• On March 15, 2024, the Consumer Brands Association (CBA) filed an amicus brief (Law360 subscription required) urging the 9th Circuit to keep a federal labeling rule allowing digital disclosure of genetic modifications to foods. The brief, which follows two similar briefs filed earlier in March by the federal government and sugar industry groups, tells the court that it “should not disturb” a 2022 ruling that left the National Bioengineered Food Disclosure Standard regulations largely intact after the rule was challenged by organic food organizations.
  • CBA’s SmartLabel tool is one program that is used widely on packaged goods to provide access to supplemental product information through a QR code. According to the amicus brief, vacating the digital disclosure provision of the regulations would instantly render millions of packages of food non-compliant, disrupt the manufacturing process, and delay the release of products while labels are revised. In addition, “any such instant change would threaten consumers’ access to safe, nutritious, and affordable foods and risk confusing consumers who . . . have increasingly begun to rely on digital disclosures.”
  • In the original lawsuit, filed in 2020, food advocacy groups claimed USDA’s rule was arbitrary and capricious because it did not deliver on the aims of the National Bioengineered Food Disclosure Act and that portions of the rule violated the First, Fifth, and Tenth amendments by limiting allowed disclosures and preempting state laws requiring additional disclosures.
  • CBA argued that the advocacy groups’ position that consumers would have difficulty accessing digital disclosures is incorrect since consumers have increased internet access and technological literacy, a telephone disclosure is also required, and the digital option reduces “the impact of over-warning on products.” According to CBA, vacating the rule could, in fact, further reduce consumer access to the information required by the disclosure rule while USDA amends the regulations. CBA also refuted the contention that there would be minimal industry disruption, claiming that an immediate change would leave food companies scrambling to interpret the court’s decision and that it would be impossible to make immediate packaging changes.  

Buyers Want An End To 7-Year Pause In Kix Cereal Suit – Law360 (subscription to Law360 required)

  • In 2015, when now ubiquitous “natural” lawsuits first began proliferating, FDA solicited comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.  As reported here, action was stayed in numerous lawsuits challenging “natural” claims on various bases.  Although the comment period closed in May 2016, FDA has not taken any further action to define “natural.” 
  • In an April 4, 2023 letter (see Law360), consumer plaintiffs claiming General Mills lied about Kix cereal made with genetically modified (GM) corn being “all natural” asked a New Jersey federal judge to end a nearly 7-year old stay of the proposed class action, arguing that food regulators are no closer today to adopting rules on bioengineered food being labeled “natural” than they were when the litigation was first stayed in 2016.  Aside from a brief period in 2021 when both sides requested a stay while pursuing a deal to end the litigation, the plaintiffs have vigorously opposed the stay, which has nevertheless been continued at least 10 times since it was imposed on June 13, 2016.  The plaintiffs project that the case may quickly settle if the stay is lifted. 
  • As significant time has passed without further movement since FDA signaled potential activity in 2015, stays have been lifted in some “natural” class action litigation that had been paused pending FDA action.  For example, in the Chobani litigation discussed here, the judge explained in lifting a 2-year stay in 2019 that the court “cannot sit idly by on an illusory assurance that something is likely to happen.”  In the General Mills lawsuit, however, the court may be again willing to wait for FDA due to a lack of urgency where the phrase “natural” was discontinued on Kix boxes in 2016. 
  • A class-action lawsuit filed at the end of last year alleged that Non GMO (genetically modified organism) claims on many of Gerber’s baby food products are false and misleading because the products contain ingredients derived from genetically modified crops and protein and/or dairy sources derived from cows raised on genetically modified feed.
  • The lawsuit alleges that Non GMO and similar claims (e.g., GMO free) are understood by consumers in a manner consistent with the definitions set forth by the Non GMO Project, a non-profit organization that offers a “Non GMO Project” certification which requires that the certified foods contain no genetically modified processes or inputs (e.g., animal food products derived from animals fed genetically engineered feed). Plaintiff credits the widespread use of the Non GMO Project label and the educational outreach efforts of the organization with aligning consumer expectations with the Non GMO Project Standard.
  • The case presents interesting issues because “Non GMO” has no defined regulatory meaning. Disclosure of the presence of genetically modified material in foods is regulated by USDA’s National Bioengineered Food Disclosure Standard (BE Standard), which mandates labeling of food that contains bioengineered material (the BE Standard uses the term “bioengineered” instead of GMO). However, claims regarding the absence of genetically modified material are regulated by FDA and, while FDA has issued a guidance document regarding these voluntary absence of genetically modified material claims, the document does not define what it means to be “Non GMO.” In fact, the Guidance discourages (but does not prohibit) the use of the term GMO in favor of terms such as genetically engineered and further recommends against the use of “Non GMO” and similar claims because of the potential substantiation challenges.
  • Compounding the difficulty of determining the meaning of Non GMO is the fact that the absence of a required bioengineered disclosure (under the BE Standard) does not mean that a food is necessarily “Non GMO.” For example, as at issue here, a food sourced from animals fed genetically modified/GMO feed is not required to be labeled as bioengineered under the BE Standard, but it would not meet the Non GMO Project’s definition of Non GMO. For our reporting on a legal challenge to the BE Standard, see our prior post.
  • We will monitor and report on this case and any other developments on the meaning of Non GMO and similar claims.
  • Last year several food organizations, including the Center for Food Safety and Natural Grocers among others, filed a motion for summary judgment seeking to invalidate USDA’s national bioengineered (BE) food disclosure standard (the “Standard”) on the grounds that it is unconstitutional and inconsistent with its authorizing statute, the National Bioengineered Food Disclosure Act (the Disclosure Act).
  • By way of background, the mandatory compliance date for the Standard was January 1st of this year, and without any court ruling on the merits of the case, all regulated entities are expected to comply with the Standard.
  • Plaintiffs challenge the Standard in part on the following grounds:
    • The Standard exempts highly processed foods which contain no detectable BE material. Plaintiffs argue that such foods can and likely will contain BE material and that the exemption is contrary to the Disclosure Act’s mandate to implement regulations covering disclosure of “any bioengineered food and any food that may be bioengineered” (emphasis added). They also argue that the exemption, which does not mandate the use of any particular technologies, creates a shifting standard and serves as a disincentive for food companies to develop and to use more sensitive technologies. Further, they argue that consumers want to know whether the food they are eating is part of the BE crop system (e.g., because of potential environmental impacts) and are not focused on whether BE material can be detected in the food.
    • The Standard mandates the term “bioengineered,” and disallows use of words such as “genetically engineered” and GMO, which Plaintiffs argue are terms better understood by consumers and widely used by a variety of stakeholders, including consumers, industry, and government agencies, including USDA itself.
    • Plaintiffs argue that USDA’s own study demonstrated that the QR code disclosure option fails to provide many consumers with a feasible means to access information and therefore the standalone QR code disclosure option runs afoul of the Disclosure Act.
    • Finally, the motion argues that the Standard is unconstitutional for a variety of reasons, including that it prevents truthful and not misleading commercial speech (e.g., through prohibition of use of the word GMO).
  • We will continue to monitor and report on this case and other developments that could impact BE labeling.
  • On November 23, organic food industry groups and advocates filed a Motion for Summary Judgment asking a California federal judge to declare the USDA’s National Bioengineered Food Disclosure Standard (NBFDS) invalid, and vacate and remand the rule, as well as to sever constitutionally infirm provisions of the National Bioengineered Food Disclosure Act (the “Act”) and declare them invalid (subscription to Law360 required). The plaintiffs, which include Natural Grocers, Citizens for GMO Labeling, Good Earth Natural Foods, National Organic Coalition, and Center for Food Safety, among others, argue that the NBFDS violates the Disclosure Act, the Administrative Procedure Act, and the Constitution. The lawsuit was originally filed on July 27, 2020.
  • Specifically, the plaintiffs state that the NBFDS falls short of fulfilling the promise of meaningful genetically engineered (GE) food labeling, as intended by the Act. As written in the plaintiffs’ memorandum, the NBFDS “excludes most GE foods from mandatory disclosure, limits the applicable labeling terminology to the obscure “bioengineered,” and allows disclosure in a form never before approved in a federal label – electronic Quick Response (QR) codes – that the Agency itself determined would conceal disclosures from many Americans.” Further, plaintiffs’ argue that the NBFDS forbids retailers from going further than what is permitted by the Standard, and restricts their ability to communicate the presence of GE ingredients or foods using familiar means and terms.
  • In a statement by their attorney, Meredith Stevenson, the Center for Food Safety noted that “[c]onsumers have fought for decades for their right to know what’s in their food and how it’s produced. But USDA instead used its authority to label GE foods by obscuring this information behind QR codes and unfamiliar technology and omitting the majority of GE foods. Fortunately, the law is [on] consumers’ side.”
  • Keller and Heckman will continue to monitor this case and report any updates.
  • The USDA’s Agricultural Marketing Service (AMS) issued final guidance to assist regulated entities in complying with the National Bioengineered Food Disclosure Standard (NBFDS). By the mandatory compliance date of January 1, 2022, regulated entities will need to disclose whether food offered for retail sale is bioengineered (BE) or contains BE ingredients. The final guidance discusses two possible ways entities can show their products do not contain BE material and thus avoid disclosure: (1) verifying that the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable (7 CFR 66.9(b)), and (2) utilizing acceptable testing methods to confirm the absence of modified genetic material (7 CFR 66.9(c)).
  • The Guidance to Ensure Acceptable Validation of a Refining Process outlines eight general steps: (1) identify raw materials, ingredients, and product-contact materials; (2) define characteristics and intended use of end product; (3) define the sequence and interaction of all processing steps used to arrive at the end product; (4) identify key step(s) in the refinement process that may influence the end product’s characteristics and its ability to meet specified requirements; (5) assemble relevant validation information that demonstrates the refinement process operates as intended to meet specified requirements (end product characteristics), conducting studies as needed; (6) continually verify the refinement process is operating as validated; (7) revalidate the refinement process, as applicable, if significant changes are made to the process; and (8) maintain record(s) of the validation and ongoing verification.
  • As our readers may recall, we previously covered the draft instructions for acceptable testing methods to confirm the absence of detectable modified genetic material. The final Guidance on Testing Methods is largely similar, and addresses five main topics: (1) general considerations in selecting a test method; (2) DNA-based methods; (3) emerging technologies and other methods; (4) general considerations in selecting a laboratory; and (5) recordkeeping requirements.
  • Keller and Heckman attorneys are well-versed in the NBFDS requirements and would be happy to assist with any questions about compliance with the final validity and detectability guidance documents.
  • On March 31, an Ohio federal judge dismissed a proposed class action lawsuit which alleged that J.M. Smucker Co. misleadingly labeled peanut butter as “natural” even though it may have contained sugar derived from genetically modified beets.  The complaint was dismissed because the “consumers’ claims were too speculative and insufficient to show that a reasonable consumer would be misled.”
  • In the order, U.S. District Judge John R. Adams said that plaintiff Graham Forsher did not allege that the Jif brand natural peanut butter was actually genetically modified, but only that one of the product’s ingredients may have been. Forsher did not provide any facts showing that the Jif peanut butter contained sugar derived from genetically modified beets, but rather simply alleged that half of the sugar production in the US comes from sugar beets. He similarly did not show that sugar actually contains any bioengineered material. Forsher argued that where food is made with ingredients possibly derived from bioengineered food, it is misleading to label the product as “natural.”
  • Judge Adams also took issue with Forsher’s failure to state adequate facts to back his assertion that genetically modified sugar beets are unnatural: “Alleging that food is created in a lab ‘utilizing different modern scientific techniques’ is not the same as alleging that ingredients are unnatural. Plaintiff does not claim that GMO-derived sugar beets are chemically created. Plaintiff also does not point to a specific statute or regulation that would deem GMO-derived sugar beets as unnatural. Defendant has complied with the FDA’s policies and regulations regarding product labeling to the extent the sugar in the Products is derived from GMO sugar beets.”

 

  • As previously covered on this blog, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) implements the National Bioengineered Food Disclosure Standard (the Standard).  On January 1, 2022, which is the mandatory compliance date for the rule, regulated entities must disclose whether food offered for retail sale is bioengineered (BE) or uses BE food ingredients.  The regulatory definition of “bioengineered food” excludes foods where modified genetic material is not detectable and USDA’s regulations discuss “detectability” at 7 CFR 66.9.  In the issuing the final rule, USDA AMS indicated it would provide further instructions on two of the provisions by which a regulated entity can determine that modified genetic material is not detectable: (1) acceptable testing methodology and (2) validating a refining process.  As we reported, USDA AMS released draft instructions for validation of refining processes on December 17, 2019.  Today, USDA AMS released for comment its draft instructions regarding acceptable testing methodology.
  • The draft instructions for acceptable testing methodology describe factors to consider when selecting a test method that is fit for the purpose of demonstrating that a food does not contain detectable modified genetic material.  The draft instructions state that entities should use validated methods accepted by international bodies (e.g., International Organization for Standardization (ISO) and Codex Alimentarius Commission (Codex)) and/or validate their own methods.  The following international standards are referenced:  ISO 24276 Foodstuffs -Methods of analysis for detection of genetically modified organisms and derived products- General requirements and definitions, ISO 21571 Nucleic Acid Extraction, ISO 21569 Qualitative Nucleic Acid Analysis, ISO 21570 Quantitative Nucleic Acid Analysis, and Codex document CAC/GL 74-2010 Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods.  Additionally, the instructions address DNA-based methods (e.g., polymerase chain reaction (PCR) methods both qualitative and quantitative are noted as being “acceptable”), emerging technologies, and other methods, as well as general considerations in selecting a laboratory and record keeping requirements.
  • Comments on the new draft instructions are due by March 4, 2020.  After USDA reviews the comments received they will publish final instructions on testing methods on their website.  Keller and Heckman has the legal and scientific expertise to assist you as you implement your validated testing methods for your refining processes. We will continue to monitor and report on developments that impact BE labeling.

 

  • On December 30, 2019, USDA’s Food Safety and Inspection Service (FSIS) published updated labeling guidelines on “Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products.” The guidelines, which were originally announced in August 2016, outline the agency’s approach of approving labels containing “not-bioengineered,” “not genetically modified,” or similar language (i.e., “negative claims”), provided that the claims have been verified by a third-party certifying organization.
  • In response to comments, FSIS clarified in the updated guidelines that it will continue to approve negative claims based either on FDA’s definition of “modern biotechnology” or the Agricultural Marketing Service’s (AMS) definition of “bioengineering” contained in the National Bioengineered Food Disclosure Standard (NBFDS). The agency will also continue to allow the use of synonymous terms such as “genetically engineered” or “GE.”
  • As previously reported on this blog, AMS published the final rule for the NBFDS on December 21, 2018. The rule established detection requirements for the definition of “bioengineered food,” created a list of bioengineered foods, and provided disclosure options for labeling of bioengineered foods, among other provisions.

The Daily Intake will not publish on Monday, January 20, in recognition of Martin Luther King, Jr. Day. The next issue of The Daily Intake will publish on January 21, 2020.

  • As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales). In May 2018, FDA issued a final rule extending the compliance dates to January 1, 2020 for manufacturers with $10 million or more in annual food sales and January 1, 2021 for manufacturers with less than $10 million in annual food sales.
  • In response to recent comments from manufacturers with annual sales exceeding $10 million, FDA announced that it will effectively extend the compliance deadline again by declining to take enforcement actions during the first six months following the January 1, 2020 compliance date. According to a newly published statement from FDA, during this six month period, the agency “plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.”
  • We will continue to monitor developments concerning the compliance date for this rule and will report them to you here.