• The food industry and Massachusetts regulators have agreed to settle a lawsuit (Massachusetts Restaurant Association v. Healey et al.) challenging the state’s animal welfare pork rules, with the state agreeing not to enforce the transshipment provisions.
  • Massachusetts voters had passed Question 3 (Act to Prevent Cruelty to Farm Animals) in 2016, which largely mirrored California’s Proposition 12 (Prop 12) applying to enclosures for sows, veal, and egg-laying chickens.
  • The law included a provision that animal welfare restrictions would not be limited to pork consumed in-state, but would extend to shipments of covered products moving through the state that were not Massachusetts-compliant.
  • The plaintiffs sued the state in August 2022, but the case was paused in anticipation of the Supreme Court decision for Prop 12.  The Court upheld Prop 12, and the Massachusetts parties later agreed to stay their case until August 23rd, as there were still unresolved issues in their challenge.
  • One of the more critical developments to come from the August 4th joint stipulation is that the parties agreed that the state will issue regulations clarifying that the pork rules do not apply to sales of whole pork meat in Massachusetts when the meat is both produced outside of the state and sold to out-of-state consumers, referred to as “transshipped whole pork meat.”
  • Besides the transshipped pork provision, the rest of the pork rules will go into effect August 24, 2023.
  • Yesterday, FDA announced its issuance of a request for information on a citizen petition asking the Agency to amend the standard of identity (SOI) for pasteurized orange juice (POJ) by lowering the minimum soluble solids content, known as the Brix level. The current SOI for POJ requires that the product contains not less than 10.5 percent by weight of orange juice soluble solids (also expressed as degree Brix), exclusive of the solids of any added optional sweetening ingredients, and the ratio of the Brix hydrometer reading to the grams of anhydrous citric acid per 100 milliliters of juice is not less than 10 to 1 pursuant to 21 CFR 146.140(a).
  • The citizen petition, Docket No. FDA–2022–P–1668, filed by the Florida Citrus Processors Association and Florida Citrus Mutual on July 25, 2022, asks the FDA to reduce the Brix level, or minimum soluble solids requirement, from 10.5 to 10 percent, citing that the average Brix level of Florida’s orange crop has steadily dropped over the past couple of decades due to a bacterial disease called “citrus greening” and severe weather. Lowering the minimum level of soluble solids might reduce the sweetness of the juice and the levels of certain nutrients.
  • The request for information seeks comment on several areas, including consumer acceptance and nutritional value of pasteurized orange juice with a lower minimum soluble solids content. The FDA is requesting the information to determine whether the SOI for pasteurized orange juice should be amended.
  • Comments are due by October 16, 2023 and may be submitted electronically here. Specifically, FDA requests comments, data, and information about the issues presented in the petition.
  • Keller & Heckman will continue to monitor developments regarding the SOI for POJ.
  • Yesterday the U.S. Court of Appeals for the Ninth Circuit affirmed (Law360 subscription required) the dismissal of two consolidated appeals on preemption grounds. In both cases, Plaintiffs had argued that Defendant Kellogg had misled consumers by making “false and misleading” front-of-pack protein nutrient content claims that (1) overstated the amount of protein in the products and (2) did not account for the protein quality.
  • The starting point for the Court’s analysis was the express labeling preemption clause in the Food, Drug, and Cosmetic Act (FDCA), as amended by the Nutrition Labeling and Education Act. In particular, 21 USC 343-1(a)(5) preempts state laws that “directly or indirectly establish any requirement for the labeling of food that is not identical to the federal requirements” set forth by the FDCA and its implementing regulations. Thus, the question presented on appeal was whether the protein claims were permitted under FDA regulations.
  • On the first issue, Plaintiffs alleged that Kellogg had used the food’s nitrogen content to calculate protein content (the “nitrogen method”) and that such method overstated the protein content of the product. However, the Court held that FDA regulations expressly permitted the use of the nitrogen method to calculate protein content and so claims challenging the use of such method were preempted. (See 21 CFR 101.13(o) which states that methods for calculating the nutrient content in nutrient content claims shall be determined by 21 CFR 101.9. 21 CFR 101.9(c)(7) in turn provides for the use of the nitrogen method for calculating protein content).
  • On the second issue, the Court held that 21 CFR 101.9(c)(7)(i) only requires a protein digestibility-corrected amino acid score (PDCAAS) adjustment (for protein quality) to be made when a protein claim is made and that such adjustment is only required to be made in the NFP (the adjusted protein value is used to calculate the % daily value (DV)). There was no question that Kellogg had made such adjustment in the NFP, and so again, Plaintiffs’ claims were preempted. Notably, the Court indicated that if such adjustment had not been made in the NFP and if the product contained “lower-quality protein” (presumably anything less than the maximum PDCAAS score of 1.0), then such protein claim could be misleading.
  • The Court was also careful to note that an NFP labeling requirement does not in itself give license to make such statement elsewhere on the product label, but in the cases presented, the FDA regulations specifically allowed for protein content claims at issue in the precise manner that Kellogg presented them in (i.e., an express protein content claim on the front of the package with an adjusted amount presented on the NFP). Furthermore, the Court noted that if Kellogg had added additional qualifiers which were not addressed by the regulations (e.g., 11 g high quality protein), a challenge to the use of such qualifiers would not be preempted, but again that fact pattern was not presented.
  • The case stands for the principle that if labeling adheres to explicit FDA labeling rules, it cannot be directly challenged as false or misleading under state consumer protection statutes. If a Plaintiff seeks to challenge a labeling claim that is consistent with an FDA regulation, their only option is to challenge the regulation itself by arguing that FDA exceeded its statutory authority in promulgating the regulation in question.

Splenda Pans Scientist’s Cancer Claims As ‘Fearmongering’ (subscription to Law360 required)

  • Sucralose is approved by FDA for use in food as a sweetener.  A May 29, 2023 published research paper, Toxicological and pharmacokinetic properties of sucralose-6-acetate and its parent sucralose: in vitro screening assays, however, reports on potentially concerning toxicological and pharmacokinetic properties of sucralose-6-acetate (S6A), which the paper describes as an intermediate and impurity in the manufacture of sucralose.  The study authors conclude that S6A is genotoxic, finding that it effectively broke up DNA in exposed cells.  Further, the paper reports that recent commercial sucralose samples were found to contain up to 0.67% S6A and also discusses studies in a rodent model that the authors interpret as suggesting that S6A may also be produced by acetylation of sucralose in the intestines. 
  • On August 8, 2023, a defamation lawsuit was filed against Dr. Susan Schiffman, the SA6 study’s lead author, in the Middle District of North Carolina by TC Heartland LLC, the producer of a sucralose product sold as Splenda, over Dr. Schiffman’s comments in a May 31, 2023 press release by NC State, where Dr. Schiffman is an adjunct professor, and in a May 31, 2023 appearance by the professor on WRAL News at 4 pm.  Heartland’s complaint (available by subscription to Law360) attacks the May 29, 2023 paper as “dishonest and deeply flawed,” specifically disputing that there is any basis for claiming that sucralose is metabolized to S6A in the human gut.  As to potential impurities in sucralose, the complaint further contends that Dr. Schiffman falsely told the press that Splenda, which Heartland maintains does not contain detectable levels of S6A, contains a “genotoxic” substance that “broke up DNA” and “can cause inflammation and even cancer”—and that Splenda contains enough of this substance to “exceed . . . the threshold of toxicological concern,” despite the paper expressly confirming that the sucralose involved in the study was not the sucralose used in Splenda.   
  • The merits of the case will be determined going forward.  We note that while FDA’s review of sucralose covers numerous safety studies on the substance and its hydrolysis products, there is no discussion of S6A as a possible impurity in sucralose or evidence for the safety of any level of potential dietary exposure to SA6. 
  • A&W Concentrate Co. and Keurig Dr Pepper Inc. have agreed to settle a class action lawsuit that claims they falsely advertised their root beer and cream soda products as containing real vanilla (subscription to Law360 required). Specifically, Plaintiffs asserted that the soda products were deceptively and misleadingly marketed with the claim “Made With Aged Vanilla,” when the products actually contained artificial vanilla flavor from ethyl vanillin. As our readers know, vanilla claims have been and continue to be a popular target for class actions.
  • A New York federal judge granted the preliminary approval of the $15 million settlement in June. Under the settlement terms, each member would receive a minimum of $5.50, or up to $25 if proof of purchase is provided. The named plaintiffs will receive $5,000. The nationwide class covers all consumers in the US who bought the drinks between February 7, 2016 and June 2, 2023. A decision regarding the amount of attorney fees and expenses is to be decided by the judge.
  • A&W Concentrate Co. and Keurig Dr Pepper Inc. have denied any wrongdoing and assert that their product labeling is in compliance with the regulations, but nonetheless agreed to the settlement to avoid continuing litigation.
  • In a recent study published in the Robert Koch Institute’s Journal of Health Monitoring, scientists stated that climate change is expected to lead to an increase in foodborne infections and presents a growing health risk in Germany.  The review looks at hazards to human health posed by relevant bacteria, parasites, and marine biotoxins in Germany including Salmonella, Campylobacter, and Vibrio, and parasites Cryptosporidium and Giardia.
  • The study authors note that climate change can lead to higher air and water temperatures, increased precipitation, or water scarcity.  This may lead to the agriculture industry relying on treated wastewater due to water shortages in the future, according to the report.  This would pose a risk to food safety because of possible contamination of irrigated produce by pathogens.
  • Campylobacter and Salmonella grow in higher temperatures and those infections typically occur in the summer months.  Because climate change has led to prolonged warm periods, the authors predict that these bacterial infections can pose a risk for longer stretches of time.  The increase in water temperature will lead to an amplification of Vibrio contamination in European seafood catching, harvesting, and farming areas, and will also expand beyond summer and autumn months.
  • Research suggests that a changing climate also has a direct impact on the prevalence and virulence of parasites, which are already very stable in the environment.  Extreme weather such as heavy rainfall and flooding, which are expected to increase as a result of climate change, grow the risk of infectious oocysts/cysts entering bodies of water, as well as the risk of contamination of plant-based foods, said researchers.
  • On August 8, FDA announced the release of its direct final rule amending the regulations that provide for the use of partially hydrogenated oils (PHOs) in food and revoking the uses of PHOs in food in light of the Agency’s determination that PHOs are no longer generally recognized as safe (GRAS) in 2015.
  • The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. Further, it revises FDA’s regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and deletes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. FDA is also revoking prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on its conclusion that these uses of PHOs may be injurious to health.
  • FDA issued these amendments directly as a final rule because the Agency views these changes as noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives.  However, the Agency also issued a companion proposed rule in the event the direct final rule is withdrawn because significant adverse comments are received. 
  • FDA is accepting public comments on both the direct final and proposed rules. Comments must be submitted by Monday, October 23, 2023, and may be submitted here.
  • Keller and Heckman will continue to monitor developments impacting the use of partially hydrogenated oils in foods.
  • On August 7, 2023, FDA issued a draft guidance which is intended to assist industry in navigating the new facility registration and product listing requirements of the Modernization of Cosmetic Regulations Act 2022 (MOCRA) (see p. 1389 of 1653).
  • MOCRA requires that persons who own or operate a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. register their facility. This registration requirement is subject to a small business exception and an exception for facilities that manufacture cosmetics regulated as drugs. Furthermore, in the case of contract manufacturers, the guidance indicates that either the contract manufacturer or the person whose name appears on the label (i.e., the “responsible person”) may register and that only a single registration is required. See draft guidance for the information required to register a facility and also optional information that FDA requests but cannot require via guidance.
  • MOCRA also requires that the responsible person for each cosmetic product submit a product listing (also subject to the same small business and drug product exceptions referenced above). However, a single listing submission may include multiple cosmetics with identical formulations or formulations that differ only in respect to colors, fragrances or flavors, or quantity of contents. See draft guidance for the information required in a product listing and also optional information that FDA requests but cannot require via guidance.
  • FDA is developing an electronic portal for registration and listing submissions which will be available in October 2023 (a paper submission process will also be available but is discouraged).
  • Cosmetic manufacturing/processing facilities must be registered by December 29, 2023, if that facility was owned or operated by the responsible person on December 29, 2022. If the facility was not owned or operated by that date, then it must be registered by the later of: (i) within 60 days after manufacturing/processing begins or (ii) February 27, 2024. The responsible person must also submit a cosmetic product listing by December 29, 2023, unless the product was marketed after December 29, 2022, in which it must be submitted by the later of: (i) within 120 day of marketing the product or (ii) within 120 of December 29, 2023.
  • The product listing number, registration number, and brand names under which the cosmetic products are sold will not be publicly disclosed. All other information is available for public disclosure consistent with the Freedom of Information Act (FOIA).
  • FDA currently administers establishment registration and product listing requirements for drugs, medical devices, and tobacco products and registration (but not product listing) for food facilities.  If FDA implements cosmetic registration and listing only via guidance without issuing regulations (as the Agency appears to be doing), FDA will be limited to requiring only the statutory elements while asking for optional elements, such as the DUNS number and electronic submission.     
  • Comments to the draft guidance are due by September 7, 2023. A broader discussion of the changes to cosmetic regulation under MOCRA, including FDA’s new recall authority, the added safety substantiation requirements, and adverse event reporting requirements, can be found in this Keller and Heckman article. Keller and Heckman will continue to monitor developments in the implementation of MOCRA.

Tea Drinkers Certified In Bigelow ‘Made In USA’ False Ad Suit (Law360 Subscription Required)

  • As previously covered on this blog, the Federal Trade Commission (FTC) adopted a final rule on July 1, 2021 that requires products labeled with unqualified “Made in the USA” or equivalent claims to be “all or virtually all” made in the United States, meaning that significant processing and final assembly of the product occurs in the US and all or virtually all ingredients or components of the product are made and sourced in the US.  The year before FTC’s decision, as discussed here, R.C. Bigelow urged the dismissal of a proposed false adverting class action lawsuit over teas labeled as “Manufactured in the USA 100% American Family Owned,” asserting that reasonable consumers know that very little tea is grown in the US and that most consumers would read “manufactured in the USA” as encompassing Bigelow’s blending, packaging, labeling, and formulating, most of which is done in the US. 
  • On July 31, 2023, a federal judge ordered the certification of a class of persons who purchased at least one box of Bigelow’s green, black or oolong tea, labeled as “Manufactured in the USA 100% American Family Owned,” at a retail store in California at any time from October 17, 2017 to present.  On the disputed prerequisites for class certification of commonality and typicality, the judge found that while the named plaintiffs, who were longtime Bigelow tea drinkers, may have considered other factors in their purchasing decisions, it is unlikely they are uniquely concerned about taste compared to the rest of the class of tea purchasers and that Bigelow would use the defense of lack of reliance against any plaintiffs.  On the issue of adequacy of representation, although they could not remember exactly when the disputed labeling began to appear and they were solicited to participate in a class action lawsuit via a website, the named plaintiffs were found to have clearly reviewed the pleadings, to understand the basis for their claims, and to have participated actively in their case.  The judge also admitted the plaintiffs’ proffered report from a food labeling specialist on the deceptiveness of the defendant’s claim, a survey supporting the plaintiffs’ price premium theory for determining damages, and a consumer survey on what is conveyed by the label’s wording.  In the required predominance inquiry, the judge rejected the defendant’s argument that a staggered rollout of the disputed labels destroys commonality, finding this does not create individual questions that predominate over common questions, but he did adjust the class definition to begin October 2017, when the label was approved, rather than July 13, 2017, as the plaintiff had proposed.  Further, the judge ruled that the label’s placement, set off to the side in bold type on the back of the box, is more prominent than labels in other cases that were deemed not “sufficiently prominently displayed to warrant an inference of class‐wide exposure.” 
  • We will monitor and report on this case and any other developments on the meaning of “manufactured in the USA.” 
  • On August 10, 2023, at 10:00am ET, the 2025 Dietary Guidelines Advisory Committee will open registration to attend a livestream Committee meeting and to provide oral comments to the Committee.  This meeting will take place on September 12 and 13, 2023.
  • The Dietary Guidelines for Americans provides advice on what to eat and drink to meet nutrient needs, promote health, and prevent disease.  It is developed and written for a professional audience, including policy makers, healthcare providers, nutrition educators, and federal nutrition program operators.  The U.S. Departments of Agriculture (USDA) and Health and Human Services (HHS) work together to update and release the Dietary Guidelines for Americans (Dietary Guidelines) every five years.  Each edition of the Dietary Guidelines reflects the current body of nutrition science.  The Dietary Guidelines for Americans, 2020-2025 is the current edition.  The Committee is currently preparing to draft the 2025-2030 Guidelines.
  • For the upcoming meeting, the Committee is interested in hearing from individuals and organizations to provide scientific input on the evidence reviews.  Interested parties may visit the Meeting 3 page to find out more about the oral comment registration process.
  • The Committee will meet approximately six times and is expected to conclude its work in late 2024.  All Committee meetings can be viewed online and the public is encouraged to submit written comments at any time.
  • Keller and Heckman will continue to monitor and relay any developments in the Committee’s work.