• Today, the U.S. Food and Drug Administration (FDA) issued a letter to retailers and distributors of cookware products to inform them that certain imported cookware products made from aluminum, brass, and aluminum alloys (Hindalium/Hindolium or Indalium/Indolium) demonstrate the potential to leach lead into food and that this cookware should not be distributed or sold in the US market.
  • FDA collaborated with the Public Health Department of Seattle and King County (PHSKC), who has tested imported cookware and associated high blood lead levels in resettled refugee populations.  Because cooking with these products showed the potential to leach lead into food, FDA states there is potential for the use of these products to contribute to elevated levels of lead in the blood.
  • Based on information provided by PHSKC, in March 2022, the FDA added the manufacturer of the cookware, Rashko Baba Co. Ltd., to an FDA import alert in an effort to prevent further sale of these products in the domestic US market.  In the spring of 2023, PHSKC was successful in getting some cookware products removed from online retail sites.
  • Keller and Heckman will continue to monitor FDA testing and regulation of cookware products.
  • A lawsuit filed in the Court of Common Pleas of Philadelphia County yesterday has levied a host of allegations related to the sale of “ultra-processed foods” (UPF) against many of the major food companies.
  • At its core, the 148-page complaint alleges that UPF, which are sold by the named defendants (and other companies), are harmful because of their high degree of processing, including the addition of many food additives. The complaint alleges that these harms cannot be attributed solely to the nutritional profile of the foods. The complaint also alleges that the foods are highly addictive and compares them to highly addictive substances like nicotine, cocaine, and methamphetamine. Moreover, the complaint extensively alleges that these foods were intentionally designed to short circuit natural defenses against overconsumption and to be addictive and that marketing campaigns have focused on children to their detriment.
  • The single named Plaintiff alleges that he was diagnosed with type 2 diabetes and non-alcoholic fatty liver disease at 16, both of which he attributes to consumption of UPF. More broadly, he alleges that the incidence of diseases such as these and obesity has dramatically increased since the 1980s, and attributes this to consumption of UPF. Notably, the complaint alleges that “UPF does not increase the risks of other conditions simply because it causes obesity… [but rather] UPF increase the risks of disease because they are ultra-processed.” 
  • The causes of action put forward include negligence, failure to warn, breach of implied and express warranties, negligent misrepresentation, fraudulent misrepresentation, fraudulent concealment, violation of consumer protection laws, unjust enrichment, conspiracy, and concerted action.
  • As we blogged about previously, FDA is conducting a joint workshop with NIH on December 17-18 with UPF among the primary topics to be discussed. In contrast to the allegations of the complaint, FDA’s Jim Jones has maintained that while UPF consumption is correlated with negative health outcomes, causality has not been demonstrated. The unsettled state of the science and the difficulty in defining UPF are likely to pose significant challenges for the Plaintiff.
  • On December 3, 2024, USDA and FDA issued a joint Request for Information (RFI) about the use of food date labeling, including terms such as “Sell By,” “Use By,” and “Best By.” Information collected from the RFI is intended to inform policy decisions, guidance, or consumer education campaigns on food date labels to “help reduce the premature discard of wholesome and safe food.”
  • USDA and FDA jointly regulate the U.S. food supply. Under current regulations, any date labeling on food products may not be false or misleading. USDA’s Food Safety and Inspection Service (FSIS) requires that if date labeling is voluntarily used, a calendar date must express a month and day; for shelf-stable or frozen products regulated by FSIS, a year must also be displayed. Date labeling is also voluntary under FDA’s regulations, except that it is required on infant formula, which is outside the scope of the RFI.
  • The RFI is being issued in response to the National Strategy for Reducing Food Loss and Waste and Recycling Organics, which was released in June 2024 to help the U.S. meet a goal of reducing food loss and waste by 50% by 2030, reduce environmental impacts of food waste, and lower costs for American families. According to comments in response to the Strategy, the use of nonstandardized date labeling causes consumer confusion and leads to premature disposal of wholesome and safe food.
  • The RFI is soliciting comments in three categories: (1) industry practices and preferences for date labeling; (2) research on consumer perception of date labeling; and (3) food loss and waste research. Comments are due by February 3, 2025, and should be submitted at regulations.gov to docket number FSIS-2024-0021.
  • Keller and Heckman would be happy to prepare comments and we will continue to monitor and relay updates on USDA and FDA’s date labeling efforts.
  • On November 21, 2024, FDA’s Front-of-Package Nutrition Labeling rule was advanced to the White House Office of Management and Budget (OMB) for review.  FDA is proposing a standardized labeling system that would provide nutrition information on the front of the package rather than on the back or side.  After OMB’s Office of Information and Regulatory Affairs (OIRA) reviews the proposed rule, it will be published in the Federal Register where it will become available for public comment.
  • On December 5, 2024, The Health, Education, Labor & Pensions Committee (HELP) held a hearing to address FDA’s efforts in combatting diabetes and obesity in America and noted the importance of labeling in achieving positive health outcomes related to diet and nutrition. 
  • The committee noted that over 35 million Americans have type II diabetes which contributed to severe health issues such as stroke, amputations, blindness, and kidney failure and which costs over $400 billion in U.S. healthcare expenditures each year.  Further, Senator Sanders noted that childhood obesity has tripped since the 1970’s and argued that this rise relates in part to the consumption of ultra-processed foods..
  • The committee also made note that other countries such as Chile, Peru, Isreal, Brazil, Columbia, and several others have enacted FOP nutrition labeling laws that are intended to influence formulation and consumption patterns.   This committee hearing follows efforts by Senators Sanders and Booker who introduced legislation earlier this year seeking to ban advertisements of unhealthy food towards children.
  • Dr. Califf responded to frustrations with the delayed timeframe in implementing the FOP nutrition labeling rule as a result of political blockages and budget restraints.  The hearing underscored the complexity of ensuring food safety and nutrition in the U.S., highlighting the need for clear labeling, adequate funding, and improved collaboration between federal and state agencies.
  • Keller and Heckman will continue to monitor updates related to food labeling and nutrition.
  • 23 members of Congress have sent a letter to FDA requesting that the agency ban the use of Red 3 in foods before the end of this Congress (by January 3, 2025). 
  • The letter cites carcinogenicity concerns with Red 3 as well as concerns that it can cause neurobehavioral issues in some children. Red 3 is known to cause cancer in rats, although the same mechanism of action does not occur in humans and the relevance of these studies in humans is contested. Nevertheless, the carcinogenicity concern caused FDA to deny petitions for the permanent listing of Red 3 for use in cosmetics and topical drugs and terminate the provisional listing of Red 3 for those uses and the provisional listing of the lakes of Red 3 for use in food, drug, and cosmetic products in 1990. The neurobehavioral effects of Red 3 and other synthetic dyes are also contested and the California Department of Public Health recently concluded that there is “no scientific consensuses” regarding their neurobehavioral impact.
  • The use of Red 3 in food is banned in California (effective January 1, 2027) and FDA is currently considering a petition to revoke its authorizations in foods (including dietary supplements) and in ingested drugs. See FDA Information Page on Red 3.
  • On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which requires infant formula manufacturers to notify FDA of a permanent discontinuance or interruption in the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the U.S. The draft guidance is titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of Infant Formula.”
  • Section 424 of the FD&C Act requires manufacturers to notify the FDA “as soon as practicable, but not later than 5 business days” after a permanent discontinuance or interruption of infant formula manufacture that is likely to cause a significant supply disruption. The draft guidance discusses notification requirements for infant formula manufacturers, including:
    • What constitutes a permanent discontinuance or interruption;
    • The definition of a “meaningful disruption;”
    • What information should be included in a notification;
    • How to notify FDA; and
    • Consequences of a failure to notify FDA.
  • The guidance is intended as one step to “improve the resiliency of the infant formula supply and to ensure that consumers have the utmost confidence that infant formula available in the U.S. is safe and nutritious.”
  • FDA is accepting comments on the guidance and will consider any comments submitted before February 3, 2025, in its development of a final guidance document. Comments can be submitted through regulations.gov to docket number FDA-2024-D-1334.
  • FDA Commissioner Robert M. Califf, along with Deputy Commissioner for Human Foods Jim Jones and Senior Clinical Advisor for Chronic Disease Haider J. Warraich, published an article recently highlighting the critical need for better research and action on ultra-processed foods (UPF).   
  • Carlos Augusto Monteiro and his team developed the NOVA classification system in 2009 which categorizes all foods based on the industrial processes they undergo into four groups.  Group 1 consists of unprocessed or minimally processed foods, while Group 4 consists of “Ultra-Processed Foods.”  Monteiro defines ultra-processed foods as, “formulations of ingredients, mostly of exclusive industrial use, typically created by a series of industrial techniques and processes.”
  • However, there are a range of definitions being used for “Ultra-Processed Foods”, and as noted in the article, “[n]utritious foods such as whole grain bread may be considered ultra-processed, but they are not necessarily associated with the same negative health outcomes and indeed have shown to be beneficial.”
  • This nuance is often overlooked in broad recommendations to avoid all ultra-processed foods, driven in part by a lack of research and consistent, clear definitions.
  • The article notes that research shows an association between ultra-processed foods and diet-related conditions, however, causality still has not been determined.
  • FDA is working to promote healthier diets through collaboration with the food industry, researchers, and public health advocates.  As we previously blogged, FDA and NIH are holding a joint nutrition regulatory science workshop in December, where ultra-processed foods will be discussed.  The article also notes that while FDA is waiting for further research on ultra-processed foods, the agency is actively addressing other prevalent nutrition issues related to UPF, such as added sugars, salt, and saturated fat.  For example, FDA issued its draft guidance on Phase II Voluntary Sodium Reduction Goals and has proposed a rule to update the definition of “healthy” claims on front of package labeling.  Addressing diet-related diseases is at the top of the agency’s priority list.
  • Dr. Califf, Mr. Jones, and Dr. Warraich also call on researchers, public health and health care groups, advocates, industry, and the public to put tackling diet-related disease at the top of their priority list. “This includes pushing for high-quality nutrition research related to ultra-processed foods, as well as supporting and strengthening ongoing efforts focused on increasing consumption of nutritious foods that are limited in sodium, added sugars and saturated fat.”
  • Keller and Heckman will continue to monitor and report on developments related to Ultra Processed Foods and Nutrition.
  • As we blogged about earlier in the month, a district court judge rejected Upside Foods’s request for a preliminary injunction blocking enforcement of Florida’s ban on cultivated meat. As we noted, the decision was not a final decision on the merits and since the decision Upside has filed an amended complaint and, most recently, Florida has filed a motion to dismiss the amended complaint.
  • The motion to dismiss covers much of the same ground that was briefed during the motion for a preliminary injunction, including the question of whether Florida’s ban is preempted by the Poultry Products Inspection Act (unsurprisingly, Florida has maintained its position that it is not).
  • The motion to dismiss also responds to Upside’s argument that the law violates the dormant commerce clause. Under dormant commerce clause precedent a facially neutral law effectuating a legitimate local interest is not invalid unless it imposes a substantial burden on interstate commerce which clearly outweighs the local benefits. Florida argues that Upside has alleged only speculative harm to potential sales in Florida and has not alleged any burden on interstate commerce.
  • We will continue to monitor and report on updates to this case (Upside Foods, Inc. v. Simpson, C.A. No. 4:24-cv-316). 
  • The 9th Circuit Court of Appeals affirmed the dismissal (Law360 subscription required) of a class action alleging that Del Monte Foods, Inc., falsely advertised its “Fruit Naturals” fruit cups as “natural” despite containing synthetic preservatives. The original lawsuit was filed in early 2023 and dismissed in October of that year.  
  • The fruit cups, which are labeled as “Fruit Naturals,” contain ingredients like potassium sorbate and methylcellulose gum. According to the plaintiff, Del Monte did not disclose that these ingredients are synthetic, and consumers are not “expected or required to ‘scour’ a product’s listed ingredients” to determine whether products are, in fact, natural. However, the district court found that, because the ingredients are specifically listed on the back label, the label was not “unambiguously deceptive” because the “front label, as clarified by the back label, [would not] mislead a reasonable consumer into thinking that the products don’t contain synthetic ingredients.”
  • In affirming the district court ruling, a 9th Circuit panel found that a survey cited by the plaintiff to support the deceptive nature of the label was uninformative because it asked respondents about the adjective “natural,” rather than the noun “naturals.” Here, the word is used as a noun in the name of the product. Further, the label depicts the picture and name of the fruit in the cups followed by the phrase “in extra light syrup.” This conveys that the fruit itself is natural, but the syrup may not be.
  • According to the panel, the labels are ambiguous, meaning that “’reasonable consumers would necessarily require more information before they could reasonably conclude’ that the front label makes a specific factual representation.” A reasonable consumer would look to the back label, which, here, “accurately and clearly discloses several synthetic ingredients,” thus resolving the ambiguity.
  • The U.S. Food and Drug Administration (FDA) is extending the comment period for its proposed systematic process for post-market assessment of chemicals in foods.  FDA will give stakeholders until January 21, 2025 to submit comments, which is an additional 31 business days from the previous December 6, 2024 deadline.
  • As we previously reported, FDA’s proposed approach includes three stages: food chemical signal monitoring, a quality and impact assessment, and a focused and/or comprehensive assessment.  FDA’s proposal seeks to proactively initiate post-market assessments of GRAS ingredients, food additives, color additives, food contact substances, and contaminants under its new Human Foods Program.  FDA’s updated approach comes as multiple states propose legislation targeting additives and ingredients of public concern, such as “generally recognized as safe” (GRAS) substances, synthetic food dyes, and other chemicals.
  • FDA specifically requests input on public engagement, review frequency and mechanisms, the potential integration of an advisory committee review, the appropriateness of the Fit-for-Purpose Decision Tree, the appropriateness of the Prioritization of Risks scheme, and the appropriateness of the two-pronged Focused and Comprehensive approaches.
  • Keller and Heckman would be happy to prepare comments and we will continue to monitor and relay updates on FDA’s post-market review process.