• On August 9, 2020, a class action lawsuit was filed against Hostess Brands, LLC, alleging that the company had deceptively marketed its product as a “carrot cake donette” when in fact it contained no real carrots.
  • Plaintiffs alleged that consumers would expect the product to contain real carrots because it was described as a “carrot cake” without qualifying this name with any of the terms prescribed by the flavoring regulation (e.g. “flavored, naturally flavored, artificially flavored”). They further alleged that it was apparent that the product did not contain any real carrots because the ingredient list did not disclose carrots and instead disclosed that the product contained “natural and artificial flavor.” Plaintiffs alleged that the “natural flavor” meant that at best the product contained an ingredient derived from real carrots, and that, in any case, consumers would not expect the product to contain any “artificial flavor.”
  • Plaintiffs are represented by Sheehan & Associates P.C. which has filed many lawsuits in the food flavoring litigation space, in particular against companies marketing vanilla products. Keller & Heckman will continue to monitor and provide updates regarding class-action litigation in the food industry.
  • We have discussed the slow progress toward a regulatory pathway for lawfully marketing FDA-regulated food and dietary supplement products that contain cannabidiol (CBD).  While CBD products remain technically illegal (aside from one FDA-approved drug), FDA is gathering information and has taken action so far only against CBD-containing products that make disease and health-related claims or contain unsafe contaminants such as heavy metals and pesticides.  Product labeling that may be false and misleading with regard to CBD content has meanwhile been the subject of a growing number of private lawsuits, such as the proposed class action discussed here.
  • The most recent Cannabis Law Report covers independent testing sponsored by Leafreport finding that of 22 beverages tested, only 4 (13%) contain the amount of CBD stated.  Three products (13%) were reported to contain a level of CBD that is 20% more (2 products) or less (1 product) than stated.  One product (5%) was reported to contain a level of CBD that is 30% more than stated.  Fourteen products (65%) were reported to have a CBD content that differed by more than 30% from the stated level, with 3 beverages containing more CBD than stated, 9 containing less CBD than stated, and 2 products containing no detectable amount of CBD.
  • The results of independent testing indicating inaccurate labeling for CBD beverages is unsurprising given that FDA’s own market survey data, as discussed in a July 2020 report to Congress, has revealed that of 78 products tested which claim to contain CBD, most contained a level of CBD that differed from the labeling by more for 20%.  Eleven such products contained no detectable CBD and 46 contained some level of tetrahydrocannabinol (THC), a narcotic, including one product with THC levels so high that it was referred to the Drug Enforcement Agency (DEA) for potential action.  Until there is an FDA regulatory framework for foods or dietary supplements containing CBD, however, buyers need to be cautious.
  • To help the food industry protect employees and maintain the safety of human and animal food throughout adjustments to operations during the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Occupational Safety and Health Administration (OSHA) have developed a number of resources and guidance materials. FDA and OSHA, working together and pulling from that existing guidance, recently developed the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic.”
  • The Checklist addresses considerations for the assessment of FDA-regulated human and animal food operations during the COVID-19 pandemic, especially when reassessing operations due to changes brought about by COVID-19 or restarting operations after a shutdown. The Checklist is divided into two primary sections: employee health, screening, and configuration of operations for social distancing to prevent or minimize the spread of COVID-19 (based on CDC and OSHA guidelines); and food safety requirements (based on existing regulations) to help assess the potential impact of COVID-19-related operational changes on food safety practices (e.g., closures, changes to food safety staff, changes to suppliers and ingredients, etc.).
  • The Checklist may be useful to various FDA-regulated food establishments that grow, harvest, pack, manufacture, process, or hold human and animal food (such as produce, seafood, milk, eggs, grains, game meat, raw materials or ingredients, and resulting food products). The Checklist also provides information for foreign facilities that manufacture, process, pack, or hold food intended for consumption in the United States.
  • While the Checklist does not constitute a standard or regulation, and does not create new legal obligations, it describes recommendations and guidance, referencing existing mandatory safety and health standards. The Checklist is not intended to be an exhaustive list of all measures to protect employee health and food safety, but to serve as a quick reference source to identify areas where additional attention may be warranted.  Operations should continue to refer to guidelines provided by state and local governments, as well as regulations, requirements, and guidance promulgated and provided by FDA, CDC, OSHA, and other relevant agencies.
  • New laws in several Mexican states will place a complete ban on the sale of food high in sugar to children, which will include harsh penalties on any sellers that disobey the directives including fines, and even jail time for repeat offenders.
  • By way of example, in Tabasco, Mexico, there is now a prohibition of the “ the sale, distribution, donation, gift, and supply of prepackaged sugary drinks, carbonated sugary drinks, sweets and prepared foods with a predominance of refined carbohydrates and vegetable fats in their solid form that contain hydrogenated fatty acids in their trans form, to minors [under the age of 18], as well as their consumption in medical and educational centers.”  Moreover, the State of Tabasco will prohibit vending machines in education centers, public and private hospitals, clinics, and health centers.  In Oaxaca, Mexico, a similar law will forbid the sale, distribution and promotion of sugary drinks, and junk food to those under age.   It will also apply to vending machines in schools.  These states will continue to allow parents or legal guardians to purchase these types of products for their children.
  • In regard to the advertising of foods high in sugar, the State of Tabasco will prohibit advertisements, posters or any type of advertising referring to the aforementioned products within a 300 meter radius from any educational centers, medical centers, and hospitals.  In addition, the price to advertise in authorized locations will increase by 25 percent.
  • These new laws follow a host of measures over the years that aim to reduce consumption of food high in sugar, including a new food labeling law, which will go into effect in October.  Other Mexican state governments, including Mexico City, Colima, Guanajuato, San Luis Potosi, and Tamaulipas have shown interest in adopting similar initiatives.   We will continue to monitor any developments.
  • On August 14, 2020, the FDA announced an update to its investigation of the cause of an outbreak in Cyclospora illnesses that were first reported in May 2020 and were initially linked to salads manufactured by Fresh Express containing iceberg lettuce, red cabbage, and carrots. As of the date of the announcement, the outbreak has resulted in 690 people across 13 states falling ill.
  • Though traceback of cases has revealed that the likely source of contamination was iceberg lettuce from California and red cabbage from Florida, environmental sampling was unable to confirm these results. The Californian farms growing the iceberg lettuce linked to the outbreak tested negative for Cyclospora, while the Floridian farm suspected of being the source of the red cabbage was not in production at the time of testing and the FDA was not able to verify that the Cyclospora present in a nearby canal was a genetic match to the clinical cases.
  • FDA’s announcement demonstrates the technological progress that it has made in Cyclospora detection, including a test method validated last year which allows the Agency to test agricultural water for the presence of Cyclospora. Furthermore, FDA’s announcement states that the Agency intends to issue proposed rules this year which will (1) enhance product traceability and (2) revise certain agricultural water requirements in the Produce Safety Rule.
  • The outbreak highlights the importance of preventative measures to mitigate the risk of food-born outbreaks—including through ensuring the safety of irrigation water used on produce— as well as the FDA’s commitment to improving its ability to investigate food-born illness outbreaks, both through advances in technology and changes to the regulatory frameworks in place. Keller and Heckman will continue to monitor and report on updates to this and other food-born illness outbreaks.

Conagra Slips Out of Parkay Spray False Ad Suit (subscription to Law360 required)

  • The Nutrition Labeling and Education Act (NLEA) requires food intended for human consumption and offered for sale to bear nutrition information that provides a serving size that reflects the amount of food customarily consumed.  FDA updated the regulations on serving sizes in May of 2016 to provide more realistic Reference Amounts Customarily Consumed (RACCs).  The RACC for “Fats and Oils: Spray types” and “Fats and Oils: Butter, margarine, oil, shortening” are 0.25 grams and one tablespoon, respectively.
  • On August 12, 2020, a California federal judge granted summary judgment for Conagra Foods, Inc. in a lawsuit filed in 2013 alleging the labeling of Parkay Spray, which is labeled as a spray-type fat and oil with a RACC of 0.25 gram, uses artificially small serving sizes in order to disguise the true fat and calorie content of its product.  The judge did not consider whether the plaintiffs would ultimately be able to prove the label is misleading or deceptive in violation of California and Hawaii consumer protection laws based on allegations that the product is used as a buttery topping, is marketed as an alternative to butter for use on foods like corn and bread, and is in fact used as a topping by consumers.  Instead, the judge found it is not possible to conclude that Parkay Spray belongs in the butter, margarine, oil, and shortening reference amount category, as opposed to the spray-type fat and oil category, because the product could not be “used interchangeably” with butter or margarine.  Accordingly, since plaintiffs seek to impose state law requirements that are not identical to the federal requirements, the judge ruled that the deceptive labeling claims are preempted as a matter of law.
  • The order otherwise pointed out that FDA has already declined to amend the spray-type fats and oils category (based on a lack of data that could be used for calculating a different RACC) after being made aware of the precise consumer concerns raised by the plaintiffs.  In this regard, the judge also refused Conagra’s request to seal the contents of consumer inquiries and complaints concerning Parkay Spray, although Conagra has 30 days to more narrowly tailor a request to seal certain other documents in the case.

 

  • A federal district court in New York is allowing state consumer protection claims to proceed against Arizona Beverage Co. (“Arizona”) for its “all natural” gummies.  As previously reported on this blog, the labeling is alleged to be misleading because the gummies contain ingredients such as ascorbic acid, dextrose, glucose syrup, and modified food starch.
  • This week, the judge in the Arizona case dismissed Wisconsin and Ohio state law claims but allowed the remaining 38 state consumer protection law claims to proceed.  The court also declined to stay the suit pending FDA’s consideration of whether to define the term “natural” in its regulations.
  • “Natural” claims remain a top target of class action litigation, though the court outcomes are not often favorable to plaintiffs.  Despite the outcomes of these cases, the class action challenges continue.
  • On August 12, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and that bear the “gluten-free” claim. The rule will have an impact on foods like soy sauce, yogurt, sauerkraut, pickles, cheese, green olives, and distilled foods, such as distilled vinegars.
  • In the final rule, FDA noted that it knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. As such, the Agency stated that it will evaluate compliance of such fermented or hydrolyzed foods that bear a ‘‘gluten-free’’ claim based on records that are made and kept by the manufacturer of the food bearing the ‘‘gluten-free’’ claim and made available to FDA.
  • The final rule requires manufacturers of these food products to make and keep records providing adequate assurance that (i) the food meets the definition of “gluten-free” before fermentation or hydrolysis; (ii) the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, (iii) measures are in place to prevent the introduction of gluten into the food during the manufacturing process.
  • We note that FDA did not change the “gluten-free” definition that it established in 2013. By way of background, in addition to limiting the unavoidable presence of gluten to less than 20 parts per million, FDA allows manufacturers to label a food “gluten-free” if the food does not contain any of the following:
    • (i) an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
    • (ii) an ingredient derived from these grains and that has not been processed to remove gluten, or;
    • (iii) an ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten.
  • In an August 12, 2020 FDA news release, Department of Health and Human Services Secretary, Alex Azar, noted that the “FDA’s final rule helps to ensure common products labeled ‘gluten-free’ really are gluten-free, equipping consumers to make the best choices for their health and their families.” FDA’s final rule is effective October 13,2020.
  • On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) gave notice of their proposal to amend the Safe Drinking Water and Toxic Enforcement Act of 1986 (“Prop 65” or “the Act”) by adopting Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods.
  • Under the existing regulation for naturally occurring chemicals in foods, a chemical is naturally occurring only to the extent that the chemical “did not result from any known human activity.”  Currently, chemicals in food created by cooking or heat processing are not considered to be naturally occurring in Section 25501.  However, this proposed amendment draws a distinction between exposures to listed chemicals in food that result from cooking or heat processing that cannot be feasibly avoided and those that can be feasibly avoided.
  • In its initial statement of reasons, OEHHA states that some degree of formation of listed chemicals in many foods is unavoidable when the foods are cooked or otherwise processed with heat and that the chemicals are byproducts of the processing, as opposed to being the intended result.  Although OEHHA acknowledges that certain amounts of these chemicals are unavoidable, OEHHA added that in many circumstances, the level of the chemical formed can be lowered by optimizing certain practices.
  • The proposed amendment states that “a person who is otherwise responsible for an exposure to a listed chemical in food does not ‘expose’ an individual within the meaning of Section 25249.6 of the Act, to the extent that the chemical was created by cooking or other heat processing if the producer, manufacturer, distributor, or holder of the food has utilized quality control measures that reduce the chemical to the lowest level feasible.”  As a result, the proposed amendment establishes maximum concentration levels for listed chemicals in foods that are produced by cooking or heat processing that are deemed by OEHHA to be the lowest levels currently feasible.   Concentrations of a chemical at or below the level identified for the specified products would not require a warning.
  • Notably, the proposed amendment includes concentration levels for acrylamide in products, like bread, cookies, crackers, potato products, prune juice, and waffles, that are deemed to comply with the proposed amendment.  We note that these levels do not relate to exposures that are below the safe harbor levels for these compounds.  In addition to acrylamide, OEHHA also notes that it could add other foods or chemicals in future rulemaking.
  • The proposed amendment would not apply to parties to an existing court-ordered settlement or final judgment establishing a concentration of acrylamide in a specific product covered in that settlement or judgment.   OEHHA is accepting comments on the proposed amendment until October 6, 2020.
  • Keller and Heckman lawyers are experienced with advising on Proposition 65.  We will continue to monitor any developments.
  • On July 31, 2020, Plaintiff, on behalf of a proposed class of consumers, filed a class-action lawsuit against Defendant Kraft Heinz Company alleging that Defendant had falsely and deceptively advertised its Maxwell House ground coffee products by “grossly” exaggerating the number of cups of coffee that could be made from them.
  • The representations at issue covered 38 varieties of coffee products and were made in each case on the front packaging of the products. Based on the products’ instructions to use one tablespoon of ground coffee to make one 6 fluid-ounce cup of coffee, and the fact that one tablespoon of ground coffee weighed five grams, Plaintiff calculated that Defendant’s products could only produce between 66% and 73% of the represented number of cups of coffee based on the net quantity of contents of the product.  The example provided in the complaint was that the product claimed to make 90 cups of coffee from a 10.5 ounce (297 gram) tin but at 5 grams per tablespoon the contents would only yield around 59 cups of coffee.  Plaintiff alleged that these misrepresentations allowed Defendant to charge more for the coffee products and induced consumers to purchase them, and that it would be unreasonable to expect a consumer  to calculate how many cups of the coffee the products could make.
  • Plaintiff’s complaint is similar to a class-action lawsuit filed in May 2020 which alleged that Folgers Coffee Company had inflated the number of cups of coffee that could be produced from its products. Keller and Heckman will continue to monitor developments in this case and trends in food class-action litigation.