Product Traceability Pilot Studies

In the wake of recent recalls the progress of implementation of the Food Safety Modernization Act (FSMA) has become more significant. The Pilot Traceability Project was announced as of last week. This project is intended to provide a structure for tracing ingredients back to their source in the event of a recall. Section 204 of FSMA requires the FDA to “establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a food borne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated …or misbranded." 

The Pilot projects will be carried out by the Institute of Food Technologists (IFT) at the direction of FDA.

A product tracing system involves documenting the production and distribution chain so that a product can be traced back to a common source or forward through distribution channels if there’s evidence of contaminated food.  The actions that follow may include removing the product from the marketplace and alerting the public if it has already been distributed.

The FDA indicated that: “What we’re looking for is a system that is practical, feasible, and rapid,” says Sherri McGarry, senior advisor in FDA’s Office of Foods. “Our No. 1 priority is protecting public health.”

McGarry explained that IFT will work with the key groups that have a stake in this endeavor—food industry, state and federal government agencies, and consumers—in developing the pilot programs. The goal is to include industries that represent the food supply chain, including farms, restaurants, and grocery stores.

The pilot programs will evaluate the types of data that are most needed for tracing, ways to connect the points in the food supply chain, and how quickly data can be made available to FDA. A key goal in the pilot projects will be to explore methods to track food and identify a common source or supplier starting at multiple points of sale. “We’re looking for a system that will allow FDA to quickly connect the dots along the food supply chain,” says McGarry. 

Business should keep an on eye on this process as the resulting programs may impose similar requirements on FSMA registrants in the future. 

On Monday, September 19, 2011, I will be speaking at The DEMATIC Material Handling and Logistics Conference  in Salt Lake City , Utah and presenting, "Field to Fork:  How the new Food Safety Modernization Act Will Affect You."  

Hold the Salt: The Gathering Push for Sodium Reduction in Food Products

By Guest Blogger Tyler Anderson

The issue of sodium content in food has been a hot topic in recent months, as our own Ken Odza has blogged about in reporting on the class action lawsuits filed against Denny’s in New Jersey and Illinois. Now the New York City Department of Health and Mental Hygiene is addressing the issue. On January 11, the Department unveiled the National Salt Reduction Initiative, targeted toward reducing the salt levels in products offered by restaurants and food companies.

This initiative reflects a voluntary goal led by New York City to reduce the salt levels in packaged and restaurant foods by 25 percent over five years. According to the initiative, accomplishing this benchmark would reduce the nation’s salt intake by 20 percent and prevent up to 800,000 premature deaths nationwide and 23,000 in New York City alone. According to Dr. Sonia Angell, director of the Cardiovascular Disease Prevention and Control Program at the Department, the average American adult consumes 3,400 to 3,500 milligrams of sodium per day, while most individuals need about only 1,500 milligrams to satisfy their health needs. The initiative has gathered a wide range of support from parties including the American Heart Association, the American Medical Association, Oregon Department of Human Services, and the Washington State Department of Health.

While the National Salt Reduction Initiative reflects a shot across the bow on the subject of sodium reduction in food products, some industry players have been moving in this direction on their own. However, as a recent Wall Street Journal article points out, many of these food manufacturers have been taking a measured approach with regard to the issue of sodium reduction and the manner in which they communicate such changes to consumers. For example, by next summer ConAgra Foods, Inc.’s Chef Boyardee canned pasta will have decreased its sodium content by roughly 35 percent over the last five years. Campbell Soup Co.’s original flavor of V8 100% Vegetable Juice has dropped its sodium content by 32 percent over eight years. Neither of these brands has made any mention of this decrease in sodium content on its packaging.

The reasoning behind this initially surprising silence is, according to food industry executives quoted in the Wall Street Journal article, that dramatic reductions in sodium content often result in different tastes and consumer dissatisfaction that manifests itself as reduced sales. According to Douglas Balentine, Unilever NV’s North American director of nutrition and health, a gradual reduction in sodium allows consumers to adjust to a less drastic change in taste as sodium content is reduced over time. This allows manufacturers to avoid problems such as those faced by the Kellogg Co. in the early 1980s when the company launched low sodium versions of its popular Corn Flakes and Rice Krispies breakfast cereals. According to Celeste Clark, senior vice president of global nutrition for Kellogg, consumers were not satisfied with the flavor of the products and the new brands were scrapped after four years. This balance between health benchmarks and industry performance will continue to shape the regulation of sodium content as this issue continues to grow in prominence.

Sodium Putative Class Action Suits to Become Epidemic?

Following the putative class suit filed last month in New Jersey by the Center for Science in the Public Interest (CSPI) against Denny’s, a similar suit was filed in Illinois (apparently CSPI is not directly involved in this action). The Illinois complaint can be found here.

Like the New Jersey complaint, the Illinois action alleges claims of consumer fraud and breach of implied warranty of merchantability. Previous posts on this site have explained why both consumer fraud and implied warranty of merchantability claims should fail on their face.

The Illinois action adds claims for unjust enrichment, accounting and ”breach of contract implied in fact.” Claims for unjust enrichment and accounting seem intertwined and not all that different from consumer fraud and breach of implied warranty claims.

Breach of contract implied in fact is more creative. Instead of directly attacking Denny's representations (which as discussed in previous posts are not really alleged to be inaccurate), this claim asserts something that looks more like a products liability claim. The claim turns not so much on “fraud” but on whether the meals sold “contained excessive amounts of sodium, such that it was not fit for human consumption.” This cause of action alleges that the “bargained for” contract between class members and Denny’s required Denny’s to provide “a meal fit for human consumption.”

While creative, the breach of contract implied in fact claim may be more problematic than the fraud and implied warranty of merchantability claims. First, as discussed previously, Denny’s discloses on its website (and according to CSPI, at its restaurants) sodium content of menu items. Like the fraud claims, proof that plaintiffs could have reasonably bargained for something different seems problematic.

Second, plaintiffs are asking the court to use its equitable powers and step into the shoes of local, state and federal health departments and regulatory agencies to pass on appropriate sodium levels in restaurant food. As a rule, courts use their equitable powers only in extraordinary circumstances (e.g., a building falls down, assets leave the country, an individual’s life or liberties at stake, etc.). If regulators and legislators have not reached consensus on regulating sodium, odds are that most judges will avoid weighing in on the issue.

Despite their problems (and probable lack of merit), best guess is that the plaintiffs' class action bar will continue copy-catting these suits across the country.  Doubtful that Denny's will be the only victim.

Facts Alleged in CSPI Sodium Suit Incongruent with Claims Asserted

Thought to be the first putative class action against a restaurant chain related to disclosure of sodium content on menus, Center for Science in the Public Interest (CSPI) has filed what appears to be a test case against Denny’s. Best guess is the case will fail on its merits (though for CSPI, success in litigation may not be the point).

The case, DeBenedetto v. Denny’s Corporation, asserts claims under New Jersey law for consumer fraud, N.J.S.A. 56:8-1, et seq., and breach of the implied warranty of merchantability under the New Jersey U.C.C., N.J.S.A. 12A:2-314(1)-(2). The theory advanced in CSPI’s complaint is that consumers have been “duped” about sodium content and that the “ordinary consumer, unschooled in nutrition and perhaps preoccupied with other matters, would not reasonably expect to encounter these high levels of sodium in one meal.”

Big incongruency in the complaint is that Denny’s does disclose sodium content in its meals. CSPI admits that Denny’s provides this information both online and in store pamphlets, but it complains that the information is “incomprehensible.” A review of Denny’s online disclosures shows a detailed nutritional chart, including sodium levels for every item on its menu. Here's an excerpt of Denny's online disclosures:

But, CSPI's complaint does not really seem to be that disclosures are not clear enough. Indeed,  CSPI argues that regardless of such disclosures by restaurants, studies show that “almost no one reads the nutrition information . . . .”

What CSPI is really saying is that sellers of salty foods (not unlike foods contaminated with E. coli) are strictly liable no matter the disclosures.  If this were the law (which as of now, it is not), few restaurants (or food manufacturers) would be exempt from paying the medical bills of their customers who develop heart disease. No doubt CSPI's real goal is "regulation through litigation" and the jury is still out whether CSPI's penchant for the court system will affect change.