is non-compliant with Good Manufacturing Practice (GMPs).
▪ may have adverse health consequences and warranting a Class I or Class II recall.
▪ contains actionable levels of a pesticide residue, aflatoxin, or chemical contaminant.
▪ is a violative low acid canned food, or acidified food regulations (failure to have a process on file for a specified product or no registration).
▪ is violative in a way that is likely to continue due to the product’s ingredients or formulation.
▪ bears or contains undeclared significant ingredients (human allergen), unapproved colors, or violate applicable standard of identity.
▪ is unapproved new human or animal drug, and will continue to appear violative until the manufacturer of such products changes the label or formula for the product or obtains agency approval necessary for legal marketing.
▪ is a post amendment device that is not subject to an approved 510(k) or premarket approval application.
▪ labeling is violative and/or not in accordance with the Nutritional Labeling and Education Act (NLEA), and such violation is likely to continue until said labeling is corrected by the manufacturer.
Moreover, foreign manufacturers of regulated products who refuse to permit or delay FDA establishment inspection may be subjected to DWPE.
Finally, if the FDA has documented an importer’s practice of repeatedly offering violative articles for importation and attempting to recondition these shipments only after FDA detention, or of repeatedly attempting to export shipments or withdraw entries after receiving a notice of sampling or other indication of interest (inquiries regarding product location), DWPE would be recommended covering either specific commodities or all regulated products offered for entry by that importer.
All such recommendations, formatted as Import Alerts, should be submitted to the Office of Enforcement and Import Operations (OEIO) for clearance. Each recommendation should include final charges, with input from the Office of the Chief Counsel (OCC), as needed. FDA’s Compliance Management Services (CMS) system serves as the central repository for all DWPE evidence.
The agency’s decision to remove a product, manufacturer, packer, shipper, grower, country, or importer from DWPE should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and the FDA has confidence that future entries will be in compliance with the FD&C Act.
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.
