• On Tuesday, March 15, 2022, U.S. District Judge Edgardo Ramos dismissed a July 2021 putative class action alleging that Dreyer’s falsely claimed that its Haagen-Dazs ice cream bars are coated in “milk chocolate.”  The complaint alleged that the representations on the label of certain Dreyer’s ice cream bars sold under its Häagen-Dazs brand were misleading, because “the phrase ‘rich milk chocolate’  on the Product’s label is deceptive [as] it implies that the Product’s coating contains only cacao ingredients rather than vegetable or coconut oil [ ]” – ingredients that are not permitted in standard of identity milk chocolate.  However, Judge Ramos concluded that the label on the Haagen-Dazs coffee ice cream bar did not purport that the product was made “only,” “exclusively” or “100% with chocolate.” Judge Ramos noted that the bars’ ingredient list disclosed the presence of vegetable oil used in the bar’s chocolate shell.
  • We reported on a similar complaint in July 2021 where an Illinois consumer filed a complaint alleging that Dreyer’s failed to inform consumers that it “uses coconut oil as a substitute for some cacao beans to make the chocolate in the vanilla milk chocolate almond ice cream bars.” This complaintant argued that “where a food has some chocolate but is mainly vegetable oils” it falls under the SOI for “milk chocolate and vegetable fat coating” and should be labeled accordingly.  Dreyer subsequently filed a motion to dismiss the claim, arguing that consumers receive, “exactly what the front label promises.” To date, no judgement has been entered for this complaint.
  • Keller and Heckman will continue to monitor these types of class action challenges and report on any developments.
  • On March 16, 2022, FDA announced its findings from a sampling assignment in which the Agency collected and tested processed avocado and guacamole from November 2017 to September 2019. The assignment tested for Salmonella spp. and Listeria monocytogenes, as part of FDA’s efforts to proactively ensure food safety.
  • FDA collected and tested 887 samples of domestic and imported processed avocado and guacamole. Salmonella spp. was found in 2 samples – neither of which had received high pressure processing (HPP) treatment, which is often used to neutralize harmful pathogens.  Listeria monocytogenes was detected in 15 samples, 8 of which had not received HPP treatment. When FDA encountered a pathogen in a sample, the Agency worked to remove all affected products from the market. The Agency also conducted whole genome sequencing on the positive samples but was unable to determine if they were associated with any known illnesses.
  • FDA’s sampling assignment confirmed that Salmonella spp. and Listeria monocytogenes may be present in processed avocados and guacamole. It also supported that HPP is effective at neutralizing pathogens. FDA will continue to sample processed avocado and guacamole for pathogens.
  • On March 11, the Tenth Circuit dismissed a pair of lawsuits that alleged Tyson Foods, Inc., Cargill Meat Solutions, Corp., JBS USA Food Company, and National Beef Packing Company, LLC, used deceptive and misleading “Product of the USA”  labels on their beef products that did not originate from cattle born and raised in the United States (subscription to Law360 required). Plaintiffs Thornton and Lucero separately sued the companies and alleged the “Product of the USA” label misled consumers because the beef had been imported from other countries and only packaged in the US. The cases were consolidated on appeal.
  • In a split opinion, the majority affirmed the dismissal because the plaintiffs’ state-law claims are preempted by federal law. The Tenth Circuit confirmed the opinion of the district court, which found that the state law claim was preempted by the express language of the Federal Meat Inspection Act in that it would create labeling requirements “in addition to, or different than” the USDA’s standards. A summary of the district court opinion is available here.
  • The Tenth Circuit noted that its preemption ruling is further supported by an executive order that was highlighted by the plaintiffs. Executive Order No. 14,036 directed the Secretary of Agriculture to “consider initiating a rulemaking to define the conditions under which the labeling of meat products can bear voluntary statements indicating that the product is of United States origin, such as ‘Product of USA.’” Although the plaintiffs’ contended that the order supported their position, the court found it provided further support for preemption.
  • As our readers know, in July of 2021, the USDA announced the initiation of a top-to-bottom review of the voluntary “Product of USA” claim. As part of the review, the USDA’s FSIS is conducting an online survey to gauge consumer awareness and understanding of current “Product of USA” labeling claims on meat products and consumer willingness to pay for meat products labeled with that claim or a potentially revised definition of the claim. The USDA has also published a notice and request for comment on the survey effort and “Product of USA” claim. The comment period is open until April 4, and comments can be submitted to www.regulations.gov, using Docket ID: FSIS-2021-0031. Please contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • An Illinois District Court dismissed a class-action lawsuit that alleged that the labeling on Kellogg Sales Company’s Unfrosted Strawberry Pop-Tarts mislead consumers into thinking that the product’s filling contained only strawberries, or at least a majority of strawberry ingredients, by including the word “Strawberry” and depicting half of a fresh strawberry and red fruit filling on the front panel of the packaging. In reality, the product’s filling also contained dried pears, dried apples, and the color additive Red 40.
  • The Court held that the claims were not actionable (i.e, a reasonable consumer would not be deceived) largely because the product did not make any representation that the product contained only strawberries or that it contained any particular quantity of strawberries. Interestingly, the Court did not address whether some minimum quantity of strawberry is required in a “strawberry” product and the opinion could be read as holding that a “strawberry” product is not misleading if it contains any measurable amount of real strawberries.
  • The case is very similar to another pair of class-action lawsuits that we have previously blogged about, one which also relates to the strawberry content of Pop-Tarts, and the other which relates to the strawberry content of breakfast bars. All three cases were filed by Sheehan & Associates.
  • As we reported, FDA released a list on January 31, 2022 of important guidance topics that are a priority for completion this year.  The list includes enforcement policy guidance concerning five of the seven foundational rules implementing the FDA Food Safety Modernization Act (FSMA).
  • On March 14, 2022, FDA published notification of availability of Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions Guidance for Industry.  The March 2022 guidance describes new or extended FSMA enforcement discretion policies as follows:
    • FDA extended the policy, announced in March 2019 Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds, not to enforce part 112 for entities engaged in the relevant activities while FDA considers rulemaking to address the unique circumstances of these commodities.
    • FDA extended the enforcement policies announced in January 2018 Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs as follows:
      • Until rulemaking involving certain farm-related activities is finalized, FDA will not enforce for listed entities (1) the part 117 (human food) and/or part 507 (animal food) preventive controls requirements; (2) the part 507 current good manufacturing practice (CGMP) requirements for the listed entities that are subject to the part 507 CGMPs; or (3) the part 117 CGMP requirements with regard to non-produce raw agricultural commodities (RACs).
      • Until the completion of new rulemaking that considers complex supply chain relationships and resource requirements, FDA will not enforce certain requirements for written assurances in part 117, part 507, the FSVP regulation, and Part 112 (the Produce Safety regulation).
      • While FDA considers the issue, it will not enforce the part 507 preventive controls requirements related to human food by-products if after separation from the human food, the entities are performing one of a limited number of identified manufacturing/processing activities.
    • FDA clarified that the enforcement discretion policies under the January 2018 guidance extend to any requirement (under FSVP or the preventive controls supply-chain program requirements) for an importer or receiving facility to verify a supplier’s compliance with a FSMA requirement which itself is associated with an enforcement discretion policy, although FSVP requirements which are not associated with an enforcement discretion policy remain subject to FDA’s usual enforcement policies.
    • FDA announced it does not intend to enforce the requirements of Part 121 (Intentional Adulteration) for those facilities that are under the farm-activity related enforcement policy described in the January 2018 guidance until the completion of rulemaking, which will clarify food facility registration requirements for those entities (e.g., facilities that would be farms except for ownership of the facility; facilities that would be farms if they did not color RACs).
    • FDA announced it does not intend to enforce the requirement for reanalysis of the Food Defense Plan (FDP) in 21 CFR 121.157(b)(3) when improper implementation of a mitigation strategy or combination of mitigation strategies is addressed through implementation of corrective actions procedures that correct the problem and reduce the likelihood of recurrence.
    • FDA extended the policy, announced in November 2017 Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food, which was extended in a November 6, 2019 update, as discussed here, not to enforce requirements for a supply-chain program for certain raw materials and other ingredients while FDA works to better understand additional practical challenges related to compliance with supplier verification and approval challenges related to co-manufacturing.
  • This guidance is immediately effective per FDA’s determination that prior public participation is not feasible or appropriate with respect to these new and extended enforcement policies because the guidance presents a less burdensome policy that remains consistent with FDA’s public health mission.  FDA will, however, review any comments that are received and revise the guidance when appropriate, as required under 21 CFR 10.115(g)(3)(ii).
  • This week the Sugar Association submitted a Supplemental petition (“Supplement”) to FDA to further support the Association’s June 2020 petition Misleading Labeling Sweeteners and Request for Enforcement Action (“Petition”).  As noted in a previous post, the Association’s petition asks FDA to promulgate regulations requiring additional labeling disclosures for artificially sweetened products, which it believes are necessary to avoid consumer deception. Other than acknowledging accepting the petition for filing on Nov. 30, 2020, (see Regulations.gov), the agency has not responded.
  • The Supplement provides new data and information that the Association believes supports its original Petition, alleging that misleading labeling is “getting more prolific in the absence of FDA action.”  According to the Association, the number of new food product launches containing non-sugar sweeteners has increased by 832% since 2000, with 300% growth in just the last five years.  To further support its position, the Association references consumer research that it commissioned, suggesting that consumers think it is important to know if their foods contain sugar alternatives.
  • The Association is urging FDA to mandate significant additional disclosures on labels of artificially sweetened food products, including the following requirements to —
    • Clearly identify the presence of alternative sweeteners in the ingredient list;
    • Indicate the type and quantity of alternative sweeteners, in milligrams per serving, on the front of package of food and beverage products consumed by children;
    • Disclose the sweetener used on the front of package for products making a sugar content claim, such as “Sweetened with [name of Sweetener(s)]” beneath the claim;
    • Disclose gastrointestinal effects of various sweeteners at minimum thresholds of  effect;
    • Require that no/low/reduced sugars claims be accompanied by the disclosure “not lower in calories” unless such products have 25% fewer calories than the comparison food.
  • Keller and Heckman will continue to monitor and report on developments.
  • On March 3, 2022, the United States Government, on behalf of FDA, filed a complaint against Salud Natural Entrepreneur, Inc. (“Salud”), as well as its owner, production manager, and quality control manager. The complaint alleged that the defendants violated the Federal Food, Drug and Cosmetic Act by distributing adulterated and misbranded dietary supplements and unapproved new drugs. The complaint also alleged that Salud did not comply with good manufacturing practices.
  • The complaint followed inspections of Salud’s facility in May 2021, during which FDA found that the company was not complying with Good Manufacturing Practice regulations for dietary supplements. During a previous inspection, FDA found that Salud had used ingredients that had tested positive for Salmonella. Further, the complaint alleged that Salud’s products did not comply with labeling requirements and made unapproved drug claims (e.g, Aloe Vera Juice as an “antiviral” and Liver Detox Tea as treating alcoholism and gallbladder pain).
  • On March 8, 2022 the U.S. Department of Justice announced that a consent decree had been issued by the Northern District of Illinois. As a result, the defendants are permanently enjoined from manufacturing, holding, or distributing any products that they claim may treat or cure disease, until the products comply with federal law.
  • A federal judge in New York denied a motion to dismiss a proposed class action complaint which alleged that the producer of Nellie’s Free Range Eggs, Pete and Gerry’s Organics LLC, deceived customers by selling eggs that were not actually “free-range” (subscription to Law360 required). According to the opinion, plaintiff Constance Mogull alleges that Nellie’s, which is one of the nation’s largest sellers of eggs, sold eggs in packaging that described them as “free-range,” with images of hens outdoors, and stated “[m]ost hens don’t have it as good as Nellie’s. 9 out of 10 hens in the U.S. are kept in tiny cages at giant egg factories housing millions of birds. Sadly, even “cage-free” is now being used to describe hens that are crowded into large, stacked cages on factory farms, who never see the sun. Nellie’s small family farms are all Certified Humane Free-Range. Our hens can peck, perch, and play on plenty of green grass.”
  • The plaintiff alleges that a reasonable consumer would understand “free-range” to mean hens are not confined and are able to move around comfortably both indoors and outdoors. She argues that Nellie’s eggs are not actually “free-range” because the hens are “crammed” into overcrowded sheds and have no or limited access to outdoor space. In their motion to dismiss, Pete and Gerry’s argued that the representations challenged by the plaintiff are true when read in context, or in the alternative, are non-actionable puffery because a reasonable consumer would not assume that the packaging language were factual claims about the lives of their hens.
  • Judge Vincent L. Briccetti disagreed and found that plaintiff adequately alleged Pete and Gerry’s made materially misleading statements that are not puffery: “Because a reasonable consumer could interpret the disputed product descriptions as factual claims on which he or she could rely, the Court denies defendant’s request for dismissal on the ground that defendant’s alleged misrepresentations are non-actionable puffery.” Judge Briccetti also declined to dismiss plaintiff’s fraud claim because she plausibly alleged that Pete and Gerry’s falsely described their eggs as “free-range” despite being a top producer of eggs in the US that is aware of its farmers’ practices and how the term “free-range” is perceived by consumers.
  • Keller and Heckman will continue to monitor and report on this case, as well as other labeling and animal welfare suits.
  • On March 7, 2022, FDA announced that it had made a low-risk determination for two beef cattle (and their offspring) which contain an intentional genomic alteration (IGA) which results in short, slick-hair coating that is potentially able to withstand heat better. As a result, FDA will exercise it its enforcement discretion, and marketing of products from these cattle and their offspring, including for food uses, will not require pre-market approval.
  • Genetic alterations may be accomplished by incorporating spliced DNA sequences into animals through random integration events or, as is the case here, by using genome editing technologies (e.g., CRISPR) to introduce genetic alterations at specific sites. Both types of technologies result in IGAs which are regulated as animal drugs because the genomic alternation is intended to affect the structure and function of the body of the animal, and in some cases, is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in the animal. See 21 USC 321(g)(1) for the definition of “drug”. Thus, as a general matter, pre-market approval for each IGA is required.
  • However, as discussed in FDA’s Draft Guidance, FDA will exercise enforcement discretion where it determines such alterations present a low risk of harm. In this case, the IGA in the two beef cattle (called “PRLR-SLICK”) was found to be low risk because it is equivalent to naturally occurring mutations and results in the same short, slick hair trait found in conventionally raised cattle that have a history of safe use in agriculture and food production.
  • This is the first such determination that FDA has made for an animal intended for use in food. Thus, the FDA determination provides insight into how FDA determines that an IGA for animals for food use will be considered low-risk. A list of all IGA enforcement discretion determinations can be found here.
  • As covered on this blog, on April 24, 2019 FDA announced a new, draft guidance on ways to help companies prepare to quickly and effectively remove from the market any violative food or other products subject to FDA’s jurisdiction.  The purpose of the guidance is to clarify FDA’s recommendations for industry and FDA staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.
  • On March 4, 2022, FDA published notice that its Final Guidance is available on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.  In addition to editorial changes made to improve clarity, changes from the draft to the final guidance include:
    • the addition of “correction” and “market withdrawal,” with these terms’ regulatory definitions, in the terminology section of the guidance;
    • the addition of language encouraging the use of electronic communications for conveying voluntary recall communications about FDA-regulated products; and
    • the deletion of section IV (‘‘References’’).

FDA did not respond to a comment that suggested replacing the word “should” with “may” as a way to provide more flexibility in recommendations that “a firm should consider establishing metrics appropriate to its recall plan” and “should implement procedures to identify indicators that there may be a problem with a distributed product that suggests it is in violation of the FD&C Act and other laws administered by the FDA.”