• On August 3, the FDA announced that it will be hosting a free hybrid public meeting to discuss the modernization of FDA recalls on September 29. The session will provide an opportunity for interested parties to share information and feedback on topics related to FDA-regulated recalls, including the following:
    • General recall preparations / contingency planning
    • Creating successful recall strategies, including methods to reach underserved communities
    • Initiating a recall
    • Strategies for public warning, including press releases, social media, and other communication tools
    • Increasing efficiency and effectiveness of recall information exchange
    • Ensuring effective recalls
    • Terminating a recall
    • Strategies for reducing recall recurrence for similar situations
  • Interested parties must register for the event at this link. The session will take place on September 29, 2023 from 9AM-5PM, and will be held both in-person and virtually.
  • Stakeholders may submit comments on the modernization of recalls to www.regulations.gov, using Docket ID: FDA-2023-N-2393. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • On July 31, the Association of American Feed Control Officials (AAFCO) approved the new “Model Regulations for Pet Food and Specialty Pet Food” which set a new standard for pet food manufacturers and distributors to follow when developing pet food labels, including standardized nutrition information, clear ingredient statements, and storage and handling instructions. AAAFCO and stakeholders have been collaborating to develop revised pet food regulations since 2015 pursuant to the Pet Food Label Modernization (PFLM) project.
  • AAFCO hopes that the pet food label changes will enhance transparency and provide clearer information in a more consumer-friendly format and recommends a transition period of 6 years for the pet food industry to incorporate the label and packing changes to products. Key updates to pet food labels include the following:
    • Nutrition Facts Box – Updated to resemble human-food labeling more closely.
    • Intended Use Statement – Updated to new location on the lower-third of the front display panel to help consumers easily identify the purpose of the pet food.
    • Ingredient Statement – Updated to clarify the use of consistent terminology and allow parentheticals and common or usual names for vitamins.
    • Handling and Storage Instructions (optional) – Updated and standardized with optional icons for greater consistency.
  • Keller and Heckman will continue to monitor developments that impact the regulation of pet food.
  • Last month the U.S. District Court for the Northern District of New York dismissed a class-action lawsuit filed by Spencer Sheehan which alleged that Starbucks coffee labeled as “100% Arabica” mislead consumers into thinking that the coffee contained no additives when in fact it contained “significantly greater than expected levels of potassium” as indicated by “[r]ecent reports based on laboratory analysis.”
  • The Court made short work of the allegations. First, the complaint contained only vague allegations of elevated potassium levels and did not include or cite to any laboratory analysis on which the Court could determine the potassium levels in the product. Second, even if the Court could establish that the product contained elevated potassium levels, the Court held that a reasonable consumer would interpret 100% Arabica to mean that the product contained coffee beans exclusively from the arabica plant, and not that it contained no additives.  
  • The Court is considering imposing sanctions against Plaintiff’s attorney Spencer Sheehan for filing a frivolous lawsuit and has ordered the attorney to show cause as to why sanctions are not appropriate. Sanctions are appropriate only where it is clear that there is no chance of success under existing law and there is no reasonable argument to modify existing law. In issuing this extraordinary order, the Court considered that Spencer Sheehan has filed 18 actions in the same district since 2021, all of which have been dismissed, and that other New York district courts have threatened him with sanctions for frivolous claims.
  • Spencer Sheehan has filed a response arguing that sanctions are inappropriate and that he had a good faith basis to file the claim, but the Court has not yet ruled on the issue.

Kraft Beats Claims Velveeta Dish Took Too Long To Cook (Law360 Subscription Required)

  • A proposed class action filed last year in the Southern District of Florida alleges that Kraft Heinz Co. falsely markets microwavable single serve cups of Velveeta mac and cheese as “Ready in 3½ minutes” and consumers are misled to expect the product will be ready for consumption in a shorter amount of time than it really takes to prepare.  In support of her claims, the plaintiff points to the directions on the back of the packaging that show 3½ minutes is the length of time for microwaving, which is only one of several steps to prepare the product. 
  • On July 27, 2023, the judge ordered the Velveeta lawsuit dismissed without prejudice but also without leave to amend for lack of standing to bring claims for damages and injunctive relief.  The plaintiff’s initial complaint, stating that she purchased the product “between October and November 2022, among other times,” was found to contradict her allegation that she paid a premium price due to the misrepresentation of the required preparation time.  The court reasoned that these multiple purchases demonstrate that the plaintiff continued to pay the alleged price premium knowing that the product was not actually capable of being ready for consumption in 3½ minutes and, as such, show she was not deprived of the benefit of her bargain. 
  • This case exemplifies the importance of the threshold jurisdictional question of standing when a plaintiff alleges not to have received the benefit of the bargain.  A court cannot otherwise consider the merits of the claims if the plaintiff lacks standing. 
  • Representative Keith Self (R-Texas) submitted an amendment to H.R. 4368, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2024. The amendment would prohibit funds in the underlying bill from being used to write, prepare, or publish any final or interim final rule relating to the proposed rule or otherwise enforcement of the proposed rule “National Organic Program; Organic Livestock and Poultry Standards” (OLPS).
  • If finalized, the OLPS proposed rule would standardize livestock health care practices, provisions for livestock handling and transport for slaughter and avian living conditions, and would expand and clarify existing requirements for livestock care and production practices. The OLPS proposed rule was published in August of 2022, and the comment period closed in October. In a press release about the OLPS proposed rule, the USDA stated that the rule “would change the USDA organic regulations to promote a fairer and more competitive market for organic livestock producers, by making sure that certified USDA livestock products are produced to the same consistent standard.”
  • The amendment would block any funding for the implementation or enforcement of the OLPS proposed rule, which would update and strengthen animal welfare standards under the NOP. However, according to the Organic Trade Association (OTA) CEO Tom Chapman, the amendment threatens more than just the update to animal welfare standards: “Organic producers and anyone who values organic needs to realize that this is about a whole lot more than animal welfare. […] the entire structure that governs USDA’s National Organic Program would be weakened, ultimately causing severe economic harm to tens of thousands of organic producers and businesses across the country, and irrefutably shaking the confidence of consumers in the USDA Organic label.” OTA has committed to stop the amendment.
  • Keller and Heckman will continue to monitor and report on the progress of the amendment.
  • On July 21, 2023, the U.S. Food and Drug Administration (FDA) denied a petition requesting that the agency reconsider its denial of a citizen petition issued May 19, 2022.  The petition requested a ban on the use of eight ortho-phthalates (phthalates) and revocation of the prior sanctioned uses for five ortho-phthalates in foods based on alleged safety concerns.
  • Phthalates are chemicals used in plastic products (most commonly in polyvinyl chloride (PVC or vinyl)) to make the material soft and less brittle.  Some phthalates may be used in food packaging or other minor food contact uses such as components of adhesives, lubricants, and sealants.
  • FDA concluded that the reconsideration petition does not provide a basis for modifying the FDA’s response to the original petition.  FDA states that it “adequately considered relevant information and views contained in the administrative record when responding to the original citizen petition.”  FDA has stated that evidence suggests that at this time the use of phthalates in food contact applications is limited and consumer exposure to phthalates from food contact uses is decreasing.
  • Keller and Heckman will continue to monitor and relay any key developments relating to food contact materials.
  • Although some consider the Netherlands to be the birthplace of cultivated meat, cultivated meat has not yet received pre-market approval in the European Union (EU).  Nevertheless, the Netherlands has forged ahead and announced that cultivated meat and seafood can be taste tested subject to the conditions set forth in the Code of Practice for Safely Conducting Tastings of Cultivated Foods Prior to EU Approval (Code of Practice). The Code of Practice is modeled after the principles used by the European Food Safety Authority (EFSA), although the review process is less extensive.  The proposed tastings will be evaluated by a panel of four experts who will conclude the tasting is either is “safe under the proposed conditions of tasting” and can proceed or “not safe under the proposed conditions of tasting” and cannot proceed. Information that must be submitted includes a description of the cultured cells, a description of the production process including all constituents of the growth media, safety information for all constituents, and an exposure assessment for all constituents. 
  • The Code of Practice also includes requirements regarding participants, procedures for the tasting, and limits testing to those conducting business in the Netherlands.
  • The United States and Singapore are currently the only countries where cell-cultivated meat products have received clearance for marketing.  For recent developments in the United States, see our previous articles on GOOD Meat’s label approval and USDA’s Directive to Inspection Program Personnel as Cell-Cultured Meats Begin to Enter the U.S. Market.
  • Keller and Heckman will continue to monitor and report on regulatory developments of cell-cultivated meat.
  • We reported on FDA’s October 26, 2020 notice of a voluntary pilot program under which FDA would assess whether private third-party food safety audit standards submitted in the study are aligned with food safety requirements in two FDA Food Safety Modernization Act (FSMA) regulations – the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.  From this 2021 pilot study, FDA planned to determine whether alignment determinations could create efficiencies for industry and FDA investigators. 
  • In a July 17, 2023, Constituent Update, FDA announced the release of the findings from the voluntary pilot program.  FDA found that the three audit standards submitted in the pilot program are in alignment with the existing requirements of the PC Human Food Rule and one audit standard is in alignment with the requirements of the Produce Safety Rule, other than the requirements for agricultural water for non-sprout produce, which were not reviewed because the rule was under reconsideration when pilot submissions were received.  FDA’s finding of alignment means that while specific elements of the third-party food safety standards and the FSMA implementing regulations may not be identical, the relevant technical components of the PC Human Food Rule or Produce Safety Rule have been addressed in the submitted audit standards.  Findings from FDA’s reviews of aligned standards can be accessed on the website, The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules.  FDA notes that the findings from this pilot study do not constitute an endorsement of any one food safety audit standard, or audits conducted under such standards. 
  • FDA’s announcement reiterates that a finding of third-party audit standards alignment could help give importers and receiving facilities confidence that the standards used to audit their suppliers adequately address applicable FDA food safety requirements and, along with results of a firm’s audits, could help FDA determine risk prioritization and resource allocation.  Nevertheless, FDA concluded that it does not currently have adequate resources to continue to review and evaluate the alignment of third-party food safety standards beyond this pilot. 
  • On July 20, U.S. Senators Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Representative Earl Blumenauer, D-Ore., reintroduced legislation, called the “Hemp Access and Consumer Safety Act,” to ensure hemp-derived CBD products are regulated by the FDA like other substances used in dietary supplements and foods. In summary, the Act would:
    • Give hemp-derived CBD products an opportunity to lawfully be used in foods and dietary supplements under the FD&C Act;
    • Prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD; and
    • Ensure that these CBD products are properly labeled.
  • The reintroduction of the Act comes six months after FDA’s January 2023 statement regarding the Agency’s approach towards CBD and its application in the food and drug industry. Specifically, the FDA, with the help of a high-level internal working group, concluded that a new regulatory pathway for CBD was needed and that the Agency expects to collaborate with Congress on this matter, although a timeline for action was unknown.
  • Of the Act, Senator Wyden stated that “[d]espite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back. […] The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.” The bill is endorsed by various advocacy organizations and trade associations, including U.S. Hemp Roundtable, Wine and Spirits Wholesalers Association, Vote Hemp, and numerous others.
  • Keller and Heckman will continue to monitor and report on the progress of the bill.
  • Center for Drug Evaluation and Research (CDER) researchers recently conducted a study titled, The effect of food vehicles in vitro performance of pantoprazole sodium delayed release sprinkle formulation, to better understand the oral drug effectiveness when sprinkled onto or into certain foods.  “Sprinkling” a drug into food vehicles is a common alternative for patients who have difficulty swallowing solid foods or medications.  Previous research has shown that mixing incompatible foods and drugs may impact the drug’s rate of dissolution in the gastrointestinal tract, potency, and may even lead to undesired side effects.
  • Researchers focused on pantoprazole sodium (antacid), which patients are currently advised to mix with applesauce or apple juice, as supported by in vivo data described in the labeling.
  • The study evaluated several food vehicles and their effect on the in vitro performance (i.e., the process of dissolving in the body) of the drug.  Researchers chose apple juice and applesauce, as well as pudding, yogurt, and milk.  The foods differed in their viscosity (thickness), pH level (or how acidic/basic an item is), and water content. 
  • In the study, the researchers sprinkled the pantoprazole sodium granules on the food vehicles for different amounts of contact time (30, 60, or 120 minutes).  Then they placed the mixture into a dissolution apparatus for in vitro dissolution testing and took samples after various time periods.
  • Researchers found that the food’s pH and the length of time it was mixed with the drug affected drug performance.  When researchers mixed the drug into low pH food vehicles, such as applesauce or apple juice, the drug performed similarly to the control group.  Conversely, high pH food vehicles, such as milk, with a long contact time (e.g., 120 minutes) caused premature drug release, drug degradation, and loss of performance.  In conclusion, researchers confirmed that an in vitro assessment can detect the effect of the food vehicle on drug performance, which has implications for evaluating drug safety and efficacy.