The pet food industry is at an exciting intersection: Consumer demand is challenging standard-bearing certitudes; human-grade diet demands are impacting formulations; environmentally packaged goods are the rave, and the need for instant gratification is changing the way consumers shop and manufacturers deliver. At the same time, the need to be agile and creative is being complicated by pending regulation and proposed changes in the law. Add to that a force entirely out of our control—court-related actions. Success in an industry experiencing such enormous transformation necessitates constant vigilance to all of these market forces, ergo today’s bird’s eye view of our legal landscape.
If you, like me, are not a lawyer, you may not be aware of the annual Food and Drug Law Institute and its annual meeting. This impressive gathering of lawyers, consultants, industry leaders, government executives and this year, a Supreme Court Justice meets for two days to address the critical issues affecting every FDA-regulated industry. Not surprisingly, there is quite a bit of emphasis placed on current court cases (and the legislation/regulation) that will play a significant impact on how you conduct business. Some may be familiar to you.
The Center for Food Safety (CFS) issuing FDA for lack of regulatory authority over GRAS (generally recognized as safe) determinations via the enabling of corporations to self-determine GRAS status.
Class-action suits have been filed against Walgreens/Rite Aid for glucosamine/chondroitin claims. In contrast, Trader Joe’s and others deal with alleged concealment of sugar in their labelling of evaporated cane juice.
GMO-labeling legislation has been introduced in 20 states, and legislation has been introduced in Congress to assert federal authority over the issue.
And of course, there is the proposed FSMA regulation.
There is much to report from this year’s FDLI meeting. In the interest of time, this blog will focus on one case of particular interest, addressed by Ralph Hall, J.D., with the University of Minnesota Law School and Counsel to Faegre Baker Daniels: Ony v. Cornerstone—the latest in a series of highly complex and evolving First Amendment cases with the potential to impact how we use claims derived from scientific research.
Until Ony v. Cornerstone, the government was the protagonist in First Amendment cases. In this case, two private-sectors corporations, competing with similar products for a specific condition (respiratory distress syndrome [ARDS] in neonates) forced the issue of protection via the First Amendment into private litigation. Speaking entirely in lay terms, one competitor, Cornerstone, commissioned a study to determine if its product was better than Ony’s. The study concluded that Cornerstone’s product is indeed better than Ony’s because there are fewer deaths and better outcomes. The study, peer-reviewed and published, was then highly publicized on the Cornerstone website. The result? Ony sued everyone—the company, publisher, medical association, journal—everyone. They claimed false and misleading advertising (citing the Lanham Act) and deceptive practices. Cornerstone replied. Freedom of speech, they asserted, afforded them the right to publish scientific articles and accurately disseminate the content. Cornerstone won in District Court. Ony lost on appeal. Case dismissed.
Why? The courts determined the right to express an opinion, constituted in this case as the result of a peer-reviewed study, is indeed protected by the First Amendment, versus statements of fact, which can indeed be actionable.
The Court concluded, among other things, Cornerstone met the three-part test for protected speech;
data was not “fabricated or fraudulently created”;
there was an accurate description of data and methodologies; and
The matter is one of ongoing scientific debate.
In short, a Lanham Act claim can’t be used to referee scientific discourse; and the First Amendment protects opinions (aka peer-reviewed studies), which if communicated accurately, can then be disseminated without regard to commercial purposes.
Can you now market claims determined by substantiated peer-reviewed research if the resulting opinions are presented accurately? I wouldn’t act too fast. Ony’s assertions against the validity of the study remained unaddressed by the Court, leaving the definition of precisely what constitutes a “standard of review” in scientific studies undefined. There is no solid definition of opinion versus fact. We don’t know the rules for claims review if there is scientific substantiation without consumer deception. And, we can’t predict if regulators will respond with new definitions and protections (for bonafide legal analysis, by all means, consult counsel!).
Corporate attorneys and marketers are anxiously awaiting rulings on several cases, including the outcome of POM in its suit against Coca-Cola for false and misleading claims of labelling of fruit juices. It is one of many instances that will impact the role of the First Amendment in efforts by private parties when challenged with unfair marketing practices.
As the courts continue their work, we will continue to watch. In the meantime, I recommend keeping up with regulatory and legislative actions by attending Petfood 2.0 on Sept. 23 – 24 in Chicago. And, if you are contemplating entering this market and participating Ingredient Marketplace, be sure to join in Petfood 2.0 Market Insights on June 3 from 1:30 – 3:00 p.m.