• In letters to Acting FDA Commissioner Janet Woodcock and Senator Ron Wyden (D – OR), the Consumer Brands Association (CBA) renewed its call for government action on cannabidiol (CBD) regulation in order to ensure consumer safety. CBA endorsed Senator Wyden’s Hemp Access and Consumer Safety Act to establish uniform CBD regulations and argued that a federal regulatory framework should empower federal regulators to:
    • Identify data that is needed to support the safe marketing of foods and dietary ingredients that contain CBD;
    • Establish the infrastructure and processes to review safety data and allow the lawful marketing of CBD-containing ingredients that are safe;
    • Ensure products are made in full compliance with existing and applicable manufacturing, processing, distributing, and product claim requirements;
    • Provide guidelines to protect trademark and intellectual property;
    • Align on how the current marketplace will transition to meet the requirements established through the new federal regulatory framework, in partnership with stakeholders.
  • CBA also advocated for federal funding of federal regulators to establish such a system. CBA proposed a two-prong approach for Congress to clarify the CBD marketplace: (1) Congress should ensure adequate funding for federal research on the health and safety of CBD products in order to allow regulators to make informed decisions; and (2) Congress should ensure that FDA has the resources to engage in market surveillance and undertake enforcement activities. CBA expressed support for the House Appropriation Subcommittee’s decision to allocate an additional $5 million to FDA’s CBD enforcement capacity in FDA’s 2021 budget.
  • CBA recently published the report “Unregulated and Exploding: How the CBD Market Is Growing Amid a Labyrinth of State Approaches and Rampant Consumer Confusion,” which explores consumers’ lack of understanding of the CBD market. For instance, the report found that on a scale of one to ten, consumers regarded their knowledge of CBD at an average of 3.3. Additionally, while 28% of Americans have used CBD, 74% of consumers were unsure if CBD is federally regulated. CBA asserts that while FDA’s use of warning letters may curb bad actors, a clear regulatory framework is needed to address consumer confusion created by the multitude of state approaches. Keller and Heckman will continue to report on developments that impact CBD and other cannabinoids.
  • The Association of American Feed Control Officials (AAFCO) is a voluntary membership association of local, state, and federal agencies that works together with FDA to regulate animal food, including by establishing definitions to describe new feed ingredients. The definitions, along with a model feed bill, are published annually in the AAFCO Official Publication.
  • AAFCO typically holds a mid-year and annual meeting in mid-January and early August, and considers a variety of issues, including changes to the model feed bill and new ingredient definitions. This year’s August meeting is scheduled for August 2-4 and will include a discussion of AAFCO’s recommendations for the use of “human grade” in the labeling of pet foods and specialty pet foods. According to the proposed guidelines, the claim may only be used to refer to the product as a whole, but every ingredient and the resulting product must be compliant with federal human food laws, including the cGMP requirements in 21 CFR Part 117.  Additionally, all facilities that process or package a final “human grade” pet food product that is considered ready-to-eat must be registered both as an FDA food facility and an FDA feed facility. The guidelines also include significant documentation requirements and labeling requirements, which, among other things, require the claim “human grade” to be juxtaposed with the statement of intended use (e.g., human grade dog food). The full proposed guidelines can be found here.
  • The AAFCO Ingredient Definitions Committee (IDC) will discuss publication of a tentative definition of Barley Protein Concentrate, withdraw of a Barley Distillers Protein Concentrate definition, and a modification to a tentative definition for a Black Solider Fly Larvae Oil.
  • Keller and Heckman will continue to monitor and report on developments in the regulation of animal food.
  •  The United States Department of Agriculture (USDA) published the Pathogen Reduction/Hazard Analysis Critical Control (HACCP) Systems Final Rule in July 1996 mandating that HACCP be implemented in all USDA inspected meat and poultry plants.  To assist establishments in meeting regulatory requirements, USDA’s Food Safety and Inspection Service (FSIS) simultaneously released generic HACCP models relevant to various process categories.
  • On July 23, 2021, USDA announced that FSIS has updated and released its Generic HACCP Model for Beef Slaughter.  The materials include updated scientific references and footnotes containing explanatory guidance and links to related sources of information.  Consistent with the 1996 model, the updated model includes a product description, ingredients list, production flow diagram, hazard analysis and HACCP plan.  The beef slaughter model may also be used as a starting point for developing a slaughter HACCP plan for other classes of livestock.
  • The updated generic HACCP model for beef slaughter follows the previous release, announced in USDA’s October 2, 2020 Constituent Update, of FSIS’s updated HACCP guide and multiple generic HACCP models.  Additional models will be posted as they are revised.
  • The House of Representatives passed the PFAS Action Act to regulate the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) on July 21, 2021. The bill’s passing follows FDA’s recently published update on testing of PFAS in food to better understand the presence of PFAS in the food supply. As our readers know, PFAS are known for their grease, water, and oil-resistant properties. They are used in a variety of consumer products, including food-contact materials.
  • As passed by the House, the bill would (1) require the Environmental Protection Agency to add two PFAS, perfluorooctanoic acid (PFOA) and perfluoroactanesulfonic acid (PFOS), to the list of hazardous substances within one year and assess all other PFAS within five years to determine whether they should be designated as hazardous substances; and (2) require EPA to determine whether PFAS should be designated as toxic pollutants under the Clean Water Act. Designation as a hazardous substance under the Comprehensive Environmental Response, Liability, and Compensation Act (CERCLA) triggers remediation for and cleanup of sites impacted by the substances but does not regulate use of hazardous substances. The bill would also require the EPA Administrator to monitor PFAS in drinking water and permit a “PFAS-free” indication on nonstick cookware.
  • The bill passed 241-183, with 23 Republican members joining Democrats, and will now move to the Senate. The Act is a revived version of a 2020 bill of the same name that passed the House in January 2020 but died in a Republican-led Senate.
  • On July 13, 2021, U.S. District Judge Rodolfo A. Ruiz II approved (subscription to Law360 required) a $16 million class settlement to resolve claims that Kraft Heinz Foods Co. engaged in deceptive labeling with its Maxwell House and Yuban ground coffee brands.  As we previously reported, the class action lawsuit alleged that Kraft Heinz “grossly” exaggerated the number of cups of coffee that could be made from the contents of the package.
  • As part of the settlement, Kraft Heinz will remove the labeling language at issue or revise the serving ranges to correspond to the cups of coffee that can be brewed when following the single cup or 10 cup directions.  Kraft Heinz will reimburse consumers at $0.80 per unit, up to a maximum of $25 per household, or up to six units without proof of purchase, according to the order.  In addition, Kraft Heinz will pay $3.9 million in attorney fees and costs.
  • Judge Ruiz concluded that the settlement is “fair, adequate, and reasonable,” provides monetary relief for the class, and ensures that Kraft Heinz will remove or correct the challenged claims.  If the case had proceeded, Judge Ruiz explained that there would likely be a “battle of experts” with an uncertain outcome and that class certification issues would have been highly contested.  Judge Ruiz also stated that the settlement “avoids the risk that class members would not obtain anything should the case be decided on summary judgment or at trial in favor of [Kraft Heinz].”
  • On July 18, a proposed class action lawsuit (Subscription to Law360 required) was filed against Dreyer’s Grand Ice Cream Inc., the makers of Haagen-Dazs vanilla milk chocolate almond ice cream bars. The complaint claims that the company misleadingly packages the product as containing “milk chocolate,” when it actually contains “milk chocolate with vegetable fat coating.”
  • Illinois consumer Lawrence Rice alleged that Dreyer’s failed to inform consumers that it uses coconut oil as a substitute for some cacao beans to make the chocolate in the vanilla milk chocolate almond ice cream bars. In the complaint, Rice states that the Standards of Identity (SOI) for “milk chocolate” at 21 CFR 163.130 require that milk chocolate be made from cacao beans with a small amount of optional ingredients, like dairy and nutritive carbohydrate sweeteners, but that vegetable fats (oils) are excluded. Rather the complaint argues that “where a food has some chocolate but is mainly vegetable oils” it falls under the SOI for “milk chocolate and vegetable fat coating” at 21 CFR 163.155 and should be disclosed to the consumer.
  • In the complaint, Rice states that the product label presents a “half-truth” and compares the ice cream bar packaging, which contains pictures of chocolate chunks, a vanilla flower, and almonds, against the ingredient list, which declares coconut oil as the least predominant ingredient but is not included in the label graphics. Rice argues that “[t]he product does not contain imitation vanilla or almond alternatives, which makes it especially misleading that it contains alternatives to chocolate in the form of vegetable oil.”
  • Rice looks to represent a class of similarly situated Illinois residents who also purchased the ice cream bars. He is asking for the court to award monetary and statutory damages, as well as injunctive relief directing Dreyer’s to cure product labels of the alleged misrepresentations.
  • On July 15, 2021, the U.S. Court of Appeals for the Ninth Circuit affirmed a district court’s dismissal of class-action lawsuit alleging that Trader Joe’s misleadingly labeled its store brand honey as “100% New Zealand Manuka Honey.”
  • The Manuka flower is believed to have antibacterial properties and provide significant health benefits. Plaintiffs’ independent testing revealed that the honey contained only between 57.3% and 62.6% honey from Manuka flower nectar (as estimated by the pollen content of the honey). Plaintiffs alleged that they had been deceived into believing that the honey was made completely from the Manuka flower because of the “100% New Zealand Manuka Honey” representation and because “Manuka Honey” was listed as the sole ingredient on the ingredient list.
  • The Ninth Circuit disagreed that the labeling is deceiving. The Court noted that it is impossible to have honey derived 100% from a single flower because bees may pollinate different types of flowers and beekeepers cannot completely prevent this. As a result, FDA permits honey to be labeled with the name of the plant or blossom if the producer has reason to believe it is the chief floral source of the honey.  See FDA’s Honey Guidelines at 5. And, since Plaintiffs’ own tests revealed that the majority of honey was derived from Manuka flower, this standard had been met.
  • The Court also rejected the argument that the representations were misleading even where the labeling was technically accurate under FDA’s Guidelines. In particular, the Court held that “100% New Zealand Manuka Honey” was ambiguous (i.e., could be a claim that the product was 100% Manuka Honey or 100% derived from Manuka flower) and that other information available to the consumer should be consulted to resolve the ambiguity. The Court held that a reasonable consumer would not have been deceived because of (1) the impossibility of making honey 100% from Manuka or any other floral source (the court noted that a purchaser of a niche product such as this are “more likely to exhibit a higher standard of care”), (2) the low price of the honey, and (3) a “10+” rating on the label, which graded the product on concentration of honey derived from Manuka flower nectar, and for which the highest score was 26+ (although the label did not include any information about the scale).
  • While the Court’s decision notes that ambiguity can be used by advertisers to confuse, it discounted those concerns in this case because Trader Joe’s had engaged in no conduct intended to deceive, i.e. adding in other ingredients; the bees and not Trader Joe’s had made the honey.

FSIS Announces Revised Guidelines for Minimizing the Risk of Shiga Toxin-Producing Escherichia coli (STEC) in Beef Slaughter and Processing Operations

  • On July 19, 2021, the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) published notice that it has updated two of its guidelines for minimizing the risk of Shiga toxin-producing Escherichia coli (STEC) in beef slaughter (including veal) and processing operations.  The beef slaughter and beef processing guidelines, which were initially published for comment on March 3, 2017 as “compliance” guidelines, provide advice on the best practices to prevent, eliminate, or reduce levels of fecal and associated microbiological contamination and address contamination with STEC in raw non-intact beef products and beef products intended for non-intact use.  Although these guidelines were developed to help small and very small establishments meet best practice recommendations, all FSIS regulated beef slaughter and processing establishments may be able to apply the recommendations in the guidelines.
  • Updates to the guidelines for minimizing the risk of STEC in beef slaughter and processing operations include:
    • Removal of the word “compliance” from the titles of both documents and other changes to clarify that the guidelines are recommendations and do not create any new regulatory requirements, a change that was made in response to concerns from industry groups that FSIS inspectors could incorrectly interpret the beef slaughter and beef processing guidelines as regulatory requirements;
    • Removal of information regarding Salmonella from both documents, as a result of FSIS choosing to address that foodborne hazard in other documents;
    • Additional information on technical procedures (e.g., cattle washing and pre-harvest interventions in beef slaughter and a brief question and answer section on antimicrobial interventions and retained water in beef processing);
    • Removal of best practices recommendations that would not be practical (e.g., the use of chlorophyll to detect contamination on carcasses); and
    • Additional information in relation to product recalls to clarify FSIS policy regarding adulterant STEC strains, which include E. coli O157:H7 as well as strains that have certain O groups (O26, O45, O103, O111, O121, and O145) and contain two specific virulence genes (stx and eae).
  • The revised beef slaughter and beef processing guidelines are expected to be posted today on the FSIS guidance web page at: https://www.fsis.usda.gov/policy/fsis-guidelines.  Although comments on these guidelines will no longer be accepted through www.regulations.gov, FSIS will continue to update these documents, as necessary.
  • Senators Chuck Schumer (D-NY), Cory Booker (D-NJ), and Ron Wyden (D-OR) unveiled a lengthy discussion draft titled the Cannabis Administration and Opportunity Act on July 14. The draft language is meant to spur and inform discussions as the senators work to create a final legislative proposal to be introduced as a formal Senate bill.
  • Section 505 of the discussion draft proposes creating a legal pathway for cannabidiol (CBD) in dietary supplements. Specifically, the draft proposes amending the definition of “dietary supplement” in 21 U.S.C. § 321(ff) to except CBD derived from hemp from the prohibition against using substances that have been approved as drugs. The draft also proposes a section that states dietary supplements would be adulterated if they contain more CBD than a limit to be set by the Secretary of the Department of Health and Human Services. Additional language would give FDA enforcement authority over noncompliant products containing CBD that are improperly labeled as dietary supplements and give FDA the authority to require safety-related labeling or packaging as needed for CBD-containing dietary supplements. The proposed language limits the possibility of CBD in dietary supplements to CBD derived from cannabis plants, limiting opportunities for synthetically-produced CBD.
  • Other provisions in the draft would decriminalize marijuana by removing “marihuana” and “tetrahydrocannabinols” from the list of Schedule I controlled substances at 21 U.S.C. § 812, expunge non-violent marijuana crimes, and allow compliant cannabis businesses access to financial services, among other items.
  • The sponsoring senators request comments from stakeholders. A comprehensive summary of the discussion draft is available here. If final language is developed and a bill is introduced, the bill would join S. 1698 and H.R. 841, other bills introduced in Congress this session that seek movement on CBD. We will continue to monitor movement on these proposals.
  • On July 12, 2021, private plaintiffs filed a proposed class action lawsuit (subscription to Law360 required) against Chobani LLC. The plaintiffs allege that Chobani misrepresented its certification from Fair Trade USA, leading plaintiffs to overpay for Chobani’s products because they believed in the certification labeling.
  • Chobani became the first in the U.S. dairy industry to be certified with the Fair Trade USA seal of approval in May 2021. Fair Trade USA is a nonprofit that grants and sets standards for the fair trade label. However, the suit claims that Chobani’s immigrant laborers work in “dangerous conditions,” dealing with hazards including slippery surfaces, aggressive cows, and heavy machinery being poorly operated on dairy farms in upstate New York. The complaint relies on a nonprofit worker groups’ report that states dairy workers did not succeed in getting Chobani’s support in unionization efforts at farms from which Chobani purchases milk.
  • Chobani stated that the lawsuit is meritless and makes “unfounded attacks on Fair Trade USA, one of the most highly-regarded third-party verification programs for environmental, social and economic standards.” This lawsuit is the most recent action filed by Sheehan & Associates, which has been prolific in recent years in lawsuits against food companies.