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 Publishes List of FSVP Importers Under FSMA
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation. As discussed in the link below, this posting is a statutory requirement under the FDA Food Safety Modernization Act (FSMA). The list…
New U.S. food manufacturing, labeling, and inspection requirements – What you need to know to export foods to the U.S.
By Food Law Blog, Maile Hermida & Elizabeth Fawell on
Join us in London for a food seminar, “New U.S. food manufacturing, labeling, and inspection requirements – What you need to know to export foods ”
On 19 April, Hogan Lovells will offer a seminar on recent developments in U.S. food law that affect all food companies exporting food to the U.S.
U.S. partners Maile…
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…
FSMA Update: FDA Begins FSVP Inspections
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP compliance date was May 30, 2017, though FSVP importers may have later compliance dates for their various suppliers that are smaller sized businesses. Inspections started earlier this summer. In this post we provide a brief overview…
FSMA Implementation Update
By Joe Levitt, Elizabeth Fawell & Maile Hermida on
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA) of interest to the food industry. In this post, we summarize the following topics:
- Delayed start date for inspections for compliance with the preventive controls requirements under the Preventive Controls for Animal Food (PCAF) rule and under the Foreign
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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…