• The California state legislature recently made amendments to AB 535, a bill that would have prohibited any reference to “California” on olive oil bottles that did not contain 100% California-sourced olive oil. However, amendments to the bill have modified the language such that brands featuring the word “California” or other references to the Golden state on pack can still sell blended olive oil products, as long as the label declares the minimum percentage of California-sourced olive oil in the products in the same font, size, and color as the word “California.” For example, the statement could be declared as “__% California” or “__% California olive oil.”
  • The original version of AB 535 also prohibited labeling a container of olive oil with claims or representations that the olives were grown in a specific region of California unless 85% of the olive oil, by weight, was produced from olives grown in that specific region. However, that section was also amended to permit truthful, not misleading statements or representations regarding geographic origin if the label, packaging material, or advertising contained no representations that are prohibited. For example, a brand name like “Napa Valley Naturals” includes reference to a specific California region, but does not make representations that the olive oil is produced in that region, and thus would not be subject to the bill requirements. However, a phrase like “Napa Valley olive oil” would be required to meet the 85% requirement.
  • The last round of amendments were read and passed in the State Senate on July 15, and referred to the Senate Appropriations Committee for a hearing to be held on August 16. Keller and Heckman will continue to monitor and report on the progress of AB 535.
  • A class-action lawsuit—filed on behalf of consumers in California, New York, and nationwide—alleges that Campbell Soup Company and Pepperidge Farm, Inc.’s Goldfish-brand snack products (the “Goldfish Products”) are misleadingly labeled.  Plaintiffs allege that the Goldfish products do not comply with 21 C.F.R. § 101.60 (“Nutrient content claims for the calorie content of foods”) because they claim “0g Sugars” or “0g Total Sugars” (i.e, sugar free claims) without disclosing that they are “not a low calorie food,” “not a reduced calorie food,” or “not for weight control.”  Plaintiffs further allege that the sugar free claims misled consumers into thinking they were purchasing low calorie foods and gave Defendants a competitive advantage over similarly-positioned products in the market.
  • Among other criteria, Section 101.60 requires that foods claiming to be “sugar free,” “free of sugar,” “no sugar,” “zero sugar,” “without sugar,” “sugarless,” “trivial source of sugar,” “negligible source of sugar,” or “dietarily insignificant source of sugar” contain less than 0.5 g sugar per serving and be labeled with a “not a reduced calorie food,” “not a low calorie food, “ or “not for weight control” disclaimer if the foods do not also meet the “low calorie” or “reduced calorie” criteria.  The regulation does not reference the quantitative claims “0g Sugars” or “0g Total Sugars,” although Plaintiffs allege that they are substantively identical to the claims delineated in the regulation.
  • We remind readers that there is no private right to enforce FDA’s labeling regulations and that a violation of a labeling regulation is not per se proof of consumer deception. The court instead must decide whether a “reasonable consumer” would be deceived by the labeling.  In recent examples like the Champion Petfoods Case and Manuka Honey Case, the courts have required extrinsic evidence of consumer deception and have considered the full range of information available to the consumer, thus making it more difficult for plaintiffs to make this showing.
  •  Certain food establishments, referred to as dual jurisdiction establishments (DJEs), are under the jurisdiction of both the Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS).  In January 2018, the FDA and FSIS announced a formal agreement, i.e., memorandum of understanding (MOU) 225-99-2001, to make the oversight of food more efficient and effective by bolstering coordination between the two Agencies.
  • In an August 6, 2021 Constituent Update, FSIS announced an updated agreement, MOU 225-20-2019, signed July 28, 2021, to further facilitate the exchange of information about DJEs.  DJEs under this MOU are limited to human food operations and exclude animal food operations, which are regulated by FDA.  The new MOU improves upon previous information exchange by:
    • Adding headquarters-level contacts for each agency to improve awareness of findings or emerging issues that may warrant more than local or regional coordination.
    • Updating the types of findings to be shared to reflect advances in understanding microbiological food hazards, including microbiological or other sampling findings in DJEs or products, which may provide information about sanitary conditions in those establishments or indicate serious adverse health consequence of products under either agency’s jurisdiction.  These results will include microbe characteristics (e.g., serotype, whole genome sequence, antimicrobial resistance profile, etc.) where applicable, and other information related to categorizing and tracking pathogens.
  • The new MOU 226-20-2019 supersedes the earlier MOU 225-99-2001 as well as MOU 225-14-0009, a formal agreement on the examination and inspection of Siluriformes fish and fish products, which was entered on April 30, 2014 following the handover of jurisdiction of Siluriformes species from FDA to USDA.
  • The Canadian Food Inspection Agency (CFIA) recently released a report on feedback it received during its consultation with stakeholders and consumers regarding its proposal to develop guidelines for simulated meat and poultry products. The agency’s November 2020 proposal set out three categories of meat and alternative meat products and called for rules treating non-animal-based meats that simulate the look and taste of conventional meat differently than alternative meats that do not attempt to replicate the taste or look of conventional meat. Food businesses would be responsible for determining which of the below categories their product falls into and would need to follow the related requirements:
    • Category 1: Traditional meat and poultry products that meet CFIA’s standards of identity for meat products. The proposal does not change any regulations for Category 1 products.
    • Category 2: Simulated meat and simulated poultry products that intend to mimic the look and taste of conventional meat and act as a substitute for a Category 1 product (e.g., products that add components to simulate bleeding or fat marbling to mimic the appearance of traditional products).
      • The products must meet the minimum protein content and rating, fat content, and vitamin and mineral requirements of the meat or poultry product they intend to substitute. They must also meet certain fortification requirements.
      • The products would need to use the term “simulated” in their common name.  In doing so, a product may use traditional terms for meat and different meat cuts, meaning common names like “simulated chicken breast” or “simulated beef tenderloin” would be used.
      • The products would also need to declare “contains no meat,” provided that traditional meat is not used as an ingredient.
    • Category 3: Other products that do not intend to act as substitutes for meat or poultry products (e.g., tofu burgers and soy patties). Plant-based foods fall into this category.
      • These products may, but need not, declare “contains no meat” on their labels. However, they must be clearly labeled and advertised in a manner that accurately and truthfully describes the product.
      • The products are not required to be fortified, as they don’t intend to act as nutritional equivalents for traditional meat and poultry products.
  • CFIA conducted a public consultation on its proposal at the end of 2020. Its recently released report summarizes the feedback it received on the proposal. The report highlights are as follows:
    • A majority of respondents are confident distinguishing products that contain meat and those that do not.
    • A majority of respondents also support the use of traditional “meat” terms on non-animal-based foods, as terms like “meat,” “burger,” and “sausage,” are no longer exclusive to traditional meat products. Traditional meat industry and some consumer stakeholders disagreed, stating that the use of these terms misleads consumers about the true nature, nutrition, and composition of non-animal-based foods.
    • The plant-based and animal-based protein industries along with many consumers said that plant-based foods should not be compared to meat and poultry products and that they are separate and unique food products.
  • CFIA has stated it plans to release a revised proposal based on the feedback it received, noting that it plans to reassess the appearance section of the guidelines to differentiate between categories 2 and 3, clarify the compositional requirements for category 3 foods, and revisit the advertising and representations section of the guidelines.
  • The Food Labeling Modernization Act (FLMA) was introduced to both Houses of Congress on August 3, 2021. If passed, the 35-page legislation co-sponsored by Representative Frank Pallone (D-NJ) and Senator Richard Blumenthal (D-CT) will update information on the food label. “This bill will bring much-needed clarity to food labels so Americans can make informed, healthy decisions for themselves and their families,” Senator Blumenthal said. (House Committee on Energy and Commerce, Press Release, August 4, 2021).  While food labels often play a crucial role in promoting healthy eating habits, the legislation claims that today’s food labeling standards do not provide adequate information that consumers need to make healthy lifestyle decisions. The FLMA’s largest initiative calls upon the Food and Drug Administration (FDA) to establish a standard front-of package labeling system for all FDA-regulated food products. Similar systems are in use in various countries throughout the world, which have been credited with prompting the food industry to decrease levels of sugar, sodium, and saturated fat in foods.
  • Although the FLMA was first introduced in 2018, the shift towards online grocery shopping during the COVID-19 pandemic has increased the need for nutrition information requirements to be available at the online point of sale. The current version of the FLMA requires nutrition information including Nutrition Facts, ingredients, and allergen information to be displayed for online grocery items. The updated version of the FLMA also encourages the use of substitutions for overconsumed nutrients, such as sodium. By amending the “standards of identity,” which currently require minimum levels of salt in some food products, to allow for the use of salt substitutes this could lead to lower rates of heart disease, hypertension, and blood pressure.
  • Additionally, the FLMA aims at eliminating marketing practices that mislead consumers. It requires products making claims about healthy ingredients like fruits, vegetables, and whole grains to list the amount per serving or include percentages of these ingredients. It also creates uniform definitions of popular marketing terms like “natural,” and will provide important information to consumers regarding caffeine content and gluten-containing grains.  We will continue to monitor and report on any developments regarding the FLMA.
  • The USDA’s Food Safety and Inspection Service (FSIS) released new guidelines for controlling Salmonella and Campylobacter in raw poultry. Salmonella and Campylobacter bacteria are responsible for 3 million illnesses per years, which account for more than 70% of the foodborne illnesses tracked by the CDC, costing roughly $6 billion annually. The guidelines help poultry establishments, including those that are small and very small, identify and implement pre- and post-harvest interventions to control Salmonella and Campylobacter as part of their HACCP systems. Additionally, the guidelines help the establishments utilize microbial testing results to monitor the performance of the HACCP systems and inform decision-making as related to hazard control.
  • On December 16, 2015, FSIS published a Federal Register notice announcing the availability of and opportunity to comment on the revised compliance guideline for controlling Salmonella and Campylobacter in raw poultry. This revision was the fourth edition of the guideline that FSIS had developed to assist establishments that slaughter or process raw poultry products to minimize or prevent the risk of Salmonella and Campylobacter in their operations. In July 2021, FSIS updated the guideline contents to reflect the most recent best practices, including use of neutralizing agents in sampling to prevent carryover of antimicrobial substances and a current list of antimicrobials for establishment use. FSIS also included improvements in the information on pre-harvest practices, with a comprehensive revision of the litter/bedding section. Notably, FSIS issued this revised document as two separate guidelines, one focused on the control of Salmonella and the other on Campylobacter.
  • The guidelines do not have the force and effect of law and are not meant to be binding. The documents are intended only to provide clarity to the public regarding existing requirements under the law or FSIS policies. Comments are no longer accepted on the guidelines, but FSIS will update the guidelines as necessary if new relevant information becomes available.
  • Malic acid is a compound that is used as a food ingredient in a variety of ways, including as a flavor enhancer, flavoring agent and adjuvant, and as a pH control agent. See 21 CFR 184.1069 (“Malic acid”). L-malic acid occurs naturally in some foods, including many fruits. In contrast, DL-malic acid is commercially manufactured and considered by some to be artificial.  Plaintiffs have frequent targeted the use of DL-malic acid in foods that are advertised as naturally flavored and free of artificial flavors. They have argued that DL-malic acid is artificial and imparts flavor to the food, and therefore that food products which contain DL-malic must be labeled as artificially flavored. In contrast, Defendants have generally argued they are not using DL-malic acid as a flavoring agent, and therefore it is not misleading to label their products as naturally flavored and/or free of artificial flavors.
  • Following this pattern, in Hayes v. General Mills, CA No. 19-cv-05626, Plaintiff had brought a proposed class action against General Mills alleging that the company had falsely and intentionally mislead consumers with claims that various fruit flavored snacks (sold under the brands names “Fruit by the Foot,” “Gushers,” and “Fruit Roll-ups”) were free of artificial flavors when they in fact contained DL-malic acid which contributed to the flavor of the products. General Mills had moved to dismiss the complaint on the grounds that DL-malic acid was not used as a flavor and therefore that the flavor statement was not deceptive. Specifically, the company argued that they use DL-malic acid in the food snack products as a flavor enhancer and not a flavor, and thus the products cannot be artificially flavored by DL-malic acid. While a “flavor” imparts flavor, a “flavor enhancer” is added “to supplement, enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.” See 21 CFR 101.22 (a)(1) (defining “ artificial flavor”) and  21 CFR 170.3(o)(11) (defining “flavor enhancer”). In other words, both parties agreed that DL-malic acid impacts the taste, but they disagreed as to whether the change in taste constituted a flavor.
  • The Court held that the distinction between a “flavor” and a “flavor enhancer” was a factual dispute that could not be resolved on a motion to dismiss, and thus allowed Plaintiff’s deceptive advertising claims to proceed. However, the Court denied Plaintiff’s request for injunctive relief because there was no immediate threat of future violation of Plaintiff’s rights. While Plaintiff may have been deceived into purchasing the product at issue, there was no such present risk where Plaintiff was aware of the alleged deception and was suing the company for it. The Court also rejected the argument that there was imminent harm to other unaware consumers and held that Plaintiff could not rely on prospective harm to other consumers to demonstrate that injunctive relief was appropriate.
  • The case demonstrates the difficulty of making natural flavor or free of artificial flavoring claims with products containing DL-malic acid and/or other ingredients that may serve multiple functions, including as flavoring agents (citric acid is another ingredient that is frequently invoked in flavor litigation). Even if a defendant ultimately prevails, it may find it difficult to avoid much of the cost of litigation since the pivotal question on the role of a substance in a food (i.e., flavoring agent or not) are factual and cannot be determined at the motion to dismiss stage.
  •  On July 26, 2021, Congresswoman Jan Schakowsky (IL-09) announced the introduction of the Food Chemical Reassessment Act of 2021 (FCRA, H.R. 4694).  The FCRA, co-sponsored by Rosa DeLauro (CT-03) and Tony Cárdenas (D-CA29), would create a new Office of Food Safety Reassessment in the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration (FDA) to study at least ten chemicals every three years and reevaluate their safety for use in food.  The new legislation would also reestablish the Food Advisory Committee, a panel of experts to advise FDA on emerging food and cosmetic safety, food science, nutrition, and other food-related health issues.
  • The FCRA, which is endorsed by several environmental and consumer groups, identifies the first set of 10 currently used substances that FDA would be required to reassess as follows:
    • Per- and polyfluoroalkyl substances
    • Ortho-phthalates
    • Tert-butylhydroquinone
    • Titanium dioxide
    • Potassium bromate
    • Perchlorate
    • Butylated hydroxyanisole (BHA)
    • Butylated hydroxytoluene (BHT)
    • Brominated vegetable oil (BVO)
    • Propyl paraben
  • According to Congresswoman Schakowsky, these chemicals were either never reviewed by FDA or were reviewed decades ago.  Schakowsky and Cárdenas are both members of the Energy and Commerce Committee, which will consider H.R. 4694 before it may possibly move forward.  Potential funding is not clear for the new Office of Food Safety Reassessment or the Food Advisory Committee, which was terminated by FDA on December 12, 2017 as a cost saving measure.
  • FDA announced it plans to host a three-day virtual event on October 19–21 , 2021. The agency seeks to discuss and exchange perspectives with industry stakeholders and interested parties about the safety of human and animal foods ordered online and delivered directly to consumers.
  • The agency has expressed interest in past updates about the role of e-commerce in food and how foods produced, manufactured, sold, and delivered to consumers without involving traditional supply chains and brick and mortar stores may fit into current regulatory frameworks and present new challenges for tracking food products. Considerations for e-commerce operations will be key components of FDA’s New Era of Smarter Food Safety initiative to modernize the agency’s approach to food traceability and improving responses to foodborne illness.
  • More information on registration and event times will be available on FDA’s website and in the Federal Register. All of FDA’s upcoming public meetings, conferences, and workshops are listed here. Information on past events is available here.
  • On July 26, 2021, the U.S. District Court for the Southern District of New York dismissed a proposed class action (subscription to Law360 required) against Wise Foods, Inc.
  • The case challenged the labeling of “Cheddar & Sour Cream Flavored” chips. Represented by prolific food class action firm, Sheehan & Associates, the plaintiff alleged that the product was misleadingly labeled because it contains diacetyl, an artificial ingredient with a buttery flavor, and that the product should have been labeled “artificially flavored” as required under 21 C.F.R. § 101.22(i)(2).
  • The Court granted Wise Foods’ motion to dismiss, stating that reasonable consumers would not reach a sweeping conclusion that “Cheddar & Sour Cream Flavored” would indicate the absence of other flavor ingredients, artificial or not. Judge J. Paul Oetken also noted that an alleged violation of federal labeling regulations does not prove in itself a violation of state law.