• On August 27, 2020 Consumer Reports published an article in which they analyzed 5 years of data collected by the US Department of Agriculture (USDA) and determined that, in some cases, the amount of pesticides found on fruits and vegetables exceeded safe levels.  Specifically, Consumer Reports determined that approximately half of non-organic fruits and vegetables posed little risk, while about 20% of the produce (including green beans, peaches, and potatoes) received poor scores.
  • While industry groups argue that pesticide residue does not pose a health risk, Consumer Reports alleges that pesticides can damage the brain and nervous system, and that even low levels have been linked to cancer, reproductive issues and various health problems. They further suggest that overall health impacts may be greater, as questions remain regarding the effects of long-term low-dose exposure.
  • To help consumers identify which produce poses the biggest potential risk from pesticides, Consumer Reports experts developed ratings for 35 fruits and vegetables based on information from USDA’s Pesticide Data Program. The ratings factor in the total number and level of pesticides on the produce, the frequency in which pesticides were detected, and toxicity using EPA’s chronic reference dose. More information on the methodology used can be found here.
  • In the article, Consumer Reports urges government agencies and Congress to take various steps to protect consumers from the alleged harms of pesticides, including banning the agricultural use of the riskiest pesticides, providing the public with easy-to-search databases, and placing import alerts on fruits and vegetables that test positive for banned pesticides.
  • On September 9, 2020, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced that it is modernizing egg products inspection methods for the first time since Congress passed the Egg Products Inspection Act in 1970.  The Egg Products Inspection Regulations final rule aligns the egg products regulations to be consistent with current requirements in the meat and poultry products inspection regulations. The new rule took effect immediately.
  • Under the new rule, federally inspected egg products plants are required to develop and implement Hazard Analysis and Critical Control Points (HACCP) systems.  USDA has stated that under the HACCP system, plants will be able to tailor a food safety system that best fits their particular facility and equipment.  This new rule will also require federally inspected egg products plants to develop Sanitation Standard Operating Procedures (SSOPs).  USDA noted that “by removing prescriptive regulations, egg products plants will have the flexibility and the incentive to innovate new means to achieve enhanced food safety.”  FSIS will continue to test for Salmonella and Listeria monocytogenes in egg products.
  • Previous USDA regulations required inspectors to be present whenever egg products were being processed.  Under this new rule, inspectors must visit federally inspected egg products plants only once per shift.  Paul Kiecker, FSIS administrator, noted that inspectors will now operate under a “patrol system,” in which they will cover multiple plants each day.
  • Notably, USDA will also assume oversight from the Food and Drug Administration of additional facilities that produce egg substitutes.  This new egg inspection rule is intended to help egg producers recover from the losses they experienced during the COVID-19 pandemic; however, consumer advocates argue that food safety might suffer as a result.
  • On August 25, 2020, Sheehan & Associates P.C., on behalf of a proposed class of New York consumers, filed a class action lawsuit against Family Dollar Stores, Inc., alleging that the company is misleadingly advertising its Eatz-brand Smoked Almonds as “smoke” flavored despite the fact that the almonds have not gone through the smoking food preparation process.
  • Plaintiffs identified “Natural Smoke Flavor” on the ingredient list, and from this disclosure, inferred that the almonds derived their smoke flavor not from the smoking process but from this added natural flavor. Plaintiffs allege that consumers would expect that foods with a “smoke” flavor have undergone an actual smoking process and that Defendant’s product should have been labeled with a qualifying term such as “Naturally Flavored.”
  • This lawsuit is almost identical to another lawsuit recently filed by the same firm regarding a Smoked Gouda Artisan Cheese product sold by Dietz & Watson, Inc. and may be a harbinger of further lawsuits against smoke flavored products. Keller & Heckman will continue to monitor and report on trends in the food litigation space.
  • The National Advertising Division (NAD) of BBB National Programs, Inc. recently launched its new Complex Track challenge process. According to NAD, the Complex Track will be a “customized experience” to “support advertising challenges that involve complex substantiation,” and offers “flexible and more predictable scheduling, greater transparency into the case review process, and deeper insights into NAD’s perspective on the evidence.”
  • Parties to a challenge under the Complex Track will initially meet with NAD (the cases will be staffed by three NAD attorneys – one lead attorney and two supporting attorneys) in a pre-case conference, to “map out the timeline necessary to compile evidence” and jointly discuss the timing of the submissions and meetings. The second case conference, held ex parte with each party after the advertiser’s initial submission but before the record closes, will involve discussions to gain “insight into the evidence received and any questions NAD has about that evidence”; offer the option to provide specific evidence or demonstrate the sufficiency of different evidence; give the parties insight into NAD’s view of the case and for NAD to share feedback; and help the parties prepare for the final case meeting(s). The subsequent post-decision processes are intended to remain the same as those applied in the Standard Track challenge process.
  • NAD envisions the Complex Track for cases that require more time and resources to resolve, such as those involving: multiple expert reports supporting or rebutting evidence; evidence that includes consumer perception surveys, scientific studies, or other technical issues that require additional time to analyze; or challenges to numerous claims made for a variety of products. NAD provides a non-exhaustive list of examples of hypothetical cases that may be appropriate for the Complex Track.
  • As previously discussed on this blog, NAD launched its Fast-Track SWIFT (Single Well-defined Issue Fast Track) challenge process in April 2020, offering an expedited process (resolution within 20 days of initiation) for relatively simple and well-defined single-issue advertising disputes. Challengers will now have three filing options available to pursue their case with NAD: Fast-Track SWIFT, Complex Track, and the Standard (original) Track.  Advertisers can request that a challenge be moved from Standard to Complex Track, subject to NAD’s discretion.

Keller and Heckman advises and represents clients in various stages and types of NAD proceedings. We will continue to monitor this new challenge mechanism as it develops.

  • On August 13, 2020, animal welfare advocates sued the U.S. Department of Agriculture (USDA) in a bid to compel the agency to issue rules to ensure the humane handling of poultry at slaughter plants.  The Animal Welfare Institute (AWI) and Farm Sanctuary filed the lawsuit in the U.S. District Court for the Western District of New York.
  • The lawsuit specifically contests USDA’s decision to reject two rulemaking petitions submitted by AWI.  These petitions requested the human handling of chickens and turkeys to prevent poultry products from being adulterated as defined by the Poultry Products Inspection Act (PPIA).  AWI filed these petitions in 2013 and 2016, citing evidence that some slaughter facilities had left large flocks of birds without food and water in plant holding areas for days at a time.  In these petitions, AWI noted that USDA enforcement records revealed that government inspectors document birds dying from causes that are unacceptable under the PPIA, such as exposure to extreme weather, blunt force trauma, and asphyxiation.  The petitions also requested that USDA’s Food Safety and Inspection Service (FSIS) use its authority under the PPIA to issue regulations for the humane treatment of poultry at slaughterhouses, arguing inhumanely treated birds are “adulterated” under the statute.  Last year, USDA denied both of AWI’s petitions noting that the PPIA does not give USDA authority to prescribe requirements for the humane handling of live birds at slaughter.
  • In their lawsuit, the animal welfare advocates allege that USDA has failed to address the systematic mistreatment of chickens and turkeys at federally inspected slaughterhouses.  The plaintiffs also allege that the inhumane treatment of poultry also compromises food safety and meat quality.  We will continue to monitor any developments.
  •  On August 28, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency announced its release of a draft report on the potential neurological impacts of synthetic food dyes in children. In particular, the report analyzed the following seven most commonly consumed food dyes in the U.S.:  (1) FD&C Blue No. 1; (2) FD&C Blue No. 2; (3) FD&C Green No. 3; (4) FD&C Red No. 3; (5) FD&C Red No. 40; (6) FD&C Yellow No. 5; and (7) FD&C Yellow No. 6.  All of these color additives are approved for use in food at 21 CFR Part 74.
  • The report, which consists of a review of the scientific literature and a risk assessment, was commissioned by the California legislature in 2018 after concerns surfaced regarding the neurobehavioral impacts of these dyes on children, in particular attention deficit hyperactivity disorder (ADHD) and other behavioral outcomes.
  • Overall, the report concluded that “synthetic food dyes may cause or exacerbate neurological behavioral problems in some children.” And, although its exposure assessment found that “[n]one of the child intake estimates based on a daily serving size of sampled foods exceeded US FDA ADI’s [average daily intake] for food dyes,” it cautioned that the studies forming the basis for FDA’s ADIs were “many decades old and were not capable of detecting the types of neurobehavioral outcomes measured in later studies.” Further, while acknowledging the need for more research on the topic and detailing recommendations for the direction of future research, the report concludes that “at a minimum . . . the neurobehavioral effects of synthetic food dyes in children should be acknowledged and steps taken to reduce exposure to these dyes in children.” A public comment period on the draft report will run until October 13, 2020. Keller and Heckman has extensive legal and scientific experience in assessing the safety of color additives. Please let us know if you are interested in submitting comments.

 Food Cos. Escape Suit Alleging False US Origin Labeling (subscription to Law360 required)

  • The Federal Meat Inspection Action (FMIA) grants the United States Department of Agriculture (USDA) exclusive authority to regulate the labels and packing of beef products.  A lawsuit, previously covered on this blog, that sought to force USDA to reinstate its country of origin labeling (COOL) rules was dismissed on June 5, 2018.  Under USDA’s COOL rules, implemented in 2013, meat labels were required to indicate where animals were born, raised, and slaughtered.  After much controversy and a ruling against the COOL requirements by the World Trade Organization (WTO), Congress repealed the COOL requirements as of December 21, 2015.  In the aftermath of the COOL controversy, a beef product label, which cannot be used until it is approved by USDA’s Food Safety Inspection service (FSIS), is permitted to bear the phrase “Product of the USA” if the product is “processed” in the United States.
  • On August 27, 2020, a New Mexico federal judge granted motions by defendant meat processing companies, Tyson Foods, Inc., Cargill Meat Solutions, JBS USE Food Company, and National Beef Packing Company to dismiss two previously consolidated putative class actions on behalf of consumers and ranchers alleging that “Product of the USA” claims are fraudulent and misleading as applied to beef from cattle raised in foreign countries and imported live for slaughter and processing in the U.S.  The judge denied injunctive relief, finding it was preempted by the express language of the FMIA in that it would create labeling requirements “in addition to, or different than” the USDA’s standards.  Further, the judge refused to consider whether USDA’s decision to approve the label may be wrong, determining that since USDA had authority to regulate country-of-origin labeling the preemption analysis stands without consideration of any evidence as to whether the labeling is misleading.
  • Although appeals are expected in the federal lawsuits in New Mexico, potential new action from the USDA could possibly cement the preemption argument.  As we have covered on this blog, on March 26, 2020, in denying two petitions requesting that the FSIS permit “Product of the USA” labeling only on meat of “domestic origin,” the USDA announced an intent to initiate rulemaking to limit “Product of USA” and certain other voluntary U.S. origin statements to meat products derived from livestock that were slaughtered and processed in the United States.
  • On August 25, 2020, the Center for Science in the Public Interest (CSPI) sent a letter urging FDA to take further enforcement against manufacturers, distributors, and retailers that sell products with tianeptine.  Tianeptine, approved as a prescription antidepressant in other countries, is being marketed as a dietary supplement in the Southeastern U.S.
  • FDA has issued warnings to consumers and companies on the dangers of tianeptine in the past. In 2018, FDA issued warning letters to two companies for the illegal marketing of products labeled as dietary supplements that contained tianeptine, which companies illegally claimed to treat opioid use disorder, pain, and anxiety.  CSPI noted that one online retailer that received an FDA warning letter in 2018, jackbgoods.com, continued to sell tianeptine supplements into late July.  Tianeptine products continue to be commonly available in gas stations, vape stores, and other retail outlets in Alabama and online.
  • CSPI believes that enforcement against supplements containing tianeptine should be prioritized, as they target a vulnerable population of recovering or active drug users during a nationwide opioid epidemic.  The letter notes that the popularity of tianeptine increased in the state after Alabama prohibited the sale of kratom, a substance that provides similar effects.  A bill has been introduced in Alabama to ban the sale of tianeptine in the state.
  • On Friday, August 21, 2020, Judge Richard Seeborg at the U.S. District Court for the Northern District of California filed an order granting Miyoko’s Creamery’s (“Miyoko’s”) motion for a preliminary injunction, which blocked the State of California’s attempts to prevent Miyoko’s from using the terms “butter,” “lactose-free,” and “cruelty free” on its vegan products that are made from coconut oil, sunflower oil, and cashew nuts.
  • By way of background, Miyoko’s filed suit in February 2020 to prevent California from enforcing its label demands, which the company argued violated their First Amendment rights.  In its December 9, 2019 enforcement letter, the California Department of Food and Agriculture’s Milk and Dairy Foods Safety Branch outlined numerous purported violations of state and federal law, including the following:
    • The “vegan butter” product does not meet the definition of “butter” at 21 U.S.C. 321a, which requires that a product be made exclusively from milk or cream, or both with or without common salt …. and containing no less than 80 per centum by weight of milkfat. The Department ordered Miyoko’s to remove the word “butter” from the label.
    • Given that the product is not a dairy product, it cannot make claims such as “Lactose Free,” “Hormone Free,” and “Cruelty Free,” which imply that the product is a dairy food without the claimed characteristics. California Food and Agriculture Code 38955. The Department ordered Miyoko’s to revise or remove the claims.
  • In regard to the core claims around “vegan butter,” Judge Seeborg noted that “the state’s showing of broad marketplace confusion around plant-based dairy alternatives is empirically underwhelming.”  Judge Seeborg also stated that while the standard of identity for butter stipulates that butter must contain at least 80% milkfat, the question at issue in this case is whether Miyoko’s use of the word “butter” in close proximity to terms, such as “vegan,” “made from plants,” and “cashew & coconut oil spread” amounts to misleading commercial speech.  Ultimately, the court disagreed that “butter,” “lactose-free,” and “cruelty free” claims were confusing or misleading.
  • Although the motion for preliminary injunction allows Miyoko’s to use the terms discussed above, the court concluded that Miyoko’s cannot use a “hormone-free” claim, as plants contain naturally-occurring hormones.
  • On July 16, the Japanese Consumer Affairs Agency (CAA) announced a revision to the Food Labeling Standards (“Standards”) of Japan under which sweeteners, colors and preservatives are no longer allowed to be supplemented with words such as “artificial” and “synthetic” when they are declared by their function names with substance name on the food label. In the meantime, food flavorings can only be collectively declared as “flavors” without further specification as to whether or not they are “artificial” (a table comparing the new rule and the existing rule is available here).
  • According to CAA’s Report on the Review Meeting of Food Additive Display Mechanism (“Report”) which was held on March 31, 2020, the above revision is based on a consumer survey result that shows consumers are more likely to avoid a food product when its label suggests use of artificial food additives, even though use of all food additives declared thereon have been evaluated and cleared by the Japanese food authority. Accordingly, CAA proposed not to distinguish the abovementioned types of artificial food additives from natural food additives in food labeling.  It is worth noting that, under the current Standards, “natural” and similar words cannot be used in the labeling of food additives.
  • The industry has until March 31, 2022 to adapt to this policy change.
  • Per the Report, CAA is also considering updating its guideline on the claims of “no additive” and “not used” under the Standards and relevant fair competition rules. The current Standards do not specifically regulate “additive free” type of claims, and thus, cause confusion among consumers when those claims are made on a voluntary basis by food business operators.
  • Keller and Heckman’s Shanghai office monitors food regulatory and labeling developments in Japan and would be happy to answer any questions.