• As previously discussed on this blog, the U.S. Food and Drug Administration (FDA) released a proposed rule on November 4, 2019 for recognizing accreditation bodies, which will, in turn, accredit laboratories to conduct food testing.  An FDA accreditation program for food testing laboratories is mandated by the FDA Food Safety Modernization Act (FSMA).  FDA’s proposed laboratory accreditation program partially incorporates two globally recognized and widely used voluntary consensus standards, ISO/IEC 17011:2017 and ISO/IEC 17025:2017, as foundational requirements for accreditation bodies and laboratories, respectively.
  • FDA has thus far received comments from the American National Standards Institute (ANSI) National Accreditation Board (NAB) and two large food industry groups.  The Food and Beverage Issue Alliance and the American Frozen Food Institute have merely asked FDA to extend the comment period beyond the original March 3, 2020 due date.  The ANSI-NAB submitted substantive comments: asking FDA to clarify proposed nomenclature (e.g., “probationary,” probationary status,” and “accredited”), to use terms consistently, and to clearly document supplemental requirements for recognized accreditation bodies and qualified accredited laboratories beyond ISO/IEC 17011 and ISO/IEC 17025, respectively.
  • FDA recently announced a 30-day extension – until April 6, 2020 – for submitting comments on the proposed rule and associated information collection provisions for the proposed regulations on the laboratory accreditation program.
  • Food Standards Australia New Zealand (FSANZ) has released its food recall statistics for 2019.  Recalls were down from 100 in 2018 to 87 in 2019.  The most common cause of recalls was undeclared allergens (32 recalls) and microbial contamination (30 recalls).
  • Australia and New Zealand are two of the three countries that have been recognized by U.S. FDA as having food safety systems that are comparable to the U.S.’s system.
  • Overall, undeclared milk allergen and Listeria monocytogenes were the most common bases for recalls, compared to other types of recalls.  These trends are very similar to recall statistics in the U.S. as well, where undeclared allergens and Listeria monocytogenes are primary bases for recalls.
  • According to the Food and Drug Administration’s (FDA) Inspection Observation Data for the Fiscal Year 2019, the most commonly cited violation during FDA food facility inspections was failing to develop a Foreign Supplier Verification Program (FSVP).  The data, which is prepared by FDA’s Office of Regulatory Affairs, reveals that there were 340 violations for failing to develop an FSVP in 2019.  This data demonstrates that there continues to be an increase in these types of violations, as FDA cited 289 importers for the same violation in 2018 and 108 importers in 2017.
  • The FSVP is a mandate of the 2011 Food Safety Modernization Act (FSMA) that requires importers to verify that food that they import into the United States is not adulterated or misbranded with respect to food allergen labeling, and produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act.
  • In 2019, FDA announced its issuance of the first warning letter using its authority under the FSMA Final Rule on FSVP.  FDA has noted that it “will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk.”  The increase in violations for failing to develop an FSVP and FDA’s announcement indicates that FDA will continue to enforce FSMA’s FSVP rule.
  • On February 24, a California federal court certified a statewide class of consumers who may have been misled by the “pure” and “100% pure” claims on honey labels produced by Sioux Honey, including Sue Bee Products.  The named plaintiff, Susan Tran, alleged that the honey products were not “pure” or “100% pure” because they allegedly contained glyphosate, which she described as a synthetic chemical and herbicide. According to the complaint, Tran began buying Sue Bee honey in 2013, but stopped when she learned that tests by an independent laboratory confirmed FDA’s findings that the products contained at least trace amounts of glyphosate.
  • Tran filed a Motion for Class Certification on August 16, 2019, requesting that the Court certify (1) an “injunctive relief class” under Civil Procedure Rule 23(b)(2) and (2) an “issue class” under Rule 23(c)(4). The injunctive relief class seeks the removal of the term “pure” from all Sue Bee Product labels, including the labels that still declare the honey to be “100% pure.” As for the issue class, Tran argued that certification of the class was appropriate on the question of “whether Sioux Honey has misled or deceived reasonable consumers by labeling its honey products as ‘pure’ or ‘100% pure’ when, in fact, the products contain glyphosate.” In a 17-page decision, U.S. District Judge Josephine L. Staton certified the “injunctive relief class,” but denied certification as to the “issue class.” The certified class is comprised of “all persons residing in California, who, from January 2014 to the Present, purchased, for personal use and not resale, Sue Bee Products.”
  • Judge Staton rejected Sue Bee’s argument that Tran had not proven consumers actually care about the “pure” and “100% pure” labeling terms by stating that even “Sioux’s own market research demonstrates that a sizable portion of the population views purity as a key motivating factor in honey-purchasing decisions.”  Judge Staton also rejected Sue Bee’s contention that Tran offered no evidence that other consumers shared her “preposterous, unrealistic definition of purity.” According to Judge Staton, the law only requires a customer to show they have purchased a product that is marketed with a material representation at this stage. Tran contends Sue Bee violated California’s Consumers Legal Remedies Act and false advertising and unfair competition laws.

Rachel Ray Dog Food Once Again Ducks False Ad Suit (Law360 subscription required)

  • We reported on a proposed class action lawsuit filed in 2018 against Rachel Ray’s Nutrish dog food brand, alleging that “natural” claims were false and misleading under state consumer protection laws, based on testing that found residues of the herbicide, glyphosate.  The New York District Judge in the Nutrish case dismissed the claims in April of last year for failure to indicate the level of glyphosate detected and to say whether it was harmful.
  • An amended complaint provided analytical results but did not address harm, continuing to argue instead that any amount of glyphosate in the pet food renders the “natural” claim false and misleading.  The judge dismissed the complaint a second time upon finding the total glyphosate alleged to be present in the Nutrish samples is between 0.005% to 0.01% of the Food and Drug Administration’s (FDA) allowed tolerance, and ruled that labeling such pet food as “natural” is not materially misleading to a reasonable consumer.
  • There may be less potential for consumer confusion for pet food, as compared to human food, because the pet food term “natural” has an official definition through the Association of American Feed Control Officials (AAFCO).  The lawsuit against Nutrish, however, while unsuccessful, pending any possible appeal, shows that natural claims on pet food could nevertheless be a target for litigation.

 

  • As previously discussed on this blog, the U.S. Food and Drug Administration (FDA) held a public meeting on September 27, 2019, to give interested parties an opportunity to discuss FDA’s effort to modernize food standards of identity (SOI).  On February 20, 2020, FDA announced it plans to reopen the comment period on a 2005 proposed rule (which had initially been jointly published with the U.S. Department of Agriculture (USDA)) to establish a set of general principles for FDA to use when considering whether to establish, revise, or eliminate a food SOI. 
  • FDA is reopening the comment period to receive new data, information, and further comments only on FDA-specific aspects of the 2005 proposed rule (including 13 general principles for food standards modernization); however, FDA has indicated it will continue to engage with USDA before finalizing the proposed rule.
  • Food SOIs are regulatory requirements related to the content and production of certain food products such as milk (as previously discussed on this blog, FDA is particularly evaluating the use of the term, “milk,” in labeling plant-based products), bread, jam, and chocolate.  As previously discussed on this blog, with the development of new types of food products and updated nutritional science, FDA is reconsidering SOIs as part of its Nutrition Innovation Strategy (NIS).
  • Written/electronic comments will be accepted for 60 days following the date of publication in the Federal Register.

 

  • On February 11, 2020, Repres­entative Alan Lowenthal of California and  Senator Tom Udall of New Mexico introduced the “Break Free from Plastic Pollution Act of 2020.” The bill would enact nationwide extended producer responsibility for all packaging materials, minimum-recycled-content mandates for certain products, a national container deposit, single-use plastic product bans, a three-year pause on new virgin plastics production facilities, and more.  The proposed legislation includes a national bottle bill, which would add a 10-cent deposit on all beverage containers, regardless of material type.  Udall and Lowenthal stated that this bill serves as a model for states and local governments to use in crafting their own legislation regardless of whether the proposal is successful in Congress.  Currently, only ten states have a container deposit law or “bottle bill.”  Some of these states are also considering proposed legislation, which would change their existing bottle bills.
  • In California, a senate committee will soon hold hearings on Sen. Bob Wieckowski’s Senate Bill 372 that would pressure beverage manufacturers to help consumers recycle.  Senate Bill 372 would also extend the Bottle Bill provisions to wine and liquor makers.
  • In Michigan, a bipartisan group of lawmakers introduced H.B. 5422–5425, which would update Michigan’s current bottle bill.  This would be the first update to Michigan’s bottle bill since 1976.  The proposed bill seeks to increase recycling rates and reduce fraud and abuse.  According to the Executive Director of Michigan Recycling Coalition, the legislation would allocate funding to the counties, which could then use it to boost existing or create new municipal recycling programs.  Moreover, H.B. 5424, would create enhanced criminal penalties for a distributor that violated the bottle deposit law with the intent to defraud and cheat.
  • In Massachusetts, H2881 and S452 seeks to include miniature containers that can hold 100 milliliters (specifically miniature liquor bottles) under the state’s existing “bottle bill” law, charging the same 5-cent deposit on their sale as other bottles.  We will continue to monitor any developments.
  • On February 13, the FDA released a supplemental draft guidance to support compliance with the Intentional Adulteration (IA) rule under the Food Safety Modernization Act (FSMA). This draft is the third and last installment of the IA draft guidance.
  • FSMA’s final IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to the public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration. In the 2016 IA final rule, FDA identified four key activities that are most vulnerable to intentional adulteration: (1) bulk liquid receiving and loading, (2) liquid storage and handling, (3) secondary ingredient handling, and (4) mixing and similar activities.
  • The supplemental draft guidance adds to the draft guidance published in March 2019 with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. For example, the draft guidance explains the differences between food defense corrective actions and food safety corrective actions as well as the verification of mitigation strategies and the verification of preventive controls. It also includes appendices on FDA’s mitigation strategies database and how businesses can determine Small and Very Small Business status under the IA rule.
  • Stakeholders may submit comments on this IA draft guidance until June 15, 2020. Keller and Heckman attorneys are well-versed in FSMA provisions and are available assist interested parties in preparing comments for submission to FDA. For assistance, please email: fooddrug@khlaw.com.

FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices

 

  • On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.”  When finalized, the guidance document will help industry submit information for efficient consultations with FDA’s Center for Veterinary Medicine regarding both animal feed petitions and GRAS Notices.
  • The draft details what information FDA would expect to review when receiving different requests (e.g., a request to review the adequacy of existing data from a completed study versus a request to review a study protocol).  The guidance also includes FDA timeline “goals” for reviewing certain types of submissions.  For example, FDA’s goal for commenting on a study protocol without method validation or preliminary data is 50 days from the date of submission receipt, whereas the goal for commenting on a study protocol with method validation or preliminary data is 130 days from the date of submission receipt.
  • FDA is accepting comments on the draft guidance through April 13, 2020.  Comments may be submitted here.
  • On February 11, 2020, Christopher Silva, a New York resident, filed a proposed class action lawsuit against Hornell Brewing Co. Inc., Arizona Beverages USA LLC, Beverage Marketing USA, Inc., and Arizona Beverage Co. (“Defendants”) over defendants’ “all natural” gummy snacks.
  • The plaintiff claims that defendants’ advertising and marketing campaign is false, deceptive, and misleading because the gummies contain several synthetic ingredients, such as ascorbic acid, citric acid, gelatin, dextrose, glucose syrup, and modified food starch.  Silva seeks to represent a New York class and individual classes for all 49 other states.
  • In the complaint, Silva cited to the United States Department of Agriculture’s Draft Guidance Decision Tree for Classification of Materials as Synthetic or Nonsynthetic (natural).  Per that guidance, a substance is natural – as opposed to synthetic – if (a) it is manufactured, produced, or extracted from a natural source (i.e. naturally occurring mineral or biological matter); (b) it has not undergone a chemical change (i.e. a process whereby a substance is transformed into one or more other distinct substances) so that it is chemically or structurally different than how it naturally occurs in the source material; or (c) the chemical change was created by a naturally occurring biological process such as composting, fermentation, or enzymatic digestion or by heating or burning biological matter.
  • Silva noted that while the synthetic ingredients are all listed on the back of the package, reasonable consumers are not expected or required to review the ingredients list on the back in order to confirm or debunk defendants’ prominent front-of-the-product claims.  The package in question includes the phrase “All Natural” on the packaging behind the words, “Arizona” and “fruit snacks.” We will continue to monitor any developments.