• On March 11, 2024, at the National Farmers Union Annual Convention, U.S. Department of Agriculture (USDA) Secretary Tom Vilsack announced the final rule to align the voluntary “Product of USA” label claim with consumer understanding of what the claim means.
  • USDA’s final rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry, and egg products only when they are derived from animals born, raised, slaughtered, and processed in the United States.  The rule will prohibit misleading US origin labeling in the market, and help ensure that consumers receive truthful information.  The claim will remain eligible for generic label approval, meaning it would not need to be preapproved by USDA’s Food Safety and Inspection Service (FSIS), but would require the establishment to maintain documentation on file to support the claim.  These claims will need to include a description on the package of the preparation and processing steps that occurred in the US upon which the claim is made.
  • USDA also published an updated labeling guidance on the use of the voluntary US-origin label claims to provide examples of claims and the types of documentation that establishments may maintain to support use of the claims.  The guidance will be open for public comment for 60 days after publishing in the Federal Register.
  • Manufacturers voluntarily using the claim must comply with the final rule requirements by January 1, 2026.
  • In January of this year, FDA testing revealed the presence of toxic yellow oleander (Thevetia peruviana) in a number of dietary supplements containing Crataegus mexicana, which the supplements refer to as tejocote root, and in one case as “brazil seed.” We note that Crataegus mexicana can also be referred to by other names such as “Mexican hawthorn,” although none of the products that have been identified as contaminated use that name. Many of these products are advertised as weight loss supplements. The FDA testing followed the lead of an earlier Centers for Disease Control (CDC) investigation, which also revealed yellow oleander contamination in tejocote supplements.
  • FDA continues to receive adverse event reports. Many of the sellers have not recalled their product, so there are significant concerns that some of these products remain on the market. FDA states that yellow oleander can cause severe, or even fatal, neurologic, gastrointestinal, and cardiovascular adverse health effects.
  • While FDA has mandatory recall authority where a product is adulterated or misbranded and there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death, it has not yet instituted any mandatory recalls and has instead worked to remove listings for these products and/or facilitate voluntary recalls.
  • On March 4, 2024, FDA published a webpage discussing the use of titanium dioxide (TiO2) as a color additive in foods. The webpage, which references a color additive petition requesting to revoke the listing for the use of TiO2 in foods, represents a stronger FDA stance regarding the safety of the additive.
  • TiO2, listed at 21 CFR 73.575, is a synthetically prepared white pigment that may be safely used as a color additive in nonstandardized foods at no more than 1 percent by weight of the food. TiO2 may also be used as a colorant in food contact materials, such as packaging materials, under 21 CFR 178.3297.
  • FDA highlighted a recent report from the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Committee on Food Additives (JECFA) that concluded that TiO2 is safe for use in food and that based on the available data, the total daily intake of the substance does not represent a hazard to health. Although the European Food Safety Authority (EFSA) took the position in a 2021 opinion that it could not rule out genotoxicity from TiO2, other international regulatory bodies have found the substance to be safe. According to the United Kingdom’s Food Standards Agency, Health Canada, and Food Standards Australia and New Zealand, there is no evidence to support that TiO2 presents any safety concerns when used in food. In addition, FDA stated that “some of the genotoxicity tests considered in the EFSA assessment included test materials not representative of the color additive, and some tests included administration routes not relevant to human dietary exposure.” Overall, FDA also did not identify genotoxicity concerns related to TiO2 and noted that the substance did not cause cancer in National Toxicology Program carcinogenicity studies.
  • The Codex Alimentarius Commission Committee on Food Additives will consider the JECFA and EFSA findings at its April meeting in Chengdu, China.
  • TiO2 was originally included in the list of substances California considered prohibiting in 2023; however, it was removed before the state passed the California Food Safety Act, banning four other substances from use in food.
  • Keller and Heckman will continue to monitor and report on any developments regarding TiO2.

  • The New York legislature has reintroduced S213B/A4424B to “protect children from junk food companies targeting them with false or misleading advertisements.” The bill passed the Senate last year, but failed to make it out of the Assembly’s Agriculture Committee. It has again advanced quickly out of committee in the Senate this year, but remains in committee in the Assembly.
  • General Business Law §§ 350 and 350-A currently prohibit false advertising generally, and Agriculture and Markets Law § 202-A prohibits false or misleading advertisements for food. Key provisions of the proposed law would:
    • Amend Section 202-A to require “special consideration” of whether food advertising is directed to children, in the analysis of whether food advertising is deceptive;
    • Amend Section 350-A to require a court to consider, in its deception analysis of food advertising, whether the advertising (1) “targets a consumer who is reasonably unable to protect their interests because of their age, physical infirmity, ignorance, illiteracy, inability to understand the language of an agreement, or similar factor,” or (2) is otherwise an “unfair act, practice, or conduct”;
    • Further amend Section 350-A to require that “special consideration” be given to advertisements directed to children, defined in another section as those “actually or apparently under the age of eighteen years.” The bill defines “consumer” as both “a person who is targeted by an advertisement” and “those acting on such a person’s behalf.” Consequently, the law would apparently apply not only to advertising aimed at children but also advertising aimed at parents or other caregivers, regardless of their age.
  • Conspicuously missing from the statute is any definition of “junk food,” making it difficult to interpret exactly what food advertising might be affected. These new provisions would be enforceable by state regulators, as well as the plaintiff’s bar, given language providing a private right of action.
  • Apart from the advertising implications, another provision would amend the mission of the Childhood Obesity Prevention Program – a Department of Health program developed in cooperation with other state agencies, including the Education Department. The provision would (1) strike current statutory language barring the program from “specifically targeting the elimination of any particular food group, food product, or food-related industry,” and (2) require the program to provide “education on access and the nutritional value of locally grown foods.” No definition of “locally grown foods” is provided.
  • Whether the law would survive a challenge based in the commercial speech doctrine remains to be seen. New York is currently litigating a lawsuit challenging its age restrictions on the sale of weight-loss and bodybuilding supplements to minors. The Bloomberg administration’s attempt to ban certain sales of sugary drinks in containers larger than 16 ounces garnered national attention before being struck down by the State Court of Appeals. On the other hand, the city’s 2006 ban on trans fats in restaurants ultimately caught on with other localities and eventually the FDA. In 2015, New York City began to require sodium requirements to be posted in chain restaurants, a practice upheld in court in 2017. More recently, New York reintroduced S6055A, a bill that would ban certain food additives in the state. That bill failed to pass last year.
  • Keller and Heckman will continue to monitor legislative and judicial developments affecting commercial speech and is always ready to assist advertisers seeking to take advantage of the full range of permissible speech.
  • On March 6, 2024, the U.S. Food and Drug Administration (FDA) sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the US, reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products.  The Agency also recommended the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain levels of lead.
  • This letter follows the recent incidents associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children.  As we have previously blogged, FDA’s investigation into the contaminated apple sauce pouches traced the contamination back to a manufacturer and cinnamon supplier in Ecuador.
  • FDA notified the distributors and manufacturers of products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe.  The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores.  No illnesses or adverse events have been reported to date related to the ground cinnamon products listed in this news release, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe.
  • Since the issuance of the letter, recipient companies El Chilar and Raja Foods, as well as Stonewall Kitchen and Colonna, have issued voluntary recalls for some of their cinnamon products.
  • FDA continues to work with the Center for Disease Control and Prevention (CDC), as well as state and local partners, to investigate elevated lead and chromium levels in individuals with reported exposure to apple cinnamon fruit puree pouches.  Keller and Heckman will continue to monitor and relay any developments in this area.
  • As we blogged about earlier this year, USDA will begin enforcing (i.e., implementing) the Strengthening Organic Enforcement (SOE) final rule on March 19, 2024.
  • The SOE rule, which makes changes to the Nation Organic Program (NOP) regulations at 21 CFR Part 205, is intended to improve oversight of organic integrity.
  • One of the many significant impacts of the rule is to increase the number of persons/businesses that are required to be certified as organic. For example, most importers, traders, and brokers of organic products, and facilities storing organic products, are now required to be certified (most retail operations remain exempt from certification).
  • More information on the SOE rule can be found at USDA’s website or, if you have questions on the rule, including whether you are now required to be certified, Keller and Heckman is ready to assist.
  • On March 4, 2024, FDA updated its list of select chemicals currently under review to include more information about the agency’s assessment of previously approved chemicals in the food supply. FDA first published a list in July 2023 to accompany an inventory of food ingredients that the agency determined through post-market review were not GRAS. The updated list includes food ingredients, food contact substances, and contaminants currently under FDA review, along with information about the status of the post-market assessments and links to public information about post-market actions.
  • For each of the chemicals in the list, FDA will progress through four risk review steps. First, FDA will review scientific information and engage with public health and research stakeholders to determine whether a risk and safety assessment is needed. If so, the agency will assess health effects on consumers, including vulnerable populations, to determine whether the chemical could pose a safety concern. Then, FDA will review the risk data to determine whether action is necessary to protect public health. Finally, FDA will take action, including revoking authorizations and approvals, working with industry on a voluntary market phase-out, developing action levels, issuing alerts, and providing information to consumers and industry.
  • The list is not intended to be comprehensive, but does include some of the contaminants that FDA is focused on through established programs like the Closer to Zero initiative and chemicals that stakeholders have asked FDA to review through citizen petitions. FDA intends to update the list regularly.
  • FDA’s assessment of chemicals in the food supply is part of its commitment to improving food safety under the proposed Human Foods Program. This program would include an Office of Food Chemical Safety, Dietary Supplements and Innovation, which is intended to develop a “systematic and more nimble process for evaluating chemicals in the food supply.”
  • Keller and Heckman will continue to monitor FDA’s post-market review of chemicals in the food supply.
  • On March 1, 2024, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not object to the use of certain qualified health claims regarding the consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are worded so as not to mislead consumers, and that other factors for the use of the claim are met.
  • A health claim characterizes the relationship between a substance and a disease or health-related condition.  A qualified health claim is supported by scientific evidence, but does not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim.
  • The letter is in response to a petition submitted on behalf of Danone North America that requested the Agency to review this qualified health claim.  The petition also noted that the evidence supports the health effects of yogurt as food rather than related to any single nutrient or compound and thus is independent of fat and sugar content.  FDA determined that there is some credible evidence supporting a relationship between yogurt intake and reduced risk of type 2 diabetes, but this evidence is limited.
  • FDA considers 2 cups (3 servings) per week of yogurt to be the minimum amount for this qualified health claim.  FDA intends to consider exercising its enforcement discretion for the following qualified health claims regarding the relationship between yogurt and reduced risk of type 2 diabetes:
    • “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.”
    • “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”
  • Earlier this month, Senator Bernie Sanders, who chairs the Senate committee on Health, Education, Labor, and Pensions (HELP), sent a letter to FDA commissioner Robert Califf in which he urged FDA to develop robust front of pack (FOP) labeling requirements for food to help consumers understand which products may be harmful to health, particularly with respect to children’s diets.
  • FDA has already conducted a literature review, two focus groups, and most recently, an experimental study on FOP labeling strategies. The research has focused on messages regarding sodium, added sugars, and saturated fat content. FDA’s unified agenda indicates that the agency intends to release a proposed rule regarding FOP labeling in June 2024 (but we wouldn’t be surprised if FDA misses that goal). 
  • However, Sanders criticized FDA’s efforts for not going “nearly far enough” and for designing a study which did not consider “some of the best international practices like the inclusion of an octagon symbol or health warnings” and which did not test for consumer purchasing preferences (the study focused on consumer understanding).
  • Sanders indicated that the HELP committee will hold a hearing on the issue in the near future and requested that FDA answer a list of questions regarding the design of the FOP study.
  • On February 26, 2024, Family Dollar Stores LLC agreed to pay $41.675 million after pleading guilty to storing food and drugs in unsanitary conditions in a rodent-infested warehouse. In addition to monetary penalties, Family Dollar and Dollar Tree stores must “meet robust corporate compliance and reporting requirements for the next three years.”
  • Family Dollar began receiving reports of rodent issues in its West Memphis, Arkansas, warehouse and in store deliveries in 2020, and by January 2021, employees were aware of the unsanitary conditions in the warehouse that caused FDA-regulated products to become adulterated. However, the company continued to ship the products until January 2022 when an FDA inspection revealed live rodents, dead and decaying rodents, rodent feces, urine, odors, and evidence of gnawing and nesting. Fumigation following the investigation resulted in the extermination of more than 1,200 rodents. In February 2022, the company initiated a recall of all drugs, medical devices, cosmetics, and human and animal food products sold since January 1, 2021, in the 404 stores that received shipments from the infested warehouse.
  • Family Dollar was sued over the rodent problem in a class action (Law360 subscription required) on February 23, 2022, following FDA’s investigation of the warehouse. The complaint alleged that Family Dollar knowingly omitted information about the infestation from advertising and promotion of its products and continued to ship products to its stores from the warehouse in violation of state consumer protection laws and deceptive trade and practice statutes. The complaint also alleges breach of implied warranty, unjust enrichment, and negligence.
  • DOJ officials commented that consumers “have the right to expect that the food and drugs on the shelves have been kept in clean, uncontaminated conditions” and that the DOJ will hold accountable companies that violate laws designed to keep consumers safe. Knowingly selling adulterated products both put public health at risk and eroded consumer trust in the safety of products they purchase. An FDA official commented that “When companies put themselves above the law and distribute food that has been held under extremely insanitary conditions, putting the public’s health at risk, we will see that they are brought to justice.”
  • Dollar Tree announced that it has created new compliance and safety roles and plans to open a “fully reimagined and refreshed distribution center” in West Memphis.