Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) is a 2011 U.S. law that moved FDA's food safety work toward preventing problems before people get sick. It is carried out through rules on preventive controls, produce, imports, transport, food defense and traceability.

  • Food safety
  • Rules, recalls & traceability

Also called: FSMA

FSMA is a federal law that President Obama signed on January 4, 2011. It gave the U.S. Food and Drug Administration (FDA) new authority and led to a set of rules. These cover good manufacturing practices and preventive controls for human food, produce safety, foreign supplier verification for importers, sanitary transportation, protection against intentional adulteration, accredited third-party certification, laboratory accreditation, agricultural water and extra traceability records for certain foods. The preventive controls rule applies to food facilities that must register with FDA. That group leaves out private homes, restaurants and retail food stores, which state and local agencies oversee instead.

FDA describes FSMA as putting prevention ahead of reacting to outbreaks. Covered facilities have to study the hazards in their products, put written controls in place, confirm the controls work and keep records that prove it. The law also gives FDA stronger enforcement tools, including the power to order a mandatory recall of violative food. For a bakery that sells to stores or distributors, FSMA rules shape the paperwork that inspectors and buyers may ask to see.

Key facts

Signed into law
January 4, 2011
Preventive controls compliance, large businesses
September 19, 2016
Very small business threshold
Under $1 million average annual food sales (inflation-adjusted)
Food safety plan reanalysis
At least once every 3 years

In a bakery or commercial kitchen

  • Find out whether your operation must register with FDA, since registered facilities fall under the preventive controls rule unless an exemption applies
  • Write a food safety plan with a hazard analysis, preventive controls, monitoring, corrective actions, verification and, when needed, a recall plan
  • Have a preventive controls qualified individual (PCQI) prepare or oversee the plan and redo the analysis at least every three years
  • Check whether average annual food sales under $1 million (inflation-adjusted) make you a qualified facility that files an attestation with FDA instead
  • Follow the updated good manufacturing practices, which now spell out allergen cross-contact controls and binding staff training requirements

For home and cottage bakers

  • A private home is not an FDA 'facility,' so a home kitchen does not register with FDA
  • Cottage food sellers mainly follow state and local rules, so check with your health department before you start selling
  • For shoppers, FSMA mostly works behind the scenes through supplier checks, written records and FDA's power to order recalls

Related entries

Sources

Written by VanillaGoods in our own words from these sources. Last reviewed October 17, 2026.

  1. Food Safety Modernization Act (FSMA), U.S. Food and Drug Administration
  2. Frequently Asked Questions on FSMA, U.S. Food and Drug Administration
  3. FSMA Final Rule for Preventive Controls for Human Food, U.S. Food and Drug Administration
  4. 21 CFR Part 117 Subpart C: Hazard Analysis and Risk-Based Preventive Controls, Electronic Code of Federal Regulations (eCFR)
  5. How to Start a Food Business, U.S. Food and Drug Administration