• On May 27th, the United States District Court for the Northern District of Illinois Eastern Division granted in part and denied in part, Defendant’s motion to dismiss a false advertising class action lawsuit which alleged that The Kroger Co. misled consumers by implying that its “Smoked Gouda” sliced cheese was cheese smoked over hardwood. The ingredient list of the cheese states that the cheese contains “added smoked flavor” which Plaintiff alleges comes from liquid smoke. Plaintiff alleges this is a material omission under the Illinois Consumer Fraud and Deceptive Trade Practices Act (ICFA).
  • The court denied Defendant’s motion to dismiss Plaintiff’s ICFA claim, finding that Plaintiff’s interpretation of the label was not “fanciful, illogical, or implausible.” The court noted that “smoked” was ambiguous and could be interpreted multiple ways–including cheese smoked over hardwood or smoke flavoring additives–holding a reasonable consumer could be misled by the “Smoked Gouda” label.
  • The court granted the motion to dismiss Plaintiff’s common-law fraud claim without prejudice and Plaintiff’s claim for negligent misrepresentation with prejudice. Plaintiff’s claim for negligent misrepresentation is barred by the economic loss doctrine (Moorman doctrine), which denies remedies for disappointed commercial expectations. Plaintiff may file an amended complaint by June 28, 2022.
  • Keller and Heckman will continue to follow and report on the various courts’ handling of class action suits alleging false or misleading flavor or ingredient implications in food in food labeling and advertising.
  • On May 27, 2022, the U.S. Department of Agriculture (USDA) reported that Agriculture Secretary Tom Vilsack had approved funds to support USDA’s Animal and Plant Health Inspection Service (APHIS) in its response efforts to the outbreak of highly pathogenic avian influenza (HPAI) in the United States.
  • HPAI requires a rapid response because it is highly contagious and often fatal to poultry. The virus has been confirmed in 35 states, affecting more than 37.9 million domestic birds.  To help ensure that APHIS can continue to perform its response activities, Secretary Vilsack has approved the transfer of $400 million from the Commodity Credit Corporation to APHIS.  Secretary Vilsack had previously approved about $130 million in emergency funding in March, along with an additional $263 million in April.
  • USDA encourages bird owners to ensure domestic birds do not come into contact with wild birds and to keep poultry confined inside during this high-risk period of migratory bird activity.  Resources for bird owners and more information about the HPAI response may be found here.
  • On May 27, Senator Edward J. Markey (D-Mass.), alongside Senators Richard Blumenthal (D-Conn.) and Elizabeth Warren (D-Mass)., introduced the Ensuring Safe and Toxic-Free Foods Act, which is described as “comprehensive legislation that ensures the Department of Health and Human Services (HHS) fulfills its responsibility to promote the health and well-being of American families by directing the Food and Drug Administration (FDA) to strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which exempts companies from seeking pre-market approval for food chemicals.” A summary of the legislation is available here.
  • The legislation would prohibit manufacturers from independently designating substances as GRAS (or manufacturing or selling food containing those substances) without supplying notice and supporting information to the Secretary of HHS. Substances that are carcinogenic or that have evidence of reproductive or developmental toxicity would be prohibited from receiving a GRAS designation. Further, the legislation would require that a GRAS Notice and all supporting information be publicly available online and subject to a 90-day review period.
  • The legislation would also direct the Secretary to create an Office of Food Chemical Safety Reassessment within FDA’s CFSAN. The new office would be responsible for reassessing the safety of existing food additives, food contact substances, color additives, and substances that had already received GRAS status. The office would be required to reassess at least 10 substances (or class of substances) once every three years. As included in the bill, the first 10 substances to be reviewed would be:
    • Perfluoroalkyl substances and polyfluoroalkyl substances
    • Ortho-phthalates
    • The class of bisphenols
    • Titanium dioxide
    • Potassium bromate
    • Perchlorate
    • Butylated hydroxyanisole (BHA)
    • Butylated hydroxytoluene (BHT)
    • Brominated vegetable oil (BVO)
    • Propyl paraben
  • With regard to the legislation, Senator Markey has said “The FDA too often falls short on their responsibility to promote food safety, highlighted recently by the baby formula crisis where FDA’s deputy commissioner for food policy did not learn about the whistleblower complaint for four months. It is long past time we revise existing food safety measures and close the loophole allowing manufacturers to self-regulate what new substances can enter our food supply.”
  • Keller and Heckman will continue to monitor the progress of the Act and provide any updates.
  • On May 27, 2022, the U.S. Department of Health and Human Services (HHS) issued a final rule withdrawing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule, which had been promulgated in the waning days of the Trump administration and would have required most rules administered by HHS to be reviewed within 5 years of the effective date of the SUNSET rule, and then every 10 years thereafter, or else be automatically repealed. As we have previously blogged about, HHS proposed withdrawing the SUNSET rule in a proposed rule issued on October 29, 2021.
  • Reiterating many of the points made in the October proposed rule, HHS justified the withdrawal because (1) the initial analysis of the rule was inaccurate and, among other things, significantly understated the resources that implementation of the SUNSET rule would consume, and the more realistic estimate would have prevented HHS from carrying out its statutory obligations and mission to protect public health; (2) the rule violated the Administrative Procedure Act (APA), including by being issued without sufficient opportunity for comment and by allowing for rules to be revoked without notice or evaluation of their importance; and (3) the rule was contrary to the policies of the Biden administration, which seeks to use the regulatory authorities of administrative agencies to confront the challenges facing the country.
  • The vast and continuing nature of the regulatory review contemplated by the SUNSET rule is unworkable and its withdrawal comes as no surprise. Indeed, even without a withdrawal, it is doubtful that the rule would have withstood legal challenge. Nevertheless, as HHS noted in the withdrawal, consistent with its obligations under the Regulatory Flexibility Act (RFA), HHS does already conduct certain more limited retrospective reviews of regulations.
  • On May 26, 2022, FDA issued warning letters to Haniel Concepts dba Free State Oils, Hope Botanicals, Plantacea LLC dba Kahm CBD, and Kingdom Harvest, alleging, among other things, that the companies were illegally selling unapproved animal drugs with cannabidiol (CBD) intended to be used in food-producing animals. While some of the companies claim that the drugs are used to “[help] farm animals with stress [and] anxiety,” these drugs have not been reviewed by the FDA to evaluate their safety and effectiveness with respect to the animals themselves, as well as the potential risks raised by the presence of CBD in human food derived from these animals.
  • FDA further challenged the positioning of some of these companies’ products as human dietary supplements, noting that they do not meet the definition of dietary supplements under the Dietary Supplement Health and Education Act. The agency also noted its concern that animal owners will rely to their detriment on unsubstantiated claims of alleviating anxiety in animals instead of seeking professional medical care when their animals are in distress.
  • Keller and Heckman will continue to monitor developments in FDA’s treatment of various CBD-containing products.
  • FDA will hold a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to provide an overview of the recent draft guidance that the Agency issued on action levels for lead in juice.
  • As previously reported, the guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” set action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and 20 ppb for lead in all other single-strength juice types. The new levels are intended to reduce the potential health effects associated with dietary exposure to lead and supports the Agency’s Closer to Zero action plan.
  • During the webinar, FDA will provide an overview of the draft guidance and answer stakeholder questions. To register for the webinar, and to submit questions or comments in advance, please visit the registration page. Questions or comments must be submitted by Tuesday, May 31, 2022. The webinar will also be recorded and posted to FDA’s website.
  • On May 24, an Illinois federal judge permanently dismissed a proposed class action that alleged Kellogg misled consumers to believe its Frosted Strawberry Pop-Tarts contained more strawberries than actually present in the product (subscription to Law360 required). The plaintiff argued that strawberries are the pastries’ characterizing ingredient and their amount has a material bearing on the product’s price, or a consumer’s acceptance of the product. However, the judge ruled that the label was not deceptive because the Pop-Tarts filling contained some amount of strawberries.
  • U.S. District Judge Stephen McGlynn found that the front of the packaging did not make a claim regarding the amount of strawberry contained in the filling, and noted that the plaintiff actually conceded that the filling does contain some strawberries. Judge McGlynn cited to Bell v. Publix Super Markets, Inc., quoting “[w]hat matters most is how real consumers understand and react to the advertising. Where the plaintiffs base deceptive advertising claims on unreasonable or fanciful interpretations of labels or other advertising, dismissal on the pleadings may be well justified.” Judge McGlynn held that the plaintiff’s interpretations of the Pop-Tarts label is unreasonable and not grounded in reality of how the public understands and reacts to advertising.
  • Judge McGlynn dismissed the plaintiff’s claim under the Illinois Consumer Fraud and Deceptive Business Practices Act (ICFA), as well as the claims of breach of warranty, negligent misrepresentation, fraud, and unjust enrichment.
  • In a letter dated May 18, 2022, FDA denied a citizen petition from Bonumose LLC which requested that the Agency (1) exempt D-tagatose from classification as an “Added Sugar” and (2) allow for the voluntary labeling of D-tagatose as a separate declaration under “Total Carbohydrates,” similar to the approach taken for sugar alcohols.
  • By way of background, FDA exercises enforcement discretion which allows allulose to be excluded from the “Total Sugars” and “Added Sugars” label declarations and allows the use of 0.4 kcal/g for allulose when determining “Calories.” See Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.  FDA had also previously requested information on the kinds of sugars that are metabolized differently than traditional sugars, any distinct physiological effects caused by those sugars, and suggestions on how those sugars should be declared and accounted for on food labels. See 85 Fed. Reg. 66335 (Oct. 19, 2020).
  • FDA declined to exempt D-tagatose from classification as an added sugar primarily because its caloric contribution of 1.5 kcal/g was not negligible. FDA explained that the declaration of added sugars is intended to allow consumers to avoid calories that do not make a significant nutritional contribution (i.e., “empty calories”). Although 1.5 kcal/g is significantly less than the 4 kcal/g that most familiar sugars (e.g., sucrose) contribute, it is also significantly more than the 0.4 kcal/g that allulose contributes. FDA also noted that at the use levels indicated in Bonumose’s GRAS Notice for D-tagatose, D-tagatose could significantly contribute to a consumer’s intake of empty calories. However, the Agency did indicate that it would not object to the use of 1.5 kcal/g for D-tagatose when determining “Total Calories.”  Because FDA determined that it was appropriate to consider D-tagatose as an added sugar, it also declined to allow for voluntary labeling of D-tagatose in a manner similar to sugar alcohols.
  • FDA’s response is interesting because it focuses solely on the caloric issue to the exclusion of differences in the way that D-tagatose is metabolized and its physiological effects. FDA’s only comment on the latter points is to note that a health claim that D-tagatose may reduce the risk of dental caries is allowed under 21 CFR 101.80.
  •  The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or a dietary supplement that contains the NDI, to notify the FDA at least 75 days before marketing.  A successful notification must show there is a history of use or other evidence of safety establishing that the NDI, when used as labeled, will reasonably be expected to be safe.  If the required premarket notification is not submitted to FDA, the dietary supplement containing the NDI is deemed to be adulterated under the Federal Food, Drug, and Cosmetic Act.  FDA estimates that more than 4,600 notifications should have been submitted since 1994 but to date only approximately 1,200 have been.
  • On May 20, 2022, FDA published notice of a new draft guidance titled, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification.”  FDA’s new enforcement discretion policy will provide a 180-day window after the guidance is finalized for those who, before May 20, 2022, have marketed products that are subject to the premarket notification requirement, without having submitted such notification, to submit a late NDI notification without risk of FDA taking enforcement action against their product solely on account of the lateness of the notification.  While FDA has provided a dedicated pathway in the CFSAN Online Submission Module for this new type of submission and intends to prioritize the review of theses notifications, FDA does not anticipate being able to complete the scientific evaluation and provide a response within 75 days after receipt.  FDA’s enforcement discretion policy would not extend to NDI-containing dietary supplements that are adulterated for safety reasons or that violate any other applicable regulatory requirements.  FDA expects this temporary policy should help facilitate enforcement actions against those that remain out of compliance with the NDI notification requirements after the enforcement discretion period ends.
  • Comments on FDA’s new draft guidance that are submitted to the Docket No. FDA-2022-D-0281 before July 19, 2022 will be considered before FDA begins work on the final version of the guidance.
  • As previously reported, on July 30, 2020, FDA worked with EPA to release a protocol to evaluate the efficacy of antimicrobial pesticides in agricultural water. The protocol established an agricultural water panel assay that companies could use to test the capability of their water treatment processes to combat strains of Listeria, Salmonella and E. coli frequently responsible for foodborne illnesses.
  • On May 17, 2022, FDA announced that it had formally updated its protocol to reflect two earlier changes that had been made since the protocol was first released.  In April 2021, FDA updated the protocol to allow companies and other agricultural water stakeholders to use data that did not comply with good laboratory practices (non-GLP) in their submissions, provided that the submissions accurately represented how the study differed from GLP standards. This change was intended to give companies and agricultural stakeholders access to more laboratories.  In April 2022, FDA amended the contact time in the protocol, changing the maximum from 1 minute to “up to 5 minutes.” This change was intended to meet current practical and scientific needs.
  • The changes are now reflected in the Efficacy Protocol and EPA Protocol Review although this document continues to be dated April 29, 2020.