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FDA’s Issues Guidance on Mandatory Recall Authority

Mandatory Recall Authority for Foods

FSMA gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

The FDA issued final guidance answers the most common questions regarding FDA’s mandatory recall process, explains what FDA considers when moving forward with a mandatory recall, and more. See below for a few of the most common questions.

What foods are subject to the FDA’s mandatory food recall authority?

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FDA Releases Information for Qualified Facilities under Preventive Controls Rules

September 14, 2018

Today, the U.S. Food and Drug Administration issued documents designed to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a “qualified facility” under those rules, and if so, what modified requirements are applicable to such facilities.

A qualified facility is generally a business that, because of its very small size, is to only modified requirements under the FDA Food Safety Modernization Act. (All facilities remain subject to current good manufacturing practice requirements.)

The first document is a guidance to help food facilities determine whether they meet the definition of a qualified facility under one of two FSMA rules: the Preventive Controls for Human Food (PC Human Food) or Preventive Controls for Animal Food (PC Animal Food) Rules.

Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.

The required attestation forms, Form FDA 3942a for facilities subject to the PC Human Food rule, and Form FDA 3942b for facilities subject to the PC Animal Food Rule, are also being released today along with instructions on how to fill them out and how they should be submitted. In addition, starting October 1, facilities will be able to submit these attestation forms electronically at https://www.access.fda.gov via the Qualified Facility Attestation Module. Please note that facilities must first create or have an existing FURLS account to access the module. Also, facilities must have a valid food facility registration to submit their attestation.

Facilities subject to the PC Human Food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018. Facilities subject to the PC Animal Food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019. Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.

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Are You a Food Facility Required to Register?

Today, the U.S. Food and Drug Administration released is the seventh edition of a guidance which answers several questions around the following topics:

1. Who Must Register
2. Who is Exempt
3. Definitions of Food
4. Holding Facilities
5. Trade Names
6. US Agent for FDA Registrations of foreign food facilities
7. When to register and renew your FDA registration
8. Unique Facility Identifier Number (October 2020)
9. Updates and Changes to FDA Registration
10. Is Food Registration information publicly available?

Who must register under the food facility registration requirements?

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U.S. FDA—FSMA Update July 2018

Food Safety Modernization Act

Most of the U.S. FDA rules under the Food Safety Modernization Act (FSMA) are finalized and compliance dates are in effect. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The law also provides the FDA with new enforcement authority designed to achieve stronger compliance and allow the FDA to better respond when problems occur. Imported food are now held to the same standards as foods produced in the United States.

Here, we provide a summary of several important deadlines and requirements.

  1. Registration and renewal of food facilities – (FFR)
  2. Preventive controls for human and animal food – (PCHF Rule)
  3. Foreign supplier verification programs – (FSVP Rule)
  4. Prevention of intentional adulteration of the food supply – (IA Rule)

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Small Entity Compliance Guide (SECG)

Small Entity Compliance Guidance for Human and Animal Food facility registrations issued by FDA, May 25, 2018

The U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The SECG explains which types of food facilities are required to register with the FDA, when and how to register. The guide also outlines the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. Note that it is the food facility that must be registered, not related trading companies. Continue reading