|Footnotes for this article are available at the end of this page.
Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or maybe this is your first attempt at it. It doesn’t matter, you’ve done your homework, made your plans, you’re ready for the next step and all you need is for the import to arrive. Then you get word: the import is ‘hung up at the border’ – detained – by the Federal Food and Drug Administration (FDA). Now what?
When Can FDA Detain a Shipment?
FDA, or Customs and Border Patrol (CBP) acting on its behalf, can detain a shipment of FDA-regulated commodities if those products in the shipment appear to be:
- an unapproved new drug;
- manufactured, processed, or packed under insanitary conditions; or
- forbidden or restricted for sale in the country in which it was produced or from which it was exported.1
An import detention occurs when a product either, upon examination, appears to meet at least one of the above criteria, or the product, manufacturer, or both appear in an FDA Import Alert.
What is a FDA Import Alert?
An Import Alert (IA) is an enforcement tool FDA can use to ‘detain without physical examination’ (DWPE), a shipment of a FDA-regulated commodity. DWPE is a detention without taking samples of, or otherwise physically inspecting the commodity, to actually demonstrate that the shipment somehow appears to violate the Federal Food, Drug, and Cosmetic Act (the Act). IAs are intended to prevent violative FDA-regulated commodities entering into U.S commerce from other countries. If the agency has sufficient evidence, based on a company’s prior actions or violative history of a commodity, to support a DWPE of a shipment of products that ‘appear to be’ in violation of the Act, it will do so. Once detained under an IA, a shipment is not allowed to proceed into US commerce unless and until the shipment is shown by, and at the expense of, the manufacturer, shipper, grower, or importer to not violate the Act.
IAs rely on a history of past violations of the Act and can be based on adulteration, misbranding, or refusal by a company to allow an FDA inspection. There are IAs covering all the different commodity types regulated by the agency and FDA publishes IAs on line.2 IAs can vary in scope and can be specific to a country, region of the world, company or companies, and industries. An IA consists of, among other things:
- an unique IA number, the first two digits of which are usually the industry code of the product;
- the publishing date of the IA;
- the name of the IA that provides a brief description of what it applies to;
- reason(s) for the IA;
- guidance describing what actions FDA may take relative to the alert;
- applicable charges; and (last, but certainly not least);
- the (dreaded) ‘Redlist’, a list of firms, products, or specific firms and which of their products are subject to DWPE under the IA. Additional companies or products are added to the Redlist as they are shown to be violative and meet any other of the criteria indicated for inclusion in the IA.
What Are Some of the Implications for a Company’s Inclusion on an IA Redlist?
Aside from the extra time and expense it will cost to import products into the U.S., there are other negative consequences of being included on the IA Redlist. Competitors and potential customers will be able to see if a firm has been added to an IA and if a company’s goods are subject to DWPE. This can cause customers to question the quality of the products, and not only those caught up in an IA. It will also likely make detained products more expensive and time-consuming for them to buy. In addition, products included on a Redlist are not likely to be imported on a predictable time-table, and – as the saying goes – time is money. In addition to the cost of proving to FDA that the products aren’t violative, perhaps by paying to send samples to a third-party lab, there is the expense to store the shipment while trying to get it released into commerce. It is also likely that FDA will examine and, as appropriate, take samples of other products from companies on the IA. The proverbial, “where there is smoke, there may be fire”, might apply. If the detention of a shipment is not resolved in a specified period of time, it causes the shipment to be ‘refused.’ Once a shipment is refused it is mandatory that it be destroyed or re-exported.
There are other regulatory consequences of a firm being on IA. For example, the Foreign Supplier Verification Program, or ‘FSVP’, requires importers of food into the U.S. to perform risk-based supplier verification activities 21 U.S.C. § 384a. The goal of these activities is “ensuring that foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventative controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with regard to the allergen labeling.”3 The fact that a prospective supplier is on an IA would not necessarily be an ‘automatic disqualification’, but the importers would have justify why it is not.
Also, importers on an IA are disqualified from participation in the agency’s Voluntary Qualified Importer Program (VQIP).4 As the name implies, VQIP is a voluntary program that importers of food in the U.S. can elect to participate in. It provides a mechanism to expedite the release of shipments of FDA regulated human and animal food.
Options Once a Shipment is Detained
A company likely becomes aware of its product being detained in a communication from FDA called a ‘FDA Notice of Action.’ These are not generated for every entry, but for those that FDA takes certain actions, such as sampling or detaining. An FDA Notice of Action for a detention also serves as the notice of hearing and some of the information it should include are:
- that the firm has the right to provide evidence to FDA in an attempt to overcome the appearance of the violation;
- how the shipment appears to violate the Act;
- an amount of time to provide testimony (usually, but not always, 20 calendar days); and
- the name and contact information of the Consumer Safety Officer (CSO) with whom the company should work to resolve the matter.
In response to the notice a company has several options: submit evidence (testimony) that overcomes the appearance of the violation, submit a request to recondition the product in a manner that corrects the violation, or request to export the shipment from the U.S. If a company chooses to present evidence to overcome the appearance that the shipment is not in violation, it is usually in the form of documents or written testimony. For example, if the shipment is detained because it appears to be adulterated with something such as Salmonella or Listeria, it may submit to FDA a report from a private, third-party lab showing that the shipment is free of the microbes.5
If a company chooses to recondition the shipment, it will propose to FDA, in writing, how it intends to treat or modify the shipment in way so that it will remove any appearance that the shipment violates the Act. For example, if a shipment of products labeled as dietary supplements appears to be misbranded because it does not contain the amount of one or more ingredients as indicated on its label, the firm could propose a relabeling of the dietary supplements in the shipment with an accurate label. If FDA accepts the written reconditioning proposal, the company may have the products in the shipment relabeled. If, upon inspection by FDA, the reconditioned product no longer appears to violate the Act, it may be released from detention.
If the company decides to re-export the shipment, and FDA agrees to allow it, it will be done under the supervision of FDA and CBP, and FDA may require the firm to provide written assurances that, under the penalty of law, it will not attempt to reimport the shipment into the U.S. If there is reason for FDA to believe there will be an attempt to reimport the shipment into the U.S., or that the shipment would pose a risk in any jurisdiction to which it is exported, FDA may choose to not allow the re-exportation. In this case, it is likely to be that the agency will require the company to destroy the shipment.
Getting Off the Redlist – Removal From Detention Without Physical Examination
Information about how to be removed from inclusion in an IA can be found in FDA’s Regulatory Procedures Manual, or ‘RPM,’ in a section titled, ‘Removal from Detention without Physical Examination.’6 The guidance section of a specific IA may also provide details about how a company can be removed.
In a nutshell, to be removed from an IA, a company must submit a petition to FDA. The petition is sent for consideration to FDA’s Office of Regulatory Affairs (ORA) Division of Import Operations, otherwise known as ‘DIO.’ The petition should be persuasive in demonstrating that the company has taken actions that will resolve the original violations that caused the products or company (or both) to be placed on the Redlist. Although there is no specific format required by FDA, the petition should, at a minimum:
- 1. review the IA for any instructions or requirements that must be met prior to removal from the Redlist, address them in way that removes the appearance of the violation(s) and establish documentation to demonstrate that you’ve done so;
- 2. identify the root cause of the violation for which the products were were placed on an IA;
- 3. describe or demonstrate that appropriate measures have been taken to address the root cause of the previous violation in a way to ensure future shipments of the same commodity will not violate the Act; and
- 4. provide evidence that five consecutive importations of the same commodity were made since the company initially appeared on the Redlist, and has initiated the corrective actions mentioned above.
AGG Observations and Advice
- Be diligent about your business partners – past violations could be an indication of current or future behavior.
- Be sure you understand the reasons and charges supporting the detention or reason for being added to a Redlist before you start planning how to respond.
- If your shipment is detained, acknowledge receipt of the Notice of FDA Action with the CSO identified as your point-of contact, but do not comment on your plans until you have all the facts and can make an informed decision. If the situation is complicated, you may request more than the time noted in the notice for your initial response (but request a reasonable extension of time and provide an explanation).
- Be very mindful of your timeline. Missing deadlines can eventually result in a detained shipment being refused.
- Not only can the process be time-consuming and confusing, it is also expensive. In addition to being responsible for the cost for organizing and obtaining any evidence or documentation (such as sampling and third-party lab reports), or any reconditioning (such as obtaining new labels and having them affixed to products), you’ll also likely be on the hook for storage expenses while trying to determine the best path forward and how to resolve the issue.
- If you plan to petition FDA to be removed from an IA, be sure:
- you understand the charges and have identified the causes for the violation;
- your actions to address the causes of the violations, as described, are adequate and you have in place systematic changes to ensure the violations will not continue; and
- the five shipments you rely on are:
- of typical commercial size;
- adequately spaced apart;
- consecutive and free of violations; and
- actually detained by FDA so that you have an opportunity to demonstrate that they are not violative.
Importing FDA-regulated food into the U.S. is a complicated process with many players and moving parts, at a minimum, you will have to deal with shippers, brokers, provide any required Prior Notice, etc. Companies may be dealing with such on their own, or may be relying on consultants or their U.S. agent. Adding the burden and time constraints of navigating FDA detentions or IAs will only increase the commercial complications and overall expense. If your company requires guidance on any aspect of importing FDA-regulated food into the U.S., AGG can assist.
 21 U.S.C. § 381
 See: https://www.accessdata.fda.gov/cms_ia/default.html
 See: https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp
 See: https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip
 See: https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing
 See: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatory-procedures-manual