•  Thirty-six leaders in the cellular agriculture industry in the Asian region signed a memorandum of understanding (MOU) agreeing to the use of the English language term “cultivated” to describe animal products grown from animal cells. Many other terms including “cultured,” lab-grown,” and “cell-based” have also been used to describe such products. The MOU was announced at Singapore’s International Agri-Food Week (SIAW) at the end of last month.
  • The MOU does not have the force of law and could be impacted by future national laws and regulations but does reflect agreement from regional industry leaders that the term “cultivated” should be used because it is a scientifically accurate term that distinguishes from traditional animal products and it elicits the most positive responses from consumers. The MOU indicates that more research is needed to determine how to translate the term into various Asian languages.
  • It is unclear whether this agreement will have any impact in the U.S., but it is noteworthy that some signatories, including Cargill, have an international presence. There are no commercially available “cultivated” animal-based products in the US, but in 2019 FDA and USDA signed a MOU regarding their respective jurisdiction over cultivated meat and poultry products (the MOU did not use the term “cultivated”). Per the agreement, FDA will regulate the early stages of development while USDA will regulate post-harvesting steps, including labeling. FDA has exclusive jurisdiction over cultivated seafood products, although the agencies have indicated that they will work jointly to ensure consistent labeling. In that regard, in 2021 USDA issued an advanced notice of proposed rulemaking (ANPR) on labeling of cultivated meat and poultry products (the ANPR used the term “cultured”), but no regulatory action appears to be forthcoming. Similarly, in 2021 FDA issued a request for information (RFI) regarding cultivated seafood (the RFI also used the term “cultured”), but the agency has also not yet taken any regulatory action.
  • We also note that several states have tried to enact bans on the use of animal-based terms (e.g., meat) on products that are not derived from animals (cultivated meat products and plant-based meat products), although courts have found such bans to be unconstitutional. See e.g., Enforcement of Arkansas Law Enjoined. We will continue to monitor and repot on any developments in the commercialization and regulation of cultivated animal products.

 Nestle Dumps Boost Beverage False Ad Suit For Good (Law360 Subscription Required)

  • Earlier this year, a California federal judge dismissed without prejudice the second amended complaint in a proposed class action lawsuit, originally filed on December 20, 2021, against Nestle HealthCare Nutrition, Inc. (“Nestle”), holding that Boost Glucose Control and Boost Glucose Control High Protein product labels would not lead reasonable consumers to believe that the drink would treat or cure diabetes, a chronic disease for which there is no known cure.  Plaintiffs alleged that the Boost products are deceptively labeled because the statements, “glucose control,” “helps manage blood sugar,” and “designed for people with diabetes” misleadingly imply that the products would have some affirmatively therapeutic impact on their blood glucose levels or otherwise mitigate, treat, or prevent pre-diabetes or diabetes.
  • On November 7, 2022, the lawsuit over Boost glucose control drinks was permanently dismissed.  Regarding new allegations in the third amended complaint that were added to address earlier deficiencies regarding whether a reasonable consumer would be deceived, the court found:
    • Allegations that the products are sold in the health and nutritional supplement sections of stores, rather than in the grocery aisles, were added to address the point that “no reasonable consumer of the targeted consumer group would expect a novel diabetes treatment to simply appear on grocery shelves out of the blue,” but are not persuasive because the plaintiffs failed to plausibly allege that Nestle held control over placement of the products;
    • FDA and FTC (Federal Trade Commission) cease-and-desist letters regarding sham diabetes treatments, bearing statements such as “keep blood sugar at an optimum level” and “diabetes support supplement,” were intended to support the inference that similar representations on the Boost labels advertise an unproven treatment but have the contrary effect because no such letter was likewise sent to Nestle; and
    • Claims that these individual plaintiffs were duped by the alleged misrepresentations on the Boost labels does not lead to the conclusion that a significant portion of persons with prediabetes or diabetes would similarly believe that a nutritional drink would control a chronic disease.

On the issue of whether the plaintiffs adequately alleged standing based on a price-premium theory, the judge acknowledged the plaintiffs’ evidence that Boost glucose control drinks are priced higher than other nutritional drinks but noted that the plaintiffs still did not allege specific facts relevant to their particular purchases.

  • It is not clear if the statements on Nestle’s Boost glucose control drinks may have been deemed misleading for the general public as opposed to the targeted consumers with diabetes to whom the court attributed some level of savviness in understanding “clear designations of the nutritional contents on the front of the label,” which together with descriptions of the products as nutritional drinks, the court found “demonstrate that the products are a food that will necessarily impact glucose levels, not a health supplement or a drug that would treat the chronic disease.”
  • On November 4, 2022, FDA announced that the Interagency Food Safety Analytics Collaboration (IFSAC) had released its annual report on “Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States.”
  • By way of background, IFSAC is a tri-agency group including FDA, the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS). Each year IFSAC analyzes foodborne illness outbreak data and specific foods that are responsible for them and releases that evaluation in an annual report. The reports are intended to help shape FDA’s priorities and keep stakeholders informed.
  • This years’ annual report found that Salmonella was caused by a variety of foods (including meats, fruits, and seeded vegetables), E. coli O157 illnesses were most often linked to vegetable row crops and beef, and that Listeria monocytogenes illnesses were most often correlated with dairy products, fruits, and vegetable row crops. Notably, attribution estimates for Campylobacter are not included in this years’ report. This is because Campylobacter outbreaks appear to differ from the sources of non-outbreak-associated-illness caused by the pathogen. FDA’s announcement notes that IFSAC is exploring alternative approaches for estimating the sources of Campylobacter illnesses.

 

  • Maine’s Department of Environmental Protection (DEP) recently published a second “concept draft” rule to implement Maine’s sweeping PFAS in consumer products legislation; comments are due tomorrow, November 10, on the second “concept draft.” Readers may recall that in July 2021, Maine passed “An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution,” which implements reporting requirements for intentionally added PFAS in consumer products.  The law also prohibits PFAS in carpets, rugs, and fabric treatments, and institutes a total ban on intentionally added PFAS by January 1, 2030.  Once Maine settles on proposed implementing regulations to advance to the Board of Environmental Protection, a formal comment period will open, likely sometime in December based on recent public statements from Maine DEP personnel.  Although the rulemaking process is still ongoing, key updates are provided below:
    • Beginning January 1, 2023, the law requires manufacturers to notify the state of any products sold or distributed in Maine that contain intentionally added PFAS. Products that contain intentionally added PFAS and which are not reported are prohibited from sale or distribution in the state.  Importantly for food companies, DEP has stated that it interprets the statute as applying to food packaging.
    • DEP does not currently have a formal system in place to report products that contain intentionally added PFAS, but DEP will accept notifications via mail or email at PFASProducts@maine.gov. Maine is currently working with the Interstate Chemicals Clearinghouse to develop a reporting database that will ultimately be made public.  The statute provides that the notification must include the following:

(1) A brief description of the product;

(2) The purpose for which PFAS are used in the product, including in any product components;

(3) The amount of each of the PFAS, identified by its CAS registry number, in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by the Maine DEP;

(4) The name and address of the manufacturer, and the name, address and phone number of a contact person for the manufacturer; and

(5) Any additional information established by the department by rule.

  • Exemptions: The statute provides for two exemptions from the reporting requirement. First, “Products for which federal law governs the presence of PFAS in the product in a manner that preempts state authority” are theoretically exempt.  However, DEP has stated that it is not aware of any federal law or regulation that would apply under this exemption.  The second exemption applies to a “product subject to Title 32, chapter 26-A or 26-B” of the Maine Revised Statutes.  Although Chapters 26-A (32 M.R.S. § 1731-1738) and 26-B (38 M.R.S. § 1741-1747) do apply to food packaging generally, DEP has stated that it will interpret this language narrowly.  An FAQ page on DEP’s website states that food packaging is only “subject to” chapter 26-A when the Department prohibits its sale by rule (which it has not yet done) and is only subject to Chapter 26-B if it contains a chemical designated as a “priority food contact chemical” by DEP’s Commissioner (which has not yet happened).  Thus, our readers should be aware that DEP does not interpret these exemptions as applying to food packaging.
  • Waivers and Extensions: Maine’s DEP is accepting requests for extensions to the reporting deadline on a case-by-case basis. Requests for extensions must be made by or on behalf of specific named manufacturers in advance of the January 1, 2023 reporting deadline.  If a manufacturer does not know if their products contain intentionally added PFAS and/or if the manufacturer cannot provide sufficient information to comply with the detailed reporting requirements listed above, that manufacturer can submit an extension request to PFASproducts@maine.gov.  Readers should be aware that all companies that are granted an extension will be listed on a publicly available document.
  • Penalties and Enforcement: Maine’s PFAS prohibition in consumer products directs DEP to adopt rules as necessary for the administration and enforcement of the statutes.  In the concept draft rule, DEP indicated that any violations are subject to DEP’s enforcement authority under 38 M.R.S. §§ 347–349.  A person who violates the provisions of the PFAS statute/reporting obligations may be subject to an investigation resulting in an administrative consent agreement, an enforcement hearing on the alleged violation, or a civil or criminal action brought by the Attorney General.  Civil penalties can be up to $10,000 per day of violation unless the violation relates to hazardous waste, in which case the person shall pay the state a penalty to be determined by a court of not more than $25,000 per day of violation.  In addition, criminal penalties (Section 349) can be up to $25,000 per day of violation.  (Section 349 indicates that violations of the provisions administered by the Maine DEP are considered a Class E crime, which is punishable up to six months incarceration and a $1,000 fine).
  • Keller and Heckman will continue to monitor and provide updates on Maine’s PFAS draft regulations.
  • Spencer Sheehan, a well-known class-action attorney, has filed a pair of class-action lawsuits in the U.S. District Court for the Northern District of Illinois, alleging that mint flavored products which do not contain mint are deceptively labeled.
  • The first lawsuit alleged that a “mint chocolate chip ice cream” statement of identity is misleading to consumers where the product’s flavor is derived from “natural flavor” and not any mint or mint-containing ingredient. The product also contains images of mint leaves on the front panel. As support for the allegation that the lack of mint is deceptive, the complaint cites to the ice cream flavoring regulation (21 CFR 135.110(f)(2)), which requires that the term “flavored” (e.g., mint flavored) be used where a product contains a natural flavor which predominates.
  • The second lawsuit alleged that consumers are misled by a gum product which is labeled as “original flavor” with a backdrop of what appears to be a blue mint leaf, but which only contains “natural and artificial flavor,” and no mint-based ingredients. Plaintiff, citing to the general flavoring regulation (21 CFR 101.22), alleged that the product should have been labeled as “naturally and artificially flavored mint” and that the failure to disclose the flavor or include the other qualifiers is misleading.
  • Although Plaintiffs have alleged technical violations of FDA’s labeling regulations, courts have consistently held that a reasonable consumer may not be aware of the intricacies of FDA’s labeling regulations and that therefore a technical labeling violation is not in itself sufficient to show that a reasonable consumer would be misled.

 Plum, Campbell Escape Heavy Metal Baby Food Suit (Law360 Subscription Required)

  • Litigation soon followed a February 4, 2021 report and September 29, 2021 supplement (discussed here) by the U.S. House of Representatives subcommittee on Economic and Consumer Policy that raised alarm over the levels of heavy metals— including arsenic, lead, cadmium, and mercury— reportedly found in baby foods produced by seven of the largest baby food manufacturers in the U.S.  Many of these class action lawsuits have been dismissed for lack of standing, among other reasons.
  • On October 31, 2022, a federal judge dismissed without prejudice plaintiffs’ fraud and consumer protection claims in a New Jersey district class action against Campbell Soup Co. and Plum PBC (formerly a subsidiary of Campbell) that alleged dangerous levels of heavy metals in Plum baby food products.  The court found that plaintiffs have not alleged a “concrete and present harm” that would establish that they have standing.  The plaintiffs’ pleadings were compared to similarly unsuccessful claims involving Sprout and Gerber baby foods and claims in California against Walmart’s Parents Choice baby food that were allowed to proceed.  As compared to the “conclusory allegations” that failed in the other cases, plaintiffs in Kochar v. Walmart, Inc., (N.D. Cal. Apr. 25, 2022) passed the standing test by:
    • Alleging that the levels of heavy metals were above “naturally occurring” levels for the products directly at issue;
    • Outlining the average levels of certain heavy metals in foods regularly consumed by children and infants per FDA testing to provide a comparative baseline necessary for the court to assess risk of harm for standing purposes;
    • Alleging that Walmart was in possession of testing data showing high levels of heavy metals present in its products based on its own internal standards;
    • Articulating a “premium price” economic injury by stating that the plaintiffs had “spent their own time and money dealing with purchasing safer baby food alternatives;” and
    • Alleging that there were costs and expenses incurred related to their efforts to ensure that their babies have not been harmed, as well as costs and expenses for treatments their babies have received.
  • It remains to be seen whether any of the heavy metals lawsuits will ultimately be successful, given the difficulties and uncertainties in determining levels that are both safe and feasible, as outlined in FDA’s Closer to Zero plan (discussed here).  It seems clear, however, that getting to trial will require more than generalized concern and alarm.  Keller and Heckman will continue to monitor and report on any developments with this case or other heavy metal baby food-related lawsuits.
  • According to the Department of Justice’s October 21 press release, a former quality assurance director for food manufacturer Kerry Inc. plead guilty to three misdemeanor offenses related to the manufacture of a breakfast cereal linked to an outbreak of Salmonella poisoning in 2018.
  • Kerry Inc.’s former Director of Quality Assurance oversaw the sanitation programs at various Kerry manufacturing plants, including a facility in Gridley, Illinois that primarily manufactured Kellogg’s Honey Smacks breakfast cereal for Kerry’s customer, the Kellogg Company.
  • In June 2018, FDA and CDC announced that an ongoing outbreak of Salmonella cases in the United States could be traced to Kellogg’s Honey Smacks cereal produced at Kerry Inc.’s Illinois facility. In response, Kellogg’s voluntarily recalled all Honey Smacks manufactured at the plant since June 2017. In July 2018, Kerry Inc. received a Warning Letter from FDA, which detailed how Agency investigators found “serious violations” of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation as detailed in 21 CFR Part 117. The present charges against Kerry Inc.’s former QA director stem from the 2018 multistate outbreak of Salmonella infections from Honey Smacks cereal, which sickened 135 people in 35 states.
  • In pleading guilty, the former QA director admitted that between June 2016 and June 2018, he directed subordinates to not report certain information to Kellogg’s about conditions at the Gridley facility. In addition, he admitted that he forced subordinates at the Gridley facility to alter the plant’s program for monitoring for the presence of pathogens, thus limiting the facility’s ability to accurately detect insanitary conditions and bacterial contaminations. “Food safety professionals cannot conceal potentially dangerous problems from customers or government regulators,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division.
  • Special Agent Lynda M. Burdelik of the FDA Office of Criminal Investigations also said that this prosecution “reinforces that if an individual violates food safety rules or conceals relevant information, [FDA] will seek to hold them accountable. The health of American consumers and the safety of our food are too important to be thwarted by the criminal acts of any individual or company.”
  • The sentencing date is scheduled for January 30, 2023. Further information about the case will be posted to the Department of Justice’s Information for Victims in Large Cases website, available at https://www.justice.gov/largecases.
  • On November 1, 2022, FDA announced that it had revised the Manufactured Food Regulatory Program Standards (MFRPS). MFRPS are food safety standards for state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods.
  • By way of background, the standards were first issued by FDA in 2007 and are intended to achieve equivalent food safety standards, inspection programs, and practices among state and federal regulators. The standards set forth a uniform basis for measuring and improving prevention, intervention, and response activities of food regulatory programs.
  • The revised version of the MFRPS includes updated term definitions, new job aides, and updates to the program elements. The changes include further emphasis on documentation and written evaluations, as well as the recognition of FDA assessment in conformance assessments.  An overview of the 2022 changes is available here.
  • On November 1, the FDA issued a proposed rule to amend the color additive regulation to increase the fee for certification services. If finalized, the fees for straight colors including lakes would be $0.45 per pound ($0.10 per pound increase) with a minimum fee of $288. There would be similar increases in fees for repacks of certified color additives and color additive mixtures.
  • Certification of certain color additives is required under the Federal Food, Drug, & Cosmetic Act in order for those colors to be used in food, drugs, cosmetics, and medical devices. The FDA analyzes samples from each batch of color additive received from a manufacturer and verifies that it meets composition and purity specifications. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.
  • In the press release announcing the proposed rule, the FDA noted that an increase in fees is needed to cover the increased operating costs of the color certification program, and that this is the first fee increase proposed since 2005 when the current schedule became effective.
  • Stakeholders may submit comments on the proposed rule by January 3, 2023. Please contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • Last month a class-action lawsuit was filed alleging that Wheat Thins are deceptively labeled as “100% Whole Grain” when they in fact contain corn starch, an ingredient Plaintiffs characterize as a refined grain ingredient
  • Plaintiffs make the case that a whole grain must include the germ, brand, and endosperm, and that the inclusion of cornstarch is misleading because cornstarch is derived from the endosperm only and is therefore not a whole grain. Further, Plaintiffs argue that the common sense meaning of 100% whole grain is that all of the grain ingredients are whole grains, and that this position is consistent with FDA’s guidance, which “recommend[s] that products labeled with ‘100 percent whole grain’ not contain grain ingredients other than those the agency considers whole grain.’”
  • However, although Plaintiffs make a noncontroversial argument that cornstarch is not a wholegrain, they nowhere justify that cornstarch should be considered a grain, rather than a starch product derived from a grain. Furthermore, the product images that Plaintiffs include in the complaint indicate that many of the product are labeled with a quantitative statement regarding the whole grain content per serving, i.e., “21g Whole Grain per 31g Serving.” Such a statement would likely put a consumer on alert that the product contains ingredients other than whole grains. See Blog post on Warren v. Whole Foods in which the Court found it implausible that a reasonable consumer would construe the claim “100% Whole Grain -18g or more per serving” to mean that the entire product is made from whole grains.
  • The Court will now have to determine whether it is plausible that a reasonable consumer would be misled by the “100% Whole Grain” label in the context in which it was presented. We will continue to monitor and report on this case.