The new rule reads that FDA now only needs “reason to believe that such article is adulterated or misbranded.”
Much has been written about the Food Safety Modernization Act (FSMA) and how it expands FDA power to recall or detain products suspected of contamination. But what does FDA define as suspect? That question lies at the heart of several recent events.
In August, the American Herbal Products Association (AHPA; Silver Spring, MD) submitted comments to FDA regarding the agency’s interim FSMA final rule, which took effect July 3. Specifically, AHPA points to how the new interim rule amends FDA’s criteria for detaining products at the point of import.
Whereas prior, FDA could detain products if it had “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals,” the new rule reads that FDA now only needs “reason to believe that such article is adulterated or misbranded.” (Italics added.)
First off, this means FDA can now apply its categorical definitions for adulterated and misbranded as they appear in the Federal Food, Drug, and Cosmetic Act. To put this in perspective, misbranded applies to infractions arguably more minor than contamination, such as typography errors on a product label.
In the Federal Register, FDA did take care to emphasize that it plans to focus its attention on more serious, and not minor, points. Also, for those nervous that FDA will go on an enforcement rampage, the agency also noted that it has thus far used its detention power sparingly. In fact, August 18 was the first time FDA used its new, revised FSMA detention authority, against Bonaterra Products for insects allegedly found in the company’s food. (AHPA also posits that many companies in fact end up complying voluntarily to avoid forced detention.)
Still, no matter what FDA says it intends to do, the fact remains that FDA now wields the power and potential to do a lot more. You can’t blame food and supplement companies for being nervous. Ambiguities like “reason to believe” or FDA’s statement that it will make decisions on a case-by-case basis leave a lot of room for imagination.
I also wonder, though, whether such ambiguity will leave room for lawsuits. While it is rare for companies to sue FDA over food safety enforcement issues, it can happen-and has happened. In late August, produce food giant Del Monte sued FDA, which earlier this year traced a Salmonella outbreak to cantaloupes Del Monte imported from Guatemala. At the time, Del Monte voluntarily recalled 5,000 cantaloupes. However, what’s really got Del Monte upset is that FDA went further and banned any cantaloupe imports from the Guatemala site. For Del Monte, one of the largest cantaloupe importers to the United States, those are apparently fighting actions.
In its lawsuit, Del Monte essentially accuses FDA of having acted without hard evidence that the cantaloupes were contaminated with Salmonella. Instead, FDA, as it often does when tracing contaminants in fresh produce, had to rely on epidemiological evidence (interviews with people infected). It also used purchasing evidence, tracking down where the cantaloupes were bought. Understandably, FDA uses such evidence because fresh produce often perishes or is consumed long before FDA is able to examine them.
To Del Monte, epidemiological evidence was not enough. It was not a “smoking gun,” as some have called it, to justify the ban. And there is always room for mistakes. FDA itself admits that up to 48% of products detained for suspected adulteration may end up in fact not being adulterated.
There are those who are worried that Del Monte’s lawsuit could scare FDA into erring on the side of caution-that is, enforcing too little. “A lawsuit like Del Monte’s could have a dangerous, chilling effect on the willingness of public health officials to recall foods or ban unsafe imports for fear of retaliation in court,” stated Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, to the press.
Likewise, however, FDA could err on the side of caution by enforcing too much. Is there a happy medium between consumer rights to safety and the rights of companies to protect their products? FDA, hopefully, will find it.
Jennifer Kwok Grebow