• 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.

 9th Circ. Says Hydroponic Food Can Use ‘Organic’ Labels (subscription to Law360 required)

  • As previously covered on this blog, the U.S. District Court for the Northern District of California ruled on March 18, 2021 against a group of traditional organic farmers and the Center for Food Safety (CFS) that challenged the U.S. Department of Agriculture’s (USDA) denial of their 2019 petition that asked USDA to bar organic certification of hydroponically grown crops on the basis that crops grown without soil cannot comply with the essential requirement of the Organic Foods Production Act (OFPA) that crop production farm plans “contain provisions designed to foster soil fertility.”  Accepting USDA’s “equally persuasive” interpretation of the OFPA to mean that if crops are grown in soil, their producers must take measures to preserve that soil’s “fertility,” the court found that USDA did not err in deciding that the OFPA does not prohibit hydroponic systems from qualifying for the National Organic Program (NOP).
  • On September 22, 2022, the Ninth Circuit affirmed the lower court ruling in favor of USDA’s policy of permitting hydroponically grown crops to qualify for the NOP, finding that the OFPA does not clearly require USDA to issue the requested rule that would bar such crops from organic certification.  The court recognized plaintiff appellants argument that the OFPA requires that organic products “be produced and handled in compliance with an organic plan,” but rejected the contention that hydroponics are excluded from the NOP based on the impossibility of hydroponics complying with the OFPA’s requirement that crop production farm plans “contain provisions designed to foster soil fertility.”  Instead, the court found USDA’s interpretation that the organic plan provision at issue applies only to crops grown in soil to be consistent with another section of the OFPA that provides “other production and handling practices…shall be permitted unless it is determined that such practice would be inconsistent with the applicable organic certification program.”
  • Interestingly, the plaintiffs did not discuss distinctions in the OFPA between a “plan” and a “practice.”  The OFPA requires that organic products “be produced and handled in compliance with an organic plan,” which by definition must include “written plans concerning all aspects of agricultural production or handling described in this chapter including crop rotation and other practices as required under this chapter.”  The contested provision on soil fertility is found in a section of the OFPA titled, “Organic plan,” and describes mandatory “practices” for a crop production plan that assumes crops are grown in soil.  In this regard, while not prohibiting other nonconflicting “practices,” the OFPA does not contain provisions for an “organic plan” that is applicable to hydroponics.
  • On September 14, 2022, Food and Drug Administration (FDA) officials reported a new outbreak of infections from Listeria monocytogenes. FDA has not yet identified a particular product linked to the pathogenic bacterial outbreak but has initiated traceback procedures. To date, FDA has confirmed 6 patients from this week’s Listeria outbreak, and the numbers appear to keep rising. It is still unclear what age group or geographic location has been afflicted by the outbreak.
  • FDA is currently actively investigating ten foodborne illness outbreaks with increasing patient numbers every week. The Center for Disease Control (CDC) continues to actively investigate a sizable E. coli outbreak suspected to have been caused by romaine lettuce served at Wendy’s restaurants in Indiana, Michigan, Ohio, and Pennsylvania starting in early September 2022. To date, 43 individuals have been hospitalized due to E. coli poisoning, and 13 new patients have been accounted for this week alone. Other current FDA investigations include a Salmonella Typhimurium outbreak that now affects 30 individuals, a Cyclospora outbreak whose patient count is now 81, and a Salmonella Mississippi outbreak that now afflicts 103 patients nationwide.
  • Notably, in March 2022, FDA opened a similar investigation into a Listeria outbreak caused by ice cream products originating from Big Olaf Creamery in Sarasota, Florida. This investigation is still ongoing, but has resulted in 24 patient hospitalizations, 1 death, and 1 miscarriage across 11 states. Keller and Heckman will continue to monitor these outbreaks as they impact the food industry.
  • On September 6, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it had reviewed a new genetically-modified tomato from Norfolk Plant Sciences.  The tomato has been modified to enhance nutritional quality and to have a purple color.
  • By way of background, under 7 CFR Part 340, developers may submit a Regulatory Status Review (RSR) request to APHIS when they believe that a modified plant is not subject to further regulation and oversight by USDA. In reviewing the request, APHIS will consider whether the plant may pose an increased plant pest risk.
  • According to Norfolk Plant Sciences’ RSR request, the tomato variety was genetically modified to produce enhanced levels of endogenous anthocyanins in the fruit, which are associated with a reduced risk of chronic and degenerative diseases, such as cardiovascular disease, obesity, and certain cancers. USDA determined that the tomato does not pose any increased plant pest risks, and that the plant may be safely grown and used in breeding in the U.S. Notably, this appears to be the is the first and only RSR to be submitted and responded to by APHIS.


  • In May, FDA Commissioner Robert M. Califf, M.D., requested an internal agency review of the FDA’s actions related to multiple reports of Cronobacter in infants, the temporary shutdown of Abbot Nutrition’s facility in Sturgis, Michigan, and confounding issues that led to a shortage of infant formulas. On September 20, the FDA released the report, “FDA Evaluation of Infant Formula Response,” which includes information obtained from more than 40 interviews with over 60 FDA staff and leadership involved with the events.
  • The report identifies five major areas of need in order to ensure the safety of the food supply:
    1. Modern information technology that allows for the access and exchange of data in real time to all the people involved in response.
    2. Sufficient staffing, training, equipment, and regulatory authorities to fulfill the FDA’s mission.
    3. Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously.
    4. Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how this translates into appropriate control measures and oversight.
    5. Assessment of the infant formula industry, its preventive controls, food safety culture and preparedness to respond to events.
  • The report highlights that there is no single action to pinpoint as the cause of the events that occurred. Rather, it was “a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area.” The report also identifies several areas in which FDA lacks authority, and how additional authorities and resources could enhance the agency’s capabilities.
  • In addition to this internal agency review, Commissioner Califf also requested an evaluation by an external group led by Dr. Jane Henney and supported by the Reagan-Udall Foundation that is intended to review various aspects of the Foods Program, including structure, function, funding, and leadership.
  • A class-action lawsuit filed by Spencer Sheehan on September 18, 2022, alleges that an apple pie product advertised as “made with real butter” is deceptively advertised because its primary shortening ingredient is palm oil, which the complaint argues is contrary to consumer expectations and results in an inferior product. As disclosed on the ingredient list, the second ingredient is “shortening butter blend,” which consists of palm oil and butter (in that order of predominance), and palm oil and soybean oil are the third and fifth most predominant ingredients, respectively.
  • Citing to 21 CFR 101.4(b)(14), the complaint argues that “shortening butter blend” is an inappropriate common name because it improperly combines animal and vegetable fats into a single ingredient name and that its sub-ingredients (palm oil and butter) should be listed individually in order of predominance. Plaintiff states that the product contains more soybean oil, water, and salt than butter, and that if butter were listed as an individual ingredient, it would be “closer to the least predominant ingredient.” It is not clear how Plaintiff can make this claim since ingredient lists disclose only relative amounts of ingredients. Furthermore, even if Plaintiff’s interpretation of Section 101.4(b)(14) was correct (and it is not clear that it is), a technical violation of an FDA labeling rule at best provides only some evidence of consumer deception.
  • The complaint is similar to other complaints filed by Spencer Sheehan relating to butter and vegetable oils that have been dismissed on the grounds that the products in question did not make representations that butter was the exclusive ingredient and the ingredient lists accurately disclosed the products’ contents. See BEF Foods Class Action (dismissing lawsuit and holding that “made with real butter” was not misleading where mashed potato product at issue also contained vegetable oils); see also Pepperidge Farm Class Actions (dismissing lawsuits and holding that “Golden Butter” crackers were not deceptively labeled where they contained vegetable oils as a secondary shortener). Nevertheless, we expect that Spencer Sheehan will try to distinguish the cited cases on the grounds that they involved products where butter was present in a greater amount than the challenged vegetable oils. In contrast, vegetable oils are more predominant than butter in the product at issue.

 Judge Backs Most Of GMO Labeling Rule, Bans QR Codes (subscription to Law360 required)

  • The National Bioengineered Food Disclosure Standard Law of 2016 (discussed here) amended the Agricultural Marketing Act of 1946 to require the U.S. Department of Agriculture (USDA) to develop mandatory uniform national bioengineered (BE) food disclosure standards for human food.  The law provides three options for a BE disclosure: text, a USDA-created symbol, or electronic or digital link (i.e., a Quick Response (QR) code that directs scanners to online information).  For QR codes, however, the law directs USDA to conduct a consumer accessibility study and, if necessary, to provide additional and comparable options to access the BE disclosure.  As reported here, the mandated Study of Electronic or Digital Link Disclosure identified significant challenges that may impact whether consumers can access the BE food disclosure through electronic or digital links.  In December 2018, USDA’s Agricultural Marketing Service (AMS) published final regulations that include text messaging as a fourth option for providing BE information with improved consumer access.
  • On September 14, 2022, a judge in the U.S. District Court for the Northern District of California ruled on a motion for summary judgement that was filed by natural and organic grocers and advocacy organizations challenging the BE disclosure standard and the implementing regulations promulgated by AMS.  Most of the challenges to the National Bioengineered Food Disclosure Standard (NBFDS) were dismissed, including a challenge of the rule’s use of the word “bioengineered” instead of more familiar terms such as “genetically engineered” or “genetically modified organism,” and a challenge to the rule’s exclusion of highly refined foods that do not contain detectable amounts of modified genetic material.  Summary judgement was granted to the plaintiffs, however, on an Administrative Procedure Act (APA) challenge to the electronic or digital link provisions of the NBFDS.  The court found that by leaving the QR code disclosure method as a standalone option (after USDA’s study revealed significant access problems) and adding a fourth disclosure option that regulated entities can select instead of the electronic disclosure method fails to comply with Congress’s express direction to “provide additional and comparable options to access the bioengineering disclosure.”
  • At USDA’s urging, the text message disclosure decision was remanded without vacatur so that the food industry and consumer access to BE disclosures will not be disrupted while USDA revisits this provision of the NBFDS.  According to the Center for Food Safety website, CFS and the other plaintiffs will consider appealing the court’s decision to uphold other provisions of the NBFDS.
  • On September 8, 2022, FDA announced that it was performing targeted sampling of leafy greens as part of its Leafy Greens STEC Action Plan (LGAP). Specifically, FDA is sampling leafy greens grown on farms and ranches in the Salinas Valley region of California during the 2022 harvest season.
  • The sampling will begin in mid-September and run through October. FDA intends to collect about 240 samples from farms and ranches in the Salinas Valley that were identified as being potentially associated with a foodborne illness outbreak. Along with leafy green samples, FDA may also collect environmental samples including water and soil. The samples will be tested for Salmonella spp. and E. coli O157:H7.
  • The Agency also released its results from a 2021 sampling assignment, in which the agency detected Salmonella enterica in one green leaf sample and Shiga toxin-producing E. coli in two other samples. The LGAP sampling effort seeks to detect and prevent contaminated products from reaching consumers and help leafy green growers to strengthen the safety of their operations. Further information on LGAP can be found on FDA’s website.
  • On September 13, the FDA announced the availability of the 4th edition of a draft guidance for industry entitled “Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4).” The draft guidance adds three additional questions. One question discusses systems recognition or equivalency determinations. The other two questions relate to FDA’s notice of a refusal under 801(m)(1) of the Federal Food, Drug, & Cosmetic Act (FDCA) for inadequate prior notice or a hold if the food article is from a foreign facility that is not registered, and also address the timeframe for making requests for FDA review of such a refusal or hold.
  • As per the Notice of Availability, the update to the draft guidance clarifies that the existence of a Systems Recognition Arrangement with or an equivalence determination of a foreign country does not exempt imported foods from that country from FDA’s prior notice requirements. It also intends to clarify when FDA will provide notice of the refusal or hold to the relevant party, and when the 5-calendar-day clock to request a review of the refusal or hold begins.
  • Stakeholders may submit comments on the draft guidance by November 14. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.