• At the end of March, U.S. federal Judge Brian A. Jackson issued a decision in Turtle Island Foods v. Strain, which blocked a Louisiana labeling law for violation of commercial free speech guarantees.  Judge Jackson concluded that the Louisiana labeling law encroached on protected commercial speech with its extensive list of prohibited language.  Commercial speech is protected by the U.S. Constitution, but the protection is more limited than other forms of speech.  When a complaint is filed for violation of commercial free speech, the party seeking to uphold the speech restriction must demonstrate that the government has a legitimate interest in restricting particular types of commercial speech, and the subject law or regulation is the least restrictive manner to regulate such speech.
  • In June 2019, the Louisiana Legislature passed the “Truth in Labeling of Food Products Act.”  The Act prohibited labeling that misrepresents a food product as an agricultural product.  In particular, the Act applied to a range of agricultural products, including, but not limited to meat.  The Act provided definitions for, and restricted the use of terms like “meat,” “beef,” “pork,” “poultry,” and “rice.” Notably, the law prohibited plant-based products from using the term “meat,” non-rice products from using the term “rice,” and sugar alternatives from using the term “sugar.”  The Act also preemptively prohibited cell-cultured meat by excluding the term from the definition of “meat.”
  • The Act became effective on October 1, 2020, and Turtle foods filed a complaint less than a week later. The company based its complaint on First Amendment freedom of speech guarantees, as well as the Fourteenth Amendment’s Due Process Clause.  The company also alleged that the purpose of the Act was to prohibit “current and intended speech.”  Although Louisiana has not taken any enforcement action against food producers, Judge Jackson concluded that the risk of enforcement is substantial.  The law provides that violators may be fined $500 per day, per offense.
  • On Monday, March 28th, the U.S. Supreme Court granted a Writ of Certiorari petition submitted by the National Pork Producers Council (NPPC) and the American Farm Bureau Federation (AFBF) in National Pork Producers Council v. Karen Ross.  The suit alleges that Proposition 12 in California violates the Constitution’s dormant commerce clause by placing an undue burden on pork producers nationally.
  • Proposition 12  establishes new standards for confinement of certain farm animals (breeding pigs, calves raised for veal, and egg-laying hens) and bans the sale of products from such animals not raised under minimum confinement standards in California. The law is not limited to producers in California. Therefore, farmers across the country who sell pork, veal, and eggs in California must comply with Proposition 12.
  • By way of background, on September 27, 2021 several agricultural groups, including NPPC and AFBF, petitioned the Supreme Court to review the Ninth Circuit’s decision to uphold California’s Proposition 12, alleging that the law’s national impact on pork producers is an undue burden on interstate commerce.  This is not the first Proposition 12 petition to go before the Supreme Court. In June 2021, the Court denied the North American Meat Institute (NAMI) request to review the Ninth Circuit’s decision to uphold Proposition 12.
  • On March 28, the FDA announced that it requested a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget. The request is nearly a 34% ($2.1 billion) increase over the Agency’s FY 2022 appropriated funding for investments in critical public health modernization, core food safety, medical product safety programs, and other vital public health infrastructure.
  • Specifically related to food, the request asks for $43 million in additional investments in food safety modernization, including animal food safety oversight. The budget will help support the agency’s continued implementation of the New Era of Smarter Food Safety and other core food safety efforts, as well as allocate regulatory oversight resources, improve the FDA’s capacity to quickly respond to ongoing public health challenges, and improve prevention-oriented food safety practices. The budget request provides significant funding to state animal food programs. In partnership with states, the FDA will expand efforts to modernize the US animal food inspection system to become more comprehensive and prevention oriented.
  • The budget also requests $14 million to improve health equity through nutrition. Specifically, the funding would reduce exposure to harmful chemicals and toxins in food.
  • To complement the funding request, the budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authority to further its mission to protect and promote the public health. The proposals include efforts to (1) modernize dietary supplement regulation, (2) require firms to notify the FDA of anticipated significant interruptions in infant formula or essential medical food supply, (3) enhance drug and biological accelerated approval provisions, and (4) require the destruction of imported products by their owner or consignee that have been refused and pose a significant risk to public health, among others.
  • Yesterday, March 28, 2022, FDA announced that a New Jersey District Court has entered a consent decree of permanent injunction against Bravo Packing, Inc.,* a New Jersey animal food manufacturer, and two of its owners and operators, Joseph Merola and Amanda Lloyd. See also Department of Justice (DOJ) Press Release.
  • It is the first consent decree of permanent injunction that has been entered against an animal food manufacturer for violating the current good manufacturing practice (CGMP) requirements for animal food in 21 CFR, Part 507. FDA had inspected the company’s facilities in 2019 and 2021 and found insanitary conditions, CGMP violations, and samples of finished product which tested positive for Salmonella and Listeria monocytogenes. FDA also issued a warning letter in 2020 in response to the findings in its 2019 inspections.
  • DOJ, which litigates on behalf of FDA, filed a complaint on March 15, 2022, alleging that Defendants had introduced adulterated food into interstate commerce. The consent decree reflects a negotiated injunction, which avoids the need for litigation over the terms of the injunction. The decree prohibits Defendants from receiving, preparing, processing, packing, holding, labeling, and/or distributing pet food unless and until the company completes corrective actions, and also provides FDA with other enforcement tools if Defendants fail to comply.
  • Although FDA usually seeks voluntary corrective actions, this case is a reminder that the Agency may pursue more forceful judicial remedies for serious and/or repeat violations. More specifically, FDA’s Regulatory Procedures Manual states that the Agency will favor an injunction when: (1) There is a current and definite health hazard or a gross consumer deception requiring immediate action to stop the violative practice and a seizure is impractical; (2) There are significant amounts of violative products owned by the same person, a voluntary recall by the firm was refused or is significantly inadequate to protect the public, and a seizure is impractical or uneconomical; or (3)There are long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through voluntary or other regulatory approaches.

*Please note that Bravo Packing Inc. has no relationship or association with Bravo Pet Foods, located in Manchester, CT.

  •  We reported on FDA’s May 7, 2021 announcement of plans to conduct quantitative research studies to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  FDA proposed an experimental study to be followed by two surveys.  FDA was required to collect comments on this proposal before submitting the plan for approval by the Office of Management and Budget (OMB) as required under the Paperwork Reduction Act (PRA).  The comment period on FDA’s plans closed July 6, 2021.
  • Today, March 28, 2022, FDA provided notice that plans to collect information have been submitted to OMB for approval of two consecutive quantitative research studies of consumer responses to the draft FOP symbols that companies could voluntarily use on packaged food as a graphic representation of the nutrient content claim “healthy.”  In response to comments on the plan put forth almost a year ago, FDA will reorder the research to perform the experimental study component first and will now conduct one survey with a larger sample size (instead of two surveys with smaller sample sizes).  FDA declined to make other changes in the experimental studies (suggested in 27 comments that were considered) including the use of images of real products, as opposed to mock images, and the use of online store settings or other naturalistic study environments.  FDA noted that later research may be necessary to address additional issues raised in the comments, such as the effect of other FOP symbols that may appear on the same package.
  • FDA maintains that the research proposal (OMB Control Number 0910-NEW) is not dependent on specific criteria for “healthy.”  Thus, while FDA’s Constituent Update promises that FDA intends to propose a revised definition “soon,” FDA contends there is no need to postpone the planned research on a “healthy” symbol until after the regulatory definition at 21 CFR 101.65(d) is updated.

 

Goldfish Cracker False Ad Suit ‘Makes No Sense,’ Judge Says – Law360 (subscription required)

  • This week, during oral arguments on Campbell Soup Company’s (Campbell) motion to dismiss, a California federal judge raised significant questions about the viability of a class action lawsuit that alleges that the labels for Campbell’s and Pepperidge Farm, Inc.’s Goldfish-brand snack products (the “Goldfish Products”) mislead consumers. As previously reported, plaintiffs allege that the Goldfish Products do not comply with 21 C.F.R. § 101.60 (“Nutrient content claims for the calorie content of foods”) because they claim “0g Sugars” or “0g Total Sugars” (i.e., sugar free claims) without disclosing that they are “not a low calorie food,” “not a reduced calorie food,” or “not for weight control.”
  • U.S. District Judge James Donato suggested that a reasonable consumer could not possibly be misled into thinking that the Goldfish Products are a “diet” snack because the Goldfish package also features a prominent front-of-pack “140 calories per serving” representation.   Judge Donato observed “it’s just as likely a consumer would see 140 calories and say this is not a diet food as it is they would look at the sugar and say I’m going to ignore the 140 calories and think this is low calorie, which makes no sense to me.” The judge did not issue a ruling at the conclusion of the hearing.
  • Importantly, FDA recently clarified that the additional statements required when making sugar content claims defined in Section 101.60(c) are not required for quantitative claims about sugar. See Industry Resources on the Changes to the Nutrition Facts Label.
  • Keller and Heckman will continue to monitor these types of class action challenges and report on any developments.
  • On March 23, 2022, FDA announced that it would hold a webinar on the Agency’s Foodborne Outbreak Improvement Plan (“Improvement Plan”). As previously reported, the Improvement Plan was released in December 2021 and is designed to help FDA and its partners enhance the speed, effectiveness, and communication of foodborne outbreak investigations. The Improvement Plan focuses on improving four specific priority areas, which FDA believes will have the most impact on outbreaks associated with human food:  tech-enabled product traceback, root-cause investigations, stronger analysis and dissemination of outbreak data, and operational improvements.
  • Deputy Commissioner Frank Yiannas and other FDA experts will be featured during the webinar and will be available to answer questions regarding the Improvement Plan. Stakeholders are invited to participate in the webinar and provide their insights as well.
  • The webinar will take place on April 13, 2022 at 2 p.m. EST. Registration is required to attend the webinar. Questions or comments may be submitted in advance of the meeting on the registration form or may be submitted during the webinar via email to SmarterFoodSafety@fda.hhs.gov.  The webinar will also be recorded and posted to FDA’s website.
  • Today, the FDA published a notice of a stay of the effectiveness of certain provisions of the June 11, 2021 yogurt standard of identity final rule. As our readers know, the final rule amended the definition and standard of identity for yogurt and revoked the definitions and standards for lowfat yogurt and nonfat yogurt.
  • Pursuant to section 701(e) of the Federal Food, Drug, and Cosmetic Act, the 2021 final rule notified persons who would be adversely affected by the rule and allowed such persons to file an objection and request a hearing. The objection must specify which provisions of the 2021 final rule are objectionable, state the grounds therefor, and request a public hearing upon such objection. Section 701(e)(2) provides that, until final action is taken by the Secretary, the filing of objections stays the effectiveness of the provisions to which the objections are made.
  • The International Dairy Foods Association (IDFA) and Chobani filed objections to the final rule. For example, among other objections, IDFA objected to the requirement that yogurt, before the addition of flavoring ingredients, has either a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or lower. This provision of the final rule is stayed and no minimum titratable acidity requirement or maximum pH requirement is in effect. Similarly, Chobani objected to the exclusion of ultrafiltered milk from the basic dairy ingredients in 21 CFR 113.200(b). Thus, the provision is stayed insofar as it prohibits the use of ultrafiltered milk. A full list of objections is included in the notice.
  •  On March 14, 2022, a class-action lawsuit was filed against Publix Super Markets, Inc. for allegedly improperly and deceptively labeling their “strawberry watermelon water enhancers” (the “product”) as flavored with “natural flavor with other natural flavors.” In addition to the direct representation of the flavor in the flavor statement, the front panel of the product also included pictures of strawberries and watermelon slices, as well as red coloring in the surrounding packaging and text.
  • Malic acid was listed in the product as the second-most predominant ingredient (after water). Malic acid comes in two stereoisomeric forms (i.e., the atoms differ in their spatial arrangement, but have the same chemical formula and are connected in the same order): L-malic acid, which naturally occurs in fruits, and D-malic acid, which is manufactured from petroleum products and is commonly found in an equal mixture with L-malic acid (i.e., DL-malic acid). Plaintiff alleged that testing of the product revealed that it contained DL-malic acid, which is an artificial ingredient, and that it impacted the flavor profile of the product. Therefore, Plaintiff alleged that the product should have been labeled as “artificially flavored” or “artificial” to avoid misleading consumers and to be in accord with 21 CFR 101.22(i)(2).
  • There have been many similar lawsuits challenging the use of natural flavoring claims in products containing malic acid. See Examples. Defendants will often argue that DL-malic acid does not contribute to the flavor profile of the food and so it need not be considered in the flavoring statement. They often make a distinction between malic acid used as a “flavor enhancer” as opposed to a “flavoring agent” as defined in 21 CFR 170.3. However, while such arguments may have merit, the determination of whether a particular substance contributes to the flavor profile of a food is a fact-intensive one which cannot be resolved as the pleadings stage of litigation. Thus, these lawsuits are rarely dismissed.
  • Plaintiff also alleged that DL-malic acid was improperly declared as “malic acid” instead of “DL-malic acid” in the ingredient list. However, at least one court has held that the requirement to list an ingredient by its common or usual name does not require that malic acid be listed by its specific isomer and that simply “malic acid” is appropriate.

 9th Circ. Blocks New Prop 65 Acrylamide Warning Label Suits (subscription to Law360 required)

  • As previously covered on this blog, on March 29, 2021, the U.S. District Court for the Eastern District of California granted the California Chamber of Commerce’s (CalChamber) preliminary injunction to temporarily bar the state and any private litigants from enforcing Proposition 65 against businesses that do not warn consumers that acrylamide in food is known to the State of California to cause cancer.  The district court found that CalChamber was likely to succeed on the merits because neither the State nor the Council for Education and Research on Toxics (CERT), which intervened as a defendant, had shown that the Prop 65 cancer warning for acrylamide in food is “purely factual and uncontroversial.”
  • In a unanimous opinion filed March 17, 2022, the U.S. Ninth Circuit Court of Appeals ruled against CERT, the sole applicant challenging the preliminary injunction on appeal, in upholding the injunction that stops new lawsuits from being filed under Prop 65 to obtain cancer warning labels on food and beverages on account of acrylamide.  On the constitutional requirement that compelled speech must be purely factual and noncontroversial, the appellate court cited robust disagreement by reputable scientific sources over whether acrylamide in food causes cancer in humans as a basis for concluding the district court did not abuse its discretion in finding for CalChamber.  In this regard, organizations such as the National Cancer Institute and the American Cancer Society have said that dietary acrylamide is not likely linked to cancer risks while others, including the International Agency for Research on Cancer, the U.S. National Toxicology Program, and the U.S. Environmental Protection Agency have stated that acrylamide is likely a human carcinogen.
  • With an injunction decision in its favor from the Court of Appeals, CalChamber now awaits the district court’s ruling on the merits of its complaint.  The defendant, CERT, was defeated in an earlier Prop 65 case over acrylamide in coffee after California’s Office of Environmental Health Hazard Assessment (OEHHA) finalized a regulation, discussed here, stating that exposure to acrylamide created during the roasting or brewing process does not pose a significant risk of cancer.