• In May of 2018, the National Chicken Council (NCC) requested that the U.S. Department of Agriculture (USDA) coordinate with the U.S. Food and Drug Administration (FDA) to exercise enforcement discretion to allow surplus broiler eggs to be processed into egg products under Food and Safety Inspection Service (FSIS) jurisdiction.  Specifically, NCC requested FSIS and FDA collaborate to exempt surplus broiler hatching eggs intended for breaking from refrigeration requirements, and instead rely on FSIS’ egg products regulations to control for Salmonella.
  • NCC explained that: “Historically, the broiler industry sent surplus hatching eggs for processing at egg-breaking plants (but not into the table egg market), where they were pasteurized under FSIS jurisdiction and oversight.  As you may be aware, in 2009, the FDA published a final rule requiring that shell eggs, including surplus broiler eggs sent for breaking, be refrigerated shortly after the time of lay.  The problem is that the timing of refrigeration under the FDA rule is incompatible with the process broiler eggs must follow.  This is because refrigerating broiler eggs prevents them from hatching – that is, they cannot be warm enough for possible hatching yet cool enough for compliance with the FDA rule.”
  • FDA denied the request in the petition on June 12, 2023 because the Agency determined the requested action would not maintain the same level of public health protection as its own egg safety rule.
  • On November 3, 2023, FSIS also denied the petition, stating that its authority to regulate egg products comes from the Egg Products Inspection Act (EPIA).  The EPIA directs the Secretary of Agriculture to maintain an inspection program to assure consumers that egg products are safe, not adulterated, and properly labeled.  FDA has authority to regulate shell eggs under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even though USDA generally has authority over meat, poultry, and egg products.  Because of this, FSIS must defer to FDA in requests regarding the use of shell eggs.
  • In a report published November 3, 2023, the European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) for a scientific opinion on the microbiological hazards associated with water use in the post-harvest handling and processing of fresh and frozen fruits, vegetables, and herbs.  Understanding water quality is crucial to limiting hazards during processing.  Such microbiological hazards include Listeria monocytogenes, Salmonella, E. coli, and viruses such as norovirus.
  • Large volumes of water are used for rinsing, fluming, chilling, cooling, general cleaning, sanitation, and disinfection.  Most post-harvest processors use the same water during many hours of operation to conserve water and energy, as access to potable water can be limited and expensive.  According to the EFSA report, current practices utilize potable water to fill the equipment and tanks during the first hour in the morning, and it is not replaced for several hours or sometimes days during processing.
  • The report stated that water control based solely on a basic prerequisite program (PRP) is no longer feasible, and an HACCP-based approach is required for water management.  Good manufacturing practices (GMP) and good hygienic practices (GHP) related to a water management plan and implementation of a water management system are critical.
  • Based on replies from the industry survey, three good practices are not yet well implemented: replacing infrastructure to avoid biofilm formation, seeking biofilm formation in the water management system, and water cooling.  Responses showed that monitoring the quality of process water was absent or weak.  Emerging agricultural practices like hydroponics, vertical farming, and urban agriculture may introduce pathogens into the food chain, although the extent of this is expected to be lower than conventional farming, according to the report.
  • The BIOHAZ Panel recommended that more information should be included in outbreak investigation reports and clear guidelines should be available to clarify how water disinfection treatments can be used in the post-harvest handling and processing of fruit, vegetables, and herbs.
  • In a November 3 brief, a proposed class of buyers urged the Eleventh Circuit to revive its claims that MillerCoors deceptively marketed Coors Light as being exclusively brewed in the Colorado Rockies with “pure Rocky Mountain spring water,” even though it is now brewed across the country (subscription to Law360 required). Lead plaintiff Joaquin Lorenzo argued that the case was wrongly dismissed and that its claims are not akin to other implausible or frivolous lawsuits, like the case that alleged the advertising for Cap’n Crunch Berries cereal deceived consumers into believing that the cereal contained actual berries. Sugawara v. Pepsico, Inc., No. 2:08-cv-01335-MCE-JFM, 2009 WL 1439115 (E.D. Cal. May, 21 2009); Werberl ex rel. v. Pepsico, Inc., No. C 09-04456 SBA, 2010 WL 2673860 (N.D. Cal. Jul. 2, 2010).
  • Lorenzo argued that this suit is comparable to others that have survived the pleading stage, like Marty v. Anheuser-Busch, which alleged that the labeling of Beck’s beer misleadingly implied it was exclusively brewed in Germany. Lorenzo claimed that “product origin advertising is a lifeblood of the consumer marketplace,” and also cited the California Supreme Court’s ruling in Kwikset Corp. v. Superior Court, which established that consumers who claim they were deceived by a product’s label into spending money they would not have otherwise spent have standing to sue.
  • Lorenzo’s claims were twice dismissed at the pleading stage. In his appeal, Lorenzo has asked the court to reverse the district court’s order dismissing the case because the court was wrong to find that no reasonable consumer would be confused.
  • Keller and Heckman will continue to monitor and report on this case and other litigation affecting the food industry.
  • Yesterday, FDA announced that it was adding new features to the electronic module (COSM) through which users can send fully electronic submissions to FDA’s Office of Food Additive Safety (OFAS), a part of the Center for Food Safety and Applied Nutrition (CFSAN). OFAS has responsibility for review of food ingredients and packaging and administers related programs including the generally recognized as safe (GRAS) notification program and the food contact notification (FCN) program.
  • With the updates users can now (1) submit documents directly to OFAS through the COSM module, (2) send secure communication to OFAS, and (3) access a dashboard displaying the current status of submissions.
  • COSM is available for the following OFAS submissions: (1) Biotechnology Notification File (BNF), (2) Color Additive Petition (CAP), (3) Food Additive Petition (FAP), (4) FCN, (5) GRAS Notice (GRN), (6) New Protein Consultation (NPC), and (7) Pre-Notification Consultation (PNC) for a food contact substance.
  • Additional information about the COSM module and how to use it can be found at the COSM webpage.

  • Companies making “friendly” claims have found few friends in the past couple of years, and have just lost another one: the Second Circuit reversed a lower court’s dismissal of a class action directed at sunscreens advertised as “Reef Friendly.” Labels disclosed that the sunscreens were “Hawaii Compliant” by containing “No Oxybenzone or Octinoxate,” two chemicals banned by Hawaii. The plaintiff alleged, and the Second Circuit agreed, that despite the disclosure and ingredient lists “Reef Friendly” claim could still convey absence of any chemicals that might harm coral reefs. The Second Circuit observed that consumers should not have to possess encyclopedic knowledge of which chemicals may or may not be harmful to coral reefs.
  • The current Federal Trade Commission Green Guides provide that “friendly” claims can avoid being deceptive with appropriate qualifications, e.g., “eco-friendly: made with recycled materials.” 16 CFR § 260.4 Ex. 1. At the same time, the Green Guides caution that these sorts of qualified claims require an advertiser to substantiate that the product is “more environmentally beneficial overall” if that is implied by the specific environmental benefit advertised. 16 CFR § 260.4(c).
  • The National Advertising Division has consistently held that “friendly” claims like “eco-friendly” or “environmentally friendly” convey broad environmental benefit claims—for products as diverse as a chewing gum and a drain clog remover, regardless of qualifications.
  • As is often the case in the advertising space, federal court decisions have been less consistent in determining how far the “friend zone” extends. In a case where the company advertised its degreaser as “Earth friendly” given the absence of certain specified chemicals, the court refused to dismiss, and litigation continues. On the other hand, a court granted a motion to dismiss where “Earth friendly” claims were accompanied by carbon footprint calculations. A third court rejected a plaintiff’s attempt to interpret “sustainable” claims to mean “environmentally friendly,” noting that it was the plaintiff, rather than the defendant’s advertising, that introduced all the “friendliness” into the litigation. Many other examples could be added, but advertisers would be well advised to keep their friends close and their advertising claims closer.
  • Keller and Heckman will continue to follow and be available to assist with advertising compliance and class action defense.
  • On October 27, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed amendments to the warning requirements under Proposition 65 (otherwise known as Prop 65 or the Safe Drinking Water and Toxic Enforcement Act of 1986), which, if enacted, would:
    • Require short-form warnings to:
      • Name at least one Prop 65-listed chemical per endpoint
      • Be in one of two specified formats (available here)
    • Require warnings on products purchased over the internet or from catalogs to:
      • Be included on or with the product when it is delivered to the consumer
      • Be prominently displayed on the product’s display page
    • Allow the use of short-form warnings on food products (which is unclear under the current regulations)
    • Allow all warnings to use the words “CA WARNING:” or “CALIFORNIA WARNING:” in place of the word “WARNING:” alone (note: using only the word “WARNING:” would still comply with the proposed requirements).
  • If enacted, consumer products manufactured and labeled with short-form warnings two or more years before the amendments become effective may be sold regardless of when the consumer purchases the product.
  • OEHHA previously attempted to amend short-form warning requirements, but the rulemaking period expired before the Agency could complete the regulatory process. During this (now expired) rulemaking period, there was much industry opposition, and we anticipate a similar response to this new proposed rule. More information on the previous rulemaking is available here.
  • The full text of the proposed amendments can be found here. Stakeholders may submit comments until December 20, 2023, and there is a public hearing scheduled for December 13, 2023, at 10:00 am (PST). Keller and Heckman will continue to monitor any revisions or updates to the proposed amendments.
  • In a Federal Register notice scheduled to be published November 3, the U.S. Food and Drug Administration (FDA) is proposing to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food (21 CFR § 180.30).  BVO is a vegetable oil that is modified with bromine.  As currently authorized, it is used in small amounts to keep citrus flavoring from floating to the top of some beverages.  BVO was removed from the codified list of Generally Recognized as Safe (GRAS) substances in 1970.
  • The Agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.  Results from these studies show bioaccumulation of bromine and toxic effects on the thyroid – a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones.
  • This proposal comes soon after California passed AB 418 in October, which prohibits BVO and other chemicals in food manufactured, sold, delivered, distributed, held, or offered in the state beginning in 2027.  However, FDA’s proposed revocation of BVO was already listed on the Spring 2023 Regulatory Agenda.
  • Comments regarding the proposed rule must be submitted by January 17, 2024.  Keller and Heckman will continue to monitor the rulemaking process and will relay any developments.
  • On November 1, the FDA published a proposed rule which would amend the prior notice regulations to:
    • Require that prior notice for articles of food and feed arriving by international mail include the name of the mail service and a mail tracking number; and
    • Require prior notice and food facility information be submitted within a certain timeframe after certain notices of refusal or holds have been issued.
  • “Prior notice” refers to the information that must be provided to the FDA in advance of the arrival of food at the U.S. border. The FDA uses prior notice information to determine what products should be inspected upon arrival. As stated in their press release, to effectively carry out the Agency’s responsibilities to detect food articles offered for import that violated FDA requirements, the FDA must be able to identify and inspect food items imported via international mail. Knowing the name of the mail service and tracking number would enable the FDA to better coordinate with the U.S. Postal Service (USPS), U.S. Customs and Border Protection (CBP), and other agencies to track and inspect articles that have been identified as a possible bioterrorism risk.
  • Additionally, requiring a timeframe for post-refusal and post-hold submissions may reduce the amount of time food articles subject to refusal or holds are held at ports which would also reduce associated monetary charges. It may also help limit the need for the FDA to review multiple and duplicative submissions.
  • Stakeholders may submit comments on this proposed rule until January 30, 2024. Keller and Heckman will continue to monitor any revisions to the prior notice regulations.
  • On October 24, FDA released a revised draft guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This draft guidance supersedes the 2014 draft guidance “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.”
  • The draft guidance pertains to approved/cleared medical products, including certain medical devices, human drugs, and animal drugs.
  • The revised guidance provides information relating to firms, i.e., “persons legally responsible for the labeling of medical products,” communicating about scientific information on unapproved uses (SIUU) to healthcare providers. SIUU communications must be truthful and non-misleading, and FDA proposes not to use communications consistent with the guidance alone as evidence of a new intended use requiring premarket authorization.
  • The draft guidance answers questions about appropriate source publications, necessary information, presentation considerations, and other general recommendations for SIUU. Source publications should be scientifically sound and clinically relevant. In addition to being truthful and non-misleading, SIUU should “provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility” of the information. The communications should be clear, objective, distinct from promotional language about approved use, and shared on appropriate media.
  • FDA is also seeking comments on two specific questions related to the guidance regarding considerations unique to communications of SIUU to researchers and any other factors firms should consider when sharing presentations to healthcare providers.
  • FDA is accepting comments until December 26, 2023. Keller and Heckman will continue to monitor developments in this area.
  • According to a recent Consumer Reports study, about one-third of chocolate contains high levels of lead and cadmium. The study tested 48 cacao-containing foods, including cocoa powder, chocolate chips, milk chocolate, and brownie, cake, and hot chocolate mixes, and follows a report of heavy metals in dark chocolate bars that we covered last December.
  • Consumer Reports assessed the lead and cadmium by comparing the amount in a serving of each product with the Maximum Allowable Dose Level (MADL) for each metal established under California’s Proposition 65. Sixteen of the 48 tested products contained levels of at least one metal that exceeded the MADL. Dark chocolate tended to have higher levels of both metals, while some of the other products had high levels of lead. The report suggests this is likely because lead and cadmium are concentrated in cocoa solids, and dark chocolate contains more cocoa solids than milk chocolate.
  • Lead and cadmium are of particular concern for pregnant women and young children, as the metals have been linked to developmental delays and learning and behavior problems. According to the report, eating just an ounce of chocolate with high levels of the metals could lead to harm.
  • The National Confectioners Association (NCA) responded to the report, saying that “chocolate and cocoa are safe to eat and can be enjoyed as treats as they have been for centuries.” According to the NCA, the report disregards lead and cadmium levels set in a Consent Judgment by the Superior Court of the State of California set in 2018 that are still in effect, and chocolate makers “remain dedicated to being transparent and socially responsible.”
  • Keller and Heckman will continue to follow and report on this issue.