How it works
FDA’s New Authority Under FSMA
1. Administrative Detention
FSMA dramatically impacts the administrative detention regulations. Prior to FSMA the statute required “credible evidence or information” of serious health hazards. This limited the administrative detention tool to scenarios of repeat violators or glaring violations. FDA agents now simply need a “reason to believe food is contaminated or misbranded” to open an investigation. Now any suspicion of adulteration or misbranding might result in a 30-day FDA hold.1,2
2. Records Inspection
FSMA significantly increases the number of records that food companies must keep. FSMA also increased FDA’s jurisdiction to gain access to records. The FDA now has the power to require food manufacturers to divulge information on potentially harmful foods. This jurisdiction extends to inspecting documents that are suspected of posing a health risk. The records inspection demands are in addition to the records that are needed by the seven core rules or by GMPs.1,2
3. Mandatory Recall
Prior to FSMA, the Agency would need a court order to compel a recall if a company refused to do so. In most cases, time is critical and going to court may waste valuable time. The FDA can now demand a recall without a court order under FSMA.
FSMA added Section 206 to the Act which provided the FDA authority to force a recall in specific instances after giving a company the option to request a voluntary recall. A mandatory recall is now in itself a threat to coerce action. The FDA will first provide a company with the option of conducting a voluntary recall.1,2
4. Suspension of Food Facility Registration
Prior to FSMA, a facility’s registration could not be suspended under any circumstances. A facility registration is important as it allows a facility to sell while also allowing the FDA to monitor what facilities to inspect. The FDA now has expanded jurisdiction under FSMA Section 102 to suspend a facility’s registration if there is a “reasonable risk” of serious health concerns or death. The suspension has the practical consequence of shutting down a facility’s operations, which means it can’t sell, produce, or market its products while it’s in place.1,2
5. Authority to Deny Entry
Under FSMA, if a food producer in another country does not permit FDA to inspect its facility, FDA can refuse to allow food from that facility into the United States.
Seven (7) foundational rules of FSMA
The heart of FSMA lies in the seven foundational rules. These rules were carefully developed over 4–5 years and fundamentally change the food safety landscape; these are:
- Preventive Controls for Human Food (PCHF) Final Rule
- Preventive Controls for Food for Animals (PCAF) Final Rule
- Standards for Produce Safety Final Rule
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Final Rule
- Accredited Third-Party Certification Final Rule
- Sanitary Transportation of Human and Animal Food Final Rule
- Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule
The seven foundational rules dramatically increase the regulatory burden on food companies to take appropriate measures to prevent food contamination and document their compliance.
The PCHF, PCAF, Produce Safety Final Rules, and FSVP, each require a hazard analysis for the purpose of preventing adulteration. The Sanitary Transportation Final Rule and Intentional Adulteration Final Rule are narrowly tailored to a specific issue, and the Third-Party Certification Final Rule governs third-party auditors.
Summary of PCHF, PCAF, FSVP, and produce safety final rules
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR Part 117)
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 CFR Part 507)
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR Part 112)
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (21 CFR part 1, subpart L)
- U.S. Food and Drug Administration, Food Safety Modernization Act (FSMA), https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma, Accessed 10 January 2022.
- Sanchez, M.C. “The Food Safety Modernization Act.” Food Law and Regulation for Non-Lawyers. A US Perspective, 2nd edition, Springer International Publishing AG, 2018, pp. 167–204.