• On December 18, 2024, the U.S. Food and Drug Administration (FDA) shared its latest test results for per- and polyfluoroalkyl substances (PFAS) in clams as follow up to its findings in the 2022 PFAS in seafood survey.  The results of FDA’s testing are used to help the agency better understand PFAS in commercially available foods and identify foods or types of foods that would benefit from targeted surveys, to help ensure a safe and nutritious food supply.
  • In the 2022 seafood survey, FDA detected high levels of perfluorooctanoic acid (PFOA) in samples of canned clams from China and determined that the estimated exposure was likely a health concern.  Between October 2022 and September 2024, FDA collected and analyzed 12 samples of processed clams with China as the country of origin.  All 12 samples had detectable levels of at least one type of PFAS, and PFOA was detected in all samples.  Three shipments were refused entry into the US.
  • In 2023, FDA also conducted a survey of domestically acquired clam samples.  All but one of nine samples had PFOA concentrations under the method detection limit and the products remained on the US market.
  • The agency is actively engaging with both imported and domestic clam firms to better understand potential sources of contamination and ways in which PFOA concentrations may be reduced.  FDA also recently issued a request for information to help fill data gaps that remain regarding PFAS in seafood and is conducting two ongoing surveys, focused on molluscan shellfish and other commonly consumed seafood.  FDA will release results of the surveys after completion.
  • Earlier this month, the National Association of Manufacturers (NAM) and more than 100 manufacturing associations sent a letter to President-Elect Trump making the case that increased regulatory compliance obligations have created a challenging business environment in the U.S. and outlining a list of de-regulatory actions that they believe will support industrial growth.
  • The letter outlines regulatory proposals across a wide range of industrial sectors and regulations, including environmental, chemical, labor and employment, and intellectual property regulations, as well as FDA’s food traceability rule applicable to certain higher risk foods (21 CFR part 1, subpart S).
  • In regard to the food traceability rule, the letter requests that the Trump administration “make these requirements more flexible and streamlined,” extend the 2026 compliance deadline by at least 3 years, and collaborate with industry on pilot projects.
  • This follows significant concerns expressed by the food industry over practical difficulties with the rule’s requirements, including concerns expressed at an October 7, 2024, virtual public meeting hosted by the Reagan-Udall Foundation. Industry comments at that meeting highlighted the complexity of the rule and difficulty in implementation, particularly with challenges related to overhauling IT systems, which are currently unsynchronized throughout the supply chain.  
  • On December 16, 2024, FDA released a new inventory of voluntary premarket meetings that the Agency has held with developers of foods from new genome-edited plant varieties. FDA holds voluntary premarket meetings to ensure the safety and lawfulness of foods from genome-edited plant varieties when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics.
  • The inventory of premarket meetings will list all voluntary premarket meetings between FDA and genome-edited plant variety developers. FDA intends to add to the inventory on an ongoing basis as the agency holds more meetings.
  • Voluntary premarket meetings are one process outlined in FDA’s Guidance for Industry on Premarket Engagement for Foods Derived from Plants Produced Using Genome Editing, which we discussed previously on this blog. Voluntary premarket meetings are not intended to represent an FDA evaluation of a developer’s food safety assessment. Voluntary premarket consultations are advised for products that are more likely to raise safety questions. Foods from genome-edited plants must meet the same food safety requirements as other foods.
  • Keller and Heckman will continue to monitor and relay any developments on foods produced from genome-edited plants.
  • On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products.  The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).  
  • MoCRA mandates that cosmetic companies report serious adverse events to FDA within 15 business days, register their facilities and list their products, ensure product safety before marketing, and comply with FDA’s authority to access records and order recalls if products are found to be unsafe or misbranded.
  • The updated guidance outlines the statutory requirements for submitting cosmetic product facility registrations and product listings.  It finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19) and introduces three new FAQs (Q20-22) for public comment.
    • Q20 outlines the responsibilities of a U.S agent, which includes assisting FDA with communications, responding to product inquiries, helping schedule inspections, and receiving documents on behalf of the foreign establishment;
    • Q21 explains that multiple buildings within three miles can share one FEI number if they are part of the same establishment and management, and can be inspected together; and
    • Q22 indicates that a product listing is generally required for all cosmetic products, including free samples or gifts, unless specific exemptions apply.  
  • The comment period is open until January 13, 2024, and comments can be submitted through the docket.  Keller and Heckman can assist in submitting comments and will continue to monitor developments related to MoCRA and cosmetics regulations.
  • 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.