• California’s Department of Food Agriculture (CDFA) recently published its finalized animal confinement regulations, codified at 3 C.C.R. § 1320-1326, as well as the accompanying Final Statement of Reasons. The finalized regulations are largely identical to the proposed second modified text, published in June.
  • By way of background, California’s Proposition 12 establishes standards for the confinement of certain farm animals (breeding pigs, calves raised for veal, and egg-laying hens) and bans the sale of eggs, veal, and pork products that do not comply with those standards (see our previous blogs here and here).
  • As our readers know, enforcement of California’s Proposition 12 was delayed for some stakeholders in January 2022, after a judge for the Superior Court in Sacramento County ordered that grocers, restaurants, and retailers would not be subject to enforcement of the new restrictions on whole pork meat sales until six months after the state enacted its final regulations. An appeal was filed by the State of California and is currently pending.
  • In addition, Proposition 12 is currently being litigated in the U.S. Supreme Court, after several agricultural groups petitioned the court to review a Ninth Circuit Court decision to uphold Proposition 12, alleging that the law’s national impact on pork producers is an undue burden on interstate commerce. The case remains ongoing. Keller and Heckman will continue to monitor this matter and report on any updates.
  •  On September 4, 2022, a class-action lawsuit was filed against Conagra for allegedly deceptively advertising its “Chile Lemon Flavor Sunflower Seeds” by failing disclose that the product was artificially flavored with DL-malic acid.
  • The complaint alleged that although the product contained aged chili peppers and lime juice solids (sources of natural flavor), malic acid is a “core component of chili pepper and lime,” and therefore also imparts flavor on the product. And, since the (DL) malic acid in question was synthetically produced (L-malic acid is the only form present in natural sources), Plaintiff argued that the product should disclose that an artificial flavor is present (e.g., Artificially Flavored Sunflower Seeds). Plaintiff also argued that, even if the malic acid acted as a flavor enhancer (which reinforces a flavor but does not impart its own flavor), the flavor statement should be “Chile Lemon Flavored” to indicate that the product does not contain “an amount of its characterizing ingredients sufficient to independently characterize it.”
  • We have previously reported on similar lawsuits, many of which have been filed by Spencer Sheehan, Plaintiff’s attorney in this case. We will continue to monitor and report on these and other similar flavor cases.
  • On August 30, U.S. District Judge Gary Feinerman dismissed a consumer class action lawsuit against Dreyer’s Grand Ice Cream Inc., the makers of Haagen-Dazs vanilla milk chocolate almond ice cream bars (subscription to Law360 required). The judge held that no reasonable consumer would understand the representations on the product label to mean that the ice cream coating contained only chocolate. Further, judge Feinerman found that plaintiff Lawrence Rice has no standing to pursue injunctive relief because he is aware that the product contains vegetable oil and therefore faces no risk of future harm or deception from the principal display panel’s failure to mention the ingredient.
  • As background, we previously reported on this case in July and November of 2021. Rice alleged that Dreyer’s failed to inform consumers that it used coconut oil as a substitute for some cacao beans to make the chocolate in the vanilla milk chocolate almond ice cream bars coating. He argued that it was false and misleading to characterize the coating as “milk chocolate” and alleged that the coatings should have been described as “milk chocolate with vegetable fat coating” because of the coconut oil that was used.
  • Rice’s claims were dismissed without prejudice for want of subject matter jurisdiction insofar as they seek injunctive relief and on the merits insofar as they seek monetary relief. Judge Feinerman gave the plaintiff until September 20 to file an amended complaint. If Rice does not replead, the dismissal will convert to a dismissal with prejudice and a judgment will be entered. Keller and Heckman will continue to monitor this case and report on any developments.
  • On August 22, 2022, FDA announced that it had moved into its third phase of the Artificial Intelligence (AI) Imported Seafood Pilot Program. This program uses AI and machine learning to support import screening efforts.
  • The AI tools can help the Agency identify supply chain patterns to predict the likelihood that an import shipment is potentially harmful and not compliant with FDA regulations. According to FDA, the pilot focuses on imported seafood because over 90% of the U.S. seafood supply comes from other countries. Further, FDA has historically encountered food safety concerns for imported seafood products along various points of the supply chain.
  • The first phase of the pilot program was launched in 2019 and consisted of an analytical proof of concept. The second phase was designed to integrate AI into existing import data systems to inform sampling decisions. This third phase of the program is intended to focus on the Agency’s ability to identify imported seafood products that may be contaminated by illness-causing pathogens, decomposition, have unapproved antibiotic residues, or contain other hazards. The third phase is expected to be completed in late fiscal year 2023.
  • The FDA’s Center for Veterinary Medicine (CVM) announced that it will host a virtual listening session on October 18 regarding the Agency’s regulation of animal foods with certain types of claims, such as claims about environmental benefits (e.g., reduced greenhouse emissions), production (e.g., growth promotion, feed efficiency), and effects on the animal microbiome. The FDA is specifically interested in receiving comments on its existing policy, PPM 1240.3605 “Regulating Animal Foods with Drug Claims,” to address the following questions:
    1. How could the FDA modernize or improve this policy?
    2. What challenges are presented by this policy?
    3. What additional types of claims or ingredients should the FDA consider in its review of this policy?
  • As background, PPM 1240.3605 states that the FDA will usually regulate nutritional ingredients or products with claims describing an intended effect on the structure or function of an animal’s body as animal food, whereas nutritional ingredients or products with production claims and non-nutritive ingredients or products with structure/function claims are usually regulated as animal drugs. The FDA wants to review this policy to evaluate how it could be updated, and changes to the FDA’s existing policy could potentially allow these products to be regulated as animal food while maintaining safety and consistency with current laws and regulations.
  • The listening session will be an opportunity for stakeholders to share feedback on how the FDA regulates animal foods with certain claims. Stakeholders interested in attending the session must register no later than 11:59pm ET on October 11. On the registration form, stakeholders may request to present during the listening session, but all presentation requests must be made by September 20. The FDA is also accepting electronic or written comments until November 17 on www.regulations.gov (FDA Docket # FDA-2022-N-2015).
  • On August 17, effective immediately, Health Canada announced the addition of the following two maximum levels (MLs) for inorganic arsenic to the List of Contaminants and Other Adulterating Substances in Food, which is incorporated by reference into the Food and Drug Regulations:
    • A ML of 0.1 ppm (100 ppb) for inorganic arsenic in rice-based foods intended for consumption by infants and young children. See Press Release.
    • A ML of 0.01 ppm (10 ppb) for inorganic arsenic in fruit juices and fruit nectars, except grape juice and grape nectar for which the ML is 0.03 pm (30 ppb). See Press Release.
  • As detailed in the press releases, Both MLs were initially proposed on April 9, 2021, and were open to comment for 75 days. No new scientific information was received in response to either proposal.
  • The 100 ppb ML in infant/young children rice-based foods is the same as the action level that FDA issued in its 2020 final guidance. Further, the ML of 10 ppb in most juice products is consistent with the action level FDA proposed in its 2013 draft guidance, which has not yet been finalized. FDA has not proposed action levels for arsenic in other types of juice. Although the MLs have been finalized, Health Canada will continue to review new scientific information relating to either proposal. Any such information should be sent per the instructions included at the bottom of the respective press releases.
  • On August 24, 2022, FDA announced that it had published the 2022 edition of its Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards). The standards are intended to provide information on the key elements of an effective retail food regulatory program for local, tribal, state, and territorial regulatory agencies.
  • The Retail Program Standards provide recommendations for creating and managing retail food regulatory programs. Recommendations include how to provide effective inspections, reinforce proper sanitation, implement foodborne illness prevention strategies, and identify areas for improvement.
  • This year’s edition of the Retail Program Standards considers comments that were made during the Conference for Food Protection 2020 Biennial meeting, including reformatted curriculum forms and alternative sampling methods. A list of jurisdictions currently enrolled in the Retail Program Standards is available here.
  • [UPDATED August 26, 2022: In a highly unusual twist, the order dismissing this case was reversed on August 24, 2022 (subscription to Law360 required).  The lawsuit and the motion to dismiss are now still pending.]
  • On August 23, an Illinois federal judge dismissed a putative class action lawsuit against Walmart over its fudge mint cookies (subscription to Law360 required). The plaintiff Eugene DeMaso claimed that the product label was misleading because the cookies did not contain fudge made from dairy fats or actual mint leaves. However, U.S. District Judge Charles R. Norgle held that the label was not misleading because no consumer expects the fudge to be made with dairy fats, or that the mint refers to anything other than a flavor.
  • DeMaso had alleged that fudge must contain dairy ingredients as its source of fat, but that the Walmart cookies contain only vegetable oils. DeMaso’s allegation was largely based on his own definition of fudge. However, the definition of “fudge” was not at issue but what a reasonable consumer expects fudge to mean. Judge Norgle held that DeMaso did not plausibly allege that reasonable consumers would expect fudge to contain fat from dairy ingredients rather than vegetable fats.
  • DeMaso also argued that the declaration of the word “mint,” pictures of mint leaves, and green packaging led consumers to believe the cookies contained mint as an ingredient. However, Walmart suggested that absent words such as “made with mint,” a reasonable consumer would only conclude that the cookies tasted like mint. Agreeing with Walmart, the court found that mint is most commonly associated with flavor, and that reasonable consumers would read the mint representation as a flavor and it would be unreasonable and fanciful to conclude otherwise.
  • DeMaso sought to pursue his claims on behalf of a class of Illinois consumers, as well as consumers in 25 other states. The case was dismissed with prejudice.
  • Healthy Babies Bright Futures (HBBF), which is an alliance of non-profit organizations, philanthropies, and scientists that designs and implements projects to reduce babies’ exposure to toxic chemicals, has released a study which found no evidence that homemade baby foods or family brand foods (defined as pre-packaged foods appropriate for the family and not just babies) are any safer with respect to heavy metals (lead, cadmium, mercury, and inorganic arsenic) than commercial store-bought brands. The study is based on HBBS testing of 288 foods, as well as analysis of food testing data from published studies.
  • While some variation was found with respect to the prevalence of particular heavy metals (commercial baby foods were less likely to have arsenic and mercury but more likely to have lead and cadmium), no difference was observed when analyzing for the presence of any detectable heavy metal:  94% of the tested commercial baby foods, and 94% of the tested homemade baby foods and family brand foods contained detectable heavy metals. Food type, and not the maker of the food, was found to be the most important variable. The report categorizes foods into 4 categories based on expected heavy metal levels: (1) “Serve” (lowest heavy metal levels, eat freely), (2) “Limit or Rotate” (moderate heavy metal levels), (3) “Serve rarely” (high heavy metal levels), and (4) “Avoid” (highest heavy metals). Of note, the “Avoid” category consisted entirely of rice products (e.g., rice cakes), which often contain high arsenic levels. Further, the reports recommends that certain otherwise nutritious foods (e.g., carrots and sweet potatoes) be fed less than daily and that different varieties be chosen to avoid potentially high heavy metal levels in these foods.
  • Overall, the report advocates a two-prong strategy. Parents should choose foods that are lower in heavy metals (“The Kitchen Solution”) while FDA should establish protective limits for heavy metals in all foods consumed by babies and young children (“The Country’s Solution”). To date, FDA has only set heavy metal limits in infant rice and juice, although its Closer to Zero plan promises to introduce additional heavy metal limits in baby foods in the coming years. Many, including HBBF, have criticized FDA’s efforts as one which is too slow and which places the burden of risk management on parents.

 Feta Maker’s ‘Greek’ Claim Crumbles On Inspection, Suit Says (Law360 Subscription Required)

  • A plaintiff’s success in one of the proliferating class action lawsuits over geographic origin hinges on whether the front label of the product at issue would lead a reasonable consumer to believe the product is made in a place other than where it is.  Explicit use of a country name in such case may doom the defendant.  In a lawsuit settled by Godiva Chocolatier, Inc. (“Godiva”), discussed here, for example, “Belgium 1926” was found to have created a plausible inference that the chocolates are of European origin.  In contrast, however, for a yoghurt made in New York with a front label containing the “Icelandic Provisions” brand name and the phrase “Traditional Icelandic Skyr” against a snow-covered backdrop, a court found references to “Icelandic” to be akin to “in the style of Iceland,” which signals that the product is not made in the place that is named.
  • On August 14, 2022, plaintiffs filed a putative class action complaint against Lactalis America Group Inc. in the United States District Court Western District of New York that alleges the labeling of Président brand feta cheese gives the false impression that the product is made in Greece, or at the very least in another European country.  Facts that allegedly create the inference of Greek or European origin are:
    • “Feta” rendered in ancient-Greek font;
    • A gold olive branch framing the brand name, Président; and
    • The slogan, “Europe’s Leading Cheese Expert” over the top of the brand name.

The complaint also notes that the statements “created by a family of artisan cheesemakers with over 80 years of French heritage” and “Dist. By Lactalis American Group, Inc.” appear in small print on the bottom of the package, and contend that the United States origin of the product can be discovered by visiting third-party websites noting the product is “Freshly Crafted in the USA” and “Made in the European tradition.”

  • Since the complaint only presents one side of the dispute, it is difficult to predict how this case will turn out.  Keller and Heckman will continue to monitor and report on this litigation.