• 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.
  •  Under FDA’s regulations, at 21 CFR 184.1408, black licorice is generally recognized as safe (GRAS) for flavoring uses at specified maximum levels of glycyrrhizin content in food such as candy.  In time for Halloween of 2017, however, FDA issued a consumer report on Black Licorice: Trick or Treat?, warning that glycyrrhizin can cause potassium levels in the body to fall and may lead to abnormal heart rhythms, high blood pressure, edema, lethargy, and congestive heart failure for some people eating large amounts, for example, 2 ounces of black licorice a day for at least two weeks.  Subsequently, as we reported in 2020, a 54-year-old Massachusetts man died of cardiac arrest after reportedly consuming a bag and a half of black licorice each day for several weeks.
  • In a July 11, 2022 opinion, a Pennsylvania district court denied a motion by The Hershey Company (Hershey) to dismiss injured plaintiffs’ strict products liability and negligence claims for failure to warn consumers of Hershey’s black licorice candies about glycyrrhizin’s health risks.  Regarding Hershey’s argument that the plaintiffs’ claims are preempted by the Nutrition Labeling and Education Act of 1990 (NLEA), the court found that to the extent a need for a safety warning is established, it would fall squarely within the language of the NLEA’s safety exception as a “requirement respecting a statement in the labeling of food,” which “provides for a warning concerning the safety of the food or component of the food.”  Thus, Hershey did not overcome a presumption against preemption that applies in areas such as food and beverage labeling that have been traditionally within the province of state regulation and the lawsuit will continue.
  • Other courts have likewise recognized the “health warning exception” to preemption by the NLEA as applicable to GRAS food ingredients that may be unsafe for certain individuals or at certain levels of consumption.  For example, New York City’s warning requirement for restaurant menu items containing more than 2,300 mg of sodium was upheld although salt (sodium chloride) continues to be GRAS.
  • On October 22, a California federal judge found that a proposed consumer class failed to show that calling a product “milk-based” is deceptive when milk is one, but not the main, ingredient in the product (subscription to Law360 required).
  • U.S. District Judge John Holcomb in his order said that the proposed class representative, Cecilia Martinez, had a limited interpretation of the product’s labeling and that Mead Johnson provided sufficient context, specifically in its ingredient list, to clarify the “milk-based” description. “Martinez [alleges] no factual support for why a reasonable consumer would narrowly interpret a something-based label to mean that that something must contribute the most to the product’s weight, relative to any other ingredient,” reasoned Judge Holcomb on Saturday.
  • The disposition comes after Martinez filed the class action suit in February after she purchased Enfamil powdered formula in September 2021, believing the main ingredient to be milk on the “milk-based” description, only to later discover that the primary ingredient was corn syrup solids. Mead Johnson argued that an object could be described by one of its ingredients, even if it is not the main ingredient. To illustrate this point, the company pointed out that while a can of chicken-based broth and a can of vegetable-based broth both have water as the main ingredient, the products would likely be described by their more distinctive characteristics of chicken and vegetables.
  • Judge Holcomb ultimately sided with the nutrition company and pointed out that FDA says only that product labels should “describe the basic nature of the food or its characterizing properties or ingredients,” and does not mention anything about conflating the characterizing ingredient of a product with its primary ingredient.
  • According to Judge Holcomb, customers could “easily” turn the Enfamil formula bottle around and look at the ingredient label to see that while milk is listed, corn syrup solids are listed higher. Therefore, the judge said, Martinez’s arguments appear to be “plausible misunderstandings.”
  • The proposed consumer class may file an amended complaint no later than November 10, 2022. The case is Cecilia Martinez v. Mead Johnson and Co. LLC, case number 5:22-cv-00213, located in the U.S. District Court for the Central District of California.
  • On October 24, 2022, a coalition of advocacy groups, led by the Center for Science in the Public Interest (CSPI), submitted a petition to FDA to ban the use of FD&C Red No. 3 colorant in food, dietary supplements, and ingested drugs.  This approved color additive is widely used in confectionery products, as well as in a variety of other processed foods.
  • The petitioners argue that FD&C Red No. 3 should be removed from the permanent list of approved color additives since FDA has already made the determination that very high doses of the additive can cause cancer in laboratory animals and that subsequent studies have reinforced that conclusion.
  • Previously, in 2008, CSPI petitioned FDA to ban all artificial food colors, including Red No. 3, but FDA rejected this request, after its Food Advisory Committee found no causal link between children’s consumption of FD&C colors approved for general use in food and behavioral effects.  However, in 2021, California Office of Environmental Health Hazard Assessment (OEHHA) published a report concluding that “[t]he scientific literature indicates that synthetic food dyes can impact neurobehavior in some children.”
  • Keller and Heckman will continue to follow the progress of this petition.