The verification of foreign suppliers as spelled out in the Food Safety Modernization Act is complicated enough that regulators and industry stakeholders are still figuring out the fine print, an expert says.
Larisa Pavlick, vice president of regulatory and compliance with the United Natural Products Alliance, spoke with NutraIngredients-USA at the recent SupplySide West trade show in Las Vegas, NV. Pavlick said the FSVP part of FSMA is a complicated section of the new law. The law was written with flexibility in mind, but in some ways that has complicated matters, Pavlick said. It’s still to be determined who is exactly responsible for what in the import of raw materials from overseas.
“FSVP affects our industry greatly,” Pavlick said. “FDA’s statistics say that more than 15% of our foods are coming from overseas. If you look at our industry itself, more than 80% of our raw materials are coming from foreign suppliers.”
Ingredient suppliers now fully part of regulatory system
According to a briefing conducted by FDA more than a year ago, dietary supplement companies in their domestic affairs are exempt from most of the aspects of FSMA (Part 117), as they are already required to comply with GMPs specific to their operations. But dietary ingredient suppliers, who up to now fell outside the purview of the Part 111 dietary supplement GMPs, will now have to comply with Part 117. And any company that is bringing in raw material from overseas, whether they are a broker, a distributor of its own branded ingredients, or a manufacturer importing direct from a foreign source, will have to deal with FSVP in some fashion. As Pavlick noted, this will in the end affect most of the industry.
“The challenge of FSVP is that it is now asking US companies that are receiving materials from around the world to verify that their foreign suppliers are meeting the expectations of US food safety rules,” Pavlick said. The verification activities have been explicitly spelled out in the rules, as has been the frequency of those activities. What remains still be fully worked out, she said, is how those are to be carried out. This could differ depending on whether the foreign supplier has specifications and performs release testing to determine if those specs are met, whether the specs are held by the importing entity in the US, or other factors.