Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an import and export program.
The CBP’s new Automated Commercial Environment (ACE) computer program has carried out several changes to the process of import logistics and information reporting for FDA regulated products. The alternatives to noncompliance with the requirements of the ACE program: A shipment may be stopped before it is even loaded at the foreign port. Ships that refuse to or fail to use the ACE program also carry a fine of up to $10,000 for every offense.
Or, when the FDA detains a company’s product; it will begin an expensive and time-consuming legal process. Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process can expect to have their shipments detained.
One more area that poses a challenge for importers is when the FDA decides that they should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold. In such a scenario, companies that go through this process attract a fine that is three times the value of the shipment. This is in addition to the other adverse legal concerns and strategies that are attached to this action. Overall, the costs of not complying with the FDA’s guidelines on imports can be very high and can carry very expensive consequences for importing companies.
There are positives, too
However, not all is lost. The FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. Aimed at incentivizing importers who instill a high degree of confidence about the quality of food they import; the nub of this plan is that it establishes an FDA-supervised, fee-based program that expedites the review and importation of foods from importers who can show a heightened level of control over the safety and supply chain aspects of the imported food items.
Another convenience that the FDA offers is export certificates. Obtainable for a modest fee; these certificates may give an importer a competitive advantage in foreign markets. An FDA export certificate is actually a requirement by a few foreign governments.
Full learning on the FDA’s new import rules for 2017
All the aspects of the new FDA import rules will be taught at a highly absorbing two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.
Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health, where he developed enforcement actions and participated in the implementation of new statutory requirements for FDA; will be the speaker. to enroll for this course, please visit Professionals Involved in The FDA’s Tougher Import Rules for 2017. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Casper will impart learning on all these topics and on the ways by which to avoid these and related common problems that can become terribly expensive when a proper strategy and plan for dealing with them are not implemented. Importers need to put in place an established and effective business planning, whose ways will be shown at this seminar. A bonus of this course is that the speaker will also include tips on how to understand FDA’s thinking and offer anecdotal examples of FDA’s import program idiosyncrasies. He will also explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.