Guest Post: Lessons Learned as FDA Exerts FSMA-Granted Authority
Manufacturing Insights Blog
By Dr. David Acheson, partner, Leavitt Partners
Although several key rules related to the FDA’s Food Safety Modernization Act (FSMA) have yet to emerge, when the FSMA was passed last year, it immediately granted the FDA several new authorities, such as mandatory recall authority, the ability to suspend a facility’s registration and increased access to records.
On November 26, 2012, the FDA let Sunland—and the world (via press release) – know that it was using its authority to suspend the company’s registration, right as Sunland was about to re-open its doors following an outbreak related to its peanut butter.
Not only is the FDA using the authorities already granted, it is clear that when the agency inspected the Sunland facility, it was keeping the FSMA’s Preventive Controls Section 103 in mind, related to production practices, systems and documentation of processes.
Specifically, FDA cited:
- A lack of records to document the cleaning of the production and packaging lines after Salmonella was detected between 2009 and 2012. We could give Sunland benefit of the doubt, and say the company did the required cleaning and just didn't document it…but in the eyes of the agency, if it isn’t documented, it didn’t happen.
- Distribution of certain lots of peanut butter and nut butters that were positive for Salmonella per Sunland’s internal testing.
- Distribution of products in which Sunland tests detected allergens but did not label them as such.
- Numerous violations of GMPs and other required handling practices.
While these citations are not different from pre-FSMA type regulator activities, it appears the FDA was looking at Sunland through more of an FSMA lens than ever before.
This scenario provides a strong example of the value of FDA's new authority. Records show that the company had placed contaminated product in the market since 2009; before the FSMA, however, the FDA lacked authority to mandate a recall or suspend/revoke facility registration.
Some may conclude that having documentation and testing products get you into trouble – so they shouldn’t test or record results. I hope that the FDA clearly points out that testing is not what gets you into trouble, it is testing and not reacting appropriately (or documenting this) that gets you in trouble.
It is essential to have systems that document that your control systems are working. It is even more important to keep those records so you can show the FDA that you have both identified and controlled risks in your program. If you haven't been preparing for the record-keeping and preventive controls rules of FSMA, be ready for the consequences.
If you haven't been preparing for the record-keeping and preventive controls rules of FSMA, be ready for the consequences.
The specifics of the provisions have not been released, but it certainly appears that the FDA is increasing the consequences of non-compliance. The agency has now stepped off first base with a suspension of registration and has achieved the big bang it was likely looking for with its first suspension announcement.
Are you well-prepared to avoid the consequences of the FDA’s new authority? If not, what are you doing right now to get ready?
Dr. David Acheson is a Partner at Leavitt Partners and oversees the company’s Food and Import Safety Practice. Dr. Acheson brings more than 30 years of medical and food safety research and experience to the firm. Since founding the food safety practice within Leavitt Partners in July 2009, Acheson has used his regulatory insight, food safety knowledge and expertise in crisis response to advise food industry clients around the globe on how to best manage risk in a global supply chain and evolving regulatory landscape.