• On November 21, 2023, Senators Edward J Markey and Senator Cory Booker introduced the Ensuring Safe and Toxic-Free Foods Act, which would end the legal entitlement to market foods based on a self-determined generally recognized as safe (GRAS) position and would instead require notification to FDA and provision of supporting information. Currently, the GRAS Notification program is completely voluntary.
  • The bill would also:
    • Require that the notice and supporting information be available on FDA’s website and subject to public comment for 90 days.
    • Prohibit carcinogenic substance from receiving GRAS designation (this is already prohibited by the Federal Food, Drug, and Cosmetic Act).
    • Prohibit substances that show evidence of reproductive or developmental toxicity from receiving GRAS designations.
    • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data with regard to GRAS designations.
    • Create a new office within the FDA which would reassess whether existing food additives, food contact substances, color additives, and GRAS substances are safe, and establish a new committee to advise on standards, processes, and methods necessary for reassessment of substances.
  • The full text of the bill does yet appear to be available online, but virtually identical legislation under the same name was introduced in 2022. While the likelihood of passage is uncertain, we will continue to monitor and report on updates to this legislation.
  • On November 22, 2023, FDA released a one-page fact sheet answering questions regarding the redundancy risk management plan requirement in the Food and Drug Omnibus Reform Act of 2022. The fact sheet is intended to provide information to manufacturers of critical foods, which FDA defines as any infant formula or medical food. The redundancy risk management plan requirement was established in response to the 2022 infant formula shortage caused by insanitary conditions at a formula plant that led to a voluntary recall and temporary production stoppage.
  • The fact sheet describes the requirements for a redundancy risk management plan, which every critical food manufacturer is required to develop, maintain, and implement. According to FDA, a risk management plan may identify and evaluate risks to critical foods, as well as mechanisms to mitigate supply chain disruptions. A separate plan is needed for each manufacturing facility, but not for each product that is manufactured within the same facility.
  • Additional safety information for consumers and manufacturers is available on FDA’s infant formula landing page. Keller and Heckman will continue to monitor and report on issues relating to infant formula.
  • On November 17, the FDA updated its Leafy Green STEC Action Plan (LGAP). FDA first released the LGAP in 2020 following recurring outbreaks linked to leafy greens caused by Shiga toxin-producing E. Coli (STEC). 
  • The update provides additional information on sampling assignments, method developments, and a status update on FDA’s long term longitudinal studies in Arizona and California. The Agency also released a new fact sheet: Adjacent and Nearby Land Uses and their impact on the safety of produce grown nearby. 
  • The LGAP is part of the FDA’s yearslong efforts, in collaboration with partners in the public and private sectors, to enhance the safety of leafy greens. Per FDA, this work has included “prioritized inspections, focused sampling, stakeholder engagement and collaboration, data sharing, root cause investigations, and advancements in the science of detection and prevention.”
  • FDA also noted that the Agency intends to discuss their vision for produce safety efforts after the transition to the Human Foods Program in early 2024.

The Daily Intake is taking a break for the Thanksgiving holiday and will return on November 27. We wish you a wonderful Thanksgiving holiday!

  • The Consumer Federation of America (CFA), a non-profit consumer advocate organization, submitted a petition to FDA on November 8, 2023, requesting that the agency amend the flavoring regulation at 21 CFR 101.22 to replace the use of “natural flavor” with “added flavor” or “added flavoring.”
  • Under 21 CFR 101.22, “natural flavor” and “natural flavoring” are those flavors/flavorings derived from natural (i.e., plant or animal) sources. Specifically, the regulation defines these terms to mean “the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.”  Artificial flavors/flavorings are defined inversely; they are flavors which are not derived from these sources.
  • The petition argues that there are often few distinctions between natural and artificial flavors, both of which are frequently highly processed. It also raises questions about the safety and healthfulness of highly processed flavors, including concerns that they may induce overeating.
  • The petition is careful to note that it does not seek to erase the distinction between “artificial” and “natural flavors” and that the proposed revision would still distinguish between the two. Furthermore, a manufacturer seeking to promote the natural quality of its flavor could still use the ingredient’s common or usual name (e.g., mint extract).
  • Keller and Heckman will follow and report on the agency’s response, if any, to this petition. 
  • A salmonella outbreak traced to cantaloupe imported from Mexico has spread through several U.S. states and Canada. As of November 17, 2023, at least 43 people in the U.S. and eight people in Canada had been infected with Salmonella linked to the same cantaloupes. At least 17 of those people required hospitalization.
  • On November 15, 2023, Sofia Produce, LLC issued a recall of all fresh cantaloupes it distributed in packages labeled with the “Malichita” brand between October 16 and 23, 2023. The cantaloupes were distributed directly to Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Michigan, Wisconsin, Texas, Florida, and Canada, and may have reached consumers through retail outlets outside of those areas.
  • The outbreak also includes Vinyard brand pre-cut cantaloupes and ALDI brand whole and pre-cut cantaloupes. Sofia Produce is contacting each of its buyers to advise them of the recall. Consumers should check to see if they have recalled products, which should not be consumed. If consumers are unsure whether they have purchased a recalled product, they are advised to contact their retailer.
  • Keller and Heckman will continue to monitor and report on food recalls in the U.S.
  • On November 13, 2023, the Federal Trade Commission (FTC) sent warning letters to the American Beverage Association (AmeriBev), the Canadian Sugar Institute, and a dozen dietitians and influencers promoting the safety of the artificial sweetener aspartame or the consumption of sugar-containing products on TikTok and Instagram. The letters allege that the dieticians and influencers did not adequately disclose that the associations paid for the endorsements. The warning letters put the trade groups and influencers on notice that further violations of the Endorsement Guides could result in fines of up to $50,120 per violation.
  • The FTC warning letters indicate that required material connection disclosures were either missing or not sufficiently prominent. In the FTC’s view, even express disclosures in social media posts, such as “Paid partnership,” “#sponsored,” and “#ad” were not compliant because they required a user to expand a truncated description or scroll down a longer post to see them, and were therefore not sufficiently conspicuous. Further, the disclosures were allegedly inadequate because some did not identify the sponsor at all, while others identified the sponsor as “ameribev,” which the FTC claimed many viewers may not understand. The warning letters also remind the trade associations and influencers that disclosures must be made in all of the same means in which the representation is made (e.g., if a video makes both a visual and an audible representation, it must also include both a visual and an audible disclosure). 
  • FTC’s recent update to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the Endorsement Guides) makes clear that disclosures about the relationship between an advertiser and an endorser must be “clear and conspicuous” (i.e., “unavoidable” and “easily understandable”), and that even tags in social media posts and certain other types of communications can be endorsements.
  • Businesses should be aware that the FTC is also proposing a new trade regulation rule to crack down on deceptive online reviews, including endorsements that lack proper disclosures of a material connection between endorser and business.
  • On November 2, the New York City Council passed a bill that will require chain restaurants with 15 or more locations to post added sugar icons and factual warning statements on menus or menu boards next to menu items and on or near food items on display that exceed a specified level of added sugars. The icon must be displayed on food items that exceed 100% or more of the daily value for added sugars as determined by the FDA (i.e., 50g) or another amount as specified by the Department of Health and Mental Hygiene (DOHMH).
  • This new legislation, Int 0687-2022, builds on the “Sweet Truth Act,” which was passed in 2021 and requires the same added sugar notifications on certain prepackaged food items at covered NYC establishments.
  • The bill has been sent to the Mayor for a hearing and signature, to be held on November 17. If signed, covered establishments will be required to display the added sugar icons no later than one year after the DOHMH issues its rules for the bill. Any covered restaurant that violates the provisions of the bill is liable for a civil penalty of $200.
  • Last month, phase 2 of Mexico’s front of pack (FOP) labeling regulations went into effect, triggering certain changes to the thresholds for FOP warnings.
  • We have previously reported on Official Mexican Standard NOM-051 which, among other things, requires FOP warnings when processed foods or non-alcoholic beverages exceed specific thresholds for calories, sugars, saturated fats, trans fats, and sodium. The changes are being implemented in three phases.
  • In phase 2, which runs from October 1, 2023, to September 30, 2025, the thresholds triggering FOP warnings for excess calories and excess sugars for liquid products, and excess sodium for solid products, have been made more stringent and changed to the following: 
    • Warning threshold for excess calories for liquid products: Greater than or equal to 70kcal total per 100mL of product or greater than or equal to 8kcal of added sugars per 100mL of product (previously the latter threshold was 10kcal of added sugar)
    • Warning threshold for excess sugars for liquid products: Greater than or equal to 10% of total calories from added sugars (previous exemption for beverages with less than 10kcal of added sugars removed)
    • Warning threshold for excess sodium for solid products: Greater or equal to 1 mg of sodium per kcal or greater than or equal to 300 mg per 100g of product (previously greater than or equal to 350 mg per 100g of product).
  • Phase 2 will also involve a review of the existing thresholds to determine if further changes are necessary. Phase 3, which will assess phase 2 criteria, will not begin until October 1, 2025.
  • A summary of the thresholds for FOP warnings (including carryovers from phase 1) can be found at USDA’s Foreign Agricultural Service webpage.

  • 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.