• On October 23, 2024, The US Food and Drug Administration (FDA) finalized its guidance document on its enforcement policy for animal feed ingredients, following the sunsetting of FDA’s longstanding Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) addressing the review of animal food definitions listed in AAFCO’s Official Publication (OP). 
  • The Association of American Feed Control Officials (AAFCO) is a voluntary organization that guides regulators and has long maintained a list of animal food ingredients and definitions.  Every state, except Alaska, has some version of the AAFCO model bill and regulations codified under their respective state laws.  Historically, FDA participated in the AAFCO ingredient definition request process by providing scientific and technical assistance to AAFCO.  In 2007, FDA and AAFCO entered into an MOU to collaborate on animal ingredient definitions to be listed in the AAFCO Official Publication.  However, the MOU expired in October 2024 and was not renewed.
  • FDA’s guidance document states that the agency does not plan to initiate enforcement actions related to feed ingredients listed in AAFCO’s official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP.   FDA does not plan to initiate action if the ingredient is not an approved animal food additive or GRAS, so long as the ingredient:
    • (1) Is included in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the 2024 AAFCO OP;
    • (2) Is used according to its intended use, specifications, and limitations listed in the 2024 AAFO OP; and
    • (3) FDA has no questions or concerns about the safety of the ingredients.
  • The agency is currently accepting comments on the guidance submitted to the docket.  Please reach out to Keller and Heckman if you would like assistance in submitting a comment to the Agency
  • Separately, AAFCO announced that it is considering a proposal from Kansas State University’s K-State Olathe Innovation Campus (K-State Olathe) to provide the scientific review for its new animal food ingredient submission pathway.  This proposed pathway would replace AAFCO’s former Ingredient Definition Request process that sunset on October 1, 2024, following the expiration of AAFCO’s MOU with FDA.
  • FDA issued two warnings letters this month for violations of the foreign supplier verification program (FSVP) requirements which are found in section 805 Federal Food, Drug, and Cosmetic Act (codified at 21 U.S.C. 384a) and in the implementing regulations at 21 C.F.R. Part 1, Subpart L.
  • The first warning letter, issued on October 1, 2024 to Paso Real Produce LLC noted the absence of FSVP documentation for the company’s imported products (avocados and limes) and followed FDA’s issuance of Form 483a FSVP Observations following an August 2024 inspection.
  • The second warning letter, issued on October 10, 2024, to Future Best Trading Inc. followed July inspections which were initiated following a positive Listeria monocytogenes sample in the company’s imported fresh Enoki mushrooms. Although the company responded to the Form FDA 483a FSVP Observations issued at the conclusion of the July inspection, FDA stated that the documents did not meet FSVP requirements, in part because their relevance was not explained and there was no indication that the company had reviewed or assessed any of the documents as part of the hazard analysis required by FSVP. The letter also noted the FSVP requirement to take prompt corrective action following the Listeria contamination incident and that while certain relevant steps that had been taken (e.g., the supplier’s food safety improvement plan), the corrective actions taken by the company had not been properly documented and incorporated into a FSVP plan.
  • Both letters warn the companies that continued failure to comply with the FSVP requirements could result in the refusal of admission of food products which appear to violate the FSVP requirements or placement on an import alert list (allowing for detention without physical examination). Import Alert 99-41 includes a list of companies which are not in compliance with the FSVP requirements.
  • An organic food industry advocacy group has asked (Law360 subscription required) the Ninth Circuit to reverse a district court decision upholding USDA’s implementation of the National Bioengineered Food Disclosure Standard, saying that the rule is “arbitrary and capricious” and is “not the uniform standard for consumers that Congress envisioned.”
  • In the original lawsuit, filed in 2020, food advocacy groups claimed USDA’s rule did not deliver on the aims of the National Bioengineered Food Disclosure Act and that portions of the rule violated the First, Fifth, and Tenth amendments by limiting allowed disclosures and preempting state laws requiring additional disclosures. A U.S. District Court judge upheld most of the law but sided with the organic industry groups in ruling that QR codes are not adequate methods of informing shoppers that food is bioengineered. Then, in March, the Consumer Brands Association, the federal government, and sugar industry groups filed amicus briefs in support of the rule, as we discussed on this blog.
  • The appeal, argued by George Kimbrell, the legal director for the Center for Food Safety, is focused on three concerns:
    • USDA’s exemption for highly refined foods with “undetectable” genetically engineered elements is contrary to the Act’s definition of a bioengineered food as one that “contains genetic material that has been modified.” According to one judge on the panel, that is “a difference without a distinction [because] it seems odd to say that something’s there when it’s not detectable.” However, according to Kimbrell, the Agency did not set a level of detection or a threshold for detectability, so there could be two different results with the same product.
    • A requirement that labels use the term “bioengineered” instead of the more commonly known “genetically engineered” or “genetically modified,” which consumers better understand.
    • While the district court found the QR code portion of the rule unlawful, the judge erred by failing to vacate that part of the rule, so there are product packages on the market that use the QR code method to disclose that the food is bioengineered.
  • The federal government argued that a product can include a genetically modified source that is no longer in the product after processing, because some processes degrade DNA to undetectable levels. Further, there are required testing standards for detection of bioengineered material and there was significant science backing USDA’s position in drafting the rule. However, one judge said that the rule leaves it in the hands of the companies to decide if DNA is detectable in the final product, which does not fulfill Congress’s intent.

  • Last week a proposed class action lawsuit was filed against Harris Teeter alleging that the company falsely and deceptively marketed a variety of flavored cereal bars as “naturally flavored with other natural flavors” when in fact the products allegedly contained synthetically produced malic acid.  See Filing (Law360 subscription required).
  • As alleged in the complaint, malic acid is naturally present in certain foods in its L-enantiomeric form, while synthetically produced malic acid contains a mixture of D- and L- malic acid (the D- and L- designations refer to different spatial arrangement of atoms much like the relationship between a left and right hand). Testing commissioned by Plaintiff’s counsel allegedly revealed the presence of D-malic acid which would indicate the presence of synthetically produced (i.e., artificial) malic acid.
  • Products bearing natural or natural flavoring claims and containing malic acid are a frequent target of class action lawsuits. We will continue to monitor and report on this lawsuit and other food litigation.
  • FDA has partnered with Purdue University and Indiana produce industry stakeholders to launch an environmental microbiology study to better understand the ecology of human pathogens, focusing on assessing risks related to Salmonella in the environment. The study is intended to develop a better understanding of the source of pathogens, their persistence, and how they transfer through the growing environment to ultimately help inform food safety practices.
  • The study is in response to outbreaks of Salmonella linked to cantaloupe grown in the Southwest Indiana agricultural region where a specific source or route of contamination was not found. The identification of other Salmonella varieties that were genetically similar to other isolates collected in the region over the last decade suggests that Salmonella is a reoccurring issue and that multiple reservoirs for Salmonella spp. may exist. According to FDA, “[t]he outbreak investigations have shown that there are complex environmental survival, proliferation, and dispersal mechanisms of pathogens in this region that need to be better understood.”
  • Researchers will sample air, soil, water, and animal scat, as well as collect weather data, to better understand what environmental conditions may encourage the survival, growth, and spread of pathogens. The study will occur at a farm in central Indiana, four Purdue-operated farms in northwest Indiana, and the Southwest Purdue Ag Center.
  • Indiana ranks sixth in U.S. cantaloupe production, according to USDA data from 2018 when Indiana growers planted 1,800 acres of cantaloupe worth $8.6 million. Growers “want to participate in this study because of their commitment to do everything they can to keep their produce as safe as possible.”
  • Keller and Heckman will continue to report on FDA’s efforts to understand and prevent foodborne illness outbreaks.  
  • On October 10, 2024, FDA hosted a public webinar to discuss the Voluntary Sodium Reduction Goals (Edition 2) and review progress.  Key FDA speakers provided updates on the latest sodium reduction targets and insights into the progress made so far.
  • As previously discussed on this blog, FDA issued Edition 2 of the Draft Guidance for Industry Voluntary Sodium Reduction Goals in August 2024.  These goals aim to encourage the food industry to gradually reduce sodium levels in packaged and prepared foods, addressing diet-related chronic diseases and promoting health equity.  Over 70% of sodium consumed in the US comes from processed and prepared foods.  The goal is to lower average daily sodium intake from 3,400 mg to 2,300 mg.
  • FDA developed baselines for sodium concentrations based on label data and created target mean and upper bound sodium concentration goals.  The target mean is an average for the food category as a whole, while the voluntary upper bound applies to every individual product and for which no individual product should exceed.
  • During the webinar, FDA highlighted the draft targets issued on August 15 and provided a preliminary assessment of progress towards Phase 1 targets.  The new 2024 guidance lowers the average sodium intake goal to 2,750 mg/day, includes restaurant data from 15 categories, and adds 3 new subcategories.
  • Key findings from the preliminary assessment include:
    • There are 16 broad food categories with 163 subcategories.  Of the 16 overarching categories, 11 categories had at least 50% of their subcategories decrease in sodium.
    • From 2010 to 2022, 52% of all food categories decreased in sodium, 34% increased, and 14% saw no change.  Packaged foods showed more significant reductions at 62% compared to restaurant foods at 35%.  Notably, 100% of subcategories in the toddler and baby food category saw a reduction in sodium.
    • Overall, 40% of food categories have already achieved the Phase I sodium targets or were within 10% of meeting those targets.
  • FDA clarified that the targets are voluntary, as this approach has proven effective globally.  The gradual and voluntary approach is designed to afford the industry flexibility, and it was noted that consumer palates adjust to salt reduction over time, and small reductions often go unnoticed.  A recording of the session is available on FDA’s meeting page here.
  • FDA is encouraging feedback on the draft targets and categories and will be accepting comments until November 14, 2024.  Please feel free to contact Keller and Heckman for assistance providing FDA comments.  We will continue to monitor for updates and provide further information as it becomes available.
  • On September 28, 2024, Governor Newsom signed California’s AB 660 into law, which would standardize date labels on food packaging.  The legislation is the first of its kind in the U.S. and intends to reduce both customer confusion and food waste.
  • The new law at Section 82001 of the California Food and Agricultural Code, requires food manufacturers, processors, and/or retailers  to use standardized language for date labels across their products.  Beginning July 1, 2026, “Best if Used By” will be used to communicate peak quality, and “Use By” will be used to communicate product safety.  To further reduce confusion on food date labeling, AB 660 prohibits the use of consumer facing “sell by” dates, reducing the likelihood of confusing “sell by” dates with quality and/or safety dates.
  • At the federal level, companion bills were introduced in the House and Senate in May 2023 (HR 3159 and S 1484) to standardize food date labels across the U.S.  With the exception of infant formula, there are no uniform federal standards for date labels.  The legislation would establish a dual label system reducing the available labeling language to two phrases: one quality date indicator and one discard date indicator.  If a manufacturer chooses to use a date to indicate when a food should be discarded for safety reasons, it must use the standard language “Use By” or “UB” if the package has limited space.
  • Keller and Heckman will continue to monitor and relay legislative developments.
  • On September 30, 2024, the U.S. District Court for the District of Oregon dismissed a complaint filed by Pratum Farm, LLC which challenged the Strengthening Organic Enforcement (SOE) provisions regarding certification of “grower groups” allowing for inspection of a sample of growers from the grower group, as opposed to inspection of every grower.
  • Grower groups are certified at a group level, and under the SOE rule, inspection by a USDA-accredited certifier is required for “at least 1.4 times the square root or 2% of the total number of producer group members, whichever is higher.” This equates to at least 10 members in a 50-member group (20% inspection rate), 14 members in a 100-member group (14% inspection rate), or 31 members in a 500-member group (6.2% inspection rate). The larger the group, the lower the minimum inspection rate. Other farms within the group that are not inspected by a USDA-inspected certifier are required to be inspected for compliance by a designated employee of the grower group.
  • Plaintiff alleged that the grower group certification regulation (7 CFR 205.403(a)(2)) is contrary to the Organic Foods Product Act’s provision for “annual on-site inspection” of organic farms. (7 USC 6506(a)(5)). Plaintiff further alleged that it had suffered harm because (1) the USDA organic seal acted as a kind of license that had been degraded through lack of enforcement, and (2) it was placed in a competitive disadvantage, as the rule had allowed other growers to sell fraudulent organic product on the U.S. market. Plaintiff is a small farm growing hazelnuts and had prompted a Federal Trade Commission (FTC) investigation of Turkish hazelnut growers.
  • However, the Court dismissed the complaint for lack of injury (i.e., standing) because the argument that Plaintiff was injured as a licensee (of the organic seal) was speculative and because Plaintiff had not shown that it had been injured by the regulation. On the contrary, the Court held that the injury it alleged could be attributed to the “unlawful action of third parties.”
  • The Food Safety and Inspection Service (FSIS) has extended the comment period for its proposed rule prohibiting the sale of chicken and turkey contaminated with certain types of Salmonella. Comments will now be accepted until Jan. 17, 2025, adding 72 days to the comment period.
  • As previously discussed on this blog, the National Chicken Council had requested a 90-day extension beyond the initial 60-day comment period and 30-day extension. Two representatives, as well as the Poultry Safety Coalition and several consumer advocacy groups had asked for an additional 180 days to comment, citing concerns that “the proposed rule is not sufficiently comprehensive and may by itself foreclose important reforms” that USDA should consider including in the final rule.
  • According to FSIS, stakeholders requested additional time to comment following the initial extension “to allow sufficient time to consider the proposal and supporting documentation to formulate comments on these documents.”
  • As a reminder, the proposed rule (published on August 7, 2024) is intended to establish standards to prevent raw poultry products that contain high levels of Salmonella from entering commerce and to require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination through the slaughter system.  
  • Keller and Heckman will continue to monitor and report on this proposed rule.
  • The U.S. District Court for the Eastern District of California has entered a consent decree of permanent injunction against Rizo Lopez Foods and the company’s co-owners.  Among other requirements, the consent decree prohibits Rizo Lopez Foods from manufacturing and selling certain food products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other federal regulations.  The consent decree requires the defendants to make corrective actions and receive FDA approval from the U.S. Food and Drug Administration (FDA) before they may resume operations.
  • As we previously reported, FDA and the Centers for Disease Control and Prevention (CDC) investigated a multi-year, multistate outbreak of Listeria monocytogenes (Listeria) infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods.  In February 2024, Rizo Lopez Foods voluntarily recalled its entire inventory of dairy products, regardless of the sell-by date of the product.
  • In total, the CDC outbreak investigation identified 26 illnesses, which occurred across 11 states and included 23 hospitalizations.  Two of the individuals subsequently died.  Four individuals were pregnant, including one who suffered a pregnancy loss.