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 United States. Second, FDA has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by FSMA, a step needed to implement VQIP. This post discusses both developments.
Imports
FDA Issues Draft Guidance on Refusal of Inspection by Foreign Food Establishments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The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections. In particular, FDA describes refusal to permit photography during an inspection as a refusal of inspection. We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign governments refuse inspection. FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.
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. We summarize these new data requirements below.
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 key topics discussed were the use of third-party certification bodies in regulatory decision-making, systems recognition, international capacity building, and commodity-specific exports and programs. We summarized some of the highlights from the hearing that may be of particular interest to food manufacturers and their trade associations. FDA has opened a docket for comments on the issues discussed at the hearing, which is open through May 16, 2017.
Click here to read the summary.