If you are a regular reader of this blog, and we hope you are, you know that we have been paying close attention to when the FDA will issue its guidance on internet and social media promotion of drugs and devices. You can find our latest update here. As we’ve said before, we, and more importantly our clients, want and need word from the FDA as to what it will consider proper and what it will not. We know the rules for print and broadcast promotion, but those media continue to lose readers/viewers to the internet, and in particular to social media. And, in that marketplace – there remain too many unanswered questions for our clients to have any comfort in using the internet as a means of communicating information about their products.
The single biggest question for which we don’t have an answer is what actually constitutes promotion. Is it providing a link to a scientific article? Is it “liking” a Facebook post? Or “re-tweeting” someone else’s comments? We just don’t know. So, while we sit and wait for the FDA to decide the answer, we thought we’d bring you a recent decision from a food labeling case that grappled with the internet issue. The rules about food labeling are different from those for drugs and devices, but in the absence of formal FDA guidance, it behooves us to be aware of what courts are saying about our cousins in the food industry.
We doubt you’ll be surprised to learn that the issue arose in the context of a putative class action brought in California alleging violations of California's Unfair Competition Law's ("UCL"), False Advertising Law ("FAL"), and Consumers Legal Remedies Act (“CLRA”); as well as unjust enrichment and breach of warranty. Wilson v. Frito-Lay North America, Inc., 2013 U.S. Dist. LEXIS 47126, at *4-5 (N.D. Cal. Apr. 1, 2013). Perhaps you’ll be slightly more surprised, as we were, that anyone was claiming they were misled about the nutritional content and value of such products as “Lay’s Classic Potato Chips, Lay's Honey Barbeque Potato Chips, Lay's Kettle Cooked Mesquite BBQ Potato Chips, Cheetos Puffs, and Fritos Original Corn Chips.” Id. at *2. Can anyone claim -- with a straight face – that they both purchased these products and that “they care about the nutritional content of food and seek to maintain a healthy diet”? This is the food of juvenile ignorance, youthful metabolism, and the occasional late night, perhaps alcohol-influenced, binge. It’s called junk food for a reason! But, back to the case.
There is a lot going on this decision, including a finding that several of plaintiffs’ claims are not preempted because the requirements they seek to impose mirror those imposed by the FDA – in drug and device parlance, they are allowable parallel violation claims. Not a result we’d champion and since we blogged about a similar result last week in Brazil v. Dole Food Company, 2013 WL 1209955 (C.D. Cal. Mar. 25, 2013), we won’t re-hash the issue here. See Wilson, 2013 U.S. Dist. LEXIS 47126 at *19-29. There is also an interesting discussion of the deference to be afforded to an agency’s informal, non-binding interpretation of its own regulations. In this case, the court found that because the regulation in question (on MSG labeling) was subject to different possible interpretations, it would give deference to the FDA’s statement on its website which “appears to be its own interpretation of an ambiguous regulatory scheme.” Id. at *26-29. Again, not a ground breaking ruling, but noteworthy.
So, that brings us to the real reason the case got our attention: “Whether Websites Mentioned on Product Labels Constitute Labeling.” Id. at *16. We think this is an issue of first impression (if our readers know otherwise, please let us know). The allegation was that statements made on the Frito Lay website are “labeling” and therefore subject to the requirements of the Nutrition Labeling and Education Act of 1990 (“NLEA”). Plaintiffs based their argument on the fact that certain bags of chips included the phrase: “Visit our website @ fritolay.com.” Id.at *18. This language is so commonplace today that it hardly gets our attention. Everyone has a website and everyone wants you to visit. With smartphones, tablets and wi-fi, you don’t even need to wait until you get home. You can check out a product’s website while you walk the aisles of your favorite supermarket. Heck, you don’t even need to type in the website. You can scan the barcode or the quick response code. Augmented reality is how we live today. So, it is not surprising at all that plaintiffs are arguing that information found on company websites is part of the product labeling.
Under the NLEA, labeling includes what goes on the product, its container or wrapper and also material that “accompanies” the product. The court had to decide whether the company’s website “accompanied” the product. Id. at *17. In this case, the court said no:
The Court does not find that the language on the www.fritolay.com website constitutes labeling under the FDCA, because as cited by Plaintiffs, none of the website language explains or supplements the individual Named Products such that the website could generally be found to "accompany" the Named Products. Even though the Named Products' labels ask consumers to visit the website, they do not state that the website will inform consumers of the details of the Named Products' nutritional facts, and none of the language Plaintiffs cite is drawn closely enough to the Named Products themselves to merit the website's being found to constitute "labeling."
Id. at *18-19. A couple of points can be teased out of that. Even though the product’s container invited people to visit the website, that invitation didn’t seek to tell people that supplemental or additional nutritional information could be found there. Id. (relying on Kordel v. United States, 335 U.S. 345 (1950) (“One article or thing is accompanied by another when it supplements or explains it . . . No physical attachment one to the other is necessary. It is the textual relationship that is significant.”)). So, the way you send people to your website and what you tell them to expect when they get there is important. And, it appears the website contained general information about the company and its products. Plaintiffs didn’t cite to specific statements made about specific products – such as would normally be found on package labeling.
While the court dismissed the claims based on language from the website, it did so without prejudice and with leave to amend “if Plaintiffs are able to provide or describe labels or website “labeling,” per above.” Id. at *19. So, they get a chance to try to fix it, if they can and if they want to. But based on the court’s definition of what it means to “accompany,” we are hopeful that simply identifying your website on your packaging isn’t go to rise to the level of “labeling.”