FSMA primarily affects companies operating in the food sector but is important for dietary supplement firms to understand as well. For the first time dietary ingredient suppliers will be responsible for their supply chains in a way that supplement manufacturers have been since the advent of GMPs in 2007, and many manufacturers produce foods and beverages in addition to supplements.
The US Food and Drug Administration (FDA) recently finalized two new rules under FSMA that require food facilities and importers of food and beverages to monitor and document the compliance status of each supplier, "including FDA warning letters or import alerts relating to the safety of food and other FDA compliance actions." The two new rules, the Preventive Controls and the Foreign Supplier Verification Program (FSVP) rules, are part of FDA's implementation of the Food Safety Modernization Act (FSMA). Importers who wish to participate in FDA's Voluntary Qualified Importer Program (VQIP) must also monitor their suppliers, as VQIP importers may not import any food subject to an FDA Import Alert or Class I Recall.
Keeping up with new demands
The FDA Food Safety Modernization Act (FSMA) is the most sweeping reform of the US food safety laws in over 70 years, and shifts the focus of the US food system from responding to contamination to preventing it. President Obama signed it into law on January 4, 2011. For more information, please click HERE.
Consulting firm Registrar Corp assists companies with FDA compliance issues and also helps foreign companies import into the US market. The company acts as an agent of record for a number of foreign firms and in that guise has had first hand experience with the labyrinthine nature of keeping up to speed on what’s happening with companies overseas. That experience helped the develop its new tool, called FDA Compliance Monitor, which is a one-stop shop of sorts for searching records of foreign companies interactions with US regulatory authorities.
“We are the communcations link between FDA and 11,000 foreign food facilities. We were first addressing a problem we had internally. We had no good way to monitor 11,000 suppliers,” David Lennarz, vice president of Registrar Corp told NutraIngredients-USA.
“The way a company would have to do it today or the way we were doing it prior to our solution, to monitor the compliance status of a US or foreign supplier you’d have to look at multiple databases, which could change the moment you close your web browser. Our compliance monitor aggregates all that information into one screen—warning letters, import alerts, inspection certificates, and so forth,” he said.
“These new FSMA rules require you to monitor your suppliers so that you can document you are aware of the potential hazards in your supply chain,” said Brendan Sampson, manager of the program. “The reports are printable and can be stored to provide proof of a company’s compliance with the monitoring aspect of FSMA.”
Real time monitoring
Lennarz said the tool can be used to set up alerts in the change of a supplier’s status. The tool can help a manufacturer, importer or retailer more effectively manage their relationship with their suppliers. Even outwardly good supply relationships, like good marriages, can conceal unwelcome secrets.
“People like to think they have these great relationships with their suppliers. The truth of the matter is that we see all the time that companies will not share information readily. We actively search out information to add to our databases, including through FOIA (Freedom of Information Act) requests. People are not always forthcoming with information, especially when it is negative information,” Lennarz said.
The tool can also be helpful to the suppliers themselves, who often might unaware in real time of a change in their own status, Lennarz said. If shipments are impounded, for example, it can often take time for that information to make its way back to the original source of that shipment, and that can sometimes come as a nasty surprise. After a supplier releases a shipment, those lots can end up in unexpected places, like the recent case of the US-owned Hellfire air-to-ground missile shipped back home from the Middle East after a training exercise only to end up in Cuba.
“Suppliers have told us, ‘I didn’t know I had an import alert. I didn’t ship that product,’” Lennarz said. “Sometimes an intermediary will buy a lot and reship it without the original supplier’s knowledge. It might be product that was not intended for shipment to the US and was perhaps not properly labeled.”