• The FDA issued a draft guidance for the Voluntary Disclosure of Sesame as an Allergen to provide food manufacturers with the Agency’s current view on sesame as an allergen and to provide recommendations to voluntarily disclose sesame in certain circumstances. The purpose of the draft guidance is to help consumers who are allergic or sensitive to sesame avoid these products.
  • Sesame is a food allergen that can cause reactions such as hives, vomiting, wheezing, and anaphylaxis. However, sesame is not one of the eight major food allergens required to be included in allergen labeling by the 2004 Food Allergen Labeling and Consumer Protection Act (FALCPA). Under 21 U.S.C. 343(i), if whole sesame seeds are used as an ingredient, they must be declared on the label, but in some circumstances, sesame can be declared in an ingredient list as “spice” or “flavor” without specifying the presence of sesame.
  • As our readers know, on October 30, 2018, the FDA published a notice inviting additional data on the prevalence and severity of sesame allergies in the US and the prevalence of sesame-containing foods sold in the US that are not required to disclose sesame as an ingredient. FDA received over 4,800 comments regarding the prevalence of sesame. Based on the information received, the FDA noted that sesame allergies may be an increasing problem in the US, and therefore the Agency intends to continue to evaluate emerging evidence and develop factors to inform future regulatory actions related to sesame and other emerging food allergens, including possible labeling requirements.
  • However, in the interim, the FDA recommends that manufacturers take the steps outlined in the draft guidance to help consumers who are allergic to sesame. In short, the Agency recommends that manufacturers voluntarily declare sesame in the ingredient list when it is used in foods as a “flavor” or “spice” in a parenthetical following the spice or flavor, such as, “spice (sesame),” “spices (including sesame),” “flavor (sesame)” or “flavors (including sesame).” If a term is used for a food that is or contains sesame, such as tahini, the FDA recommends that sesame be included in a parenthesis, e.g. “tahini (sesame)” in the ingredient list.
  • Keller and Heckman attorneys are well-versed in food allergen labeling requirements and would be happy to assist with any questions about compliance with the voluntary sesame labeling draft guidance.
  • Whole Foods has moved to dismiss a consumer class action that alleges that its “365 Everyday Value Organic Instant Oatmeal, Oats and Flax” product is deceptively advertised because it misleads consumers about the presence of sugars and non-whole grain ingredients.
  • Specifically, in regard to the sugar allegation, Plaintiffs had alleged that “dehydrated cane juice solids” misleads consumers into thinking that this ingredient was something other than sugar. Whole Foods countered that the front label made no representation as to the product’s sugar content and that the product’s back label could not have deceived any reasonable consumer because the nutritional fact statement disclosed that the product contained 11 grams of sugar. Whole Foods also argued that Plaintiffs had not alleged what they understood “dehydrated cane juice solids” to be and that consumers would not be surprised that oatmeal is sweetened by sugar.
  • In regard to the whole-grain claim, Plaintiffs had alleged that the use of a whole grain stamp on the front label misled consumers into thinking that product contained only whole grains. Whole Foods argued that this was an unreasonable interpretation because the product’s name and images on the front of the product label disclosed that it contained Flax, which was not a whole grain. Further the whole grain stamp itself suggested that other ingredients were present by stating “100% Whole Grain – 18 g or more per serving.”
  • In addition to these arguments that a reasonable consumer would not be deceived by the product’s sugar and whole grain representations, Whole Foods also made a number of other arguments including that that Plaintiffs did not have a private right of action to enforce the Federal Food, Drug, and Cosmetic Act regulations.
  • Keller and Heckman will continue to monitor and report on food and beverage class action litigation.

 

  • As previously discussed on this blog here, FDA announced a proposed rule that would establish additional traceability requirements for persons who manufacture, process, pack, or hold certain high risk foods designated in a new “Food Traceability List” (FTL) that was published along with the proposed rule on September 21, 2020.  The proposed requirements would apply to foods listed on the FTL, including certain cheeses, shell eggs, nut butter, various fruits and vegetables, finfish, Crustaceans, Mollusks (bivalves), and ready-to-eat deli salads, as well as foods containing FTL foods.  The first of three public meetings on the proposed new traceability rule was held on November 6, 2020.  Dates for the remaining two meetings are November 18, 2020 and December 2, 2020.  (See details here.)
  • On November 5, 2020, to assist stakeholders in understanding the proposed new traceability requirements, FDA announced the availability of additional  resources as follows:
    • A tool for exploring the methods and criteria that FDA used to score commodity-hazard pairs, and the results that were used to determine which foods to include on the FTL;
    • A pre-recorded webinar by Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, and Angela Fields, a traceability subject matter expert, discussing the benefits of the proposed rule, who would be subject to the rule, what the proposed key requirements are, exemptions and more;
    • A “who is subject to the rule?” flowchart; and
    • A key terms glossary.
  • Keller and Heckman will continue to monitor and report on any updates to the proposed rule and is available to assist in drafting comments.
  • On October 29, 2020, Plaintiff, on behalf of a proposed class of consumers, filed a class action lawsuit alleging that Arizona Beverages USA LLC deceptively labeled its Arnold Palmer Half & Half Iced Tea Lemonade products as “Lite,” and that as a result of these misrepresentations, Plaintiff was induced to pay a higher price for the products.
  • According to the complaint, per 21 C.F.R. § 101.56, the Arnold Palmers may only be labeled as “Lite” if they contain at least one third less calories than an appropriate reference food. In contrast, the complaint alleges that the product is loaded with sugar and calories and that there is no reference food which allows for this “Lite” claim to be made. Indeed, the complaint notes that the product, which contains 130 calories per 12 oz bottle, has only 10 less calories than a 12 oz can of coke.
  • Keller and Heckman will continue to monitor and report on developments in this case and other trends in food-class action litigation.

Kellogg Gets 2nd Win In Vanilla Flavor False Ad Suit (subscription to Law360 required)

  • As our readers may recall, a California federal judge dismissed a proposed class action on June 22, 2020 alleging that Kellogg Sales Company falsely and misleadingly labeled and advertised Bear Naked Granola V’nilla Almond as being flavored “with vanilla flavoring derived exclusively from vanilla beans when the ingredient list reveals otherwise.”  U.S. District Judge Roger T. Benitez found the lead plaintiff’s argument that Kellogg’s listing of “natural flavors” in the ingredient list, as opposed to “vanilla flavor” or “vanilla extract,” is acknowledgement that vanilla flavor or extract is not an ingredient in the product amounts to speculation rather than an allegation of sufficient facts.
  • On October 29, 2020, the California federal judge dismissed the case a second time, again finding an insufficient factual basis that the granola product was mislabeled.  While the judge agreed that a picture on the product label of a vanilla plant and the word “vanilla,” with no qualifier, would be deceptive if the product does not contain enough vanilla from vanilla beans to independently characterize the product as “vanilla,” the judge found the plaintiff has offered no proof that the flavoring in the product is not from vanilla beans, rejecting the argument that because vanilla is expensive, Kellogg would have included it in the ingredient statement if it were actually present.  Citing a recent decision in Sonner v. Premier Nutrition 971 F.3d 834 (9th Cir. 2020), the judge also dismissed the complaint, which seeks equitable relief, on the basis that the plaintiff failed to plead he lacks an adequate remedy at law.
  • Because the proposed class action was dismissed without prejudice, the plaintiff may amend the complaint a second time to cure the equitable pleading issue and attempt somehow to provide factual evidence of an inadequate level of vanilla from vanilla beans.
  • On October 28, 2020, a plaintiff filed a proposed class action in the United States District Court Southern District of New York.  In the lawsuit, the plaintiff claims that Pepperidge Farm, Inc. (“Pepperidge Farm”) purported that its crackers are made only with “butter” as a shortening ingredient when in reality they are made with vegetable oils, which are less costly than butter.
  • In the lawsuit, the plaintiff argues that Pepperidge Farm intentionally designed the label to mislead, deceive, and defraud consumers because “consumers prefer butter to chemically produced ‘vegetable’ oils when baking for reasons including  taste, health, and avoidance of highly processed artificial substitutes for butter.”
  • By way of background, on March 1988, the U.S. Food and Drug Administration (FDA) released Compliance Policy Guide (CPG) Section 505.200 “Butter” Featured in Product Name.  The CPG  notes that the Agency will consider a name “Butter ____________” or the use of the word butter in conjunction with the name as false and misleading unless all of the shortening ingredient is butter.  Moreover, FDA stated that if the product contains both butter and shortening, but a sufficient amount of butter to give a characteristic butter flavor to the product, an appropriate name would be “butter flavored ____________.”  Lastly, if the product contains any artificial butter flavor, the product will need to be labeled in compliance with 21 CFR 101.22(i)(2).
  • The front of Pepperidge Farm’s cracker package includes the words “Golden Butter” but does not say “vegetable oil.”   We will continue to monitor any developments.
  • On October 26, 2020, the FDA held a webinar in which it discussed its progress in implementing the blueprint for the New Era of Smarter Food Safety and its vision for the path forward. The webinar focused on the four Core Elements of the blueprint with leaders of the teams assigned to each Core Element addressing their respective contributions and visions. Additionally, Frank Yiannas, the Deputy Commissioner for Food Policy and Response at the FDA, delivered the opening and closing remarks in which he discussed the need to build upon the Food Safety Modernization Act (FSMA) and leverage new technologies to improve food safety and adapt to changes in the industry. He stressed that while the FDA was leading the charge, it was a collaborative effort that could not be done without the assistance of a wide variety of stakeholders, and that the FDA was committed to transparency throughout the process.
  • Kari Irvin, Deputy Director of the Office of Coordinated Outbreak Response and Evaluation, in the Center for Food Safety and Applied Nutrition (CFSAN) addressing Core Element 1: Tech Traceability, discussed the importance of creating a foundational language in this space. She stated that the Proposed Rule for Food Traceability is an effort to establish the common language and encouraged all stakeholders to comment on the proposed rule and participate in the coming public meetings on the proposed rule. Comments on this proposed rule are due on January 21, 2021.  She further stated that the FDA is not looking at any single technology and stated that one goal of creating a common language is to allow multiple systems to operate together.
  • Mark Moorman, Director of the Office of Food Safety, CFSAN, addressing Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response, emphasized the importance of information sharing, both within industry and government, in order to learn from adverse effects. In particular, he discussed the importance of data analysis to predict future outbreaks, the need to conduct root cause analysis of outbreaks, and the importance of clear communication to consumers.
  • Andreas Keller, director, Multi-Commodity Foods, Office of Food Safety, CFSAN, addressing Core Element 3: New Business Models and Retail Modernization, discussed the FDA’s efforts to evaluate the effectiveness of retail food regulatory programs, encourage the development and implementation of new systems and technologies to promote food safety, and study the impact of changing consumer behaviors, especially in light of the COVID-19 pandemic.
  • Conrad Choiniere, Director, Office of Analytics and Outreach, CFSAN, addressing Core Element 4: Food Safety Culture, stated that the blueprint seeks to develop a food safety culture within the FDA and among industry and consumers. Furthermore, he stated that the FDA’s role is not to mandate a predetermined food safety culture, but rather to study the issues and provide advice so that industry, and other stakeholders, can each develop their own unique food safety culture tailored their particular needs. He also noted that the Global Food Safety Initiative (GSFI) food culture safety standard is among the sources of information that the FDA was considering in developing its approach.
  • Keller and Heckman will continue to monitor and report on developments related to the New Era of Smarter Food Safety.

 

  • FDA’s regulations implementing the FDA Food Safety Modernization Act (FSMA) requirements for Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), and Foreign Supplier Verification Programs (FSVP) permit the use of third-party audits as supplier verification activities.  Additionally, FDA’s July 13, 2020 New Era of Smarter Food Safety Blueprint (discussed on our blog) indicates that to the extent third-party audit data are reliable and align with FDA’s regulatory food safety standards, FDA may use such data in risk-prioritization for FDA regulatory activities, such as inspections of both imported and domestically produced foods.  In this regard, FDA has developed templates that may help determine how well third-party audit standards align with the requirements under the PCHF, PCAF, and FSVP rules.
  • On October 26, 2020, FDA published notice and invited requests for participation from owners of third-party human food safety standards and others interested in participating in a voluntary pilot program for assessing third-party food safety standards for alignment with FDA’s PCHF and/or FSVP rules.  Under the pilot program, FDA plans to select and assess up to five third-party food safety standards.  FDA will evaluate:
    • The resources required to review and assess third-party standards for alignment with the PCHF and FSVP;
    • The ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment; and
    • Whether the audit standard comparison templates that FDA developed are helpful in making alignment determinations.
  • The pilot program will run through October 26, 2021 or longer, as needed.  Applications to participate are due by November 25, 2020.  FDA will publish information on its website regarding the third-party standards that FDA determines to be in alignment with FDA regulations.
  • On September 18, 2020, California Governor Gavin Newsom signed Assembly Bill 3336 (“AB-3336”) into law.  AB-3336 (codified at Section 113930.5 to the Health and Safety Code) sets new safety standards for third-party delivery applications, including sanitation and temperature standards.
  • The standards set in AB-3336 are consistent with the requirements for restaurants and stores, but this is the first time that third-party delivery applications have expressly and independently been required to follow them as well.  AB-3336 defines a “third-party food delivery platform” as a “business engaged in the service of online food ordering and delivery from a food facility to a consumer.”
  • AB-3336 requires ready-to-eat food delivered through a third-party food delivery platform to be transported in a manner in which the ready-to-eat food is protected from contamination.  The law would require all bags or containers in which ready-to-eat foods are being transported or delivered, from a food facility to a customer through a third-party food delivery platform, to be closed by the food facility with a tamper-evident method prior to the food deliverer taking possession of the food.  Additionally, food holding areas must meet sanitation standards, and food must be maintained at a temperature necessary to prevent spoilage.
  • AB-3336 provides that enforcement officers may recover, from a third-party food delivery platform, reasonable costs that are associated with enforcement against food deliverers who transport and deliver ready-to-eat food for the platform.  The law also allows enforcement officers to penalize food delivery applications for violations of the law.  Additionally, a person who violates any provision of the code may be subject to criminal prosecution for a misdemeanor offense.
  • On October 19, 2019, organizations representing conventional and cell-based /cultured meat, poultry, and seafood companies, including the Alliance for Meat, Poultry and Seafood Innovation and the North American Meat Institute, wrote a letter to the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) stating that “although these products have not yet come to market in the United States, market entry is fast approaching, and there is significant interest in the regulation of these products, particularly regarding applicable labeling requirements.”
  • In their letter to USDA, the groups stated that they are committed to supporting and complying with principles that ensure labeling is truthful and not misleading, does not disparage cell-based/cultured or conventional products, enables consumers to distinguish between such products, and is consistent with the safety and nutritional qualities of the product.
  • By way of background, in 2019, USDA and the U.S. Food and Drug Administration (FDA) announced a formal agreement that stated that both agencies would jointly oversee the production of human food products derived from the cells of livestock and poultry.  The agreement stated that FSIS will have oversight of the labeling of cell-based/cultured meat and poultry while the FDA will oversee the labeling of cell-based/cultured seafood.  Moreover, on October 6, 2020, FDA issued a Request for Information on the labeling of foods comprised of or containing cell-based/cultured seafood, in which FDA notes that it intends to use the information and data resulting to determine what type(s) of action, if any, the Agency should take to ensure that these foods are labeled properly.
  • In the letter, the groups urged USDA to also solicit data to propose and establish an appropriate mandatory labeling requirement for cell-based meat and poultry products.  The groups recommended that FSIS issue an Advance Notice of Proposed Rulemaking (ANPR) to obtain more information and supporting data on finished product characteristics for cell-based/cultured meat and poultry products, mainly those that may require labeling, as this information will provide FSIS with substantive data needed to better inform the Agency’s decision-making process.  The groups added that FSIS has issued ANPRs to obtain information from industry, consumers, and other stakeholders in the past, and that it could do so for the labeling of cell-based/cultured products as well.