• On November 23, organic food industry groups and advocates filed a Motion for Summary Judgment asking a California federal judge to declare the USDA’s National Bioengineered Food Disclosure Standard (NBFDS) invalid, and vacate and remand the rule, as well as to sever constitutionally infirm provisions of the National Bioengineered Food Disclosure Act (the “Act”) and declare them invalid (subscription to Law360 required). The plaintiffs, which include Natural Grocers, Citizens for GMO Labeling, Good Earth Natural Foods, National Organic Coalition, and Center for Food Safety, among others, argue that the NBFDS violates the Disclosure Act, the Administrative Procedure Act, and the Constitution. The lawsuit was originally filed on July 27, 2020.
  • Specifically, the plaintiffs state that the NBFDS falls short of fulfilling the promise of meaningful genetically engineered (GE) food labeling, as intended by the Act. As written in the plaintiffs’ memorandum, the NBFDS “excludes most GE foods from mandatory disclosure, limits the applicable labeling terminology to the obscure “bioengineered,” and allows disclosure in a form never before approved in a federal label – electronic Quick Response (QR) codes – that the Agency itself determined would conceal disclosures from many Americans.” Further, plaintiffs’ argue that the NBFDS forbids retailers from going further than what is permitted by the Standard, and restricts their ability to communicate the presence of GE ingredients or foods using familiar means and terms.
  • In a statement by their attorney, Meredith Stevenson, the Center for Food Safety noted that “[c]onsumers have fought for decades for their right to know what’s in their food and how it’s produced. But USDA instead used its authority to label GE foods by obscuring this information behind QR codes and unfamiliar technology and omitting the majority of GE foods. Fortunately, the law is [on] consumers’ side.”
  • Keller and Heckman will continue to monitor this case and report any updates.
  • Earlier this month, a class-action lawsuit was filed against 7-Eleven, alleging that the company deceptively marketed its “Wasabi Delight Flavored Snack Mix” without including real wasabi in the product. Plaintiff’s counsel is the prolific food litigation attorney, Spencer Sheehan.
  • The complaint points to the product’s ingredient list as evidence that the product includes no real wasabi. Although the ingredient list includes a variety of ingredients that at first glance appear to dispute the claim that the product does not contain real wasabi (e.g., wasabi powder), the sub-ingredients reveal that they are not made from the wasabi plant. For example, the “wasabi powder” (a sub-ingredient of “crunch wasabi peanuts”) consists of maltodextrin and mustard seed.
  • The complaint alleges that real wasabi is valued by consumers for its nutritive and antioxidant properties and its distinctive taste, and that they pay a premium for it. The complaint also suggests that by failing to label the product as “artificially flavored” 7-Eleven deceives consumers and violates FDA’s flavoring regulation at 21 CFR 101.22.
  • As with many of these deceptive advertising lawsuits, the complaint produced no extrinsic evidence of consumer deception. While such evidence will ultimately be important, it is not necessarily required to survive a motion to dismiss which is governed by a permissive plausibility standard.
  •  N-acetyl-L-cysteine (NAC) is widely available as a dietary supplement and is also used to treat acetaminophen (Tylenol) poisoning and other conditions, such as lung collapse.  In July 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to seven companies about products containing NAC.  FDA’s July 29, 2020 Constituent Update explains that claims to cure, treat, mitigate, or prevent hangovers make these products unapproved new drugs.  Further, as described, for example, in the July 29, 2020 warning letter to LES Labs, even if the product labeling did not have therapeutic claims, which make the products unapproved new drugs, the product could not be lawfully marketed as a dietary supplement because, finding no evidence that NAC was marketed as a dietary supplement or as a food prior to September 14, 1963, when NAC was approved as a new drug, FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  The definition of a “dietary supplement” specifically excludes articles that are approved as new drugs, certified as antibiotics, or licensed as biologics, or authorized for investigation for therapeutic uses for which “substantial clinical investigations have been instituted and for which the existence of such investigations has been made public” and which were not “marketed as a dietary supplement or as a food” before such approval, certification, or authorization.
  • On November 24, 2021, FDA posted a Constituent Update requesting information on the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns.  FDA’s public request follows letters issued by FDA in tentative response to two citizens petitions (June 1, 2021 Council for Responsible Nutrition (CRN) petition and August 18, 2021 Natural Products Association (NPA) petition) that ask FDA to reconsider its position on the use of NAC as a dietary supplement.  Both petitions characterize FDA’s “drug exclusion” position on NAC as a sudden policy change.  For example, the CRN petition notes that FDA has “considered over 100 structure-function claim notifications regarding NAC and at least one qualified health claim petition for a dietary supplement containing NAC, and has not objected to the presence of NAC in any of these products.”  Both petitions ask FDA to distinguish NAC use as a dietary supplement from its use a drug based on the form of administration, i.e., ingestion in the case of a dietary supplement, and intravenous injection or inhalation when used as a drug.  The NPA petition additionally asks FDA, alternatively, to initiate discretionary rulemaking to permit NAC as a lawful dietary supplement under the FD&C Act.
  • FDA is asking all interested parties to submit the requested information on NAC by January 25, 2022, while FDA continues to evaluate the CRN and NPA citizen petitions.  FDA will provide a final response to both petitioners directly once its review is completed.  In the event that FDA is not persuaded that the “drug exclusion” does not apply, and there is insufficient safety data to initiate rulemaking that could make certain dietary supplement uses of NAC legal, it remains to be seen whether future FDA warning letters will target NAC-based dietary supplements that do not make drug claims.  It is possible that FDA may instead exercise enforcement discretion in the same manner it has for other products, such as cannabidiol (CBD), that are actively marketed as dietary supplements despite FDA’s clear position that the “drug exclusion” applies.
  • On November 19, a proposed class of consumers sued Del Monte Foods Inc. in Illinois federal court over a “no preservatives” claim on its canned Farmhouse Cut Green Beans. The proposed class alleged that the salt added to the green beans causes the “no preservatives” claim to be false and misleading.
  • The complaint, filed by named plaintiff Jaymee Fleming, alleges that consumers are increasingly looking for foods produced without preservatives, and that Del Monte charges a premium for its green beans by claiming that they have no preservatives. Fleming further alleges that the green beans packaging advertises that they are “with natural sea salt,” noting that salt can be added for taste as well as preservative effect. Fleming argues that Del Monte uses the salt as a preservative because it prevents deterioration of the green beans, makes it harder for bacteria to survive in the can, prevents and slows discoloration, and helps the green beans maintain texture and flavor. Thus, Fleming argues that the claim “no preservatives” is misleading to consumers who do not want to consume any type of preservatives in their food.
  • Fleming alleges that by using the salt, Del Monte gains an advantage over other companies and is able to charge more for its products by claiming that they are made without preservatives. Fleming seeks to represent two classes of consumers who purchased green beans: one for buyers in Illinois and another for buyers in North Dakota, Rhode Island, Michigan, Virginia, Wyoming, and Delaware. Keller and Heckman will continue to monitor and report on any developments.

The Daily Intake is taking a break for the Thanksgiving holiday and will return on November 29. We wish you a wonderful Thanksgiving holiday!

  • On November 14, 2021, a class-action lawsuit was filed in an Illinois District Court against Inventure Foods, Inc. for allegedly falsely and deceptively marketing its Cheddar Cheese Flavored Crunchy Fries Snacks (Baked) as “fries” when they were predominantly made up of cornmeal and not potato.
  • The fries at issue are sold under the TGI Fridays brand name and disclose on the ingredient list that “whole grain corn meal” and “enriched cornmeal” are the first and second most predominant ingredients. “Potato flakes,” which are alleged to be “chunks of dehydrated mashed potato,” are listed as the fourth most predominant ingredient.
  • The lawsuit alleges that consumers expect that products advertised as “fries” will predominantly consist of potatoes and that consumers value potatoes “for their distinctive taste and nutritive properties.”
  • The complaint only cites only to statutory provisions that prohibit false and deceptive advertising generally and states that “[d]ictionaries define ‘fries’ as long thin pieces of fried potato.” It also is unable to point to any technical violation of FDA’s regulations or data showing that consumers are deceived by fries made from cornmeal. While further evidence of consumer deception will ultimately be needed if the case is to survive a motion for summary judgment, we will monitor and report on this case to see if the allegations are deemed sufficient to survive a motion to dismiss.
  • The United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) routinely monitors clusters of illnesses to determine if FSIS-regulated products may be the source of food-borne illnesses.  FSIS posts information on active outbreak investigations to a table on its website when there is compelling evidence that an FSIS-regulated product is the source.  The primary pathogens involved in FSIS outbreak investigations are Salmonella, Shiga toxin–producing Escherichia coli (STEC), Listeria monocytogenes (Lm), and Campylobacter.
  • In a November 19, 2021 Constituent Update, FSIS announced that it has posted on its website an after-action review report for the investigation of a 2018 multi-state outbreak of Lm illnesses associated with ready-to-eat (RTE), Asian-style pork patty products that resulted in 4 hospitalizations.  Whole genome sequencing (WGS) analysis of bacterial isolates from routine FSIS product and environmental samples indicated the historical presence of the outbreak strain at a single FSIS-regulated establishment.  The Investigation further revealed that the pork patty products were cooked using a process that was not validated to ensure all pieces were thoroughly cooked, and there was a history of Lm harborage and opportunities for contamination after cooking that were not considered by the establishment.
  • The Lm outbreak linked to pork patties was only the second reported multistate outbreak of listeriosis linked to a FSIS-regulated product since 2005.  Nevertheless, as noted in the investigation report, FSIS may consider an update of Directive 10240.4 (Verification Activities for the Lm Regulation and the RTE Sampling Program) to include additional instructions for inspection personnel when verifying if a product is exposed to the environment after undergoing a cooking step.
  • As previously reported, on October 19-21, 2021 FDA hosted a three-day virtual summit to discuss the safety of foods sold online and delivered directly to consumers. A recording of the meeting and event materials are available on the summit siteFDA indicated that approximately 4,100 people registered for the virtual summit.  FDA heard from “heavy hitters” in the food delivery world— including Amazon, Blue Apron, Grubhub, Instacart, Kroger, and Wendy’s— regarding controls and innovations that they use to maintain food safety.
  • Discussions included the topic of “ghost kitchens” and the necessity for food safety measures that include food handler training and consumer education.  International regulatory parties also discussed their own experiences in this area and noted the lack of consistent standards between nations in this area.  FDA learned that populations across all ages and economic divides order food online. FDA noted that the issue is not unique to the United States and that, in fact, China’s food delivery apps have the largest market penetration with the United States coming in second.
  • FDA will consider the discussions from the meeting to tackle questions regarding the appropriate time and temperature controls to ensure food safety and how to safeguard against cross-contamination between ready-to-eat and raw foods.  Public comments may be submitted electronically to regulations.gov under Docket FDA-2021-N-0929 and will be accepted until November 20, 2021.
  • On November 12, President Biden announced his intent to nominate Dr. Robert Califf to be the new Commissioner of Food and Drugs. Dr. Califf, who is internationally recognized as an expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine, also served as the FDA Commissioner under former President Barack Obama from February 2016 until January 2017. Dr. Califf is currently a professor of medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute, and also works as Head of Clinical Policy at Verily Life Sciences, which is a life sciences research organization.
  • According to a press release from the White House, President Biden is “confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making” during a critical time in the country’s fight to put an end to the COVID-19 pandemic. Dr. Califf had strong bipartisan support in 2016, and President Biden is currently urging the Senate for a swift confirmation.
  • If confirmed, Dr. Califf will replace Dr. Janet Woodcock, who has been serving as the Acting FDA Commissioner since January 20, 2021. Keller and Heckman will continue to monitor and report on any developments.
  • FDA, in coordination with EPA, has issued updated advice about eating fish for those who might become or are pregnant or breastfeeding and for children ages 1-11 years.
  • While the advice incorporates the Dietary Guidelines for Americans, 2020-2025, overall, it has remained the same and consumption of fish that is low in mercury continues to be recommended. The advice classifies fish into three tiers based on mercury content: “Best Choices,” “Good Choices,” and “Choices to Avoid.” It also identifies a subset of the “Best Choices” fish that are even lower in mercury.
  • Pregnant and breastfeed women are advised to eat two to three 4 ounce servings of “Best Choices” fish or one 4 ounce serving of “Good Choices” fish a week. Children are advised to eat two servings per week from the “Best Choices” fish, although recommended serving size varies between 1 and 4 ounces, depending on age.
  • The advice notes information regarding the following health benefits of fish consumption:
    • Child brain development through provision of omega-3 and omega-6 fats, iron, iodine (during pregnancy), and choline. Choline also supports development of a baby’s spinal cord, and fish can provide iron and zinc which promote immune function.
    • Moderate scientific evidence shows that it can help a baby’s cognitive development.
    • Strong scientific evidence of heart health benefits.
    • Moderate scientific evidence of better bone health, decreased risk of becoming overweight, and decreased risk for colon and rectal cancers when relatively high levels of fish are eaten in combination with other healthy foods.
  • FDA notes that as part of its Closer to Zero action plan, it will evaluate research on mercury consumption by babies and young children, and consider this information in the light of benefits of fish consumption to determine whether further updates to the advice are necessary.
  •  Our readers will recall a 2019 agreement by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) on joint oversight of the production of cell-cultured products from animals traditionally under FSIS jurisdiction (livestock, poultry, and catfish).  Under the agreement FDA will oversee cell collection, growth and differentiation and FSIS will oversee cell harvesting, processing, packaging, and labeling.  As discussed in detail here, on September 3, 2021, FSIS published an advanced notice of public rulemaking (ANPR) seeking comment on the labeling of cell-cultured meat and poultry products.
  • FSIS announced on November 12, 2021 that in response to several stakeholder requests, the comment period for submitting information solicited in the ANPR on the labeling of cell-cultured meat and poultry products, which was initially set to close on November 2, 2021, will be extended by an additional 30 days.  Among the broad range of questions for comment, the main issue is whether labeling should differentiate cell-cultured products from traditionally slaughtered products, and if so, what terms should be used.  The labels of any cell-cultured meat or poultry products marketed before rulemaking is completed must clearly differentiate the products from slaughtered meat and poultry products, and such labels may need to be changed once final regulations are implemented.
  • The comment period on labeling of cell-cultured meat and poultry products will now end on December 2, 2021.  We will be happy to assist interested parties in submitting comments in response to the ANPR.