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Import Alert 89-08
Import Alert 89-08: Detention of Class III Medical Devices without a Premarket Approval
Background
FDA reviews imported medical devices regularly to ensure that all required approvals and clearances, registrations and product listings have been completed. When FDA finds medical devices that lack required approvals or clearances, it will add the foreign manufacturer and its products to this Import Alert.
How do Firms get on this Import Alert?
Companies that have designed and marketed alternative or novel medical without first obtaining expert help in identifying and complying with FDA medical device approval or clearance requirements can expect to find their devices and they foreign manufacturing sites added to this Import Alert. Medical devices are designated by law as Class III, requiring a Premarket Approval (PMA) unless FDA has expressly exempted that requirement. Most novel devices do not enjoy that exemption and so they are treated under the law as requiring the PMA.
Effects on Businesses Involved
Correcting product labeling and marketing materials and preparing and filing any applicable Premarket Approval or Premarket Notification will take a significant amount of time and money, and should not be attempted without the advice of counsel. Additionally, companies may experience delays in importation of other products from the listed companies. FDA often attempts to find similar violations with other products, which can slow down other, legal shipments into the U.S.
How do Companies get off this Import Alert?
Obtaining removal from this Import Alert will first require a detailed regulatory review of the medical devices and their labeling and marketing materials to identify the regulatory requirements under the law. Then, by relabeling or modifying the marketing materials and/or preparing and submitting necessary evidence and data to FDA proving the product can be used safely and effectively we can provide that information to FDA in the form of an Import Alert Petition to remove the foreign manufacturer and its products. For this Import Alert, affected firms should seriously consider requesting an Import Alert Petition Viability Review to determine the next critical steps.
Import Alert 66-41
Import Alert 66-41: Detention of Unapproved New Drugs in the United States
Background
FDA has been on high alert looking for imported products which include unapproved, illegal, or fraudulent drug claims in product labels, internet marketing websites, or other flyers and promotional materials. Unapproved drugs present serious safety and effectiveness concerns because consumers may forego FDA-approved remedies or even medical intervention and instead be fooled into using unapproved, illegal and fraudulent drug products.
How do Firms get on this Import Alert?
FDA reviews imported product labels and internet marketing websites looking for unapproved drugs. Some imported products might look like they are only cosmetics or dietary supplements or foods or safe, over-the-counter medicines or alternative medical remedies, including homeopathic, Chinese and Ayurveda Medicinal products. Yet, if FDA determines label or internet marketing claims fall within drug claim categories (intending the products to diagnose, treat, mitigate, cure or prevent disease or to affect the structure or function of the body) FDA will add those products to this Import Alert. Products listed on the Red List for this Import Alert will be Automatically Detained.
Effects on Businesses Involved
Even if future entries of the same products bear corrected labeling and claims, FDA will still Automatically Detain all shipments of listed products. If the products’ labels or their marketing materials still bear the illegal drug claims, FDA may not permit the importer to relabel the product depending upon which drug charge FDA brings against the imported products.
How do Companies get off this Import Alert?
Removing a company and its products from this Import Alert will require a thorough label and marketing review to remove and revise drug claims. It will still be necessary to prove to FDA that the changes were adequate and have been completed and that future shipments will contain products that bear only legal claims.
Import Alert 16-81
Import Alert 16-81: Detention of Seafood Products
Background
FDA created this Import Alert for listing foreign seafood firms that have had Salmonella contamination problems. This import alert does not include shrimp from Bangladesh, Hong Kong, India, Indonesia, Taiwan, and Thailand, covered by Import Alert 16-18, or shrimp from India, covered by Import Alert 16-35. All other seafood and shrimp products tested and found to contain Salmonella appear on the Red List for this Import Alert. Although FDA created this Import Alert because of the severity of the food-borne illness caused by Salmonella, it covers raw, uncooked seafood as well as cooked Ready to Consume seafood. Of course, unless fresh or frozen raw seafood is intended for raw consumption, later cooking would destroy any Salmonella in the product. This demonstrates FDA’s “zero-tolerance” for Salmonella in food, which is mostly due to the cross contamination risks represents.
How do Firms get on this Import Alert?
FDA adds firms to this Import Alert if any of their products test positive for Salmonella. Just one positive sample will prompt FDA to refuse the tested shipment, resulting in destruction or exportation of the entire tested lot, and t0 place the firm on the Red List of this Import Alert, resulting in Automatic Detentions of all future shipments of the same (or even similar) products from that foreign processor.
Effects on Businesses Involved
Raw seafood is highly perishable. Consequently, this Import Alert can significantly restrict a company’s access to the U.S. market because of the delays caused by FDA Automatic Detentions. It is not uncommon that resolving FDA Automatic Detentions through private laboratory testing can take longer than the shelf life of raw, fresh seafood. Because Salmonella is considered a significant food safety risk the public nature of this Import Alert can be very damaging to a company’s business with existing customers. Even if future shipments are clean, FDA will Automatically Detain them until the processor and its products are removed from the Red List. FDA may also require foreign processors to submit corrective actions and a new Hazard and Critical Control Point (HACCP) plan for Agency review prior to releasing shipments. That HACCP plan review, if required, will significantly increase delays because the plans are rarely reviewed by the FDA officer detaining the shipment but have to be submitted to FDA Headquarters for review.
How do Companies get off this Import Alert?
Firms can be removed from this Red List, but shipping five consecutive clean shipments alone will not solve the problem. Rather, evidence must be submitted to FDA in the form of a Import Alert Petition proving that the reasons that led FDA to add the firms to the Red List have been resolved. Companies should consider requesting an Import Alert Petition Viability Review to determine whether there is adequate evidence to prepare and submit an Import Alert Petition.
Import Alert 45-02
Import Alert 45-02: Foods Containing Illegal/Undeclared Colors
Background
Manufacturers must use FDA-approved colorants in food. FDA has determined that some colorants are unsafe and therefore illegal to use in human and animal foods. Colorants that are illegal in the United States may be permitted in other markets, such as the European Union, so a Company could accidently send the wrong product to the USA rather than a market where the color is permitted. Regardless of whether the manufacturer meant to use the illegal colorant or to send the shipment to the USA, FDA will add the manufacturer and its food to the Import Alert Red List.
How do Firms get on this Import Alert?
FDA reviews product labels and randomly tests products entering the United States. If an adulterated colorant is found, FDA detains the goods and adds the firm to Import Alert. Also, if a food label ingredient list declares a color incorrectly, FDA will presume that the color is not permitted or from an uncertified batch. This can cause FDA to add the company to the Import Alert Red List.
Effects on Businesses Involved
Manufacturers on this Import Alert will experience costly delays when FDA automatically detains the products. Some foods listed on this Import Alert are perishable. Automatic detentions of perishable food items can take so long to resolve, the shipment is spoiled and commercially lost. Moreover, many holiday items contain specific colors that FDA will suspect are illegal, resulting in additional testing of other foods from the same Red Listed manufacturers. Missing delivery windows for holiday items can be financially devastating to a company.
How do Companies get off this Import Alert?
Food Companies on the Red List will be required to identify, correct and document the manufacturing or labeling problems that originally caused FDA to add their food products to this Import Alert. A firm should consider receiving an Import Alert Petition Viability Review to correct the critical safety and manufacturing issues. In addition, if FDA originally placed the company on the Import Alert based upon a labeling error, food companies should consider a Food Label Review.
Import Alert 53-06
Import Alert 53-06: Detention of Cosmetics Due to Illegal Colors
Background
FDA originally issued this Import Alert in 1985 because they detected illegal color additives in cosmetics manufactured by Taiwanese firms. Later, FDA noticed manufacturers in other countries were also using illegal colorants in mascaras, eye dust, lipstick and other cosmetic products. FDA created this Import Alert so districts would automatically detain imported cosmetics containing illegal colors. In 2018 the alert was revised to include misbranding charges in addition to the original adulteration charge.
How do Firms get on this Import Alert?
Today, the country-wide Taiwanese automatic detention has been removed from this particular Import Alert. Cosmetics are not subject to automatic detention unless they are from a manufacturer that FDA has added to the Red List. Some companies may be on this import alert simply because they declared legal, permitted colors incorrectly. FDA will interpret such errors to mean the colors discovered or declared to be in the cosmetics are not permitted, illegal and unsafe or are from uncertified batches.
Effects on Businesses Involved
A firm will find this import alert especially expensive to deal with. It is common for imported cosmetic shipments to contain many, many different cosmetics with different colors. Color is one of the primary attributes of most cosmetics. Even if future cosmetic shipments do not contain illegal colorants, FDA will still automatically detain all entries for private testing, prolonging the entry process. Because there are so many different colors in most cosmetic shipments, each cosmetic type has to be separately sampled and tested. That is expensive. In addition, cosmetics are common holiday gifts. When FDA adds a cosmetic company to an Import Alert, it makes it harder for them to meet critical deadlines for holiday sales. Because such a large portion of retail sales in the USA are generated prior to or during holidays, missing the window for holiday products could be very devastating.
How do Companies get off this Import Alert?
Cosmetic Companies on the Red List will be required to identify, correct and document the manufacturing or labeling problems that originally caused FDA to add them to the Import Alert. A firm should consider receiving an Import Alert Petition Viability Review to determine and address the critical issues. In addition, if labeling was involved in FDA’s decision to add the company to the Import Alert, cosmetic companies should consider a Cosmetic Label Review.
Import Alert 99-19
Import Alert 99-19: Detention of Food Products Due To Salmonella
Background
While many Import Alerts relate to Salmonella contamination in specific food types (like seafood or shrimp), this Import Alert is a catch-all for all food products found to contain Salmonella. FDA has determined that many different foods, such as raisins, chocolate, fresh produce contain Salmonella. FDA created this Import Alert to provide guidance to districts, telling them they may automatically detain specific products exported or manufactured by those firms on the Red List.
How do Firms get on this Import Alert?
FDA adds companies to this Import Alert if any of their food products have been tested and were discovered to be contaminated with Salmonella. FDA is particularly concerned with Ready To Consume (RTC) foods – those that require no further processing before they are customarily consumed. Therefore, fresh produce, finished chocolate or other candies, breads and cereals, and raisins or dried goji berries are good candidates for this Import Alert if FDA finds they are contaminated.
Effects on Businesses Involved
A firm will find this detention costly since it affects the life, value and quality of the food item. Some foods on this alert are perishable or have only a moderate shelf life. The delays in the supply chain and logistics due to the import alert will cause some of the automatically detained food to become significantly reduced in value. FDA has zero tolerance for Salmonella in most cases. So contaminated foods will be refused, and exported or destroyed.
How do Companies get off this Import Alert?
Companies can petition FDA to be removed from this Import Alert. You must show there is no longer an a basis to believe future shipments will be contaminated with Salmonella. However, this will require more than just multiple clean entries and an Import Alert Petition. A firm should consider receiving an Import Alert Petition Viability Review to determine the best arguments and facts for obtaining removal from this import Alert.
