• On September 30, 2022, a federal court granted summary judgment in favor of the USDA (and other government defendants), thereby rejecting a challenge by several consumer organizations to the agency’s New Swine Slaughter Inspection Service (NSIS) Rule, which establishes an alternative voluntary inspection system (84 Fed. Reg. 52,300 (Oct. 1, 2019).
  • Plaintiffs argued that the NSIS Rule violated the Federal Meat Inspection Act (FMIA) by transferring statutorily required inspection duties to slaughterhouse employees. The Court rejected this argument because, consistent with the FMIA requirements, the NSIS Rule provided that every animal carcass was inspected by USDA inspectors pre- and post- slaughter. Contrary to the allegations, the new responsibilities of slaughterhouse employees under the NSIS Rule (e.g., sorting animals prior to slaughter and palpating and excising lymph nodes) were not inconsistent with FMIA and USDA’s inspection responsibilities. Indeed, they helped to facilitate them.
  • The Court also rejected Plaintiffs’ argument that USDA’s rulemaking process violated the Administrative Procedure Act (APA) because it irrationally departed from prior practice and was based on a flawed pilot project and risk assessment. In particular, the Court found that USDA had established that the new system would provide at least as much protection as the existing system and would improve the effectiveness of the inspection system.  Furthermore, the Court also found that USDA’s reliance on a pilot study, a risk assessment, and other data and information relied upon by the NSIS Rule was not arbitrary and capricious.
  • On October 6, 2022, FDA and CDC released data from the 2022 National Youth Tobacco Survey, a school-based, cross-sectional, self-administered survey of U.S. middle school (grades 6–8) and high school (grades 9–12). The study was conducted from January to May 2022. According to the survey, 14.1% of U.S. high school students and 3.3% of middle school students reported having used an e-cigarette at least once in the last 30 days.
  • This number is up slightly from 2021, when about 11.3% of high school students and 2.8% of middle school students reported using an e-cigarette at least once in the last month. That year, the survey was administered online as students around the country were engaged in remote learning due to COVID-19. As a result, FDA cautioned, “[d]ue to changes in methodology, including differences in survey administration and data collection procedures in recent years due to the COVID-19 pandemic, the ability to compare estimates from 2022 with those from prior NYTS waves is limited; differences between estimates might be due to changes in methodology, actual behavior, or both.”
  • Overall, the 2022 numbers indicate a sharp decline from the 19.6% of high school students and 4.7% of middle school students who reported previous-month e-cigarette use in 2020, the last time the survey was conducted completely in schools, and just after the federal legal age to purchase tobacco products, including e-cigarettes, was officially raised from 18 to 21 in January 2020. The year before, in 2019, past-30 day youth vaping peaked at 27.5% of high schoolers and 10.5% of middle schoolers:
    Past-30 day E-Cigarette Use Reported Among High Schoolers Past-30 day E-Cigarette Use Reported Among Middle Schoolers
    2022 14.1% 3.3%
    2021 11.3% 2.8%
    2020 19.6% 4.7%
    2019 27.5% 10.5%
  • FDA emphasized that the number of minors vaping illegally is still far too great, and that much works needs to be done. “It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use,” said FDA Commissioner Robert M. Califf, “We cannot and will not let our guard down on this issue.”
  • Also according to the CDC, traditional, combustible cigarette use among youth continues to fall to historically low levels. In 2021, 1.9% of high school students and 1.0% of middle school students reported smoking cigarettes in the past 30 days. A little over a decade ago, in 2011, 15.8% of high schoolers and 4.3% of middle schoolers reported smoking cigarettes.
  • FDA also announced the issuance of a warning letter to the distributors of Puff Bar, the synthetic nicotine disposable e-cigarette brand most popular among those students who reported vaping, as well as a Marketing Denial Order (MDO) denying marketing authorization for the Hyde disposable e-cigarette. The manufacturer of that product, however, indicated in a press release that it had actually received a Refuse-to-Accept (RTA) letter for a technical error in its Premarket Tobacco Product Application (i.e., failure to include a translation certification for certain materials in its application that were not in English), and not an MDO, which follows after a scientific review of a marketing application.
  • It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty. All authorized e-cigarettes are posted on the FDA’s Tobacco Product Marketing Orders
  • Be sure to follow our sister blog on tobacco and e-vapor matters, The Continuum of Risk, and register for Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15-16, 2023 in Irvine, California. Details and registration information can be found here.
  • On September 27, 2022, the White House announced the release of a strategy which aims to address food insecurity and diet-related diseases by 2030.
  • The five pillars of the strategy are: (1) improving food access and affordability, (2) integrating nutrition and health, (3) empowering all consumers to make and have access to healthy choices, (4) supporting physical activity for all, and (5) enhancing nutrition and food security research.
  • Proposals for the third pillar will likely be the most consequential for the food industry. In particular, the report indicates that:
    • FDA will study and develop appropriate front of pack (FOP) labels. We note that FDA recently received a citizen petition requested mandatory FOP labeling while Canada has recently mandated FOP labels, although the requirements will not be enforced until 2026.
    • FDA will update the nutrition standards for “healthy” claims. A proposed rule with criteria for “healthy” foods was published on September 29th.
    • FDA will publish a request for information to inform future guidance for the food industry regarding online labeling of nutrition, ingredient, and allergen information.
    • FDA will issue sodium reduction targets beyond those issued in a 2021 voluntary guidance document.
    • FDA will collaborate with other agencies and stakeholders regarding what steps can be taken to reduce intake of added sugars, the declaration of which has been required since 2021.
  • We will continue to monitor and report on developments in the implementation of the plan that impact the food industry.
  • On September 21, the FDA and the Centers for Disease Control and Prevention (CDC) entered into a Memorandum of Understanding (MOU) to outline an agreement through which both agencies intend to advance collaborative efforts to reduce the occurrence of foodborne illnesses in retail and foodservice establishments. The MOU outlines three primary goals:
    • (1) increase uniformity, consistency, and capacity of state, tribal, local, and territorial regulatory agencies (STLT) retail food protection programs;
    • (2) promote industry’s active managerial control (AMC) of foodborne illness risk factors and promote a culture of food safety; and
    • (3) maintain a strong FDA and CDC workforce to assist STLT partners.
  • To achieve the three primary goals, the FDA and CDC have the following objectives:
    • Improve STLT’s effectiveness in conducting inspections and investigations
    • Promote a culture of food safety and food safety management systems
    • Improve research in support of foodborne illness risk factor reduction
    • Improve the knowledge, skills, and abilities of the FDA and CDC staff
  • The FDA and CDC have historically worked together to control foodborne illness risk factors for foodborne illness outbreaks, and believe that this MOU will ensure enhanced continued collaboration on this type of work.
  • As You Sow and the National Confectioners Association released a report on August 18, 2022 that determines the predominant sources of lead and cadmium in chocolate products and how best to reduce these levels.  A multi-disciplinary panel of four experts have been investigating the matter for three years.  The report is part of the 2018 settlement agreement reached in As You Sow v. Trader Joe’s, in which the plaintiff alleged that numerous chocolate makers failed to warn the public about levels of lead and cadmium in their products, therefore violating California’s Proposition 65.
  • The report concludes that cadmium can be found in cacao and chocolate due to its presence in tropical soils where it is harvested.  Cadmium contaminates the roots of the plant, where it is then deposited into the nibs of the cacao beans.  The experts concluded a short term solution would be to mix high and low-cadmium cacao beans, whereas long-term reductions could be achieved by changing soil compositions or cacao genetics.
  • The investigation found that lead contaminates the outer shells of the cacao beans, rather than through the roots.  The sticky coating of the outer shells allows lead particles from soil, dust, and power plant air pollution to stick to the cacao beans as they are dried and fermented in open air.  The investigation revealed that, where feasible, minimizing soil contact and optimizing contaminant removal during the cleaning, roasting, and shell removal stages should help reduce lead contamination.
  • In the 2018 settlement, the parties agreed on new threshold levels of lead and cadmium that would trigger product warnings, based on cacao content: products with up to 65% cacao content (0.065 ppm and 0.320 ppm, respectively); products with between 65% and 95% cacao content (0.1 ppm and 0.4 ppm); and products with greater than 95% cacao content (0.2 ppm and 0.8 ppm).  Based on their findings, the experts could not reach an agreement whether it is feasible to lower the agreed upon lead and cadmium thresholds in chocolate.  All experts agreed that the trigger levels for lead were feasible to comply with and that it would be feasible to have a lower standard, but they disagreed with how low a level is feasible.  The majority of the four experts concluded it is not feasible to lower the cadmium thresholds.  Moving forward, the parties will meet to discuss whether or not to change the threshold levels for lead and cadmium put forth in the settlement.  Any party can file a motion with the court to request a change and, if approved, the change would take effect one year later.  If no motions to change threshold levels are made, the levels decided in the settlement will remain in place.
  •  After the publication of its May 2022 Enforcement Discretion Guidance (discussed here), FDA issued letters of enforcement discretion to various companies for marketing specific infant formula products in the United States without having submitted a mandatory new infant formula notice and perhaps not meeting all regulatory and statutory requirements for infant formula.  FDA’s policy is meant to increase the supply of infant formula in the U.S while ensuring that any non-compliant infant formula that it allows to be introduced into interstate commerce under this policy will be safe and nutritionally adequate.  As we have previously reported, FDA announced plans in June to facilitate the continued use of infant formula marketed under the enforcement discretion policy past its November 14, 2022 expiration date.
  • On September 30, 2022, FDA announced a new guidance, Infant Formula Transition Plan for Exercise of Enforcement Discretion, whereby manufacturers of infant formula marketed subject to enforcement discretion may submit information related to exempt infant formulas while continuing to market such products beyond November 14, 2022 while they work toward meeting all FDA requirements.  Specifically, FDA’s Infant Formula Transition Plan Guidance identifies phases and timing expectations as follows:

Phase 1: By December 5, 2022, covered manufacturers wishing to continue to market covered exempt infant formula products under FDA’s exercise of enforcement discretion after January 6, 2023, should submit to FDA a letter of intent identifying which specific infant formula products that the firm intends to bring into full compliance with all applicable regulatory requirements;

Phase 2: By February 28, 2023, covered exempt infant formula manufacturers should submit to FDA a detailed plan for meeting applicable infant formula requirements;

Phase 3: By August 1, 2023 covered exempt infant formula product manufacturers should submit information and documentation;

Phase 4: Data related to exempt status and clinical evidence should be submitted by January 5, 2024 (if a clinical study is not required), or June 6, 2025 (if a clinical study to support use of product for the intended medical condition is conducted); and

Phase 5: A New Infant Formula Submission must be made by February 16, 2024 (if a clinical study to support use for the intended medical condition is not required), or July 18, 2025 (if a clinical study to support use of product for the intended medical condition is conducted).

  • FDA’s Infant Formula Transition Plan Guidance will remain in effect until October 18, 2025, or later if FDA deems an extension necessary.  Any manufacturer of a new infant formula product, including a manufacturer that is not currently marketing an infant formula product under FDA’s May 2022 enforcement discretion policy, may submit a New Infant Formula Submission at any time.
  • In response to industry concerns for mislabeled beef products, U.S. Agriculture Secretary Tom Vilack recently said that the “Product of the USA” label on meat products should undergo a full-scale review. Vilack maintains that he is “committed to ensuring that the ‘Product of USA’ label reflects what a plain understanding of those terms means to U.S. consumers.” In March, we reported that the Tenth Circuit dismissed lawsuits based on meat producer’s use of allegedly deceptive and misleading “Product of the USA”  labels on their beef products that did not originate from cattle born and raised in the United States.
  • The issue of country-of-origin beef labeling (“COOL”) continues to be a source of debate. Earlier this week, the FTC finalized a rule that is intended to tighten the use of the Made in the USA standard. The FTC said that this update would benefit small businesses who lack the resources to defend their products from foreign imitators. However, the FTC rule does not require USDA action. In response, the beef industry is demanding Congress to act swiftly.
  • R-CALF, a group of USA-based cattle ranchers, has been pushing hard for reforms on COOL. On September 22, R-CALF released a poll that shows staggering support for mandatory COOL legislation by the American public. R-CALF reports that 86 percent of American voters support the American Beef Labeling Act that reinstates mandatory country of origin labeling for beef, and 90 percent of voters are concerned that foreign importers of beef can legally put a “Product of USA” sticker on a package containing beef that was born, raised, and harvested outside the United States.
  • Currently, Congress is working through prospective beef labeling legislation that would require USDA oversight of COOL. The American Beef Labeling Act (S.2716) is a bipartisan bill that was introduced in the Senate in 2021; however, the bill has languished without action in the U.S. Senate Agriculture Committee. In March 2022, a bipartisan companion bill was introduced in the U.S. House (H.R.7291), which has also seen little to no progress in the House Agriculture Committee. Keller and Heckman will continue to monitor these legislative developments and USDA action.

 

  • On September 28, 2022, FDA announced that it had issued a proposed rule with criteria for when foods can be labeled with the claim “healthy” on their packaging. The proposed rule intends to align the definition of the “healthy” claim with the updated nutrition facts label, the current Dietary Guidelines for Americans, and current nutrition science.
  • The proposed definition would permit the “healthy” claim on food products that (1) contain a certain meaningful amount (determined using the daily recommended amount) of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines (e.g., fruit, vegetable, dairy), and (2) adhere to specific limits for certain nutrients like saturated fats, sodium, and added sugars. The threshold for the limits is based on the percent of the Daily Value for the nutrient and varies depending on the food group.
  • With the proposed rule, FDA intends to empower consumers and help foster a healthier food supply by encouraging manufacturers to reformulate their food products to meet the updated definition. The agency is also considering the development of a symbol that manufacturers could use to demonstrate that their products meet the “healthy” claim criteria.
  • The proposed rule follows the White House Conference on Hunger, Nutrition, and Health as well as the release of the national strategy to end hunger and reduce diet-related diseases by 2030. FDA notes that it intends to continue taking steps to improve nutrition and health and that the agency’s future planned actions include developing a front-of-package labeling system, making nutrition information more easily available when grocery shopping online, and working to lower the sodium content of food in the food supply.
  • FDA is accepting comments on the proposed rule until December 28, 2022. Comments may be submitted by mail or electronically at regulations.gov (FDA Docket # FDA-2016-D-2335). Keller and Heckman will continue to monitor and report on any developments.
  • On September 27, the FDA released “Activities to Enhance the Safety of Imported Produce,” a report which details how the Agency’s 2019 strategy for safeguarding imported food specifically applies to imported produce. For background on the FDA’s “Strategy for the Safety of Imported Food,” see our February 2019 blog.
  • The new report outlines how the agency is working to enhance the safety of fresh fruits and vegetables through four goals that were established in the 2019 strategy document. The report details how the FDA works to achieve each goal.
    • Goal 1 – Food Offered for Import Meets U.S. Food Safety Requirements
      • Specifically for Goal 1, the FDA relies on international inspections, use of verified foreign suppliers through effective implementation of the FSVP final rule, audits such as those conducted under FDA’s Accredited Third-Party Certification Program or other programs aligned with FDA produce safety requirements, incentivizes importers to use verified suppliers through the Voluntary Qualified Importer Program (VQIP), leverages oversight efforts of regulatory counterparts with strong food safety systems, and increases awareness and training of produce safety requirements.
    • Goal 2 – FDA Border Surveillance Prevents Entry of Unsafe Foods
      • Some of FDA’s activities for Goal 2 include enhancing and refining FDA’s import screening and entry review process, optimizing use of sampling of imported produce, utilizing import alerts and import certifications, improving testing methods and tools to determine admissibility of produce offered for import, and maximizing the benefit to border surveillance from state and other partnerships.
    • Goal 3 – Rapid and Effective Response to Unsafe Imported Food
      • For Goal 3, the FDA maximizes effectiveness of FDA’s response to an event involving imported produce, enhances the efficiency and effectiveness of recalls, and uses information sharing-opportunities to prepare for and respond to unsafe imported produce.
    • Goal 4 – Effective and Efficient Food Import Program
      • For Goal 4, the FDA has developed an improved understanding of the global inventory of produce facilities and farms and conducts performance assessments of the effectiveness of import activities.
  • Keller and Heckman will continue to monitor and report on any developments that impact produce safety requirements.
  • On September 26, 2022, FDA released food safety prevention strategies for Salmonellosis and listeriosis associated with imported enoki and wood ear mushrooms and Salmonellosis associated with bulb onions.
  • The strategies are intended to help prevent the outbreak of foodborne illness associated with these foods and, building on the knowledge that FDA and its public health partners have learned during outbreak response investigations, they examine commodity-hazard pairings, potential sources of contamination, actions that can be taken to reduce incidence of future outbreaks, and knowledge gaps that require further research.
  • FDA is working on other food safety prevention strategies which will be released as they become available.