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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…

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…

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…

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…

The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all…

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…

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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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 …

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…