• The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) launched a new online system to allow the electronic application, tracking, and receipt of export certificates involving animal food, drugs, and devices. The CVM Export Certification Application and Tracking System (CVM eCATS) will assist those seeking to export CVM-regulated animal products to satisfy importing country requirements for certification, as well as help governments verify the authenticity of FDA export certificates (which provide FDA’s official attestation regarding a product’s regulatory or marketing status based on available information).
  • Manufacturers of CVM-regulated products were previously required to submit paper applications, and CVM would issue export certificates, via mail. The new system is expected to reduce the time needed to complete the application process, simplify the process for applying for multiple certificates, allow governments to verify the authenticity of export certificates online, and allow FDA to more efficiently review and track applications and issued export certificates.
  • Although hard copy applications will continue to be accepted, FDA strongly encourages applicants to use the new portal and system. Step-by-step instructions for applicants are available at FDA’s website, here, and further information is available here and here.
  • On July 1, 2020, the U.S. Department of Agriculture’ (USDA) Food Safety and Inspection Service (FSIS) denied a petition submitted by the Physicians Committee for Responsible Medicine (PCRM), a plant-based diet advocate group, which requested that USDA require all processing plants operating in the U.S. and all facilities shipping meat and poultry products into the United States to test their products for the presence of SARS-CoV-2.
  • In its May 20, 2020 petition, PCRM also asked that FSIS require these meat/poultry facilities to report the number of workers or worker family members with presumptive or confirmed SARSCoV-2 infection and those dying of COVID-19 to local public health authorities on a weekly basis.  In addition, PCRM requested that USDA post the number of FSIS inspectors with presumptive or confirmed SARS- CoV-2 infections and those dying of COVID- 19 on the USDA website on a weekly basis.   PCRM also stated that it wanted meat and poultry to carry a label stating: “Warning: Workers in the U.S. meat and poultry processing facilitates have been sickened or killed by the SARS-CoV-2 virus, and this product has not been certified virus-free.”
  • In its letter denying PCRM’s petition, USDA stated that public health and food safety experts have found no evidence to support the belief that COVID-19 is transmitted by meat or poultry products.  USDA also noted that PCRM’s petition did not include any reference studies or supporting information to show that COVID-19 can be transmitted by meat and poultry products or any other food.  USDA stated that if the purpose of PCRM’s petition is to prevent the spread of COVID-19, USDA believes that resources would be better spent by implementing measures in the Center for Disease/Occupational Safety and Health Administration guidance to prevent the spread of COVID-19 among establishment workers.   By way of background, PCRM previously petitioned USDA to declare feces an adulterant in meat, but USDA denied that petition.
  • 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 June 26, 2020, Sheehan & Associates, P.C., on behalf of a proposed class of Plaintiffs, filed a class action lawsuit against Hain Celestial Group, Inc. asserting that the company had deceptively labeled its “Organic Plus Vanilla Soymilk” because it (1) contained non-vanilla flavor and (2) disguised sugar as “Evaporated Cane Juice.”
  • On the first claim, Plaintiffs alleged that the ingredient list’s disclosure of “Vanilla Flavor With Other Natural Flavors” indicated that the product contained non-vanilla flavor. Furthermore, they alleged that this non-vanilla flavor contained vanillin. Additionally, they alleged that because vanilla is governed by standards of identity (see 21 CFR 169.175 (“Vanilla extract); 21 CFR 169.177 (“Vanilla flavoring”)), the general flavoring rules of 21 CFR 101.22, including the designation of “with other natural flavors,” do not apply and any non-vanilla flavor must be disclosed as an artificial flavor.
  • As to the sugar claim, Plaintiffs alleged that consumers expect an ingredient with the term “juice” to be derived from a consumable fruit or vegetable, that “evaporated cane juice” “had little in common” with this definition of juice because it was “another name for . . . ‘sugar,”’ and that the choice of labeling resulted in the misleading impression that the product was a better nutritional choice than comparable products.
  • Plaintiffs’ vanilla claim echo a plethora of similar class-action lawsuits, many dozen of which have been filed by the same firm. However, unlike some of these cases, including one that was recently dismissed, Plaintiffs did not solely rely on the declaration of “natural flavors” in the ingredient list to conclude that a non-vanilla flavor was present, but rather specifically allege that the challenged product contains vanillin. Keller & Heckman will continue to monitor and provide updates regarding class-action litigation in the food industry.
  • Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies such as the Food and Drug Administration (FDA) must obtain approval from the Office of Management and Budget Review (OMB) for each collection of information they conduct or sponsor.  A “collection of information” includes an Agency’s request or requirement that members of the public submit reports, keep records, or provide information to a third party.  The PRA requires Agencies to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment before submitting the proposed collection of information to OMB for review and clearance.
  • FDA announced in the July 6, 2020 Federal Register that it has asked OMB for a Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed.  Techniques that would fall under the generic clearance include individual in-depth interviews, small group discussions, focus groups, and observations for collecting data on consumers’ perceptions, attitudes, motivations, and behaviors regarding food and cosmetic products, dietary supplements, and animal food and feed.  The techniques are expected to yield information from stakeholders that will assist FDA in developing quantitative study proposals and will complement other research efforts.  FDA proposes to submit a collection for approval under this generic clearance only if it meets the following conditions:

o      The collections are voluntary;

o      the collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government;

o      the collections are noncontroversial;

o      personally identifiable information (PII) is collected only to the extent necessary (for example, collections that collect PII to provide remuneration for participants of focus groups and cognitive laboratory studies) and is not retained;

o      information gathered will not be used for the purpose of substantially informing influential policy decisions; and.

o      information gathered will yield qualitative information; the collections will not be designed or expected to yield statistical data or used as though the results are generalizable to the population of study.

  • FDA proposes to submit individual qualitative collections to the OMB for approval under this generic clearance with an abbreviated supporting statement and supporting documentation (e.g., a copy of the interview or moderator guide, screening questionnaire).  Additionally, individual qualitative collections would also undergo review by FDA’s institutional review board, senior leadership in the Center for Food Safety and Applied Nutrition (CFSAN), and PRA specialists.
  • On June 24, 2020 the Chinese Institute of Food Science and Technology (CIFST) published a draft group standard for plant based meat products and will be soliciting comments until July 25, 2020.  While the standard is merely a guidance document for industry, it is the first standard in China that is specific to the plant-based category.  CIFST’s draft standard provides extensive requirements for plant-based meat, including:
    • Definition of Plant-Based Meat Products;
    • Product Classification;
    • Basic Content Requirements (e.g., no animal-derived protein; fat is permitted; and non-plant ingredients (other than water and salt) should be no more than 10% of the product formulation); and
    • Technical Specifications (e.g., sensory requirements, physical and chemical parameters, contaminants, microbial limits, use of food additives, and product labeling).
  • Notably, CIFST’s draft standard explicitly supports the use of qualifying terms such as “plant-based,” “plant protein,” “non-animal source,” to describe plant-based meat.  Further, the terms “sausage,” “beef,” “meat ball,” “hamburger,” and “bacon,” etc., which traditionally refer to animal source products, are also permitted, so long as the product name clearly indicates its true nature, i.e., that the product is plant-based.
  • By way of background, in November 2019, the food authority in China — State Administration of Market Regulation (SAMR) — issued the draft amendments of its food labeling regulations.  SAMR’s draft regulations mandate that terms, like “artificial,” “imitated,” or “veggie” be added to a product name when the product’s plant raw ingredients serve to give the food characteristics that imitate organs and tissues of other organisms.
  • Although SAMR’s labeling regulations have not been finalized, SAMR’s regulations will trump the CIFST’s draft standard, as SAMR’s regulation is legally binding to all food sold in China.  We will continue to monitor the regulatory developments pertaining to plant-based foods.
  • On June 25, a California federal judge denied a Motion to Dismiss by the California Department of Food and Agriculture (“the Department”) in a case brought by Miyoko’s Kitchen (“Miyoko’s”), a producer of a variety of plant-based, vegan products that are designed to resemble dairy products and are marketed with product names that references dairy analogues, such as “vegan butter” and “vegan cheese.”
  • As background, Miyoko’s filed suit in February 2020 in response to a December 9, 2019 letter from the Milk and Dairy Foods Safety Branch of the Department. The letter outlined numerous purported violations of state and federal law, including the following:
    • The “vegan butter” product does not meet the definition of “butter” at 21 U.S.C. 321a, which requires that a product be made exclusively from milk or cream, or both with or without common salt …. and containing no less than 80 per centum by weight of milkfat. The Department ordered Miyoko’s to remove the word “butter” from the label.
    • Given that the product is not a dairy product, it cannot make claims such as “Lactose Free,” “Hormone Free,” and “Cruelty Free,” which imply that the product is a dairy food without the claimed characteristics. California Food and Agriculture Code 38955. The Department ordered Miyoko’s to revise or remove the claims.
  • Miyoko’s filed suit in a bid to prevent California from enforcing its label demands, which the company argued violated their First Amendment rights. Miyoko’s alleged that, based on the Department’s letter, they were forced to develop custom packaging for California and change marketing and packaging materials nationwide at great cost, or risk prosecution. However, California argued that Miyoko’s lawsuit was “not ripe” and that the company lacked standing to sue.
  • U.S. District Judge Richard Seeborg agreed with Miyoko’s, holding that “Miyoko’s has met its burden of establishing a credible threat of prosecution.” Further, Judge Seeborg stated that “in the First Amendment context, a showing of even a modest risk of enforcement should weigh in favor of a finding of justiciability.” The court is expected to next rule on Miyoko’s Motion for Preliminary Injunction, which would allow the company to maintain its labeling while the case proceeds.
  • On June 24, 2020, the Centers for Disease Control (CDC) and the Occupational Safety and Health Administration (OSHA), in consultation with the Food and Drug Administration (FDA), issued safe practice guidelines (the “Guidelines”) for the seafood processing industry during the COVID-19 pandemic. The Guidelines are not intended to replace the general guidelines that OSHA, CDC, and FDA have previously issued and, in many instances, repeat and incorporate certain elements of them.
  • The Guidelines state that the work environment common to the industry, including work in close quarters and extended periods of contact, increase the risk of transmission of COVID-19. However, they reiterate that non-respiratory transmission (such as through contact with a seafood product), while theoretically possible, is unlikely. Echoing past guidance, the Guidelines urge seafood processors to create COVID-19 control plans that include (1) plans to prevent the introduction of COVID-19 into the workplace (including screening and monitoring of workers), (2) installing engineering controls (such as physical barriers and ventilation), (3) administrative controls to encourage social distancing and other best practices, and (4) providing appropriate personal protective equipment (PPE) for any identified hazards that are not otherwise mitigated by the control plan. In guidance specific to the seafood processing industry, the Guidelines also suggest that offshore workers should quarantine for 14 days prior to their entry into a vessel and that offshore vessels should be prepared to disembark and/or treat workers who develop symptoms while at sea.
  • For coverage of previously issued COVID-19 guidance click here. Keller & Heckman will continue to monitor any updates regarding COVID-19 and its impact on the food industry.

 No Meat to Tyson ‘Prime Pork’ False Ad Suit, Judge Says (subscription to Law360 required)

  • USDA grading and quality symbols are available to provide information to consumers about USDA graded beef’s tenderness, juiciness, and flavor.  ‘Prime’ denotes the highest quality (juiciest) beef.  The USDA does not grade pork in the same way it grades beef.
  • On June 26, 2020, a Florida federal judge dismissed a proposed class action lawsuit over the packaging for Tyson Fresh Meat, Inc.’s ‘Chairman’s Reserve Prime Pork’ and advertising by Tyson and The Fresh Market, Inc. that compares the pork to beef products sold as ‘prime.’  The judge found that a reasonable consumer who knows enough about USDA’s grading procedures to recognize that beef can get the ‘prime’ grade would know that USDA does not grade pork in the same way and would notice the absence of a USDA label that appears on all graded meat.  Thus, the ‘Prime’ label on the pork is nonactionable puffery.
  • The judge found that USDA’s approval of Tyson’s label for the pork did not preempt the plaintiffs’ false advertising claims because USDA does not regulate advertisements.  Key to Tyson’s victory, however, the judge found plaintiffs did not allege that advertisements for the pork contained language suggesting that USDA grades pork or that it had graded their products in particular.

 

  • On June 22, 2020, U.S. District Judge William B. Shubb (Eastern District of California) granted summary judgment in favor of Plaintiffs Monsanto Company and a number of farming groups and associations; denied a competing motion for summary judgment filed by California Attorney General Xavier Becerra; and entered a permanent injunction barring enforcement against Plaintiffs of the Proposition 65 (Prop. 65) cancer warning requirements for glyphosate. See National Assoc. of Wheat Growers et al. v. Becerra, Case No. 2:17-civ-02401, 2020 U.S. Dist. LEXIS 108926 (E.D. Cal. June 22, 2020).
  • On Nov. 14, 2017, Plaintiffs sued Lauren Zeise, director of California’s Office of Environmental Health Hazard Assessment (OEHHA) (who was later dismissed from the case and replaced with the Attorney General), alleging in part that OEHHA’s listing of glyphosate under Prop. 65 as a carcinogen, and the resulting warning requirements, violate Plaintiffs’ First Amendment rights by compelling them to make “false, misleading, and highly controversial statements.” As previously reported in this blog, and reiterated in the Memorandum and Order at issue, the Court initially entered a preliminary injunction precluding enforcement of the warning rules (but declined to prohibit the placement of glyphosate on Prop. 65’s list of carcinogens, as it constituted permissible governmental speech). See Wheat Growers, 2020 U.S. Dist. LEXIS 108926, at ** 8, 26. Without reaching issues such as whether glyphosate is indeed carcinogenic, or whether Prop. 65 is good policy, the Court found that the safe harbor warning language stating that glyphosate is “known to the state of California to cause cancer,” could mislead the average consumer, as “[i]t is inherently misleading for a warning to state that a chemical is known to the state of California to cause cancer based on the finding of one organization [International Agency for Research on Cancer (IARC)] . . . when apparently all other regulatory and governmental bodies have found the opposite.” See id. at **9-10.
  • After affirming its prior decision that the First Amendment challenge was ripe, the Court determined that the compelled Prop. 65 warning did not constitute “purely factual and uncontroversial information”; thus, the Court refrained from applying the corresponding lower standard of scrutiny under Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626 (1985). See id. at **19-24. Instead, having determined that Zauderer was inapplicable, the Court applied intermediate scrutiny under Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980), and determined that the government failed to meet its burden of showing that Prop. 65’s warning requirement for glyphosate directly advances the asserted government interest, and that the compelled speech is not more extensive than necessary to achieve that interest. See id. at **34-36.
  • We will continue to monitor this case, throughout the potential period of appeal to the Ninth Circuit Court of Appeals. This ruling (if upheld or not appealed) potentially opens the door to challenge other Prop. 65 warning requirements where evidence of carcinogenicity or reproductive toxicity is arguably inadequate or controversial.