The recent warning letter was addressed to Rainfield Marketing Group, based in Vernon, CA. The letter related to a recall that the importer had issued on enoki mushrooms that the company had sourced from S. Korea. A California Department of Health test found the shipment was contaminated with Listeria monocytogenes. The importer issued a voluntary recall in July 2021.
Enoki mushrooms were associated with a large scale incidence of Listeria contamination, an episode which seemed to have concluded in 2020. However, the mushroom species continues to be a substance of concern, with recalls because of Listeria contamination recorded in 2021 and again earlier this year.
FSVP compliance failure
In the Rainfield case, FDA discovered in a subsequent inspection that the company was not in full compliance with the Foreign Supplier Verification Program (FSVP). This is a provision of FSMA, the Food Safety Modernization Act, which became law in 2010 and was implemented in stages over the following years. FSMA has been called the most sweeping revamp of food safety regulation in the United States since the 1937 inauguration of the Food Drug and Cosmetic Act itself.
FSVP requires companies to evaluate the safety procedures of their suppliers and verify that controls have been put in place to mitigate known risks. In the case that these suppliers are complying with local food safety laws, FSVP requires that the US importer document how that safety regime is equivalent to US requirements.
Why supplement companies need to pay attention
While many of these FSVP failures relate to food shipments, dietary supplement companies, especially ingredient suppliers, need to take notice, too. Dietary ingredient suppliers were exempted from the Dietary Supplement Health and Education Act, the overarching regulation for the dietary supplement industry. FSMA has closed that loophole.
“FSMA addresses what the potential risks are and how they are being managed. We have to have processes in place to verify how those are being dealt with via preventive controls, and we have to verify that with an audit or record review,” said Larisa Pavlick, vice president of compliance and regulatory fo the United Natural Products Alliance.
“Within our industry you hear about how you’ve done testing and then you released the product. Under FSMA we have to go one step further up the supply chain to verify that something is working. We can’t just do micro testing then say the shipment is clean,” she said.
Another issue that came up in the Rainfield warning letter was an inspection that had been promised but that was not documented. Pavlick said she always warns clients to not promise things they can’t or don’t intend to deliver, because it is something FDA will always look for.
“When you do a written response to a regulatory communication, if you say you’re going to do something, you’d better do it, and document that you did it,” Pavlick said.