Using Software to Make Sure Food Suppliers Are FDA Compliant

One of those rules is the FSVP, which at its most basic level requires that the same food safety standards are applied to all foods sold in the U.S., whether they’re produced in Minnesota, Mexico, Morocco, or Montenegro. The program puts the onus on U.S. importers to verify that their foreign suppliers are producing food in a manner that provides public health protection and to ensure that the supplier’s food isn’t adulterated or misbranded with respect to allergen labeling.

The rule was formally finalized in 2015 and the first compliance date was set in May 2017, with compliance dates extending throughout 2020. According to the FDA, compliance dates for FSVP are based on:

• The foreign supplier’s size: Companies will have a longer amount of time to comply with FSVP rules when suppliers qualify as small or very small businesses. The FDA has helpfully provided a Small Entity Compliance Guide
• The company’s role in the food supply chain: Importers that are also manufacturers and subject to supply-chain provisions of preventive control rules should refer to compliance dates in those established rules. If this is applicable, then those rules may provide more time for compliance than the FSVP dates outlined on the FDA website.
• Whether suppliers are subject to other rules: Importers whose suppliers are already subject to preventive control or produce safety rules may also have more time to demonstrate compliance.

Evaluating Foreign Food Suppliers

Under the FSVP, importers are responsible for leading the evaluation of their foreign suppliers, which includes taking actions such as:

• Determining known or reasonably foreseeable hazards with each food.
• Evaluating the risk posed by a food, based on the hazard analysis and the foreign supplier’s performance.
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities.
• Conducting supplier verification activities.
• Conducting corrective actions.

“Hazards” are anything defined as being reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for the purposes of economic gain, such as substituting a less-costly ingredient. This could include:

• Biological hazards, such as parasites and disease-causing bacteria.
• Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens.
• Physical hazards, such as glass or metal.

If an importer finds that one of their foreign suppliers is at risk for nonconformity or is using processes and procedures that might put public health at risk, the importer must promptly take corrective actions. These actions could include discontinuing the use of that supplier until the cause of noncompliance has been addressed. Importers are also subject to their own set of conformities that ensure their quality and safety standards adhere to the FDA’s regulations.

Beyond investing in software, importers should also identify ways to prepare their suppliers for FSVP inspections, such as performing a mock inspection. By taking the time to walk through all the FSVP criteria ahead of time, importers will be able to pinpoint any challenges or quality concerns that need to be addressed before the FDA inspectors arrive.

While FSVP preparedness is undoubtedly time-consuming for suppliers and importers alike, it’s also critical to ensuring the safety of our products and, ultimately, our consumers. And although it’s essential that importers get themselves and their foreign suppliers ready for inspection as soon as possible, it’s even more important that they establish quality management best practices to consistently ensure the quality of the products they deliver to the public, support more efficient supply chain management, and instill consumer trust. Thankfully, with the right tools and processes in place, every company will be able to easily maintain compliance and product quality year-round.