Greetings from “Table Talk” Juris Law Group Monthly Food Digest, where we delve into noteworthy developments in the realm of food regulation over the past month. In this issue, we explore significant updates in food regulation, including FDA guidance changes, third-party safety audits, and state-level legislation that could impact your business. As always, we welcome your feedback and invite you to reach out to our team with any questions or comments. For queries or further discussion, you’re welcome to reach out via email at [email protected].
- FDA’s Issuance of Warning Letters to Three Manufacturers of Infant Formula
In late August, the FDA took significant action by issuing Warning Letters to three manufacturers of infant formula. These letters were the outcome of extensive facility inspections conducted at each company over the past few months. Importantly, these inspections led to the issuance of a Form 483 and the initiation of a product recall due to concerns regarding potential contamination by Cronobacter sakazakii.
The FDA’s decision to release these Warning Letters was accompanied by an official press release. In this statement, the FDA underscored that these actions are part of their routine regulatory process and reflect their ongoing commitment to bolstering regulatory oversight.
Of particular note within these Warning Letters is the FDA’s clear expectations concerning the conduct of root cause investigations when pathogens are identified. The FDA has voiced strong criticism of these companies for failing to perform whole genome sequencing (WGS) analysis on Cronobacter sakazakii strains discovered in their facility environments. The agency views WGS as a critical tool for conducting comprehensive root cause analyses. For instance, WGS results could reveal whether the same strain of the pathogen is responsible for multiple contamination incidents. This information is invaluable in determining the appropriate corrective actions and verification procedures needed to effectively address the contamination issue. It’s worth noting that the FDA had previously expressed its stance on the significance of conducting WGS on finished product and environmental isolates and comparing these findings as part of a thorough root cause analysis. This perspective was outlined in the FDA’s Letter to Industry dated March 8, 2023.
The significance of these Warning Letters extends beyond the infant formula industry. The FDA’s strong emphasis on the role of WGS in root cause investigations has broader implications. The agency is actively urging companies to embrace WGS as a fundamental tool for root cause analysis, especially in situations where there is a potential resident pathogen within the facility environment. This development underscores the FDA’s commitment to ensuring the safety and quality of products across various sectors.
- FDA Reveals Traceability Rule Inspection Schedule and Unveils New FAQs
The FDA has recently made significant updates to its Food Traceability Frequently Asked Questions (FAQs), shedding more light on the agency’s Product Tracing System and addressing various compliance-related inquiries pertaining to the Traceability Rule.
One of the notable points of this update is the confirmation that the compliance date for the Traceability Rule remains January 20, 2026, for all entities subject to the rule. However, the FDA has stated its intention not to commence routine inspections for compliance until the year 2027. It’s important to note, though, that FDA may still conduct inspections for compliance with the rule on a case-by-case basis, particularly during outbreak investigations, once the stipulated compliance date of January 20, 2026, is reached.
The FAQs further outline FDA’s ongoing efforts to establish an internal Product Tracing System (PTS) for the receipt and analysis of food traceability data from industry stakeholders. Companies will have the option to provide electronic traceability records to FDA through the Safety Reporting Portal (SRP), a secure web-based platform. Alternatively, they can transmit their electronic records to FDA via email, with FDA subsequently handling data uploading into the PTS. Once uploaded, the PTS will automatically process this information into a standardized supply chain visibility data format known as EPCIS (Electronic Product Code Information Services). It’s important to clarify that while EPCIS is an openly accessible data standard that can promote interoperability across supply chains, it is not a mandatory requirement for compliance with the Food Traceability Rule, and there’s no obligation to furnish FDA with food traceability data in EPCIS format.
Following data processing, the information will be accessible to authorized government users through an open-source data visualization platform called FoodChain Lab (FCL). This platform is designed to create comprehensive end-to-end supply chain diagrams based on the processed data, which can then be overlaid onto interactive geographic maps. FDA anticipates that this automated visualization functionality will be instrumental in identifying potentially contaminated foods or ingredients during foodborne outbreak investigations.
The significance of these developments lies in the FDA’s decision to postpone routine inspections until 2027, providing businesses more time for compliance preparations. However, companies should recognize that the full compliance period may be necessary to update their recordkeeping practices effectively. Therefore, it is imperative for companies to promptly devise their compliance strategies. Should you require assistance in conducting a gap assessment or have inquiries regarding compliance with the traceability rule, please feel free to reach out to us.
- FDA’s Listening Session Regarding Recall Modernization
On September 29th, the FDA hosted a day-long public listening session on recall modernization. Over 40 stakeholders, including consumers, manufacturers, and related industries, participated. Although the discussion covered all FDA-regulated products, the main focus was on foods and medical devices. A recording of the session will be available on the FDA’s website soon.
Why it matters: You can still submit written comments to the FDA until October 27, 2023, to contribute to the recall modernization efforts. This is a chance to influence recall procedures and regulations across various industries. You can submit your form by accessing this link.
- Passage of California Legislature’s Baby Food Heavy Metal Testing and Disclosure Bill
On September 13, the California state legislature successfully passed AB 899, a legislative measure aimed at amending the Sherman Food, Drug, and Cosmetic Law within the state. This amendment introduces a set of comprehensive testing and disclosure mandates targeting lead, mercury, cadmium, and arsenic in baby food products, applying to items that are “sold, manufactured, delivered, held, or offered for sale in the state.” As of now, the bill awaits the consideration of Governor Newsom.
Throughout the legislative session, the bill underwent several revisions. The final version, which you can access here, outlines specific testing requirements for the presence of lead, cadmium, mercury, and arsenic. It also establishes proficiency standards for laboratories entrusted with conducting these tests. Additionally, the bill mandates certain products to bear a QR code on their packaging, guiding consumers to pertinent testing results and providing access to the FDA’s guidance on the health implications of heavy metals, particularly on children.
This development holds significant implications. If Governor Newsom affirms the bill by signing it into law or takes no action by October 14, the legislation will be enacted. This means that manufacturers will be obligated to comply with testing requirements commencing on January 1, 2024, followed by the implementation of disclosure requirements on January 1, 2025. These requirements, unique to the state of California, represent a notable step towards enhancing safety standards for baby food products, addressing concerns related to heavy metal contamination that currently lack comprehensive regulations at both the state and federal levels.
- FDA’s Release of Additional FSMA Guidance
The FDA has recently unveiled two highly anticipated chapters from its multi-chapter draft guidance, strategically crafted to assist food facilities in complying with the preventive controls for human food rule under FSMA (21 CFR Part 117).
The first of these chapters focuses on a critical aspect of food safety, major food allergens. It outlines comprehensive guidelines on how food facilities can establish and implement a robust food allergen program. This program encompasses various elements, including the adoption of good manufacturing practices, allergen preventive controls, label controls, and the implementation of a supply chain program, where applicable.
The second chapter delves into the realm of acidified foods. It provides valuable insights into how manufacturers can leverage practices developed to meet the requirements of the acidified foods regulation (21 CFR Part 114) to fulfill their obligations under the FSMA preventive controls rule.
Importantly, stakeholders and interested parties have the opportunity to contribute their input on these draft chapters. The FDA is welcoming comments, with a submission deadline set for March 25, 2024. This engagement is vital as it ensures that the agency considers a wide range of perspectives and insights as it proceeds with the finalization of this guidance. These chapters represent a significant step in bolstering food safety regulations and practices within the industry, and your input can play a pivotal role in shaping their ultimate form.
- FDA’s Details on Virtual Public Meetings Regarding Reducing Added Sugars Consumption
The FDA has announced upcoming public meetings and listening sessions set for November 6-8, 2023, focused on reducing added sugars consumption in the U.S. These sessions aim to explore efforts by federal agencies, communities, and private industry in this regard.
You can register for these sessions here and submit questions during registration.
The listening sessions offer a chance to provide feedback on future steps to reduce added sugars intake. Starting November 6, 2023, you can submit comments on this topic to the Regulations.gov docket (FDA-2023-N-3849) until January 22, 2024. Your involvement can help shape strategies to tackle this important health issue.
- FDA’s Progress on Front of Pack Nutrition Labeling Consumer Research
Following approval from the White House Office of Management and Budget, the FDA has initiated a quantitative consumer research endeavor focusing on Front of Pack Nutrition Labeling (FOPNL). This research encompasses six preliminary FOPNL concepts and three simulated food products, including breakfast cereal, frozen meals, and canned soup.
In addition to this research, the FDA has outlined plans for upcoming focus group studies that will take place subsequent to the quantitative research. These sessions are designed to further enhance the FDA’s comprehension of how consumers respond to various FOPNL schemes. These upcoming focus groups will present participants with FOPNL designs across a broader range of food products, including pasta sauce, orange juice, whole wheat bread, sports drinks, frozen dinners, iced coffee beverages, whole grain cereals, and carbonated soft drinks.
The significance of this consumer research lies in its pivotal role in shaping the FDA’s strategy to propose a rule establishing an FOPNL system for packaged foods. Notably, many of the schemes under evaluation are “interpretive,” implying they go beyond providing purely informational content. This approach raises legal questions regarding the FDA’s authority under the Federal Food, Drug, and Cosmetic Act and its adherence to the First Amendment in mandating such information on food packaging.
The FDA has been actively advancing its FOPNL initiative and anticipates presenting a proposed rule in 2024. This timeline represents a slight adjustment from the previously announced goal of December 2023. Consequently, the outcomes of this research will significantly influence the direction and potential regulatory requirements in the realm of Front of Pack Nutrition Labeling.
- Annual Conference Hosted by NAD on Developments in Advertising Law
The National Advertising Division (NAD) of BBB National Programs recently held its annual advertising law conference in Philadelphia. During the event, NAD attorneys discussed emerging trends they’ve observed in recent cases, including increased scrutiny of endorsements, consumer reviews, environmental claims, and the use of seals and certifications in advertising.
Food and beverage cases made up 13% of all NAD decisions over the past year, consistent with previous years. NAD also highlighted its ongoing efforts to streamline decision-making and expedite case resolution.
The conference featured panels that brought together industry experts and government representatives to share best practices and discuss topics like claim substantiation, AI in advertising, consumer reviews, influencer endorsements, and environmental and social benefit claims.
Sam Levine, Director of the Federal Trade Commission’s Bureau of Consumer Protection, outlined the FTC’s consumer protection priorities. These priorities include addressing junk fees, deceptive pricing, and challenging “dark patterns” in online interfaces designed to manipulate consumer behavior. The FTC recently proposed updates to its negative option rule to make canceling recurring subscriptions easier. Levine also mentioned sending notice of penalty offense letters to approximately 670 companies and the FTC’s intent to pursue targeted enforcement actions related to substantiation, seeking injunctive and monetary relief.
Importance: The NAD plays a pivotal role in influencing the landscape of claims and advertising. Therefore, gaining insights into case trends and the priorities of both the NAD and the FTC is essential for the success of any robust advertising and marketing compliance program.
- Citizen Petition Requests FDA to Designate Gluten as a Major Food Allergen
Celiac Journey, a patient advocacy group founded by a family with a celiac disease-affected child, has submitted a citizen petition to the FDA. They’re requesting two key actions: (1) mandating the inclusion of “gluten containing grains” (defined as wheat, barley, rye, and oats) in ingredient statements for all packaged foods, and (2) adding gluten to the list of allergens that require management for cross-contact, aligning with the agency’s Compliance Policy Guide 555.250.
Celiac Journey emphasizes the importance of this petition by noting the growing prevalence of celiac disease, which affects over 3.3 million Americans. They argue that this move would align with the Biden Administration’s goals of serving underserved communities, including those with celiac disease.
Significantly, if the FDA were to treat gluten as an allergen for labeling and cross-contact management, it would likely necessitate a substantial effort from the industry, similar to the preparations made for the FASTER Act that included sesame as a major food allergen.
The petitioner asserts that the FDA already possesses the legal authority to enact these changes, referencing 21 U.S.C. Section 343(x) and citing substantial support for treating gluten as an allergen from comments submitted in response to FDA’s April 2022 draft guidance on evaluating the public health importance of non-“major food allergens.”
The FDA has opened a docket for comments on Celiac Journey’s petition, providing an avenue for stakeholders to weigh in on this important issue.
- District Court Judge’s Varied Rulings on Malic Acid Labeling Challenges
In two class action cases challenging the labeling of similar products, a federal district court judge in the northern district of Illinois made divergent rulings on motions to dismiss (MTD) concerning the same issue. In one case, the judge granted the MTD with prejudice, while in the other, she denied it. Both cases revolved around allegations that consumers were misled by drink mixes containing malic acid, considered artificial, and used as a flavor without disclosure on the front label panel.
In the first case, the judge ruled that no reasonable consumer could be misled because the package clearly stated “Natural Flavor with Other Natural Flavors,” which didn’t represent an affirmative claim of being free from artificial flavors. The judge asserted that label omissions are actionable only if they create an “affirmatively false impression,” not an “incomplete” one.
However, the second case had a different outcome. Here, the label not only featured the “Natural Flavor with Other Natural Flavors” statement but also included a “no artificial flavors” claim. The judge found this combination plausible for the plaintiff’s argument that a reasonable consumer could be misled.
This matter holds significance as plaintiff’s lawyers persist in challenging the labeling of products containing malic acid, leading to numerous pre-suit demand letters and court complaints. While some judges exhibit skepticism towards such claims, the varying outcomes in these Illinois drink mix cases underscore the evolving nature of labeling cases. Ultimately, the specific language used to convey product attributes remains a crucial factor, emphasizing the importance of details in these cases.
- Ongoing Progress in Heavy Metals Litigation
In the wake of reports from Congressional committees and NGOs revealing the presence of heavy metals in baby food, spices, and chocolate, plaintiff’s attorneys have initiated a series of class actions. These cases are slowly progressing through the courts, with judges recently issuing rulings on motions to dismiss in cases involving all three product categories in September. Despite rejecting defendants’ arguments based on preemption and primary jurisdiction, the judges have taken actions ranging from dismissing two of the cases (with an opportunity to amend) to significantly narrowing the claims in the third case.
These developments carry significance as they shed light on the challenges plaintiffs face in crafting complaints that center on the undisclosed presence of heavy metals and can withstand well-structured motions to dismiss. For instance, in the spice case, the court dismissed the plaintiff’s argument that the label phrase “The Taste You Trust” constituted an affirmative misrepresentation of safety, deeming it non-actionable puffery. In the absence of such statements and plausible allegations regarding the unsafe levels of heavy metals or deviations from industry standards for warnings about heavy metals in spices, the judge dismissed all counts in the complaint.
While these cases are ongoing, these early results underscore that constructing a complaint in such cases can be a complex task for plaintiffs. It’s worth noting that defendants have also achieved dismissals in other heavy metal-related cases on primary jurisdiction grounds, and the question of primary jurisdiction concerning baby food is currently under consideration by the 2nd Circuit.
We value your perspective, so if you have any comments or feedback, don’t hesitate to contact any member of our team. We are keen to hear your thoughts.
