Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers
Tags: admission, china, CIQ, compliance, contents, declaration, facility, FDA, FDCA, federal, Food drug and Cosmetic act, foreign, GMP, good manufacturing practice, health, import refusal, inspection, labeling, manufacturer, net quantity, origin, Quarantine, regulatory, report, united states, violation
FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public to be made aware of products that were found to appear to violate the FDCA. Fine.
But what happens when a foreign government reads the FDA Refusal Report page without intimate knowledge of the FDCA? Foreign regulatory bodies have, and will subject, manufacturers of FDA-regulated products to enforcement actions because the manufacturer merely appears on the FDA Refusal Report, whether or not the reason for the refusal related to (a) an issue concerning the health or safety of the product, or worse (b) whether or not the article complied with the law of the exporting country—and the law of the originally-intended country of origin—at the time of export.
In the first instance, a manufacturer may incorrectly list, for example, its Declaration of Net Quantity of Contents on a food label by listing the weight in milligrams, not avoirdupois pound and ounces. If FDA detects the error, charges the importer with violating the FDCA, and the error is not corrected, the article could be refused. If the article is refused, the manufacturer will appear on the FDA Refusal Report page, not because there is a health or safety risk associated with the product, nor because there may be current Good Manufacturing Practice violations to be concerned about. Because the manufacturer appears on the FDA Refusal Report page due to an uncorrected, highly-technical, labeling violation.
In the second instance, if a foreign regulatory body, such as China Inspection and Quarantine (CIQ) reviews FDA’s Import Refusal Report page and sees a manufacturer on the report, CIQ may engage in enforcement activities unrelated to the particular violation. For example, CIQ may revoke the export license of the manufacturer subject to a refusal and may conduct a facility inspection.
- Benjamin L. England, Founder