An import alert, also called an FDA automatic detention list, is given to a company or country when FDA has past evidence of a shipment being violative. They are used by FDA to provide notice to its District Offices and FDA import inspection and compliance officers that a foreign manufacturer and its products appear to be in violation of the Food Drug and Cosmetic Act (FDCA) or other FDA regulations.
In most circumstances, firms and products that are listed on an import alert are automatically detained by FDA without the added step of FDA conducting an inspection, examination, or sampling of the product (also called Detention Without Physical Examination or DWPE). Once on an import alert (red listed), FDA will continue to detain the affected products until the manufacturer, shipper, grower, or importer proves to FDA that the violation has been corrected (green listed).
The FDA publishes its import alerts on the internet, so competitors and potential customers are able to see that a firm has been added to an import alert and its products are subject to automatic detention (DWPE). It is very important for importers, manufacturers, or shippers listed on an FDA import alert to get off the alert as soon as possible.
How does an Import Alert Come About?
FDA has the authority to examine any regulated shipment to verify that it complies with the law. They canrefuse a product based on an examination or any other evidence. So they have the right to detain any other shipment from the same company (or country) of the same product based on the first shipment’s violation — this being the “any other evidence.”In other words, shipment number one becomes evidence of noncompliance for all other following shipments.
This is where the concept of an import alert comes from. An import alert is an internal agency directive, where the agency has said there is sufficient evidence to conclude that a shipment will appear violative based on other evidence that was not necessarily gathered from this direct shipment. This can pertain to an individual company; for example, FDA tested past shipments which came back positive for salmonella so they may assume all incoming shipments will test positive. Or it can be country-wide where, for example, the shrimp from country X has been proven to be violative, therefore, any shrimp imported from there is also presumed violative. It is important to note that FDA’s action is not actually against a particular company or country. Rather, they are “in rem” or “against ‘the thing’.” The product is in violation of the law, not the company, it just so happens that the importer/firm speaks on behalf of the product.
Why is an Import Alert so Devastating?
When FDA adds a company to an import alert, or when FDA issues a country-wide import alert for certain products, everybody suffers. The processors subject to the alert suffer because their products will then be subject to FDA Automatic Detention. U.S. importers suffer because now they must pay additional costs to store the product prior to FDA import release and for additional testing or processing in order to obtain FDA release after import detention. Lastly, consumers also suffer because FDA import alerts increase product costs.Although many companies are on an FDA import alert for good reason, many do not belong on an alert. Because FDA has failed to provide adequate public information about how to be removed from an import alert, many companies stay on FDA import alerts for months, years or even decades.
Some companies might not even realize they are on import alert, especially if they are a foreign company. For instance, an importer may have obtained the manufacturer’s product from a third country or from a shipper who was not authorized to ship to the U.S. In such cases, the manufacturer may learn it is on the alert only after it ships to an authorized distributor in the U.S. and finds FDA automatically detaining legitimate shipments because the agency previously caught unauthorized shippers exporting products never intended for the U.S. market and out of compliance with U.S. laws.
What Types of Import Alerts Are There?
There are two major ways a product is added to the import alert system:
- Manufacturing Problems (the way the product is made)
- Product Problems (the product itself)
Manufacturing problems can include issues like; unsanitary conditions in a product facility that need to be inspected and documented over a period of time to prove otherwise. These tend to be harder to prove and if a company is on import alert for this type of problem, there is no point in shipping product until these issues are resolved because there will be no way to prove the shipment is not violative from its port of detention. A company cannot test their way out of a manufacturing problem. Product problems, on the other hand,might be solvable at the detention stage if they can be proven compliant through testing.
Import alerts are usually categorized as:
- Country or area wide (such as for the possible presence of melamine in Chinese vegetable protein products)
- Country/Worldwide (filth in tamarind products)
- Shipper (a seafood product from specific shippers due to decomposition)
- Manufacturer/Product specific (medical device firms who refuse to allow FDA inspections)
What do the Terms Red, Yellow, and Green List Mean?
- Red List- includes companies or products that FDA has discovered (usually by testing imported products or inspecting documents or the facility) have previously exported unsafe, adulterated, misbranded, or unapproved products. Red listed companies cannot freely import into the U.S.
- Yellow List- is reserved for products that FDA is investigating more closely because of repeated previous problems. FDA might use a Yellow List to increase its scrutiny on products coming from listed companies to make sure the company does not belong on the Red List or to develop the evidence to eventually create a country-wide or region-wide import alert. Companies on the Yellow List will not usually have their shipments automatically detained; however, they will suffer many more FDA import inspections, examinations, and testing.
- Green List- Some problems exist more pervasively in a specific country or region than they do in the rest of the world. FDA creates an import alert that applies to certain products originating in that country – even if the company shipping the product has never had the problem or was not even in business when FDA discovered the evidence! FDA issues exemptions from these alerts when a company proves, using strong evidence and argument, that the import alert should not apply to them. If FDA agrees, FDA places that company on the import alert’s “Green List” and they can import into the U.S. without being subject to automatic detention.
Okay, I am on an Import Alert. Now What?
Once FDA has issued an import alert the importer can seek release of the shipment by proving to FDA that their shipment is actually compliant. Once evidence has been gathered and given to FDA that proves that the shipment is not violative then FDA will release the shipment. This process continues indefinitely, with each new shipment, until the company seeks removal from the import alert.
To seek permanent release from an import alert you must prove two main things to FDA.
- Have you solved the problem?
- Have you demonstrated you can produce a compliant product?
This can be proved by investigation, documentation, consistent corrective action, and (typically) at least five consecutive clean shipments.FDA expects to see this documentation in a particular format, with arguments that demonstrates the manufacturer and its products no longer appear to be in violation of the law.All of this proves a pattern of compliance. The importer collects these items, plus any other directives the agency may have given, and submits them. If everything is in order then they will take the company off of import alert and shipments will begin to come in as normal.
What is included in an Import Alert?
An import alert has the following sections:
- The Import Alert Number (FDA uses a 2-number system, where the first number indicates the product industry code)
- The Publish Date
- The Type of Alert
- The Name of the Import Alert
- The Reason for the Alert
- The Guidance on what Action FDA may take and how to be removed from the Alert
- The Product Description
- The Charge
- Countries (for country- or area-wide alerts)
- List of firms and their products subject to DWPE
- List of firms and their products that have met the criteria for exclusion from DWPE
What are the most Common Types of Import Alerts?
99-19: Salmonella in food products
45-02: Illegal/undeclared colors in foods and cosmetics
53-06: Adulterated/Misbranded Cosmetics due to Color Additive Violations
16-81: Salmonella in seafood and other food products
66-41: Unapproved new drugs
89-08: Medical device lacking the appropriate FDA clearance
Being listed on an import alert could be devastating to a foreign company, which may not even be aware it is on the alert. There are over 150 separate FDA Import Alerts that affect, literally, thousands of manufacturers, shippers, growers and importers, and hundreds of countries. Don’t be one of them. Together with our sister law firm, Benjamin L. England & Associates, we can seek removal or exemption of your company from import alert, making the way through clear for your imported product. We represent many foreign food, drug, cosmetic, and medical device companies before FDA seeking and obtaining removal or exemption from import alerts of all types.
We make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses to help them get off and stay off import alert. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States.