FDA is the federal agency that is responsible for overseeing most of the U.S. food supply. FDA is responsible for protecting the public health by ensuring the safety and security of our nation’s food supply; this is a vital part of FDA’s mission and a primary task of FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The U.S. FDA Food Safety Modernization Act (“FSMA”) gives the FDA greater authority to prevent food safety problems and concerns and increases the agency’s enforcement powers to achieve higher rates of compliance with the law’s requirements. The FSMA also gives FDA new powers to hold imported foods to the same standards as domestic foods and to suspend food facility registration numbers for non-compliance.
The FDA has several requirements for domestic and international facilities. A significant requirement is that all domestic and foreign facilities that manufacture, process, pack, or hold food or beverages for importation or distribution in the U.S. update their registration with the FDA biennially. This must be followed to avoid suspension of your facility registration and delays upon importation.
Our pre-compliance services for food products include product and label review, U.S. Agent services for foreign food facilities registration with the FDA, and potential registrations with the FDA.
Our team ensures that:
- Food and beverage labels comply with FDA’s laws and regulations,
- All required nutrition and ingredient labeling requirements are included,
- Layout and design restrictions are met,
- You are advised of any non-compliant claims on your product, and
- You are advised of color additive rules and compliance with certification requirements.
- You are meeting registration requirements
- If you act as the Foreign Supplier Verification Program (FSVP) Importer, you have a FSVP plan in place
Foreign Supplier Verification Program (FSVP) Services
The U.S. FDA Food Safety Modernization Act (FSMA) provided the FDA greater authority to prevent unsafe food from entering the U.S. and increased the FDA’s enforcement powers. The FSMA also gave FDA the power to hold imported foods to the same standards as domestic foods and to suspend a food facilities registration for non-compliance.
One of the many requirements under FSMA is that food importers (or their agents) must develop a Foreign Supplier Verification Program (FSVP) to provide adequate assurances that their foreign suppliers are producing compliant food. Importers covered by the FSVP regulation must put in place foreign supplier verification programs (FSVPs) to verify that their foreign suppliers are producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls (for human or animal food) or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling (21 CFR 1.502(a)).
For more information on FDA requirements visit FDA’s website on importing food here.
A qualified individual must develop your FSVP. This qualified individual must have the education, training, or experience (or combination thereof) necessary to perform the activity, and must be able to read and understand the language of any records reviewed in performing an activity.
A Preventive Controls Qualified Individual (PCQI) is a person that has successfully completed adequate training or is otherwise qualified through job experience to develop and implement a food safety plan. A PCQI manages important aspects of the food safety program and ensures that preventive controls are effective and proper records are maintained. Diaz Trade Law has trained PCQI specialists that are qualified to develop, review, and/or implement your FSVP.
FDA is actively performing FSVP inspections. Many inspections are resulting in warning letters as the importers do not have the required FSVP in place. Diaz Trade Law can assist you in preparing for your FDA inspection, working to develop, review, and/or implement an effective FSVP so that you are prepared for your FDA inspection.
Want more information? Check out our webinar: “Importing Food in Compliance with U.S. FDA and Surviving a FSVP Audit.”
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