The new law, known as FSMA (usually pronounced FIZZ mah), in the most sweeping change in how the food industry is regulated since the Food Drug and Cosmetic Act of 1937. The law has seven major rules associated with it that are in various stages of full implementation.
FDA recently launched a new portal that will track the industry’s compliance and what the agency is finding in its inspections.
Early data looks good
Acting FDA Commissioner Ned Sharpless, MD, said that while it is too soon to make a judgment on trends, the early returns on how the law is functioning look good.
“While we expect that it will take several years to establish trends in the data, the initial data show that since 2016, the majority of companies inspected are in compliance with the new requirements of the preventive control rules. Additional FDA data also show that overall, industry has improved the time it takes to move from identifying a recall event to initiating a voluntary recall, from an average of four days in 2016 to approximately two days in 2019. In fact, comparing the FSMA data with our recall data shows the bigger picture, demonstrating the effectiveness of preventive measures as food recalls once again have reached a five-year low," Sharpless said in a recent statement.
The new portal, called the Food Safety Dashboard, collates information that FDA has collected in its inspections. The data can be downloaded in spreadsheets that show the inspection results by quarter starting in fiscal year 2017. The initial metrics are tracking outcomes in the areas of inspections and recalls for FSMA rules that include:
- Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls rules for both human food and food for animals (preventive controls rules). The first compliance dates for these rules occurred in September 2016.
- Imported food safety, including data relevant to the Foreign Supplier Verification Program (FSVP) rule. The first compliance date for importers subject to FSVP occurred in May 2017.
Underlying portal is useful
Larisa Pavlick, vice president of global regulatory and compliance for the United Natural Products Alliance, said the new data collection effort might over time provide a useful tool for industry.
“On the bigger picture it would make sense to know what problems FDA is solving,” Pavlick said. Her preliminary view is that the site from which the inspection data appears to be drawn from an FDA data portal that has been functioning for a number of months. She said while it is too early to judge the functionality of the new FSMA site, the underlying portal is highly useful in that the inspection results of individual companies can be searched.
“I think it’s a great tool. It takes the time necessary for a FOIA (Freedom of Information Act) request out of the way or the wasted time begging your supplier for their regulatory history,” she said.