• A 54-year-old Massachusetts man died of cardiac arrest after his consumption of a substantial quantity black licorice. The man reportedly consumed a bag and a half of black licorice each day for several weeks.
  • The Food and Drug Administration (FDA) has warned consumers about the potential risks of overconsumption of black licorice.  Specifically, FDA has warned people 40 or older that eating 2 ounces of black licorice a day for at least two weeks may cause an irregular heart rhythm or arrhythmia.
  • Licorice root and black licorice contain glycyrrhizin, which can cause potassium levels in the body to fall, potentially triggering abnormal heart rhythms, as well as high blood pressure, edema, lethargy, and congestive heart failure.
  • FDA advises consumers not to eat large amounts of black licorice at one time, to stop eating black licorice if experiencing irregular heart rhythm or muscle weakness, and to consult a healthcare professional regarding possible interactions that licorice may have with drugs or supplements.
    • On September 22, 2020, the Berkeley City Council passed the “Healthy Checkout” bill (the Bill), an ordinance that requires “large retail stores” to offer healthy food and beverages at the checkout lane, such as chewing gum and mints with no added sugars, fruit, vegetables, nuts, seeds, legumes, yogurt or cheese, and whole grains.  Berkeley council members Kate Harrison and Sophie Hahn co-authored the Bill with the support of the Center for Science in the Public Interest, which stated that this Bill will prohibit large retail stores from selling “unhealthy food and beverages,” like soda and sugary foods at checkout lanes.
    • The Bill defines “large retail store” as “a commercial establishment selling goods to the public with a total floor area over 2,500 square feet and selling 25 linear feet or more of food.”  Section 9.82.030 of the Bill states that each retail store must ensure that all foods and beverages sold in checkout areas “comply with the following list of qualifying food and beverage categories: (A) beverages with no added sugars and no artificial sweeteners; (B) food items with no more than 5 grams of added sugars, and 200 milligrams of sodium per labeled serving; (C) food items must be in the following categories: chewing gum and mints with no added sugars, fruit, vegetables, nuts, seeds, legumes, yogurt or cheese and whole grains.”  A total of 25 retailers throughout the City of Berkeley, including stores such as Safeway, Whole Foods, and Trader Joes, will have to adhere to the ordinance.
    • Council member Kate Harrison stated that the “new regulations do not prohibit junk food entirely — retailers will still be allowed to sell the items in other parts of the store — just not at the eye-level of a child in the checkout lane.”   In 2014, the City of Berkeley was also the first city in the United States to pass a soda tax.  The “Healthy Checkout” Bill will go into effect on March 1, 2021 and health inspectors will begin enforcing the policy on January 1, 2022.
  • On September 21, 2020, the FDA announced a proposed rule that would establish additional traceability requirements for persons who manufacture, process, pack, or hold certain high risk foods designated in a new “Food Traceability List” (FTL) that was published along with the proposed rule. While the proposed requirements would only apply to foods listed on the FTL as well as foods containing FTL foods as ingredients, voluntary industry-wide adoption of the practices is encouraged.  Some examples of the foods on the FTL include: cheeses (other than hard cheeses), shell eggs, nut butter, various fruits and vegetables, finfish (including smoked finfish), Crustaceans, Mollusks (bivalves), and ready-to-eat deli salads.
  • The proposed traceability requirements would require the establishment and maintenance of records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs). The following CTEs are identified in the proposed rule:
    • Growing.
    • Receiving. There are additional KDEs for “first receivers,” defined as the “first person (other than a farm) who purchases and takes physical possession of a listed food.” Only originated foods (food that are grown, raised, caught, or harvested) have a first receiver.
    • Creating, defined as the making or producing of a food on the FTL using only ingredient(s) that are not on the FTL (e.g. the making of peanut butter (on the list) from peanuts (not on the list)).
    • Transformation. Involves changing a food on the FTL, its package, and/or its label, such as by combining ingredients or processing it (e.g. making peanut butter sandwich crackers because one of its ingredients (peanut butter) is a food on the FTL). Transformation does not include the initial packing of a single-ingredient food or creating a food.
    • Shipping.
  • A detailed list of KDEs required for each CTE can be found here. In addition to these KDEs, the proposed rule would also require regulated entities to keep various other records of their traceability program to help regulators understand how it is operated, including a description of the relevant reference records, a list of food on the FTL that are shipped, and a description of how traceability lot codes are assigned.
  • The proposed rule includes a number of exemptions, including for certain types of small originators, farms that sell produce directly to consumers (and certain foods produced and packaged on a farm), foods that are processed in a certain way to destroy microorganisms, produce that is “Rarely Consumed as Raw” (RCR), transporters, non-profit food establishments, persons dealing with food intended for personal consumption, and persons holding food for individual consumers. Partial exemptions would also be available for commingled raw agricultural commodities (RACs), retail food establishments (FDA is considering a full exemption for small retail food establishments), farm-to-school and farm-to-institution programs, and for food from fishing vessels.
  • The proposed rule will be available for public comment for 120 days from the date of publication, which is scheduled for September 23. Comments should be submitted to docket FDA-2014-N-0053 on regulations.gov. Keller and Heckman will continue to monitor and report on any updates to the rule and is available to assist in drafting comments.

 

  • The Food and Drug Administration (FDA) is one of 27 agencies and offices within the U.S. Department of Health and Humans Services (HHS).  FDA’s final rules have typically been signed by the FDA Commissioner, or more often a lower appointed officer within the agency.  FDA’s rules have not usually been signed by the HHS Secretary, who is a Cabinet member with the primary role of advising the President on public health-related matters.  The authority of an appointed officer to sign a final rule has been challenged recently in the context of FDA’s “Deeming Rule,” which extended the Agency’s tobacco authority to e-cigarettes.  In 2019, vaping industry plaintiffs unsuccessfully attempted to invalidate the rule by questioning the authority of the FDA official (the Associate Commissioner for Policy) who signed the rule.
  • In a September 15, 2020 memorandum reported on last week by The New York Times, the current HHS Secretary, Alex Azar, barred the FDA and other health agencies from signing any new rules regarding the nation’s food, medicine, and other products under the HHS umbrella.  The Secretary’s office characterized the new policy as an overdue “housekeeping” matter unrelated to any particular agency or current issue.  Others, however, questioned the impact of this new policy on public trust in the standard scientific and regulatory processes at health agencies, noting the timing of the Secretary’s memorandum close on the heels of controversial COVID-19 guidelines posted over the objection of its own scientist by the Centers for Disease Control and Prevention (CDC), which reversed course this weekend after charges of political interference, and questions about when a new corona virus vaccine will be approved.
  • Regardless of any other impact, such as possibly creating a new avenue of attack on FDA’s deeming rule, the new requirement that rules be signed by the HHS Secretary certainly presents a new layer of red-tape that could substantially delay the rulemaking process for all FDA regulations.
  • As previously reported on this blog, a multi-state listeriosis outbreak in 2015 linked to Blue Bell Creameries LP’s ice cream products contaminated with Listeria monocytogenes led to recalls, state regulatory enforcement actions (discussed here), civil litigation (including shareholder lawsuits), and criminal prosecution of the company and its former president. According to the Centers for Disease Control and Prevention, at least 10 people were sickened with listeriosis and hospitalized in Arizona, Kansas, Oklahoma, and Texas, and three people in Kansas died.
  • Pursuant to a plea agreement filed in federal court in Austin, Texas, in May 2020, the company pled guilty to two misdemeanor counts under the Federal Food, Drug, and Cosmetic Act of distributing adulterated ice cream products through interstate commerce. After conviction, Blue Bell was recently sentenced to pay $17.25 million in criminal penalties ($9.35 million in criminal fines and $7.9 million in forfeiture). According to the U.S. Department of Justice (DOJ), this represents the largest-ever criminal penalty following a conviction in a food safety case.
  • Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal facilities. According to DOJ, the combined total of $19.35 million in fine, forfeiture, and civil settlement payments constitutes the second largest-ever amount paid in resolution of a food-safety matter (the largest to date is a $25 million fine paid by Chipotle Mexican Grill Inc. in connection with a three-year deferred prosecution agreement to avoid conviction through implementation of an improved food safety program). According to the U.S. Department of Justice’s (DOJ) press release announcing the Blue Bell plea agreement, since reopening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for listeria prior to shipment.
  • In a related federal action in the same court, Blue Bell’s former president, Paul Kruse, was charged with seven felony counts (including attempt and conspiracy to commit mail fraud, wire fraud, and attempted wire fraud) for his alleged efforts to conceal from customers what the company knew about the listeria contamination. Among other allegations, Kruse allegedly directed Blue Bell employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason, directed employees to tell customers who inquired that there was an unspecified issue with a manufacturing machine instead of informing them that samples of the products had tested positive for listeria, and directed employees to conceal and destroy evidence. In July 2020, the court dismissed the felony charges for lack of subject-matter jurisdiction, after Kruse successfully argued that while prosecutors had filed an information to charge him, they had failed to properly secure the required indictment or, in the alternative, a waiver of the right of indictment.

 

  • On September 16, 2020, Upton’s Naturals Co. and the Plant Based Foods Association filed a lawsuit against the state of Oklahoma, challenging the constitutionality of the Meat Consumer Protection Act (“the Act”), a recent law that requires plant-based food companies to include a disclaimer if they use a meat term, such as “burger,” “hotdog,” “meatball,” “jerky,” “sausage,” “chorizo,” and “bacon.”  In the lawsuit, plaintiffs argue that this law was passed to prevent competition with the meat industry and that it violates the First Amendment.  This law passed earlier this year and will take effect on November 1, 2020.
  • By way of background, the Act bars plant-based foods from being labeled with meat terms without a disclaimer, which must be the size of the product’s name, even if they are labeled “meatless,” “vegan” or “plant-based.”  The Act expressly prohibits advertising “a product as meat that is not derived from harvested production livestock.”  However, the Act states that “product packaging for plant-based items shall not be considered in violation of [the Act] so long as the packaging displays that the product is derived from plant-based sources in type that is uniform in size and prominence to the name of the product.”
  • States, including Arkansas, Louisiana, Mississippi, Missouri, Montana, South Dakota, and Wyoming have enacted laws similar to the one in Oklahoma.  The lawsuit against Oklahoma differs from previous complaints filed because of the size requirement included in the mandate.  In the lawsuit, plaintiffs state that the Act would require companies to redesign their labels specifically to suit the regulations in Oklahoma, which will require a substantial amount of time and resources in order to ensure compliance for a single state.  According to the complaint, no other state besides Oklahoma requires plant-based food labeling to have disclaimers the same size as their product names.
  • Violations of the law can include fines of up to $10,000 for each offense and are considered misdemeanors, which can result in up to a year in prison.  We will continue to monitor any developments.
  • On September 11, 2020, Defendant Conagra Brands, Inc. filed a motion for summary judgment in which it argued that Plaintiff’s claim – that Conagra had misled consumers by marketing Wesson brand cooking oils containing GMO ingredients as “100% natural” – should be dismissed because Plaintiff had failed to specify the injury that she had suffered in a presuit demand letter as required by Massachusetts law.
  • By way of background, the First Circuit Court of Appeals had previously reversed a district court’s dismissal of the complaint, holding that Conagra could not demonstrate that its labeling conformed with the FDA labeling policy and that Conagra had “confused the FDA’s informal policy not to restrict the use of the term natural with a rule defining it.” In other words, because the FDA had not affirmatively approved the labeling of GMO products as “100% natural,” dismissal was not warranted.
  • In its motion for summary judgment, Conagra alleged that the demand letter amounted to a bald assertion that Conagra’s labeling practices violated the law and did not allow Conagra to assess the injury that the Plaintiff had allegedly suffered. In particular, Plaintiff did not provide any details regarding her purchase or the value of the product as purchased and “as promised” and, even when prompted to correct the deficiencies in the letter, merely asserted that that the injury was “apparent.” Conagra’s Motion also rebutted Plaintiff’s assertions and argued that (1) it had not waived the presuit demand deficiency argument by failing to include it in its motion to dismiss (because a waiver of an affirmative defense can only be made in a pleading) and (2) a lawsuit in another jurisdiction did not give Conagra notice or in any way modify Plaintiff’s legal obligation to write a legally sufficient demand letter prior to litigation.
  • Keller and Heckman will continue to monitor and provides updates on lawsuits that target natural claims.

 

  • Meat, poultry, and egg products may not be sold, offered for sale, or otherwise distributed in commerce without prior approval of labels by the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS).  Prior approval is granted in one of two ways: (1) “Sketch approval,” which entails Agency review of food labels; and (2) “Generic approval,” which is label approval obtained by virtue of the label being in compliance with applicable regulations.  Generic label approval has been in place in some form since 1983.  In a 2013 rulemaking, FSIS expanded the categories of labels eligible for generic approval and agreed to continue evaluating generic labels that are voluntarily submitted.
  • In a new Proposed Rule published in the September 14, 2020 Federal Register, FSIS announced plans to cease evaluating labels voluntarily submitted to FSIS that are eligible for generic approval and to expand the types of labels that are eligible for generic approval.  Under this proposal, the following labels would be eligible for generic approval, would no longer be required to be submitted to FSIS for prior approval, and could no longer be voluntarily submitted to FSIS for evaluation:

(1) Labels on products for export that deviate from FSIS requirements;

(2) labels that list ingredients in the ingredients statement as being certified ‘‘organic’’ (e.g., organic garlic) under the Agricultural Marketing Service (AMS) National Organic Program;

(3) labels that display geographic landmarks, such as a foreign country’s flag, monument, or map;

(4) labels that make ‘‘negative’’ claims identifying the absence of certain ingredients or types of ingredients (e.g., statements such as ‘‘No MSG Added,’’ ‘‘Preservative Free,’’ ‘‘No Milk,’’ ‘‘No Pork,’’ or ‘‘Made Without Soy’’); and

(5) labels of all products that receive voluntary FSIS inspection (e.g., rabbits; elk, bison, and migratory water fowl; and closed-faced sandwiches), some of which are not covered under the Agency’s current generic approval regulations.

  • FSIS has opened a 60-day period (ending November 13, 2020) for submitting comments on the proposed rule.  In addition to fully adopting the proposed rule, FSIS will also consider either taking no action, or adopting the proposed rule in part by continuing to provide industry the option to have FSIS evaluate labels that would otherwise be generically approved.  FSIS will also consider the alternative of having all labels to be generically approved.  No timeline was provided for promulgating a final rule with associated dates for compliance and enforcement actions.
  • Notably, FSIS states it does not believe this new proposal for expanding eligibility for generic approval and discontinuing evaluation of voluntarily submitted labels that are eligible for generic approval is affected by any of the findings of a June 2020 Audit Report by the Office of Inspector General (OIG) on Controls Over Meat, Poultry, and Egg Product Labels or FSIS’s responses to these findings.  OIG’s June 2020 report includes a finding, disputed by FSIS, of reduced assurance that establishments’ generic labels used in commerce meet requirements because FSIS does not have an adequate process to determine whether establishments’ generic labels meet requirements.
  • 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.