• 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.”  

• The U.S. Food and Drug Administration’s (FDA’s) Foods Program has posted a new website listing regulations it plans to publish by October 2024 and long-term regulations it is prioritizing for publication at a later date. Additionally, FDA has updated the list of guidance topics it is considering and expects to publish by the end of 2024.
• Regulations are officially announced in the Unified Agenda of Regulatory and Deregulatory Actions published each spring and fall. Some of the regulations FDA has listed on its website include use of the “healthy” nutrient content claim, the use of ultrafiltered milk in cheese and cheese related products, and front-of-package nutrition labeling, among others.
• The following five topics have been added to the list of guidance documents the FDA expects to publish by the end of December 2024:
o Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry;
o Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry;
o The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry;
o Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry; and
o Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry
• Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.

  • A class-action lawsuit was filed (Law360 subscription required) last week alleging that Defendants’ Motts, LLP and Keurig DR Pepper Inc. falsely and misleadingly labeled their product, “Mr. & Mrs. T Original Bloody Mary Mix,” as containing “no added preservatives” when it contains citric acid, which is alleged to function as a preservative.
  • FDA defines “preservative” in part as “any chemical that, when added to food, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices . . .” 21 CFR 101.22(a)(5). Citric acid is affirmed as GRAS in 21 CFR 184.1033 for general use in food. The Food Chemicals Codex monograph for citric acid describes its functions as a “sequestrant; dispersing agent; acidifier; flavoring agent.”    
  • Plaintiff argues that the primary function of citric acid in the product is as a preservative, regardless of any other functions it may perform, especially because “Defendants have not declared a contrary purpose for adding citric acid and the Products separately contain flavorings (i.e., ‘natural flavor’) as an ingredient.” However, we note that products may contain multiple flavors, and there is no requirement that a flavor be declared as such (i.e., citric acid, when used as a flavor, could be declared as “citric acid.”). Furthermore, citric acid could be used as a “flavor enhancer,” a substance “added to supplement, enhance, or modify the original taste and/or aroma of a food, without imparting a characteristic taste or aroma of its own.” 21 CFR 170.3(o)(11).
  • At the pleadings stage, the Court will have to decide whether Plaintiff has sufficiently alleged that citric acid acts as a preservative. Compare Hu v. Herr Foods, Inc.,251 F. Supp. 3d 813 (E.D. Pa. 2017) (holding that plaintiff failed to adequately allege that citric acid acts as a preservative in the product at issue) with Mason v. Reed’s Inc., 515 F. Supp. 3d 135 (S.D.N.Y. 2021) (holding that Plaintiff had adequately alleged that citric acid acted as a preservative). Although such cases frequently settle, we will continue to monitor and report on any substantive decisions in this case.
  • An Illinois consumer has filed a proposed class action against The Wonderful Co. LLC, the bottler of Fiji Natural Artesian Water, claiming that the water contains microplastics. The claim alleges violations of the Illinois Consumer Fraud and Deceptive Business Practices Act, common law fraud, and unjust enrichment for intentionally labeling the products as Natural Artisan Water, even though the company knew or should have known the product contains microplastics.
  • The complaint cites a 2018 study on synthetic microplastic contamination in bottled water, which found that 93 percent of bottled water showed signs of contamination. An additional study in 2019 found that the microplastics in bottled water originated from mechanical stress caused by frequent opening and closing of the plastic cap on the bottles.
  • Microplastics have been shown to cause toxic effects in marine life, as well as mammals, including humans. While the full extent of these effects in humans is not fully understood, studies have shown that they can cause problems in the immune, gastrointestinal, endocrine, and cardiovascular systems.
  • The complaint notes that FDA has not defined the term “natural,” but has long considered it to mean that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected in that food.” The claim alleges that labeling the bottled water as “natural” is false and misleading and deprived plaintiffs of the ability to choose the quality of products they purchase and consume.
  • Keller and Heckman will continue to monitor this lawsuit and the issue of microplastics in bottled water.
  • Following a previous recall of its Chewy granola products in December, Quaker Oats has broadened its recall to its granola bars, snacks, and some varieties of its popular Cap’n Crunch cereal products sold nationwide due to possible Salmonella contamination.
  • The U.S. Food and Drug Administration (FDA) has provided a list of the affected products, which now include the following:  Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple, Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple and Splendid Strawberry Variety Pack, Quaker Chewy Granola Bars Yogurt Strawberry Flavor, Cap’n Crunch Treats Crunch Berries Cereal Bar, Quaker Chewy Granola Breakfast Cereal Strawberry, Cap’n Crunch Cinnamon Crunch Cereal, and Cap’n Crunch OOPS! All Berries Instant Oatmeal.
  • Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
  • The listed products were sold throughout the US, Puerto Rico, Guam, and Saipan.  Consumers can scan the SmartLabel QR code on the product package to determine whether it has been recalled.
  • Keller and Heckman will continue to monitor and relay any updates regarding food safety.
  • Recently released documents indicate that FDA has recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from a Schedule I drug to a  Schedule III drug under the Controlled Substances Act. Schedule I drugs have a high potential for abuse, have no currently accepted medical use (CAMU), and there is a lack of accepted safety for their use under medical supervision. In contrast, Schedule III drugs, have a lesser potential for abuse than Schedule I and II drugs, have a CAMU, and their abuse may lead to moderate or low physical dependence or high psychological dependence. 21 U.S.C. § 812.
  • As to the first factor mentioned above (high potential for abuse), FDA noted that “marijuana is the most frequently abused federal illicit drug” and produces a wide range of responses, both positive and negative, but concluded that “it does not produce serious outcomes compared to drugs in Schedules I or II.” Notably, marijuana ranked at the very bottom of drugs when it came to a number of undesirable metrics including overdose, poisoning, emergency room visits, and hospitalizations.
  • As to the second factor mentioned above (currently accepted medical use), FDA concluded that that there is widespread experience with medical use of marijuana by licensed health care providers operating under state-authorized programs and that there was “some credible scientific support” for the use of medical marijuana to treat anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, chemotherapy induced nausea and vomiting, pain, and post-traumatic stress disorder.
  • On the third factor mentioned above (dependence liability), FDA concluded that marijuana can lead to low or moderate physical dependence in heavy users, and can produce psychic dependence, but that the probability of a serious outcome is low.
  • The DEA will ultimately be responsible for the decision. We will continue to monitor and report on developments.