The Foreign Supplier Verification Program (FSVP) was created under the 2011 Food Safety Modernization Act (FSMA) with President Obama. The idea behind the FSVP is to put more burden on importers to verify the food safety compliance of their foreign suppliers.
The Food and Drug Administration (FDA) finalized FSVP regulations in 2015 and then began “educational phase” enforcement in 2018. Real enforcement began in the summer of 2019 with the FDA issuing its first FSVP Warning Letter and creating a new import alert for the FSVP: Import Alert 99-41.
Now importers without a compliant FSVP plan will be subject to a public Warning Letter and possible placement on Import Alert 99-41, which will cause the FDA to detain and likely refuse all specified imported products consigned to that importer.
Because a petition and/or reinspection will be required before the goods can overcome the charges in the import alert, placement on the FSVP Import Alert could function as a full ban on some or all of the importer’s products until a petition is submitted and granted.
The best way to avoid this fate is to hire an attorney that is qualified to help you develop a complaint FSVP plan.
The FSVP is just a foreign supplier qualification program. Under FSVP regulations, the FDA requires that importers verify that their foreign suppliers conform to FDA food safety regulations and FSMA’s Preventative Controls (or that they follow procedures that provide the same level of food safety).
Therefore, the most critical components of the FSVP are evaluating your supplier’s food hazard controls, evaluating their overall compliance, and incorporating a verification step (such as on-site audits or testing) to determine actual compliance.
The FSVP is a paperwork regulation. Consequently, good record-keeping is central to a successful FSVP plan.
This is especially true for documenting not only the initial evaluations, but also documenting the required periodic reevaluations and corrective actions when compliance issues arise over the years. If you have not documented a compliance activity, then the activity did not happen according to the FDA.
Companies need to work with a qualified individual who has the training, experience, and education necessary to carry out the FSVP requirements. An FDA attorney can act as a qualified individual or help direct your qualified individual – who will need to develop and help you carry out your FSVP plan, including performing hazard analysis and reevaluations.
All importers subject to the FSVP will be subject to an FSVP inspection at their offices. Having your plan in place and solidly documented will make an inspection go much smoother.
FSVP Importer – The entity responsible for complying with the FSVP. The FSVP definition of “importer” is different from the U.S. Customs “importer of record” (the person responsible for the compliance of imported goods, filing documents, and payment of duties).
The FSVP importer is (1) the U.S. owners or consignee of the imported food at the time of import, or (2) absent a U.S. owner, the U.S. Agent of the foreign owner or consignee. The U.S. Agent must have signed a statement agreeing to be the FSVP importer.
Hazard Analysis –An evaluation of certain food hazards (biological, physical, or chemical) including dangerous bacteria, pieces of metal, or harmful chemicals. This is coupled with an evaluation of the adequacy of controls implement based on the likelihood and seriousness of the hazards.
Preventative Controls – The short name for Hazard Analysis and Risk-Based Preventive Controls. This consists chiefly of a written food safety plan, hazard analysis, a recall plan, and preventative controls calculated to minimize or eliminate hazards.
Warning Letter – A public official warning that documents the FDA’s allegations that your operations and/or products violate the law.
Import Alert – An FDA-created list of companies and/or countries that have known compliance problems. The FDA uses Import Alerts to automatically detain (without evidence) specified products from companies or countries listed on the alert.
We are qualified individuals that can help you navigate the FSVP. This includes developing a new plan, evaluating your current plan, responding to a Warning Letter, getting you removed from an Import Alert, or representing you during an FDA FSVP inspection.
Given the current FDA move toward harsher and harsher FSVP enforcement, you need an experienced partner to help you stay ahead of the compliance curve.
Take the first step to freedom and schedule a call with us today.