We quizzed leading food law attorneys to find out what food manufacturers should keep on the radar, from slack fill, CBD, malic acid, and Prop 65, to natural claims, as we enter the New Year ...
Stuart Pape, Polsinelli: I’m watching cell-cultured meat because the regulatory framework will not keep pace with the development of market-ready products by companies. That, coupled with likely lawsuits from conventional meat interests promises to make 2019 an interesting year.
William Acevedo, Wendel, Rosen Black & Dean: In 2019 CBD will prove problematic for US-based companies. Likely encouraged by investments by tobacco and alcohol brands in Canadian companies, the departure of Jeff Sessions, and lax enforcement by the FDA of its prohibition of CBD as a food ingredient, companies will misread the signs and make and/or continue to make unsubstantiated claims about the effect(s), if any, of CBD within their products.
David Biderman, Perkins Coie: In 2019 I'm watching for lawsuits over trace elements of any supposed ‘contaminants’ —part per billion levels that make no difference whatsoever, but which can be detected by suspicious labs or by enhanced analytical techniques.
Bruce Silverglade, OFW Law: 2019 will be the year that private plaintiff class action cases surpass the FDA as the primary enforcer of laws prohibiting misleading food labeling.
Food companies, when evaluating marketing claims should automatically conduct a class action risk analysis (in addition to checking compliance with FDA rules) to determine whether they should risk using a particular claim like handcrafted, wholesome, and pure. FDA has no definition for such terms and it’s anyone’s guess how a court will rule on them.
Allan Zackler, Wendel, Rosen: Prop 65 cases are likely to expand in the coming year as new, more rigorous regulations come into play.
Recent notices filed by OEHHA cover substances including arsenic in dietary supplements; cadmium, lead and lead compounds in dietary supplements and breastfeeding supplements; acrylamide in French fried and sweet potatoes, nuggets and crackers; lead and arsenic in cinnamon, cumin, curry powder, psyllium husk powder, chocolate and energy shakes; and cadmium in chocolate.
That said, a longer-term issue for the food industry, as well as the rest of humanity, will be the effects of climate change on agricultural crops and fishing. More wildfires, flooding, hurricanes and temperature changes will affect crop production, growing seasons, crab and lobster fishing and much more.
Bob Niemann, partner, Keller and Heckman: [Watch out for] more slack fill cases, which account for about 12% of all class action filings. It is difficult for judges to grant motions to dismiss or even summary judgements, because the content of packaging has to be literally held and examined in order to weigh the contents.
There is hope in California with some new legislation recently passed by Gov Jerry Brown. This new Assembly Bill 2632 amends B&P code section 12606[b] to add three, and possibly four safe harbor applications for companies to evidence the fill and contents of packaging. While this may assist companies on a go forward basis, the claims for this type of class action go backward in time and will take time for the companies to catch up with the use of these new methods.
Ryan Fournier, Morgan Lewis: FDA’s oversight of dietary supplements will emerge as a hot topic in 2019. In response to the plaintiff’s bar and state actors targeting dietary supplement manufacturers for product labeling, the FDA announced the formation of a dietary supplement working group. Its goal is to review certain internal operating procedures and modernize and improve FDA’s oversight of the dietary supplement industry.
Many dietary industry segments including producers, distributors, retailers, and the financial markets will be interested in FDA’s new policy measures on this topic, which Commissioner Gottlieb stated will be releasing very soon.”
Dale Giali, Mayer Brown: Multi-function ingredients – chameleons of the food false ad world – will continue to be popular [eg. is malic acid a flavor or an acidulant?]. Consumer attorneys challenge any ingredient that could possibly function as what is labeled as being absent (‘no preservatives,’ ‘no artificial flavors’), even when the ingredient is in the product for an entirely different function.
Anthony Anscombe, Steptoe & Johnson: One of the most important things we’ll see in 2019 is a decision from the 9th Circuit on what class action plaintiffs must prove in order to establish loss causation and entitlement to restitution under the unlawfulness prong of the unfair competition law.
Many food and beverage class actions involve allegations of various regulatory violations involving issues that are neither deceptive nor material to consumers. Any decision that supports an award of restitution for ‘unlawful’ conduct that does not induce reliance and cause deception could fuel cases against food and bev manufacturers, as well as against other FDA regulated industries.
Brian Sylvester, Wiley Rein: Cellular agriculture came to life in 2018 from Capitol Hill to the halls of the FDA and the USDA. We rounded out the year with the agencies agreeing to jointly exercise oversight. In 2019, we can look forward to further engagement from regulators as they seek to partner with stakeholders to chart a regulatory path forward, establishing greater regulatory certainty for this burgeoning sector.
2019’s regulatory conversation will focus on crafting a functioning regulatory review process, building on existing precedents – with an emphasis on pre-market assessments, inspections and labeling. Certain interests are still not quite sold on this technology and could seek to impose roadblocks through legislation or onerous rulemaking.
Therefore, stakeholders should keep a close pulse on developments at both the USDA and FDA, as well as on Capitol Hill.
Angela Spivey, Alston & Bird: Although the FDA has - so far - limited public enforcement measures on CBD to issuing warning letters to a handful of companies making therapeutic claims related to serious disease conditions, I would not be surprised to see it take a more robust approach to enforcement if, thanks in part to the 2018 Farm Bill, the market for hemp-derived products continues to expand.
(The 2018 Farm Bill...will significantly reduce barriers that hinder cultivation of hemp, but it will not affect the FDA's position that cannabidiol (CBD) and tetrahydrocannabinol (THC), cannot lawfully be included in foods or dietary supplements.)
Laura Venker, Alston & Bird: While most food companies have provisions in supply chain contracts that allocate financial responsibility if their product is recalled, it is less common for contracts to address which party bears the risk if an advisory statement is issued that affects the marketability of the product, as happened in November 2018 when FDA and the CDC advised consumers not to eat romaine lettuce and retailers and restaurants not to sell or serve it.
Given FDA’s increased reliance on advisories statements, I expect to see an increased focus on this issue in supply chain agreements, especially for higher-risk foods, in 2019.
George Salmas, The Food Lawyers: Courts are beginning to rule that labeling which is 100% compliant with FDA regulations can simultaneously be misleading under other federal law (the Lanham Act) and serve as the basis of a class action. Purveyors’ regulatory departments will be unaware of this nuance, resulting in increased food labeling class actions in 2019.
Angel Garganta, Venable: In the New Year, we can expect to see a continuation of the growing trend among plaintiffs’ lawyers to challenge food and beverage labeling and advertising based on the presence of allegedly 'unhealthy,' 'natural,' or 'artificial' ingredients or production techniques.
Such cases will continue to challenge as misleading truthful nutrient content and other labeling claims based on the presence of even trace amounts of allegedly 'bad' chemicals or of necessary preservatives or stabilizers. The plaintiffs’ bar will thus continue to capitalize on consumer desire for simpler and more natural food by demonizing substances and processes that sound strange or unfamiliar, but are critical to modern food production, low consumer cost, food safety, and shelf stability.
And they will continue to do so with little or no evidence of actual physical or economic injury to consumers, but in many cases, will withstand motions to dismiss and raise litigation costs.