The FDA Shifts From Food Safety to Public Safety

The two leaders specifically singled out the 2008 Salmonella outbreak linked to contaminated peanut butter products, calling it “a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls.” Although there is no general indication that food safety has been declining in the U.S., the FDA now seems to be orienting itself toward building in more preventive controls and setting for itself a goal of preventing any possibility of contamination.

Response Strategies

The two new leaders inherit an agency that already has substantial regulatory clout in the realm of inspections. Domestic and imported food manufacturing facilities must conform to the FDA’s good manufacturing practices (GMP), which cover standards for worker sanitation, plant construction, and cleanliness. When the FDA conducts surveillance and investigation of a food processing facility for GMP compliance, it may review everything from production history and firm management to direct observation of “objectionable conditions” and “deficiencies.”

The new orientation of the FDA toward preemptive, swift, and aggressive enforcement with a public health agency perspective suggests that such steps will presage a more vigorous domestic inspection and regulation effort. The FDA has noted that the new senior officials promise “swift, aggressive, and effective enforcement” and that they are concerned that pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.”

Statements such as these, coupled with actions such as the removal of review of most warning letters by the FDA’s chief counsel’s office, raise the notion that the FDA’s new top officials are switching the orientation of the agency from that of a deliberate, regulatory agency to a swiftly responding public health and safety agency, similar to a CDC or Federal Emergency Management Agency model.

Food producers would be well advised to begin developing response strategies that prepare for a more active role by industry regulators in an increasingly sensitive public health atmosphere. And any response strategy must include identifying the source of an alleged food problem and assuring the public and regulators of an operational solution.

An initial period of disruption should also be expected. If the FDA’s new leaders expect to set such worthy but vague goals as “promote health” and “prolong life,” it will be unclear for some time what they expect industry to do to move toward these targets. These goals could remain vague and easy to reach, as long as the U.S. population continues to extend its longevity.

In that case, it will remain impossible to sort out the contribution made by the FDA or regulated industry. On the other hand, the breadth of the goals could lead the FDA to demand anything it wishes of industry without providing clear direction. It is to be hoped, and indeed expected, that these worthy goals will eventually become reified in clear regulations, guidance, and intermediate measures that allow reasonable direction—within FDA’s jurisdiction—for industry.

The FDA’s move toward using its new aggressive public health stance “to build a system with multiple levels of oversight” and to regulate the entire chain from production to processing to distribution to consumption is in its early stages, but the implications are clear. Food producers must exercise more collective responsibility throughout the supply chain. They must know where food commodities are from, verify production compliance with all applicable standards, and be prepared to supply all required documentation in the event of regulatory inquiry.

Once the expected new proactive standard is more firmly established, there will be no turning back from anything other than full compliance with an FDA that promises to move swiftly and aggressively and, as then-deputy commissioner Dr. Sharfstein showed in the pistachio pre-call, preemptively. ■