FDA Eyeing Increased Compliance With FSVP Program, Agency Official Says
SAN DIEGO -- The FDA is ramping up scrutiny on food importers that aren't fully complying with Foreign Supplier Verification Program requirements, said Dan Solis, assistant commissioner for import operations with the agency's Office of Regulatory Affairs.
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“The major reason for a lot of noncompliance with FSVP is not having an FSVP program at all. For legislation that’s been out since 2011, that’s not an excuse anymore, and we’re going to elevate up our enforcement action for those who continue to not have an FSVP program and you’re importing food into the United States,” Solis said during a panel discussion with representatives of other partner government agencies at the Western Cargo Conference last week.
Actions that the FDA could take for noncompliance include barring the company from importing into the U.S. or revoking a company’s registration information, Solis continued. Because the agency is planning to increase its FSVP enforcement, brokers should message clients, which may not be aware that they don’t have an FSVP program but should be part of it, he said.
Solis also said the FDA is looking at ways to “entice” industry to participate in the VQIP program, potentially tying it to partnerships such as CBP's Customs-Trade Partnership Against Terrorism (CTPAT). There are currently only five participants in the FDA's trusted trader program, which has been in place since 2020.
Meanwhile, importers should be seeing the effects of the FDA's latest internal reorganization. Under the FDA Office of the Commissioner are two newly created offices, the Office of Inspections and Investigations (OII), which is Solis’ office, and the Human Foods Program. The Food Centers and the Food Laboratories have been incorporated into the Human Foods Program (see 2302030055), while the Office of Cosmetics and the Office of Medical Products and Specialty Laboratory Operations are in the Office of the Chief Scientist.
The Human Foods Program encapsulates any food-related activities under the FDA, while the Office of Cosmetics will track importers’ compliance with new requirements that are part of the Modernization of Cosmetics Regulation Act of 2022, or MoCRA (see 2309050042).
Lab results will also be coming from different offices now and not the brokers’ local FDA office, according to Solis’ presentation.
“When investigators go to your firm to collect the sample, where does it go? It goes into a Food Lab or Chemistry [Lab]. Those labs are no longer attached to our Office of Regulatory Affairs or OII,” Solis said.
This latest reorganization kept the Office of Import Operations intact, which bodes well for customs brokers because it ensures that expediting legitimate trade compliance functionality and decisions remain with the broader Office of Inspections and Investigations, according to Solis.
Within the OII, one of the changes is that the Division of Food Defense Targeting, which receives all the imported food notices per the Bioterrorism Act, is now being called the Division of Targeting Analysis, according to Solis.
“Not only [is this division] doing more data analysis and intelligence research- or risk-informed decision making, but they’ve been able to get pre-manifest data and evaluate and analyze that. So that means pre-entry, a lot of that information is being supplied” to CBP’s Commercial Targeting and Analysis Center, Solis said.
“It was very beneficial for us, especially during COVID, to have this division looking at beyond just food. I think we can all remember the critical medical product supplies that needed to get to the healthcare providers, vaccines, [personal protective equipment] PPE, even the COVID test kits -- those needed to be cleared faster. One of the divisions that we were able to facilitate many of those transactions was our Division of Target Analysis. And because of that expansion ... we truly saw the benefit of 24/7 operation at this division.”
As a result of these changes, Solis urged customs brokers to pay attention to annual renewal deadlines in case the websites give a different deadline.
“The websites may have changed in the way you used to access those deadlines. Deadlines may change, dates may change, the office name may change, including email addresses, but the contact phone numbers should not change,” Solis said. He said the old FDA email addresses should still function even though there might be changes to the email addresses, too.