• 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.  
  • On February 22, 2024, the U.S. Food and Drug Administration (FDA) issued a guidance for industry that addresses how firms should voluntarily engage with the Agency before marketing food produced from genome-edited plant varieties.  The guidance reaffirms that the risk-based approach FDA has taken for foods derived from genetically engineered plans under the new plant variety policy also applies to the newer foods from genome-edited plants. 
  • FDA identifies and describes two processes by which firms may voluntarily inform FDA of steps they have taken to ensure food safety: (1) voluntary premarket consultations and (2) voluntary premarket meetings.  The voluntary premarket meeting is recommended for developers to inform the Agency of their foods when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics.  Voluntary premarket consultations are advised for products that are more likely to raise safety questions.
  • FDA’s Plant Biotechnology Consultation Program intends for developers to engage with the agency to determine appropriate oversight pathways to bring safe, innovative plant-based products to market.  Foods from genome-edited plants must meet the same food safety requirements as foods derived from traditionally bred plants.
  • FDA is currently accepting public comments on the draft guidance.  Keller and Heckman will continue to monitor and relay any developments in this area and can assist with any comment submissions.
  • Today, FDA unveiled its Information on Select Dietary Supplement Ingredients and Other Substances (the “Directory”), which is an updated version of the prior Dietary Supplement Ingredient Directory, which was released in 2023 and replaced the Dietary Supplement Ingredient Advisory List.
  • The Directory is intended to allow the public to quickly look up FDA commentary and/or actions on certain ingredients that have been used in products marketed as dietary supplements. The revised Directory adds categories classifying the type of agency action/communication (e.g., safety issue, absence of new dietary ingredient notification), records the date that each ingredient is added to the directory, and streamlines the introductory text on the webpage. 
  • The Directory represents FDA’s continued efforts to ensure that dietary supplements contain ingredients with an appropriate regulatory status and which are safe. In a 2022 draft guidance intended to encourage manufacturers and distributors of new dietary ingredients and dietary supplements containing new dietary ingredients to submit new dietary ingredient notifications (NDINs), FDA noted that it is likely that thousands of dietary supplements containing new dietary ingredients are unlawfully marketed without a NDIN.
  • A NDIN is required where a dietary ingredient has been used in dietary supplements for the first time after October 15, 1994 (i.e., a “new dietary ingredient”) and such ingredient has not been present in the food supply.
  • 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.