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FDA Import Alerts: A Primer

Editor’s note: We asked Alli Condra, who is pursuing her LL.M. in Agricultural and Food Law at the University of Arkansas, and is the recipient of the Marler Clark Graduate Assistantship, to give us the legal background on import alerts. Here is her summary:


The FDA and Imports

The Food and Drug Administration (FDA) is responsible for ensuring that imported foods are safe and that unsafe imported foods will not reach consumers.[1]   Under the Food, Drug, and Cosmetic Act (FD&C Act), FDA has the authority to prevent the admission of any imported products that violate the Act. [2] 

Refusing Entry after Inspection


FDA has the power to refuse admission of a product if, upon “examination of such samples or otherwise,” the product appears to have violated FD&C Act in one of four ways: the product was “manufactured, processed, or packed under insanitary conditions;” is forbidden or restricted in sale in the country in which it was produced or from which it was exported;” is adulterated or misbranded; or is in violation of certain recordkeeping requirements.[3]  

In fiscal year 2010, there were 9,974,958 shipments of imported food to the United States.[4]   FDA was able to physically examine only 2.1 percent of those shipments (equal to 768,235 inspections).[5]   Had the FDA found a violation of the FD&C Act during one of those examinations, it could refuse to admit the product into U.S. commerce.  Given the low number of inspections conducted at the ports of entry, it is not surprising that in some situations products that have already been admitted into the United States are found to have violated the FD&C Act, requiring FDA to take action to protect consumers.

Import Alerts: Refusing Entry without Examination


An alternative to the inspection at port of entry process comes in the form of an “import alert.”

When FDA has enough evidence or other information that a certain imported product, whether prior to or after admission, is unsafe (or in some other way has violated or potentially could have violated the FD&C Act), FDA will issue an “import alert.” [6]   

An import alert is a notification from FDA to its field staff that all future shipments of the imported product may be refused admission without physically examining the product in each shipment (called “Detention Without Physical Examination” or DWEP). [7]   

FDA field offices, centers, and other government agencies (state and federal) provide information to and request import alerts from FDA’s Division of Import Operations and Policy (DIOP).   DIOP then gathers and reviews this information about the imported products and works with the Division of Field Science to ensure laboratory-testing methods are appropriate and reliable, and determine whether an import alert should be issued. [9] 

After an import alert has been issued for a shipment of food and the shipment has been refused admission, it is the importer’s responsibility to introduce evidence within 10 days to show that the product does not violate the Act. [10]   If the importer does not adequately prove that the product is safe, the product must be destroyed or exported within 90 days. [11]   The import alert will stay in place and all future shipments of the product will be denied admission until the violation is remedied, the importer provides enough evidence that the shipment is safe for consumers, or other conditions imposed by FDA are met. [12] 

What Triggers an Import Alert?


Import alerts are issued for a variety of reasons and on a variety of levels.  In FDA’s Regulatory Procedures Manual, FDA explains that “[d]etention without physical examination … is appropriate where 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.” [13]

For example, the manufacturer or grower could have a problem or history of problems in their growing or processing facilities that have not been remedied and which have the potential to cause harm to consumers.  The product may have tested positive for a dangerous microbiological substance.  FDA has issued import alerts for seafood products contaminated with Salmonella, for seafood contaminated with Listeria monocytogenes, and for honey contaminated with Chloramphenicol.  An import alert may be issued after a recall of product that has already been distributed throughout the states.  The recent import alert for cantaloupes from Asuncion Mita, Guatemala, was based on findings of alleged contamination likely due to use of contaminated irrigation water, poor hygienic practices of workers, and/or processing produce with Salmonella contaminated water.  Additionally, an import alert may be issued for a specific product, manufacturer, shipper, grower, geographical area, and/or country, depending on the issue.

According to the FDA Regulatory Procedures Manual, in those instances where at least one sample of the product has been found to violate the Act and the type of violation, if not remedied, could result in serious health consequences, FDA is more willing to recommend an import alert based on just one violative sample. [14]   For example, the product may have adverse health consequences, contain an unacceptable level of pesticide residue, or contain undeclared significant ingredients (such as allergens) or unapproved colors. [15]   Other types of violations will require more than one sample showing a violation before an import alert will be issued.

What authority does FDA have to do this?


FDA has clear statutory authority to detain products after examination if they appear to have violated the FD&C Act.[16]   The authority to issue import alerts, which do not require physical examination of the product, is a little less clear, although FDA argues that the FD&C Act is explicit about FDA’s authority to do so. [17]   

The Act states that “[i]f it appears from the examination of such samples or otherwise” that a product has violated the Act in some way, FDA may refuse admission of the product. [18]   It is the language “or otherwise” on which FDA bases its authority to issue import alerts.  There is no explicit language about import alerts in the Act or in the regulations promulgated under the Act.[19]   However, in FDA’s Regulatory Procedures Manual, FDA asserts that “Congress authorized FDA to refuse admission of regulated articles based on information, other than the results of examination of samples, that causes an article to appear to violate the FD&C Act.” [20]  

Del Monte Fresh Produce recently challenged the FDA’s issuance of an import alert against cantaloupes from a farm in Asuncion Mita, Guatemala. [21]   Del Monte Fresh Produce asserts, among other things, that FDA is required to comply with more stringent administrative procedures before issuing import alerts.  Others have also questioned FDA’s authority to issue import alerts and what procedures are required. [22]

Problems Import Alerts Have for Industry


The automatic detention and refusal of entry for imported products can cause serious consequences for importers and other players in the production and import chain.  FDAImports.com, a group of consultants and attorneys that help industry through the import process, lists “shipment delays, supply-chain risks, increased costs and budget overages, not to mention the additional burden it places on a supplier to prove to FDA why [there] should not be [an] Import Alert” as some of the serious
consequences facing an importer after being issued an import alert.[23]   Producers and importers of perishable goods are in an especially precarious position, as those products will not likely be salvageable if the importer is able to remove itself from the import alert list.

FDA has the resources to inspect only a fraction of the imported products that enter the United States each year; 2.1% of imported products were inspected last year.  FDA is charged with protecting consumers from products that are unsafe, especially those with adverse health impacts.  The duty to protect consumers and a lack of resources requires FDA to take action swiftly without the opportunity to inspect every shipment intended for import.

At this time, FDA will likely continue to issue import alerts and prevent the importation of products that it believes violate the FD&C Act in order to protect consumers from potentially harmful problems. The recently passed Food Safety Modernization Act addressed import alerts only in that the importers will be responsible for food inspection and reexamination fees. Unless and until the federal courts review FDA’s authority to issue import alerts, they will remain an important and controversial part of the U.S.’s food safety system.

[1]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm.

[2]  21 U.S.C. § 381(a) (2011).

[3]  21 U.S.C. § 381(a) (2011).

[4]  Report to Congress, Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices Provisions of the FDA Food Safety and Modernization Act, April 6, 2011, http://www.fda.gov/Food/FoodSafety/FSMA/ucm250569.htm.

[5]  Report to Congress, Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices Provisions of the FDA Food Safety and Modernization Act, April 6, 2011, http://www.fda.gov/Food/FoodSafety/FSMA/ucm250569.htm.

[6]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm. 

[7]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm. 

[8]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm.

[9]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm.a

[10]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm. 

[11]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm. 

[12]  FDA: Consumer Health Information, Import Alerts Guard Against Unsafe Products, August 2011, available at www.fda.gov/forConsumers/ConsumerUpdates/ucm269384.htm.

[13] FDA REGULATORY PROCEDURES MANUAL, Chapter 9: Import Operations and Actions, 9-19 (2011), available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf.

[14]  FDA REGULATORY PROCEDURES MANUAL, Chapter 9: Import Operations and Actions, 9-21 (2011), available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf.

[15]  FDA REGULATORY PROCEDURES MANUAL, Chapter 9: Import Operations and Actions, 9-22 (2011), available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf.

[16]  21 U.S.C. § 381(a) (2011).

[17] See FDA REGULATORY PROCEDURES MANUAL, Chapter 9: Import Operations and Actions, 9-19 (2011), available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf.

[18]  21 U.S.C. § 381(a) (2011).

[19] 21 U.S.C. § 381(a)(2011); 21 C.F.R. §1.94(a) (2011).

[20]  FDA REGULATORY PROCEDURES MANUAL, Chapter 9: Import Operations and Actions, 9-19 (2011), available at http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf. 

[21]  See http://www.foodsafetynews.com/2011/08/del-monte-sues-fda-over-cantaloupe-restrictions/ for a link to the complaint.

[22]  Christine M. Humphrey, The Food and Drug Administration’s Import Alerts Appear to be “Misbranded”, 58 FDLJ 595 (2003), available at http://www.perishablepundit.com/docs/fda-alerts-misbranded.pdf; Bellarno Intern. Ltd. v. Food and Drug Admin., 678 F. Supp. 410 (E.D.N.Y. 1988).

[23]  FDAImports.com, FDAImports.com Overcomes Import Alerts and Other Obstacles:  2 Success Stories, http://www.fdaimports.com/blog/fdaimports-com-overcomes-import-alerts-and-other-obstacles-2-success-stories/ (last accessed Sept. 8, 2011).

[24] Opponents to the new fees are forming a coalition: http://www.fdaimports.com/coalition.php.

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