That is the belief of two legal experts \u2013 Leslie Krasny of Keller and Heckman and Yvonne McKenzie of Pepper Hamilton LLP \u2013 who tried to map out future trends in food labeling litigation on Wednesday (Nov. 6) during a panel discussion at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference in Washington D.C. <\/p>\n
Krasny, who manages the Keller and Heckman law firm\u2019s office in San Francisco and has extensive experience labeling and advertising litigation, said she expects to see an increase in litigation related to the processing of food products. <\/p>\n
\u201cFor example, a lot of juices now have been treated with [high pressure processing] HPP to give them a longer shelf life,\u201d Krasny said. <\/p>\n
The HPP process, which is also used as a partial kill step by manufacturers, is a type of pressure treatment that only increases the temperature of a product by a small increment and is conducted under refrigerated conditions, Krasny explained. And yet, there has been increasing interest by the plaintiffs’ bar to press HPP juice manufacturers to indicate on the label that their cold-pressed products have been heated, Krasny said. <\/p>\n
Krasny believes that this type of litigation will continue to grow and expand to other products besides juice, such as Greek yogurt that was made using thickeners, instead of traditional cheese-cloth straining to achieve the right texture. Plaintiff lawyers can also easily apply the same logic to products that feature claims such as \u201chand-made\u201d or \u201chand-crafted,\u201d Krasny said. <\/p>\n
\u201cThese are all sort of variations on a theme,\u201d she said. <\/p>\n
McKenzie, on the other hand, predicted an increase in lawsuits targeting added sugars, especially in view of the lawsuits filed by a team of California attorneys led by Jack Fitzgerald, founder of the Law Office of\u00a0 Jack Fitzgerald PC in San Diego. Those lawsuits have targeted cereal manufacturers \u2013 including Kellogg\u2019s, Post Foods and General Mills \u2013 stating that the companies are falsely advertising their products as healthy, when in fact, they contain a high level of sugar, which when consumed in excess can cause anything from heart disease to type 2 diabetes.<\/p>\n
In at least one of those cases \u2013 the lawsuit that involves Kellogg\u2019s cereal – a U.S. District judge in August denied the company\u2019s motion to dismiss, allowing the litigation to move forward. The class action lawsuit takes aim at eight specific lines of Kellogg\u2019s cereals, as well as snack and breakfast bars. <\/p>\n
\u201cJack Fitzgerald and his group have filed lawsuits alleging that foods that have too much added sugar ate toxic and unhealthy,\u201d McKenzie said. \u201cI feel that he is testing a theory out with it. He has filed a few cases and have gotten some traction in at least one of them.\u201d <\/p>\n
This could easily blow up, because many products contain added sugars, said McKenzie, a partner in the law firm’s Philadelphia office. <\/p>\n
\u201cAnd if the theory is that added sugar is toxic and causes a serious health risk, then it could be expanded out to the cereal manufacturers, the breakfast manufacturers,\u201d she said. <\/p>\n
Krasny agreed with McKensie, but also noted that those could depend on new scientific research on the health impact of added sugar. Many of those sugar-focused cases involve products that are directed at people who exercise regularly or participate in endurance sports, Krasny noted. <\/p>\n
\u201cYou need a certain amount of carbs to do that \u2013 whether they are more complex carbs or added sugars,\u201d she said. \u201cAnd I think we need better information on how much is too much.\u201d <\/p>\n
According to McKenzie, courts in the future may also see an uptick of cases targeted at products that imply the meaning of \u201cnatural,\u201d either by using similar terms (such as \u201cpure\u201d or \u201csimple\u201d) or by channeling the idea that their products are natural through the use of imagery, without using the term directly. <\/p>\n
\u201cWhen you are using terms that are not defined by regulation \u2013 you potentially have more risk,\u201d McKenzie explained. \u201cMore nebulous terms, like \u201cpure\u201d or \u201csimple,\u201d are more susceptible to confusion among consumers and all you need to form the basis of a lawsuit is whether a reasonable consumer would have a different opinion.\u201d <\/p>\n
The same issue applies to products which, instead of using the term \u201cnatural\u201d directly, use the serene images of farms and pastures to convey the same meaning, McKenzie noted. <\/p>\n
\u201cWhen we advise clients on their labeling, that has to be taken into account,\u201d McKenzie stressed. \u201cIt has to be reviewed holistically \u2013 what impression are you trying to leave with the consumer,” she said. “It\u2019s not just the term you are using but it\u2019s the entire message you are trying to convey.\u201d <\/p>\n
‘Natural’ and ‘healthy’ cases to continue<\/h2>\n
A part of the problem and the reason why manufacturers are beginning to avoid the use of \u201cnatural\u201d is that the claim remains undefined\u00a0 in regulatory language. And that has created a maelstrom of ongoing litigation that still shows no signs of subsiding. <\/p>\n
According to McKenzie, “natural” remains the top labeling term in class action litigation and will likely continue to be an issue in the future, in large part because FDA has not defined the term in regulatory language. <\/p>\n
\u201cThis is a claim that has been an issue for a number of years and there is a lot of litigation out there involving ‘natural,’\u201d McKenzie said. <\/p>\n
FDA in 2015 announced<\/a> its intent to define the term but after collecting public comments, regulators grew quiet and have not shown any signs they may be ready to tackle the issue. <\/p>\n \u201cRight now we are in a holding pattern,\u201d McKenzie explained. <\/p>\n Last year, judges were willing to wait for FDA to release a definition and many “natural” cases were stayed<\/a> by courts under the doctrine of primary jurisdiction. But now that more time has passed with no word from the agency, some courts have started lifting those stays, McKenzie noted. <\/p>\n \u201cNow you see a lot of courts lifting the stays, you see the plaintiffs getting a little antsy and trying to lift the stays,\u201d she said. \u201cI think this may be an area where you are not going to have that defense if you have a \u2018natural\u2019 class action on your hands.\u201d \u00a0<\/p>\n That is why in new cases that involve the use of \u201cnatural,\u201d courts are refusing to grant stays, McKenzie noted. <\/p>\n In the case of Hint, Inc. in which questions the use of propylene glycol, a synthetic substance, in \u201call-natural\u201d flavored water, for instance, a judge has already indicated that a stay will not be an option, McKenzie said. <\/p>\n \u201cThere are many theories to support a natural claim,\u201d McKenzie said. <\/p>\n Cases so far have targeted products advertised as \u201cnatural\u201d that contain artificial flavors, synthetic additives, or genetically engineered (GE) ingredients. <\/p>\n In more recent litigation, plaintiffs have challenged \u201cnatural\u201d claims on products containing trace amounts of glyphosate (Nature\u2019s Valley) or propylene glycol (Hint Inc.). <\/p>\n Whether an all-natural product can contain GE ingredients has been a hot question in \u201cnatural\u201d litigation, and plaintiffs have gone as far as targeting products that were derived from animals that were given rBST or GE feed (Sargento<\/a>, Dannon<\/a>).<\/p>\n \u201cThe plaintiffs are only going to get more creative,\u201d McKenzie said. \u201cI don\u2019t think this is going to be a claim that is going to go away. There has been [an increase] in 2017 compared to 2016 in all ‘natural’ litigation and it is because plaintiffs\u2019 attorneys are being more creative in finding avenues to attack the ‘natural’ claim.\u201d<\/p>\n Legal experts in September estimated<\/a> that 2017 is on track to become a record year for “natural” claims.\u00a0<\/p>\n Just like \u201cnatural,\u201d the \u201chealthy\u201d claim remains a ripe source of litigation that does not show signs of slowing down, McKenzie and Kresny said at the FDLI conference. Though unlike \u201cnatural,\u201d the term \u201chealthy\u201d is a defined claim, which generally can be applied to products that are low-fat, low-sodium, and have 10% of certain nutrients. However, FDA is in the process of updating its old definition to account for new science on the health benefits of \u201cgood\u201d fats and in the process of reviewing thousands of public comments, with no signs of resolution in sight.<\/p>\n Litigation involving \u201chealthy\u201d claims, in the meantime, has proliferated, and while once cases only focused on whether a product is in violation of the claim (such as the case against Kind Inc.), more recent lawsuits, like the ones against cereal makers Post and General Mills, have had a greater focus on the presence of added sugars in products that claim to be healthy, McKenzie noted. <\/p>\n The burning question that remains on the table now is whether FDA will finalize new definitions for the use of \u201chealthy\u201d and \u201cnatural.\u201d<\/p>\n According to Krasney and McKenzie, it is more likely for FDA regulators to define \u201chealthy\u201d than to tackle the thornier \u201cnatural\u201d claim. <\/p>\n \u201cI see \u2018healthy\u2019 as more science-based, even though the science has changed,\u201d Krasny said, as she compared \u201cnatural\u201d to where the term \u201corganic\u201d stood the 12 years after the Organic Food Standards Act was passed and before the National Organic Program was put in place. The term \u201corganic\u201d in that period was viewed in the same way \u201cnatural\u201d is viewed now, because there was no consensus on what the term actually means, Krasny said. <\/p>\n \u201cFDA now is looking for a consensus and if you are looking for a consensus on what ‘natural’ should mean, that is a long haul,\u201d she noted. <\/p>\n McKenzie agreed. \u201cI think \u2018healthy\u2019 is going to be an easier road to go down if you are the FDA,\u201d she said. \u201cI think \u2018natural\u2019 is just tough.\u201d<\/p>\n \u00a0<\/p>\n<\/p><\/div>\n That is the belief of two legal experts \u2013 Leslie Krasny of Keller and Heckman and Yvonne McKenzie of Pepper Hamilton LLP \u2013 who tried to map out future trends in food labeling litigation on Wednesday (Nov. 6) during a panel discussion at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference … <\/p>\nWill FDA define the terms?<\/h2>\n
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