• Effective January 1, 2023, sesame joined the list of major food allergens.  The U.S. Food and Drug Administration (FDA) now requires that foods containing sesame are subject to specific food allergen regulatory requirements, including labeling and manufacturing requirements.
  • This addition to the list of major food allergens is the result of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which was signed into law April 23, 2021.  With the addition of sesame, there are now nine major food allergens that trigger these special disclosures: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.  Previously, in November 2020, FDA recommended food manufacturers voluntarily disclose sesame as an ingredient on food labels.
  • Foods introduced into interstate commerce before 2023 do not need to be removed from the marketplace or relabeled to declare the presence of sesame.  Accordingly, depending on shelf life, it will be some time before all sesame-containing products feature updated allergen disclosures.
  • In a December 30 order, an Illinois federal judge dismissed a proposed class action lawsuit against Target which alleged that the brand’s Market Pantry “fruit punch” flavored concentrated liquid water enhancer misled consumers into believing the product contained only natural fruit flavoring (subscription to Law360 required).
  • The Market Pantry “fruit punch” product declares “Natural Flavor with Other Natural Flavors” on the principal display panel and lists “malic acid” as the second ingredient. Plaintiff Jessica Gouwens argued that based on her own lab analysis, the product contained artificial dl-malic acid, and therefore the product’s front label should have also disclosed the presence of artificial flavor. She alleged that she would not have purchased the product had she known that dl-malic acid was an ingredient.
  • However, U.S. District Judge Iain Johnston held that Plaintiff Gouwens did not sufficiently plead that the flavor labeling omission would mislead a significant portion of the targeted consumers to be deceived or misled into thinking that the product’s taste was only from natural flavors. The flavor labeling statement “Natural flavor with other natural flavors” does not amount to an affirmative representation that the product is free from artificial flavors. Indeed, Judge Johnston states “[a] reasonable consumer would not believe that a shelf-stable, bright red fruit punch flavored liquid water enhancer was free of artificial ingredients absent an affirmative statement to the contrary.”
  • Gouwens sought to pursue her claims on behalf of a class of Illinois consumers, as well as consumers in several other states, for violations of consumer fraud laws. The case was dismissed with prejudice.

  • On December 28, 2022, FDA issued the 2022 edition of the Food Code. The FDA Food Code represents FDA’s best advice to address the safety and protection of food offered at retail and in food service, and is intended to be a model for adoption by state, local, tribal, and territorial regulatory bodies.
  • The last update to the Food Code was in 2017 and typically the Food Code is updated on a four-year cycle. However, FDA weighs retail food stakeholder input through the Conference for Food Protection and, in this cycle, the conference was pushed back to 2021 due to the COVID-19 pandemic. Accordingly, FDA adjusted the Food Code release by a year. The next edition will be published in four years (2026).
  • The changes to the Food Code include:
    • The addition of provisions relating to food donation, clarifying that food which is stored, prepared, packaged, displayed, and labeled according to the code’s safety provisions can be donated.
    • Adding sesame as a major food allergen to be consistent with the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which established sesame as the 9th major food allergen and went into effect on January 1st of this year.
    • Informing consumers, in writing, of major food allergens as ingredients in unpackaged food.
    • Adding labeling of major food allergens in bulk food that is available for consumer self-dispensing.
    • Creating new requirements for the allowance of pet dogs in outdoor dining spaces.
    • Revising the definition of intact meat, including enhancements to clarify time/temperature cooking requirements.
  • A comprehensive list of changes to the Food Code can be found here.
  • On December 15, 2022, Consumer Reports published an article in which they report that some dark chocolate bars contain excessive amounts of cadmium and lead. Cadmium and lead are heavy metals that have been linked to adverse health effects.
  • Scientists at Consumer Reports measured the amount of heavy metals in 28 dark chocolate bars from a variety of brands. Cadmium and lead were detected in all of the bars that were tested. Further, the article notes that for 23 of the bars, eating an ounce per day could exceed levels established by public health authorities and Consumer Reports.
  • The article notes that dark chocolate has a reputation for being healthier treat because of its cocoa solids which include antioxidants. However, the cocoa solids also contain the heavy metals. For that reason, the article concludes that dark chocolate is generally higher in heavy metals than milk chocolate.
  • Research shows that lead and cadmium may get into the cacao in different ways – with cadmium being absorbed from the soil during growth and lead getting in after beans are harvested. Thus, Consumer Reports suggests that addressing the contamination will require different solutions for each heavy metal. In the meantime, the article urges consumers to be mindful of the risks and minimize potential harms where possible.
  • On December 20, the FDA issued the final guidance document, “Best Practices for Convening a GRAS Panel.” A “GRAS panel” means a panel of qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food as part of a Generally Recognized As Safe (GRAS) determination.
  • In most cases, a substance’s GRAS status can be determined without a GRAS panel if the safety of the substance is supported by evidence of general acceptance. For example, peer-reviewed primary safety studies or secondary reviews of primary literature may provide evidence of general acceptance. However, the guidance explains the value of a GRAS panel in providing evidence to support “general acceptance,” and also highlights best practices to help those interested in convening a GRAS panel:
    • Identify GRAS panel members who have appropriate balanced expertise;
    • Take steps to reduce the risk that bias will affect the credibility of the GRAS panel report, including the assessment of potential members for conflict of interest and the appearance of conflict of interest; and
    • Limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).
  • The FDA intends for the clarification of best practices to help promote a consistent, science-based approach to evaluating the safety of substances added to human or animal food. The Agency advises that the recommendations of this final guidance be consulted  regardless of whether the GRAS status is submitted to the FDA as a GRAS Notice or whether it is an independent conclusion (i.e., self-GRAS position).
  • The Office of Science and Technology Policy (OSTP) issued a request for information (RFI) today in which it invites public comment on the Coordinated Framework for the Regulation of Biotechnology (the “Coordinated Framework”).
  • The Coordinated Framework, which is a Federal regulatory policy for ensuring the safety of biotechnology products, was first issued in 1986, updated in 1992— to affirm that federal regulation should focus on characteristics of the product and the environment into which it being introduced, and not on the process by which it is produced—and then updated again in 2017 to clarify the roles of EPA, FDA, and USDA. And, in September of this year, Executive Order 14081 directed the three agencies to clarify and streamline regulations to support the safe of use of biotechnology products.
  • Accordingly, the RFI requests comment on seven questions related to the Coordinated Framework. The questions include a request for comment on identification of any regulatory gaps, inefficiencies, or uncertainties; data or information to improve any identified issues; and new or emerging biotechnology products that the agencies should be prepared to address. Comments to the RFI are due by February 3, 2023. Also, on January 12, 2023, OTSP will host a virtual event in which it will listen to public feedback on the RFI.
  • The manufacture, sale and import of livestock feeds are regulated in Canada under the Feeds Act and Regulations and Health of Animals Act and Regulations administered by the Canadian Food Inspection Agency (CFIA).  In 2021, the CFIA proposed amendments that would repeal and replace its outdated Feeds Regulations, 1983.  CFIA consulted with the public regarding 9 proposed incorporated by reference (IBR) documents including the Canadian Feed Ingredients Table (CFIT). 
  • On December 13, 2022, the CFIA released an overview and request for comments on proposed changes to the CFIT resulting from feedback on the initial public consultation and the CFIA’s further internal review of the CFIT for clarity and consistency.  The proposed changes in the CFIT include:
    • changes to the glossary,
    • amendments to the names of the classes and subclasses,
    • review of names of single ingredient feeds (SIFs),
    • standardization of labelling statements,
    • standardization of caution and warning statements,
    • standardization of worker safety statements,
    • standardization of required labelling statements that contain to health and safety information, and
    • standardization of other required labelling statements.

In addition, the updated CFIT reflects all SIFs that were added or modified as a result of the regular SIF approval process subsequent to the earlier public consultation on the updated Feeds Regulations. 

  • The proposed changes to the CFIT are open for consultation from December 13, 2022 to January 14, 2023.  The CFIA anticipates publishing the final amendments to the Feeds Regulations, including the updated CFIT, in the Canada Gazette in spring 2023. 
  • Update: The formal Federal Register notice was published on December 20, 2022, and comments are due on February 21, 2023.
  • On December 14, 2022, at an open meeting of the Federal Trade Commission (“FTC” or “Commission”), FTC commissioners voted unanimously to publish a Notice in the Federal Register announcing a Request for Public Comments on potential amendments to the Commission’s Guides for the Use of Environmental Marketing Claims (“Green Guides” or “Guides”). 
  • The FTC solicits comments on the ongoing need for the Guides and on specific claims addressed in the Guides, including “recyclable,” “recycled content,” “degradable,” “compostable,” and more. It also asks if it should initiate a rulemaking process and address claims it declined to consider during the last review, such as “organic” and “sustainable.”
  • Importantly, given the growth in some state laws that purport to restrict claims, the FTC asks for input on whether the Guides conflict with federal or state laws. This proceeding is expected to garner significant input.
  • Once the Notice is published in the Federal Register (which the FTC anticipates will be in mid-January 2023), interested stakeholders will have 60 days from the date of the Notice to submit comments to the FTC, unless an extension is granted. 
  • For more information about the FTC Notice, please read our report here.
  • EMA occurs when someone intentionally leaves out, removes, or substitutes a valuable ingredient in a food or when a substance is added to a food to make it appear better or of greater value.
  • The sampling was designed to identify products that contained less expensive undeclared added sweeteners, such as corn and cane syrups.
  • FDA collected and tested 144 samples of imported honey from bulk and retail shipments from 32 countries.  FDA found 10% of samples to be violative and refused entry of these violative shipments into the U.S.  The associated companies and products have been placed on an import alert.
  • Violative samples are subject to agency action, such as recall and import refusal and, where appropriate, FDA may consider pursuing criminal investigations.
  • You can refer to this FDA Guidance for more information on proper labeling of honey and honey products.
  • On December 12, the FDA published a systematic review of the scientific literature on food safety culture (FSC) as part of the Agency’s New Era of Smarter Food Safety blueprint. As our readers know, the FDA launched the blueprint in July 2020 as a means to outline the Agency’s plan to create a safer food system over the next decade. The FDA commissioned the systematic literature review to produce a synthesis of the published literature to answer three overarching questions:
    1. What is FSC?
    2. How is FSC developed and maintained?
    3. How is FSC assessed?
  • As discussed in the literature review, while FSC is defined in various ways, the most frequently cited definition defined FSC as “the aggregation of the prevailing, relatively constant, learned, shared attitudes, values and beliefs contributing to the hygiene behaviors used within a particular food handling environment (Griffith, Livesey, and Clayton 2010).”
  • The literature review identifies key determinants that contribute to a FSC, such as leadership and communication, and also describes some best practices to promote FSC, including promoting FSC as a necessary and critical business matter for all employees. However, the authors found that there is a gap in the literature about what a strong and effective FSC would look like among general consumers and about how FSC is defined in a regulatory agency. Similarly, the literature does not take into account employees’ diverse political, familial, racial, and other cultural identities or how these identities may influence FSC.
  • The FDA intends to use this research to inform its continued efforts in support of food safety culture and as a means to implement effective food safety management.