Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. Below is additional information on FSMA.
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
Foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. Under the new law, FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in our approach to Food Safety. For example, for the first time, FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain. Preventive controls include steps that a food facility would take to prevent or significantly minimize the likelihood of problems occurring. The new law also significantly enhances FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.
The elements can be divided into five key areas:
- Preventive controls- For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.
- Inspection and Compliance- The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food; thus, the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
- Imported Food Safety- FDA has new tools to ensure that those imported foods meet US standards and are safe for our consumers. For example, for the first time, importers must verify that their Foreign Suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. Food Safety standards.
- Response- For the first time, FDA will have mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls.
- Enhanced Partnerships- The legislation recognizes the importance of strengthening existing collaboration among all Food Safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal Food Safety officials.
U.S. consumers enjoy the benefit of imported foods from more than 150 countries. The Food Safety Modernization Act (FSMA) gives FDA new tools to ensure that those imported foods meet US standards and are safe for US consumers. New authorities under the Act include:
Importer accountability – importers must verify that their Foreign Suppliers have adequate preventive controls in place to ensure safety
Third party certification – FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with US Food Safety standards;
High risk foods – FDA now has the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of admission into this country
Additional resources are directed toward foreign inspections
FDA now has the authority to refuse entry into the US of a food that has refused U.S. inspection.
This new law puts prevention up front for FDA. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. Under the Act, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required. FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues. Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary.
The FDA attorneys and consultants of C. Humphrey & Associates, P.A. represents domestic and international companies who manufacture, hold and distribute foods. Our FDA law firm provides regulatory representation regarding a range of regulatory food law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of food product development and marketing.
Our FDA law firm counsels clients regarding compliance with a variety of statutory and regulatory requirements and guidance documents covering foods including:
- Establishing Preventive Control Plans
- Foreign Supplier Verification Program
- Voluntary Qualified Importer Program (VQIP)
- Labeling and advertising in compliance with FDA and FTC requirements
- Establishment registrations under The Bioterrorism Act, including acting as U.S. agent for foreign facilities
- Recordkeeping and records access under FSMA
- FDA Import Alerts for Foods
- Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls
- FDA Inspections
- Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA criminal and civil penalties)