Have you been watching?
Early in 2019, I traveled to New Jersey to attend a conference that was specifically conducted to inform the area importers of how the FSVP law was going into effect and what they needed to do to meet the regulation requirements. One of my co-speakers was John Johnson III, now of Counsel at Shook, Hardy & Bacon L.L.P.; at the time of the event, he was a Senior Associate Attorney at Benjamin L. England & Associates, LLC. One thing that John mentioned in his presentation was his experience watching the FDA in action with rolling out a new regulation. He referenced the approach they took with Seafood HACCP and Juice HACCP regulations and he predicted that the new FSVP (Foreign Supplier Verification Program) rule would be enforced similarly.
I typically do not mention the history of the regulations; especially when everyone is required to meet the requirement. However, it is important to understand how the law has been rolled out to see that he was exactly right!
According to the FDA website, The law first went into effect for larger businesses on March 19, 2017. And a majority of the businesses were required to meet the law requirements on March 19, 2018, however, some companies have until July 27, 2020 if they are qualified as a very small business and the foreign supplier qualifies for the produce safety applicable sprouts rule or is eligible for an exemption to the produce safety rule.
According to the publicly available Inspection Citation list on the FDA website, the first citations for FSVP [21 CFR 1.502(a) and 1.502(b)(1)] were initiated in June 2017. These citations were given as a form of "educational enforcement," meaning that the FDA only recorded that they visited these facilities and logged that they didn't have a plan in place, but did not give them a warning letter. Registrar Corp was quoted in a February 26, 2020 Food Safety News article stating that the most common FSVP citations to date are the following:
1. Failing to follow or maintain the FSVP
2. Failing to translate the FSVP into English when applicable
3. Failing to sign and date the FSVP upon modification
4. Failing to make adequate assurances of a supplier's food safety
The article states that the total reported citations issued are 354, however the citation list has a total of 771 logged between June 30, 2017 and Feb 5, 2020.
When John Johnson III presented at our mutual event in March 2019, he predicted that the FDA would take approximately 18 months from the initial educational visits before they would start issuing the Form 483a. The first Form 483a warning letter was issued on July 30, 2019 to Brodt Zenatti Holdings LLC. This is exactly 18 months from effective date for most businesses and it appears the FDA held true to the prediction.
So what has happened since this citation?
There have now been 9 warning letters issued related to FSVP:
7/30/2019 Brodt Zenatti Holdings LLC
8/27/2019 Agroson's LLC
12/31/2019 El Molino Bakery Supplies Inc
1/7/2020 Kohyo America, Inc.
1/21/2020 Swagath Home Foods LLC
1/21/2020 Dinamix Distribution, LLC
2/18/2020 Mission LLC
2/25/2020 Hindy Import Inc.
2/25/2020 Banjaras Inc
FDA is now requesting for information and giving 24 hours of time to respond. My connections are noticing a new trend though, it is escalating quickly. If you do not respond, you are at risk of getting issued a 483a (a warning) for not having an FSVP plan. Also if you do respond, expect that the FDA might show up the next day for your inspection instead of being able to schedule with them. They were scheduling as a courtesy, but this is no longer guaranteed.
If you are struggling with your FSVP and need help with it, our teams can help you! We have a tried and true method of sending questionnaires to suppliers and evaluating their responses. With your help to gather the appropriate documents and information from your foreign suppliers, we can do conduct the hazard analysis, write your FSVP plan, and work together with you to ensure you are in compliance to the rule requirements. Schedule a free consult if you would like to learn more about our program and how we can help you with yours!