FDA Shakeups Causing Import Enforcement Confusion: Former Official
NEWPORT, R.I. -- Restructuring at the FDA is causing confusion in the agency's approach to import enforcement, according to Domenic Veneziano, a former director of import operations at the agency.
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Veneziano, now an FDA consultant at Sandler and Travis, said that the Trump administration "came in with wrecking balls" to the FDA, leaving the agency with "individuals who don't understand, in my opinion, what it actually means under the law to have an appearance of a violation." This is causing the agency to place shipments on import alert and making products subject to detention without physical examination "without having a solid background," he said at the Coalition of New England Companies for Trade's (CONECT) Northeast Trade and Transportation Conference on Oct. 29.
Overall, Veneziano said that he sees "a lack of knowledge within the agency" about what an import alert or the appearance standard "really is." He said this is causing the agency to detain imports "without good knowledge."
Restructuring also is causing the agency to be overburdened, Veneziano said, because "they took all the compliance staff" that handled "the inspection aspects of it," and moved them to "the Centers," meaning the Center for Drug Evaluation, Center of Foods, and similar entities. Because they "absorbed all of the compliance aspects," the centers are now "making all the decisions on the import side," he said. The centralization is causing "a lot of delays," he said, and "what used to take a month to get an import removed from an import alert and a petition review, is now taking three months to get done."
Communication with the agency has become opaque due to the restructuring, Veneziano said, creating "a lot of frustration" for brokers as they try to determine who is responsible for detaining imports. In the past, he said, it was possible to make a phone call to "that port, to that district and know exactly who's handling that entry to try to get it released," but now it is "taking forever to try to figure it out."