The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act (FSMA) regulations. Under the FSVP rule, importers must take steps to verify that their foreign suppliers produce food that satisfies U.S. food
Imports
FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for 2020 and Beyond
FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand food safety monitoring. The statement details how FDA would use requested funds, if provided by Congress, to build a “smarter, more technologically advanced…
Updated Chinese Tariffs Impact Food Products
By Martin Hahn, Xin Tao & Erika Ward on
China announced a second round of American products that could be subject to retaliatory tariffs between 10 to 25 percent. The proposed list would target $60 billion worth of additional United States products, including many food products. China has not yet identified the effective date in the event it implements these tariffs.
FDA Begins Accepting VQIP Applications and Recognizes First Accreditation Body under FSMA’s Accredited Third-Party Certification Program
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) has taken two important steps to launch the Voluntary Qualified Importer Program (VQIP) under the FDA Food Safety Modernization Act (FSMA). First, FDA has started accepting applications for participation in VQIP, a voluntary, fee-based program which offers expedited review and entry of human and animal food into the…
FDA Issues Draft Guidance on Refusal of Inspection by Foreign Food Establishments
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all…
Action Required: FSVP Implementation Triggers New Data Entry Requirements for All Imported FDA-Regulated Foods on May 30, 2017
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
There will be significant changes at the U.S. border starting May 30, 2017, that will affect all imported FDA-regulated foods—even if they are exempt from the Foreign Supplier Verification Programs (FSVP) regulation under the FDA Food Safety Modernization Act (FSMA). All food imports will be rejected at entry unless certain new information is provided to…
FDA Holds Public Hearing on Food Safety Import Strategy Under FSMA
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Kaitlin Welborn on
Earlier this month, the Food and Drug Administration (FDA) held a two-day public hearing that addressed the agency’s plans to engage in strategic partnerships to enhance the safety of imported foods. FDA used the hearing as an opportunity to ask questions of and learn from private entities and food safety authorities in other countries. The…