Splenda Maker Falsely Touts Diabetes Benefits, Suit Says (subscription to Law360 required)

  • As our readers may recall, a defamation lawsuit was filed on August 8, 2023 by TC Heartland LLC, the producer of a sucralose product sold as Splenda, against Dr. Susan Schiffman, the lead author of a May 29, 2023 scientific paper reporting 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.  In addition to attacking the research paper itself, Heartland’s complaint alleges that Dr. Schiffman made demonstrably false toxicology claims to the press about Splenda (which the company says does not contain detectable levels of S6A). 
  • On August 17, 2023, a proposed class action was filed in the Northern District of California against Heartland by a Type II diabetes patient accusing the company of false advertising and other consumer protection law violations by marketing Splenda-brand “diabetes care” shakes, zero calorie sweetener packets, sweet teas and multi-use syrup products to health-conscious consumers, including those with Type 2 diabetes, as a healthy sugar alternative even though sucralose has been shown to worsen diabetes, among other alleged harms.  As support for the plaintiff’s contention that Splenda products made with sucralose are neither healthy nor suitable for the claimed purposes of helping to manage blood sugar and aiding in diabetes care, the complaint cites the 2023 Schiffman paper and other published scientific articles, as well as the World Health Organization’s (WHO) May 15, 2023 guidelines urging against the long term consumption of sucralose and other nonnutritive sweeteners to achieve weight loss or to avoid non-communicable disease. 
  • While Heartland has not yet responded to the immediate lawsuit, the company’s press releases dispute claims in the 2023 Schiffman paper and other papers that would raise safety concerns for sucralose, highlighting alleged flaws in the research or conclusions of these papers.  Another press release objects to even the limited scope of WHO’s guidance, framing it as based on evidence with a “low certainty” level.  Heartland has also pointed to other favorable, and purportedly more convincing scientific studies, as well as reviews by FDA and international food regulatory authorities that support the safety of sucralose.  Keller and Heckman will continue to monitor any developments in the cases involving Splenda.
  • On July 26, the FDA responded to a January 30, 2023 citizen petition filed by the Center for Science in the Public Interest (CSPI) regarding sesame allergen labeling by denying two of CSPI’s petition requests and granting one request. See Docket FDA-2023-P-0342.
  • Specifically, CSPI’s petition requests were as follows:
    • Request 1. “Issue a notice to manufacturers, similar to [FDA’s] June 1996 “Label Declaration of Allergenic Substances in Foods; Notice to Manufacturers,” declaring that companies cannot meet their obligation to control allergen cross-contact risks by adding major food allergens intentionally to foods;”
    • Request 2. “Finalize [FDA’s] “Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)”…to likewise reflect the policy that companies cannot add major food allergens to mitigate cross-contact risks;” and
    • Request 3. “Clarify in guidance that while cross-contact risks can be declared voluntarily in a ‘may contains’ advisory statement, they cannot be declared by naming the allergen in the ‘Contains’ statement or ingredient list, as these are reserved for declaring actual ingredients.”
  • Regarding Requests 1 and 2, CSPI stated that certain manufacturers are intentionally adding sesame to products instead of implementing allergen preventive controls and included examples of companies who have either publicly or privately shared that they have added sesame to their products in response to the FASTER Act. CSPI argued that this practice is illegal and violative of both the law and the intent of FDA’s food safety rules because it “further elevates the risk to consumers by increasing potential exposure to the food allergen.” In response, FDA denied Requests 1 and 2. The Agency stated that they expect firms to adhere to good manufacturing practices and preventive controls, and that the Agency does not encourage the intentional addition of sesame to foods where it is not normally an ingredient, but that such a practice is not violative.
  • As for Request 3, CSPI asked the FDA to clarify that declaring an ingredient or allergen in the ingredients list when it has not been intentionally added to food is a prohibited practice and renders the food misbranded. FDA granted CSPI’s third request and stated that “the laws and regulations do not permit the addition of “sesame,” or any other major food allergen, on the label in the ingredient list or the “Contains” statement if that major food allergen is not an ingredient used to make the food.” FDA recently addressed the practice of using allergen advisory statements in a final guidance entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry,” which notes that allergen advisory statements are not a substitute for adherence to current good manufacturing practices or, when applicable, food allergen preventive controls. The guidance also states that any allergen advisory statement must be truthful and not misleading. Further, in May of 2023, FDA announced the availability of draft compliance policy guide (CPG) entitled “Compliance Policy Guide Sec. 555.250 Major Food Allergen Labeling and Cross-contact,” in which the Agency states that “Major food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the “Contains” statement.
  • In the conclusion to their response, FDA stated that while the Agency is not taking action with respect to Requests 1 and 2, they are “actively looking into and engaging on this practice of companies intentionally adding sesame to foods that, prior to the passage of the FASTER Act, did not contain sesame.” Keller and Heckman will continue to monitor for FDA’s engagement on this practice and report any updates.
  • 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.