In August, the US Food and Drug Administration announced plans to implement “re-examination” fees under the recently enacted Food Safety Modernization Act from importers who fail to comply with requirements materially related to food safety. Set to go into effect on October 1, the new fee structure will create additional costs and fees for both importers and consumers, according to Benjamin England, CEO of FDAImports.com and a former FDA employee.
The new process requires that at least two examinations of a food take place before FDA can assess an imported food fee. However, England says that because FDA has so broadly defined what constitutes as the "first examination," many imported food shipments that use FDA resources will be subject to the import fees. These re-examination fees will come to $224 per hour plus expenses, according to England, which will then be passed on to consumers in the form of higher food costs.
FDA provides four examples of when an importer can expect to pay a re-examination fee. These are: when imported food is reconditioned or relabeled; when an importer seeks release of an imported food under FDA detention; when an importer or foreign manufacturer petitions FDA requesting removal from FDA's import alert; and when FDA supervises destruction of FDA-refused food.
England says FDA's FSMA shifts how the group defines "examination" in two ways. The first is that FDA defines an "examination" outside the context used in the original, Food Drug and Cosmetic Act, and in its own regulations. FDA is over reaching its authority granted in the FSMA, according to England, by including activities involving shipments on import alert as part of those subject to re-examination fees, even when FDA’s own definition are detained expressly “without physical examination.” The second policy shift is that for counting FDA examinations to apply the fee, FDA focuses on imported food-generally, rather than a specific shipment of imported food. As a result, subsequent shipments of the original product put on import alert will also be subject to re-examination fees, according to England. Additionally, foreign manufacturers must pay FDA a fee to review a petition that seeks a product's removal from import alert.
England will speak about FDA's FSMA changes and other issues affecting the pet industry at the upcoming Virtual Petfood Forum on October 6. For more information or to contact Benjamin England, call +1.410.740.3403 or visit www.fdaimports.com.