Warning Letter Provides Insight on FDA’s Priorities
By Of Counsel John Johnson III
The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety Modernization Act (FSMA)’s Preventive Control Rule. This is the requirement that a food facility must have and implement a written food safety plan to control known or reasonably foreseeable food safety hazards. Additionally, the warning reflects that FDA continues to prioritize seeking compliance with preventive controls and sanitation practices to avoid undeclared Major Food Allergens (which we discussed in A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens. The list has been expanded to include sesame, which we discussed in Look Beyond the Label: How the FASTER Act Impacts Food Manufacturing).
FDA has been relatively silent about the Preventive Control Rule in 2021, issuing only four Warning Letters directly on that topic. For context, FDA issued at least more than double that number of Preventive Control Rule warnings in 2020. In addition, this year FDA has issued 47 Warning Letters about a different FSMA rule: the Foreign Supplier Verification Program (FSVP), the requirement that importers perform a risk-based foreign supplier approval verification activity.
The numerous FSVP Warning Letters share a similar tune: FDA typically cites that the importer failed to have an FSVP and that they must create a compliant program. Although the FSVP process requires conducting a hazard analysis and evaluating the foreign supplier’s controls for the identified food safety hazards, FDA’s FSVP Warning Letters do not provide much insight into the agency’s opinion about which hazards require a preventive control.
In the Maribel’s Sweets letter, FDA not only cited the facility for not having a Food Safety Plan (which requires a hazard analysis) but also proceeded to perform a hazard analysis for the facility. This level of specificity provides valuable insight into FDA’s expectations given that draft Preventive Control Rule guidance was published in January 2018 and several important chapters have been “coming soon” for three years, including Chapter 11 (Food Allergen Controls).
This warning is a reminder that a facility should expect an FDA inspection after a recall, which also happened in two of the other three 2021 Preventive Control Rule Warning Letters. While FDA’s post-recall facility inspection will focus on the underlying issues associated with the recall (such as allergen controls and sanitation practice), FDA will look at the entire food safety and sanitation program for compliance. So while FDA was relatively silent in 2021 about the Preventive Control Rule and allergens in its Warning Letters, this end-of-the-year letter emphasizes that this remains a priority.
