• The attorneys general from 20 states sent a letter to FDA urging the agency to take official notice of three documents relating to lead in baby food in support of a 2022 petition for reconsideration requesting actions on heavy metals in food for babies and young children. The group of attorneys general filed a citizen petition on October 21, 2021, which FDA denied. The group then filed a reconsideration petition on June 1, 2022. That petition is still pending.
  • The 2021 petition urged FDA to drive down the levels of lead, inorganic arsenic, cadmium, and mercury in food intended for babies and young children, including by issuing guidance on finished product testing. According to the petition, this testing would amount to a “preventive control” that should be performed by food manufacturers. Now, the attorneys general say that a January 2023 guidance document on lead action levels, FDA’s public notices relating to the investigation into elevated lead levels in applesauce, and a December 2023 report on the inspection of the applesauce manufacturer provide additional support for the reconsideration petition.
  • According to the attorneys general, these documents “make it evident that some manufacturers and distributors of baby foods in the U.S. currently lack a clear understanding of the proper way to apply preventive controls to avoid adulteration of finished baby food products.” In the documents, FDA reported that the baby food products contained more than 200 times the maximum acceptable concentration of lead under the proposed action levels, yet there was no finished product testing prior to the recall. The harm to children demonstrated in the documents reinforces the need for required toxic element testing in finished products for babies and young children.
  • The letter requests FDA take official notice of the documents without reopening the administrative record since the documents are official and reliable FDA publications.
  • On January 30, 2024, the Fair and Accurate Ingredient Representation on Labels Act (“FAIR Act“) was introduced in the House and Senate. The FAIR Act calls for new labeling requirements for cell-cultured meat and plant-based meat alternative (PBMA) products, including use of terms like “imitation” and “cell-cultured” on labels.
  • The measure addresses PBMAs in the following ways:
    • Defines “imitation meat/poultry” as any food that “uses a market name, descriptors, or iconography for, or is otherwise represented as meat or poultry; is manufactured to appear as a meat or poultry; or approximates the aesthetic qualities (primarily texture, flavor, and appearance) or chemical characteristics of specific types of meat or poultry – but does not contain any meat or poultry.”
    • Requires that products be designated as either “imitation,” or some other descriptive term, such as “black bean burger” or “meatless chicken tenders.”
    • Requires disclaimers to be included on label indicating that the product does not contain meat or poultry.
    • Expands the authority of the U.S. Department of Agriculture (USDA) over meat and poultry to include PBMAs.
  • The measure addresses cell-cultured products in the following ways:
    • Defines “cell-cultured products” as “any product capable of being used as a human food that “is made wholly or in part from any cell culture or the DNA of an amenable species or live bird” and that “is grown or cultivated outside of the live animal from which the cell culture or DNA was acquired.”
    • Provides USDA with clear authority over labeling and directs the agency to require the words “cell-cultured” or “lab-grown,” in type of uniform size and prominence, to be included immediately adjacent to the name of the food on its label.
    • Codifies the current “shared regulation of lab-grown meat and poultry” between the U.S. Food and Drug Administration (FDA) and USDA, though USDA will retain authority over labeling.
  • The bill has received support from agriculture, poultry, and livestock trade groups, though the Plant-Based Foods Association (PBFA) has voiced its opposition, arguing the Act will unfairly target the growing plant-based food industry. Keller and Heckman will track and report on any developments regarding this Act.
  • On Monday Campbell Soup Company was hit with a class-action lawsuit (Law360 subscription required) which alleged that the company’s V8 line of products are deceptively labeled and mislead consumers into thinking that the products are “wholesome, naturally-flavored, healthful fruit-juice beverages for kids,” when in fact they are allegedly “almost entirely water and high fructose corn syrup, artificially flavored to taste like fruit juice.”
  • Based on the ingredient lists, Plaintiffs allege that products contain at most 1-2% of the fruit and berries on the labels, and in some cases, none at all. Citing to Campbell’s own online statements, Plaintiffs also allege that the products contains synthetic malic acid which is used for flavor.
  • The products depict various fruits on the principal display panel with characterizing flavor statements such as “berry flavored . . . with other natural flavor.” Under the flavor labeling regulations in 21 CFR 101.22(i), the characterizing flavor must be labeled as “artificially flavored” or “artificial” if it contains any artificial flavor which “simulates, resembles, or reinforces the characterizing flavor.” Defendant is likely to argue that the malic acid is used as a “flavor enhancer” (supplementing a taste or aroma without imparting its own taste or aroma) and not a “flavoring agent” (imparting its own taste or aroma).
  • Plaintiffs also allege that the products are deceptively labeled as sources of antioxidants and vitamins, where in fact these nutrients are alleged to be randomly added in violation of FDA’s fortification policy and in amounts that are negligible in comparison to real fruit juice.
  • We will continue to monitor and report on this and other litigation in the food industry.
  • On February 5, 2024, Rizo-Lopez Foods, Inc. voluntarily recalled its dairy products due to potential Listeria monocytogenes contamination. The recall stems from an outbreak including cases dating back to 2014 and CDC inspections in 2017 and 2021. In response to a sample that tested positive for Listeria in January 2024, Rizo-Lopez recalled one batch of cotija cheese. CDC and FDA reopened the investigation when an analysis showed that the same strain in that sample caused illness in an outbreak that was reported in December 2023.
  • The recall includes cheese, yogurt, and sour cream sold under multiple brand names nationwide. In addition to Rizo-Lopez brands, the products were used in dressings, sauces, kits, and more under other brands, including Bright Farms, Costco, H-E-B, and Trader Joe’s, among others. The full list of affected products is available on FDA’s webpage covering the outbreak.
  • As of February 12, there have been 26 reported illnesses, 23 hospitalizations, and two deaths across 11 states. Listeria is a bacteria species found in moist environments that can survive and grow even under refrigeration. People infected with Listeria may develop symptoms including fever, muscle aches, nausea, vomiting, and diarrhea. More severe cases may include headache, stiff neck, confusion, loss of balance, and convulsions. Symptoms may develop in anywhere from a few hours to three months after eating contaminated food. Listeria can be particularly harmful to people with weakened immune systems, people over 65, and pregnant women and babies.
  • Although the investigation is ongoing, FDA’s inspection of the Rizo-Lopez facilities turned up an environmental sample that tested positive for the same strain of Listeria that is causing illness in the outbreak.
  • Keller and Heckman will continue to monitor this outbreak and report on any updates.
  • Five members of Congress have commented on a petition filed by Perdue Farms that was submitted to the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS).  The petition requests that FSIS conduct rule-making to define separate “free range” and “pasture-raised” claims for meat and poultry products.  The petition also requests that FSIS update its guidance on claims related to living and raising conditions to ensure that the claims align with consumer expectations. 
  • In their statement to FSIS, the congressmen requested the following: “As USDA evaluates the petition and considers policy changes, we ask that the Department establish a robust stakeholder input process to ensure no unintended consequences.  Changing the requirements for individual marketing claims will have both upstream and downstream economic impacts on production practices, retail opportunities, and input requirements.”
  • The congressmen (Rep. Mark Alford, R-MO; Rep. Lloyd Doggett, D-TX; Rep. Jason Smith, R-MO; Rep. Eric A “Rick” Crawford, R-AR; and Rep. James R. Baird, R-IN) added that any changes in claim requirements must be considered in consultation with the U.S. Food and Drug Administration (FDA), as changes could impact FDA-regulated products as well (e.g., dairy and shell eggs).  The delegation also recommends an Advanced Notice of Proposed Rulemaking to facilitate complete engagement from stakeholders throughout the affected industries.
  • The petition is currently pending in the FSIS Office of Policy and Program Development for review.  Keller and Heckman will continue to monitor and relay developments regarding the petition.
  • As our readers are likely aware, in November of last year, WanaBana voluntarily recalled apple cinnamon fruit pouches which were linked to acute lead toxicity in children. The products were sold under the WanaBana, Schnucks, and Weis brand names. The subsequent investigation traced the contamination to cinnamon from Austrofoods, an Ecuadorian food distributor. Cinnamon at the Austrofoods’s facility was also found to contain elevated levels of chromium, although it was not clear from the testing whether it contained chromium III, or the more toxic chromium VI. Considering the very high levels of lead and chromium, FDA raised the possibility of intentional economic adulteration.
  • The contaminated (ground) cinnamon was supplied to Austrofoods by Negasmart (also known as Negocios Asocidos Mayoristas S.A.), which sourced the cinnamon sticks from Sri Lanka but had the sticks processed by Carlos Aguilera. Both Negasmart and Carlos Aguilera are also Ecuadorian companies.
  • In the most recent update, released yesterday (February 6th), FDA announced that Ecuadorian officials have reported that the cinnamon sticks from Sri Lanka were found to be uncontaminated and that the cinnamon processor, Carlos Aguilera, is the most likely source of contamination. Per the report, Carlos Aguilera is “not in operation at this time.”
  • The recall highlights the complexity of modern supply chains and the difficulty in orchestrating a response when the issue crosses borders. FDA cannot take direct action against companies that do not export products to the United States including, in this case, Negasmart and Carlos Aguilera.
  • Florida Governor Ron DeSantis expressed his support of two bills in the Florida Legislature that would ban the cultivation and sale of lab-grown (cultivated) meat products. He said in a public statement that the bills will “protect our meat . . . We are going to have meat in Florida. We are not going to do that fake meat.”
  • House Bill 435 and Senate Bill 586  would prohibit the manufacture and distribution of cultivated meat in the state and establish criminal penalties for doing so. The bills define “cultivated meat” as “any meat or food product produced from cultured animal cells.” Violating the ban results in a second-degree misdemeanor, and a restaurant, store, or other business could have its license suspended for selling cultivated meat products. In addition, food establishments that distribute or sell cultivated meat would be subject to fines and revocation or suspension of the establishment’s permit. Products in violation of the ban would be subject to an immediate stop-sale order.
  • Both bills were filed in November 2023. The House bill was found favorable by the Agriculture, Conservation & Resiliency Subcommittee and is now in the Agriculture & Natural Resource Appropriations Subcommittee. The Senate bill has been introduced in the Agriculture, Commerce and Tourism, and Fiscal Policy committees.
  • With these bills, Florida joins several other states, including Arizona and Texas, in moving toward banning lab-grown (cultivated) meat products. Keller and Heckman will continue to monitor and report on legislation related to cultivated meat.
  • Originally introduced in November 2023, the Illinois Food Safety Act (SB 2637) proposes to prohibit the manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains brominated vegetable oil (BVO), potassium bromate, propylparaben, and Red dye 3.  However, the bill’s sponsors indicated on January 23, 2024 that he and fellow legislators intend to amend the bill to include titanium dioxide, though it has not yet been formally included.
  • Illinois’s bill closely follows bills proposed in California, New York, and New Jersey (AB 418, S60551A, and NJ A5436, respectively), though California is the only one yet to pass.  Titanium dioxide was also originally included in the proposed list of banned additives in California, but was later removed.  Titanium dioxide is included in NY S60551A and NJ A5436.
  • If enacted, the Illinois proposal would take effect January 1, 2027 (like California), while the S60551A ban is proposed to go into effect January 1, 2025.  NJ A5436 would take effect a year and a month after enactment, though there has been no action on the bill since its introduction in May 2023.  SB 2637 proposes fines of $5,000 for a first violation and $10,000 for each subsequent violation.
  • As we previously reported, the U.S. Food and Drug Administration (FDA) also proposed to revoke its regulation authorizing the use of BVO in food.  The comment period for this FDA proposal closed on January 17, 2024, with 41 public comments submitted.  These comments are currently under review.
  • Keller and Heckman will continue to monitor and relay any developments regarding these proposed bans on food additives.
  • Yesterday FDA announced the release of revisions to the introduction and Appendix I of its “Hazards Analysis and Risk-Based Preventive Controls for Human Food” (HARPC) Draft Guidance. The guidance document is intended to assist in the implementation of the hazard analysis and preventive control for human food requirements in 21 CFR Part 117, Subpart C.
  • The revised introduction includes additional general information, new sections on training (as relevant to HARPC), a list of references used in the guidance and expected to be used in future chapters of the guidance, and a compilation of additional resources.
  • The revisions Appendix I, which is intended to assist in the identification of hazards, include a revised discussion of the purpose and development of the appendix, revised product categories to better reflect food ingredients instead of finished products, replacement of process-related hazard analysis tables with a discussion of the hazards, an updated discussion on food allergen hazards, and citations to other sources of information, in particular for less common hazards.
  • FDA encourages any comments to be submitted within 120 days of the announcement of the availability of this revised draft in the Federal Register. That Federal Register notice is currently scheduled to be published on Friday, February 2, 2024. 
  • A class action filed January 28 in Pennsylvania alleges that Blue Diamond Growers’ “Smokehouse” almonds are deceptive because the products’ smoke flavors come primarily from synthesized liquid smoke, rather than from exposure to hardwood smoke.
  • According to the claim, the word “Smokehouse” appears across a red ribbon with orange borders and above a “fiery orange polygon, evocative of fire,” which gives consumers the impression that the almonds were made in a smokehouse. However, the label does not disclose that the almonds’ flavor does not come from actual smoke. While the ingredient list includes “Natural Hickory Smoke Flavor,” which is a form of pyroligneous acid or synthesized liquid smoke, the claim alleges that this information does not inform consumers that the almonds were not subject to smoking over hardwood.
  • FDA requires companies to declare pyroligneous acid or other artificial smoke flavors as an “artificial flavor” or “artificial smoke flavor,” and no representation may be directly made or implied that a food flavored with pyroligneous acid or artificial smoke flavor has been smoked or has a true smoked flavor. 21 CFR 101.22(h)(6). Further, the claim argues, competitor products do “conspicuously disclose” that the smoked taste is from flavoring, rather than hardwood smoke, on their front labels, making the Blue Diamond product misleading because it is not “uniform among all identical or similar products.” 21 CFR 102.5(a).
  • The claim also alleges that the smokehouse flavored almonds are conspicuously labeled as having a “smokehouse flavour” outside of the United States, and past versions of the packaging in the U.S. were truthfully labeled as “hickory smoked.”
  • This is not the first time Blue Diamond has been the subject of a deceptive advertising claim over the “smokehouse” label. In 2023, similar claims were filed in Illinois and Wisconsin, with the Wisconsin case being dismissed because “no reasonable consumer would interpret the label as describing the production method, versus flavor.”