A Funny Thing Happened on the Way to the Border: Avoidable Mistakes with FDA-Regulated Product Detentions

Al Stewart’s 1970s song, “On the Border,” comes to mind every so often when an existing or new client contacts us as their product is stopped at the United States border by the Food and Drug Administration.  Lately, during the recent pandemic, we have received more calls where the detentions are often due to what we might call unforced errors.  Mistakes, such as the failure to properly list the product or register the manufacturing facility, can cause the product to be “misbranded.”  Incomplete or missing paperwork or wrong information on the product label or the lack of a code (e.g., National Drug Code) can cause delays with imports if FDA (or Customs) cannot readily locate the product or manufacturer in a government database.

Any FDA Import Alert might read that the product is misbranded, adulterated, unapproved, or does not have an Emergency Use Authorization (EUA) (or all of the above).  Reconditioning of the product, at this point, is likely too late (or not possible in the case of a pending EUA), and the only recourse left would be for the distributor or importer to ship the product back to the country from where it came — resulting in loss sales, irate or frustrated customers, and potential lawsuits.

With many COVID-19 products, some companies mistakenly believe that their products (e.g., N95 respirators, face masks, gloves, test kits) are covered by some FDA blanket enforcement discretion, waiver, EUAs, or allowance for a certain category when, in fact, this was not the case.  For example, there has been some confusion about importing COVID-19 test kits after submission of an EUA.   While there is a mechanism that may allow some manufacturers to distribute tests before obtaining authorization (and after providing notice to FDA that the tests has been validated) for the product, unless the manufacturer has notified FDA that it intends to distribute a test, the test kit cannot be shipped into the U.S. until the agency has granted the authorization.   Submission of the EUA is not sufficient for the product to be imported into the country.  Therefore, distributors should have a good understanding of where the test manufacturer is in the process obtaining an EUA before entering into contracts to purchase tests kits from a foreign manufacturer.  While FDA was quickly reviewing EUA requests for tests kits at the beginning of the pandemic, after having so many issues with inaccurate test results, it is being more measured when it comes to authorizing new test kits.

AGG Observations

• Proactive planning, proper organization, careful and delivered attention to detail, and knowledge of (and compliance with) FDA’s requirements that apply to each product being imported can help mitigate these common mistakes.
• Many of these deficiencies are due to business pressures to move quickly but, as we all know, haste can make waste. Navigating FDA’s regulatory labyrinth is not easy on a given day, much less during a pandemic.  Companies should not make it harder on themselves by committing unforced errors.
• Any shipment that contains COVID-19 related products is more likely to be physically inspected by FDA. In order to minimize the chance of detention, importers should be proactive by including as much information about the products’ regulatory status in the documentation submitted at the time of import, particularly if importing pursuant to enforcement discretion or an EUA.
• Distributors and importers should have built-in protections in their purchase orders in the event that a product that they import into the country is determined not to be acceptable (e.g., test kit does not receive an EUA due to lack of validation data) and may need to be recalled.