FDA Posts Overview of Its Entry Process, Detention, Sampling, Etc.
The Food and Drug Administration has posted a November 30, 2011 presentation with a broad overview of its import operations and how it regulates imported products. It describes in general terms the statutory authority of Section 801 of the Federal Food Drug & Cosmetic (FFD&CA), FDA's entry review process, detentions, examinations and sampling, refusal of admission, etc.
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FDA Can Refuse Entry Based on Appearance of Violation from Exam or Otherwise
FDA states that Section 801 of the FFD&CA on imports and exports provides FDA with its general statutory authority to refuse admission to imported FDA-regulated products.
FDA has this authority if it appears from the examination of the article or otherwise that it: (i) has been manufactured, processed, or packed under insanitary conditions; or (ii) is forbidden or restricted in sale in the country in which it was produced; or (iii) is adulterated (such as by containing a substance that makes a product inferior, impure, not genuine, etc.), misbranded (falsely or misleadingly labeled), or in violation of section 505 (New Drugs).
FDA notes that the “or otherwise” part of this authority means that FDA can also refuse admission based on historical data or information or evidence from other sources.
FDA Evaluates Admissibility & Can Release, Examine, Request More Info, or Detain
FDA states that after entry of an FDA-regulated product is made to U.S. Customs and Border Protection, CBP forwards it to FDA to begin its admissibility process. FDA entry reviewers have several options. They can release the product; request an examination of it; request additional information or documents; or recommend detention of the product.
If Examined, FDA Looks for Filth, Packaging Defects, Misbranding, Etc.
If the product is examined, FDA field personnel look for evidence of filth, decomposition, packaging defects, mishandling of products, misbranding, etc. Such exams may uncover the “appearance” of violations.
May Send Product to Lab for Further Analysis
If field personnel decide to collect a sample for further review, it is packaged and shipped to the appropriate laboratory for analysis.
“Detention & Hearing” Begins if Apparent Violations Found in Exam or Sampling
If apparent violations are discovered during examination or sampling, the Detention and Hearing Process begins.
Import Alerts. FDA adds that its Import Alerts provide information to the field offices that can be used to detain goods without having to actually examine or sample them. This keeps FDA from having to examine and sample products over and over. Products stay on an Import Alert until the firm proves it can produce a compliant product.
Sends Detention Notice to Importer/Consignee with Reasons, Timeframe, Contact
FDA sends a Detention Notice to the importer and consignee which indicates its belief that the articles are subject to refusal. FDA will state its reason(s) and note the right to provide testimony or evidence to refute FDA’s claims. The Detention Notice will also provide a timeframe for response and an FDA contact name and number.
Importer Can Present Evidence to Refute Violation, Ask to Recondition Product
FDA explains that its detention of a product is an administrative process and not a physical hold of the product. This means that the importer has the right to take possession of the article.
The importer also has the right to give evidence to refute the appearance of a violation which caused the detention. In addition, the importer can petition FDA to recondition the goods to bring them into compliance. This could include relabeling a misbranded product, cleansing an adulterated product, etc. Any reconditioning must be approved by FDA.
FDA Either Lets Detention Stand (Refuses Admission) or Overturns It (Releases Product)
Based on the evidence and whether the product can be brought into compliance, the detention will either stand (and the article refused admission) or be overturned (and the article released).
If the product is released, it may be distributed. However, FDA still has jurisdiction over the product, and release does not preclude future FDA action if a problem is found later.
Refused Products Must Be Exported or Destroyed
FDA states that refused products must either be exported or destroyed and that civil penalties apply if they are not. In addition, FDA notes that it also has the authority to seize products and then seek their destruction through court order if certain conditions are met.