The past five years have seen two historic updates to longstanding regulatory regimes, both aimed at improving safety. We all want the food we eat and the products we encounter to be harmless, and the Food Safety Modernization Act and the Consumer Product Safety Improvement Act aim to make them safer.
For food and consumer product companies, however, this increased safety is accompanied by the heightened cost of regulatory compliance and risk of civil litigation. the ultimate impact of both reforms is still far from clear. Here, food safety and product liability experts break down the risks and offer their recommendations for navigating the new requirements.
The Food Safety Modernization Act
The Food Safety Modernization Act (FSMA), which became law in January 2011, is the biggest change to food safety regulation since Franklin D. Roosevelt signed the Food, Drug and Cosmetic Act in 1938. It came on the heels of a string of headline-grabbing outbreaks of foodborne illnesses: In 2006, E. coli-tainted spinach killed three people and sickened hundreds, and a Salmonella outbreak was linked to peanut butter. Salmonella sickened people across 43 states in 2008 and was linked to contaminated chili peppers, tomatoes and cilantro. And in the summer of 2010, nearly 2,000 cases of Salmonella led to a recall of hundreds of millions of eggs.
Each of these cases and numerous similar outbreaks led the Food and Drug Administration (FDA) to identify that a problem existed and then trace it back to certain products and facilities, where investigators probed the source and cause of the contamination to prevent future outbreaks. The central goal of FSMA was to change the paradigm from reaction to prevention.
Wave of Litigation
Richard Morgan, managing partner at Bowman and Brooke, says he expects FSMA to contribute to rising private lawsuits against food companies and that food safety litigation is going to be “the big litigation wave of the next 10 years.”
And because FSMA contains a number of prohibitions on its requirements preempting state and local laws, Morgan says food companies are going to be more at risk than drug and device companies that can fall back on preemption. Expect lawsuits to spike when the FDA’s regulations come into effect, he says.
The Consumer Product Safety Improvement Act
Like the Food Safety Modernization Act, the Consumer Product Safety Improvement Act (CPSIA) came partly in response to widely publicized safety issues. In the case of CPSIA, which President George W. Bush signed into law in 2008, it was a deluge of children’s toy recalls, many imported from China, due to excessive levels of lead. (A lead-free toys bill was folded into the broader CPSIA.) Among its requirements was a mandatory testing and certification process for manufacturers—any party that makes, produces or assembles a product—to ensure children’s products are free of unacceptable amounts of lead or phthalates.
On a broader level, CPSIA also updated the Consumer Product Safety Act to expand the Consumer Product Safety Commission’s (CPSC) staff and budget, substantially increase penalties for certain violations and establish a searchable public database of consumer-submitted product hazard complaints.
Heller says a team of company employees, in-house lawyers and outside counsel should monitor consumer correspondence in the database, and if a trend or issue arises, they should take action immediately, including reaching out to the consumer to further investigate the report and test the consumer’s product. If plaintiffs later try to introduce reports into evidence in a trial, such groundwork will have prepared the defense team to present a set of facts showing that a report is not substantially similar to the litigation and should not be admitted.
In October 2012, a federal district judge in Maryland delivered a ruling that may give industry members some measure of comfort. In the first successful legal challenge of the database, he blocked the CPSC from publishing a report on its database, saying it would violate the Administrative Procedures Act. The unnamed company that was the subject of the report had filed a lawsuit under seal challenging publication, saying that it had provided evidence to the CPSC that the report was inaccurate but that the commission still planned to publish it.