February 23, 2017 – Chip English, Partner, Davis Wright Temaine LLP, gave a presentation on food and beverage regulations and emerging clean label laws that evoked recent drone videos of food and beverage entrepreneurs blithely surfing the waves while oblivious to the great white sharks perusing succulent, clean label menu choices from below. Metaphorically speaking, of course. English is a Partner in the Washington, D.C., office of the law firm Davis Wright Tremaine, LLP. “I am the lawyer to dash cold water on all these wonderful clean label claims that people want to make,” he began.
“There are a whole lot of things that arguably could make clean label claims. But the meaning of some claims is not so clear. We still don’t know what ‘free-range’ or ‘cage-free’ are, and, although there are some hints of what ‘natural’ means, most such claims remain in the eye of beholder. What is ‘local’…10 miles, 50 miles, 100 miles? Does ‘local’ signify a different distance in New York City vs. in Des Moines, Iowa? Then, there are the emerging label claims: made from kitchen ingredients; craft; made from scratch; small batch, homemade…what do they all mean?”
“So, if you want to try to define such claims on your product, good luck, because lawyers will then tell you what they mean after the fact,” English continued.
According to the U.S. Code of Federal Regulations, a food shall be deemed misbranded if its label is false or misleading in any particular regard (21 CFR 343(a)(1)). But, while there can be a grey area surrounding the small number of clean label terms the Food & Drug Administration (FDA) has defined, there is a big grey area of terms that remain undefined. Regulatory uncertainty provides considerable leeway for plaintiffs to complain about a product claim, said English.
According to English, the bulk of outstanding legal actions focus on “natural” and “healthy” claims. He provided examples. “Healthy” can be an exceedingly narrow and difficult term against which to conform a product. Though the product is loaded with a surfeit of very healthy ingredients, the manufacturer of the KIND nutrition bar received a warning letter from the FDA in 2015 saying that its products could not be designated “healthy,” because their saturated fat content put them out of compliance with FDA guidelines for the term “healthy.” KIND bars contain saturated fat-rich nuts, otherwise known as a health food in most quarters. The company was ordered to remove all references to “healthy” from its packages…and website. Although FDA has allowed KIND to keep references to healthy on its bars and website (after some back-and-forth with the agency), use of the term outside of the narrow regulatory framework carries risk. [Editor’s note: In what it terms a “re-evaluation,” the FDA has since permitted KIND the use of the term “healthy” in relation to its “corporate philosophy,” not as a nutrient claim. See https://goo.gl/M7P1bC]
English cited a large retailer, COSTCO, that made “healthy” claims about a coconut oil product. This was based, in part, upon the oil’s medium-chain triglyceride (MCT) content. Yes, the science does say that MCTs are healthier than other oils, but some of the MCTs thereof are saturated, and their contents in these oils can vary greatly, so…lawsuit!
Sometimes, federal agency jurisdictions overlap. Quaker Oats was sued in 2016 over packaged oat cereals sporting “100% Natural” claims. However, the oats contained minute levels of pesticide residues; the Environmental Protection Agency (EPA) has jurisdiction over establishing pesticide tolerance levels and has not established pesticide tolerance levels in all food. The result: lawsuit.
Packaging graphics also matter. When a large retailer promoted an organic milk package featuring a cow happily jumping a fence, plaintiffs argued that the “organic”-label package was misleading, because the milk producer actually kept its cows in tightly confined quarters. Although he remains unsure of what future American labeling regulation will bring, especially given a new political administration in Washington, D.C., English counsels food companies not to remain passive. “There is an important role for industry to establish and present its own standards to the government, rather than wait for lawsuits to be filed.”
For individual companies, he counseled them to assess their own risk tolerances: “How important is a claim to your product’s success, and can you back it up with evidence whereby to substantiate it? Look at all aspects of your product, including the messages that the packaging imagery conveys.” In other words, surf at your own risk!
Emerging Clean Label Claims: Regulations & Liabilities, Chip English, Partner, Davis Wright Tremaine LLP, ChipEnglish@dwt.com
The summary above is an excerpt from the “2016 Clean Label Conference Magazine.”
This presentation was given at the 2016 Clean Label Conference. To download presentations from this event, go to https://cleanlabel.globalfoodforums.com/category/clean-label-rd-academy/
See past and future Clean Label Conference Events at https://cleanlabel.globalfoodforums.com/clean-label-events/