The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections.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 We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign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 FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.

Click here to read more.

FDA recently shared information regarding a number of ongoing FDA Food Safety Modernization Act (FSMA) implementation issues. This post summarizes updates and developments regarding the following matters:

1. The written assurance requirements under several FSMA regulations;
2. Industry concerns regarding the Intentional Adulteration regulation;
3. Regulation of human food by-products for use as animal food when these materials are further processed to facilitate storage and distribution;
4. Various initiatives regarding implementation of the Produce Safety rule; and
5. Compliance with the Sanitary Food Transportation rule.

Click here to read more.

The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food on its behalf and, as explained below, will affect contracts between brand owners and co-manufacturers, and brand owners and suppliers.

Click here to read more.

FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules. Second, FDA finalized its Guidance on current Good Manufacturing Practice (cGMP) requirements for animal food. Third, FDA developed a training program for carriers who are subject to the Sanitary Food Transportation rule. Finally, FDA released a new web page that lists compliance dates for rules that form the foundation of FSMA.

Read more.

There have been several notable recent developments involving FSMA implementation. Most significantly, FDA proposed to extend the compliance dates for the agricultural water provisions of the Produce Safety rule and announced it will delay the start of Produce Safety rule inspections until spring 2019.  Additionally, FDA has issued another chapter of its Preventive Controls for Human
Foods (PCHF) draft guidance, which addresses the use of heat treatment process preventive controls.

In addition to summarizing these developments, this post also provides a reminder that the next round of FSMA compliance dates for the Preventive Controls rules is September 18, 2017.  Read more.

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 of how these inspections are progressing based on the inspections we have learned about.

Read more.

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 Supplier Verification Programs (FSVP) rule for animal food importers;
  • Guidance for low-acid canned food (LACF), seafood, and juice manufacturers regarding compliance and exemptions under FSMA;
  • Updated domestic and foreign reinspection fee rates for fiscal year (FY) 2018;
  • Release of new Food Safety Plan Builder software to assist with development of food safety plans; and,
  • Clarification regarding the definition of “retail food establishment” for purposes of the waiver from requirements under the Sanitary Transportation of Human and Animal Food rule.

Click here to read our update.

There have been several recent developments regarding implementation by the Food and Drug Administration (FDA) of the FDA Food Safety Modernization Act (FSMA) that should be of interest to the food industry. In this post, we summarize the following topics:

  • Regarding imports:
    • FDA’s recognition of Australia’s food safety system as comparable to the United States, which allows for modified Foreign Supplier Verification Programs (FSVP) requirements of certain foods imported from Australia;
    • Information from FDA to importers about key things they need to know about compliance with the FSVP rule and what to expect during upcoming inspections;
    • Launch of a website where organizations can apply for recognition as a third-party accreditation body.
  • Information from FDA on the agency’s implementation of the Sanitary Transportation of Human and Animal Food (Sanitary Food Transportation) rule;
  • FDA’s plans to extend the compliance dates for the agricultural water requirements of the Produce Safety regulation; and
  • Inflation-adjusted values applicable to several very small business-related definitions used in the FSMA rules.

    Click here to read more.

May 15, 2017, was the “stand up” day for the Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) new organizational structure under its Program Alignment initiative. The Program Alignment initiative began in 2013 as an effort to modernize and strengthen the agency’s workforce and to improve public health response. A key aspect of the Program Alignment initiative is a shift from the current geography-based district offices to program-specific “division” offices where staff are aligned by FDA-regulated product – i.e., there will now be distinct food-based offices, inspectors and labs and distinct medical products-based offices, inspectors and labs. This means that, over time, food companies will be inspected by individuals trained in food inspections, not drug or device inspections. This increase in specialization is intended to create a more proficient workforce and increase the efficiency of FDA operations.

With the change to program-specific division offices, some of the former district offices have been merged together. Practically speaking, this means that for some food companies, the contacts in their respective division offices may have changed. Other key changes under the Program Alignment initiative include a reorganization of the import program, state cooperative programs, and FDA’s field laboratories, and the creation of a Produce Safety Network. We have provided an overview of the key organizational changes at ORA that impact the food industry.

Click here to read more.

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.

Click here to read more.