FDA reports progress on food safety law

Lisa Schnirring

Jul 7, 2011 (CIDRAP News) The US Food and Drug Administration (FDA) recently reported progress on implementing the new FDA Food Safety Modernization Act (FSMA), including several measures that took effect Jul 3, such as the authority to suspend food facility registration when it believes foods could pose a risk.

The report, posted on the FDA's Web site, covers developments that have taken place within the first 6 month of the law's passage. President Obama signed the FSMA into law on Jan 4; it represents a major overhaul of the nation's food safety laws that apply to food regulated by the FDA.

Timelines in the new law allow for key requirements and programs to be implemented with long lead times. Phasing in the new lawwith its $1.4 billion price tag over the next 5 years is expected to face tough headwinds in times of difficult federal budget constraints.

On Jun 16 the US House of Representatives cut $87 million from the FDA's food safety funding for fiscal year 2012, which some lawmakers said could slow the implementation of the FSMA, according to a Jun 17 Food Safety News report. The Senate has not started work on the main 2012 appropriations bills.

The FDA, however, is still pressing for the law's original funding level, according to a Jul 5 Bloomberg News story.

The authority to suspend food facility registration that went into effect Jul 3 will give the FDA a tool to block the import or domestic distribution of foods that it believes could cause serious health consequences to humans or animals.

Two additional Jul 3 milestones include issuing an anti-smuggling strategy to prevent smuggled food from entering the country and the release of draft guidance that clarifies the FDA's expectations on new dietary ingredients, a resource for dietary supplement manufacturers.

The FDA developed the anti-smuggling strategy with the Department of Health and Human Services and the Department of Homeland Security, according to the progress report. It includes working with US Customs and Border Protection (CBP) to review historical data to better establish targeting criteria. The FDA and CBP will also share information on imported shipments and work together to identify ones that may contain smuggled food.

When possible, the agencies will publicize food smuggling enforcement actions to deter future attempts, the FDA said.

The draft guidance on new dietary ingredients is designed to ensure that consumers aren't exposed to health risks from new dietary supplement ingredients that have unknown safety profiles. The guidance requires supplement manufacturers to notify the FDA when they intend to add a new ingredient to their products, except when it has already been part of the food supply and has not been altered for use in the supplement.

The FDA added that the guidance should help manufacturers recognize when premarket safety notifications are warranted.

Another authority that went into effect Jul 3 allows the FDA to administratively detain for up to 30 days foods that it believes are adulterated or misbranded while it determines if actions such as seizures or federal injunctions are needed.

On May 5 the FDA issued an interim final rule that requires food or feed importers to report the names of countries that have refused entry of products, according to the report.

In other FSMA-related actions, the FDA said it held a stakeholder meeting on the new law's inspection and compliance provisions on Jun 6, which drew 700 participants in person or on webcast. On May 23 it also opened a docket to gather information about how facilities identify hazards linked to specific types of food and feed processes, which it will use to develop new guidance. Comments are due by Aug 22.