• In December 2021, FDA published a notice of proposed rulemaking to amend the agricultural water provisions of the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (i.e., the “Produce Safety Rule”). The proposed revisions were in response to stakeholder concerns that the pre-harvest agricultural water provisions were too complex and prescriptive. As we have previously blogged, the proposed amendment would replace the detailed pre-harvest agricultural testing requirements in the Produce Safety Rule with provisions that allow for a systems-based agricultural water assessment that are designed to be more feasible to implement and adaptable to future advancements.
  • FDA has now announced a supplemental notice of proposed rulemaking in which it is requesting comment on only the compliance dates for the proposed pre-harvest agricultural water provisions for covered produce other than sprouts. The proposed compliance dates would allow time for covered farms to prepare for compliance and for other stakeholders, including state regulators, to develop education, outreaching, training, and other tools to facilitate understanding and compliance. The proposed compliance dates are as follows:
    • 2 years and 9 months after the effective date of a final rule for very small businesses, defined in 21 CFR 112.3 to mean “a farm that is subject to any of the requirements of this part [the Produce Safety Rule] and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $250,000.”
    • 1 year and 9 months after the effective date of a final rule for small businesses, defined in 21 CFR 112.3 to mean “a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $500,000; and the farm is not a very small business as defined in this section.”
    • 9 months after the effective date of a final rule for all other businesses.
  • In addition, although no changes to the harvest and post-harvest requirements have been proposed, to allow for adequate preparations, FDA also announced that it intends to continue to exercise enforcement discretion for the harvest and post-harvest agricultural water provisions for covered produce other than sprouts until the following dates:
    • January 26, 2025 for very small businesses.
    • January 26, 2024 for small businesses.
    • January 26, 2023 for all other businesses.
  • Comments to the proposed compliance dates can be submitted until September 19, 2022

 Target Wants Juice Pouch Labeling Suit Popped (Law360 Subscription Required)

  • A federal class action complaint, filed June 22, 2022, alleges the words “Natural Flavor With Other Natural Flavor” directly below “Fruit Punch” render the omission of “artificially flavored” deceptive on Target Corporation’s label for Market Pantry brand liquid beverage concentrate water enhancer containing malic acid as the second-most predominant ingredient (after water).  We have reported on a similar class-action lawsuit filed against Publix Super Markets, Inc. for their “strawberry watermelon” water enhancer.  In both cases, the plaintiffs allege that testing detected DL-malic acid, which is an artificial form of malic acid that impacts the characterizing flavor of the products and, therefore, the products should have been labeled as “artificially flavored” or “artificial” to avoid misleading consumers and to comply with 21 CFR 101.22(i)(2).
  • In a memorandum filed July 13, 2022, Target disputes whether the plaintiff has plausibly alleged that the malic acid in the product acts as a “flavor” and that it is “artificial.”  In addition to these assertions, as wells as the related arguments over distinctions between a “flavor enhancer” and a “flavor” under FDA’s regulations, which courts have found cannot be resolved on a motion to dismiss, Target has also built arguments for dismissal based on the assertion that it never made any representation on the product’s label or elsewhere that the water enhancer was all-natural or free of artificial flavors.  Specifically, the memorandum argues that the artificial flavor status of malic acid is immaterial because the omission of an “artificially flavored” statement, even if it were required for malic acid (Target argues it is not), does not transform the FDA-mandated statement “Natural Flavor With Other Natural Flavor” into a claim that the water enhancer is “all natural,” nor would it lead a reasonable consumer to assume that a shelf-stable, bright red “fruit punch” concentrate is free of artificial ingredients.
  • Unless there is room to argue that consumers who wish to avoid artificial ingredients may for some reason be uniquely concerned with flavors, as opposed to the artificial status of ingredients with other functions, such as sweeteners or colors, the court may possibly grant Target’s request for dismissal on the basis that noncompliance, if any, with FDA’s flavor labeling regulations, would not deceive a reasonable consumer about the “natural” quality of the fruit punch water enhancer.

 

  • In February 2021, the U.S. House of Representatives subcommittee on Economic and Consumer Policy released a report on the levels of heavy metals found in baby foods and the respective manufacturers. The report findings described “significant levels of toxic heavy metals” based on internal documents and test results submitted by baby food companies.  Lawsuits quickly followed, including many actions against Gerber Products Co., that allege Gerber falsely and deceptively failed to disclose the presence of unsafe levels of heavy metals in their baby foods.
  • Gerber argues in a recent motion to dismiss (see filing; Law 360 subscription required) that the primary jurisdiction doctrine should control. For background, the primary jurisdiction doctrine is a judicial doctrine used when courts and an agency have concurrent jurisdiction, but the court favors administrative discretion and expertise in deciding the issue.   In this case, Gerber argues that the Food and Drug Administration (FDA) is in a better position to decide “acceptable levels of heavy metals in baby foods” because of the need for expertise in issues of infant nutrition.
  • Gerber further alleges that Plaintiff’s claims are preempted by the Food, Drug, and Cosmetic Act (FDCA). Gerber argues that Plaintiff’s demand for mandatory disclosures on packaging is preempted by FDA because it is the Agency’s role to establish national policy on food safety and labeling.  Finally, Gerber says the Plaintiffs fail to plead deception, pointing to a lack of misleading statements on their packaging and no legal requirement to disclose heavy metals on a product label.
  • Keller and Heckman will continue to monitor and report on this litigation and any responsive regulatory actions or developments.
  • On July 12, 2022, FDA announced its recognition of six accreditation bodies under the Laboratory Accreditation for Analyses of Foods (LAAF) program. Accredited bodies under LAAF may, in turn, accredit laboratories to the standards established under the Food Safety Modernization Act of 2011 (FSMA).
  • By way of background, FSMA directs FDA to establish a program for the setting of food by accredited laboratories.  FDA’s final rule on LAAF became effective on December 1, 2021, and provides eligibility requirements and procedures on how FDA will oversee the LAAF program.  The LAAF program aims to improve the reliability of certain food testing through enhanced FDA oversight of participating laboratories and accreditation bodies. To be eligible for LAAF recognition, an accreditation body must be a full member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory to the ILAC Mutual Recognition Arrangement with demonstrated competence to ISO/IEC 17011:2017(E) and a scope of “Testing: ISO/IEC 17025.”
  • As previously reported, on February 11, 2022, FDA announced the launch of the LAAF application portal where interested accreditation bodies may apply for recognition under the LAAF program. A list of the recognized accreditation bodies will be listed in the public registry. Additional information and commonly asked questions on FSMA and the LAAF program may be found here.
  • On July 12, the FDA announced that it issued warning letters to four companies for illegally selling honey-based products that could pose a significant health risk to consumers due to the presence of active drug ingredients not listed on the product labels. The FDA’s laboratory testing found that product samples contained ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional and both may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
  • It is a violation of federal law to market food products containing tadalafil and/or sildenafil. The warning letters cited that some of the products are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and lack FDA approval. Additionally, some of the products are represented as dietary supplements even though tadalafil and sildenafil are excluded from the dietary supplement definition.
  • The warning letters were issued to: Thirstyrun LLC (also known as US Royal Honey LLC), MKS Enterprise LLC, Shopaax.com, and 1am USA Incorporated dba Pleasure Products USA. The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
  • As recently as April 2022, the FDA had previously warned consumers about more than 10 honey-based products that contained hidden drug ingredients, like tadalafil and sildenafil. In December of 2020, the FDA also warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart, and other retailers. As noted in the press release, the FDA has stated that the Agency is “committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.”
  • As we previously have reported, in May FDA announced an enforcement discretion policy which would allow certain non-compliant infant formula to be marketed in the U.S. The policy, which will remain in effect until November 14, 2022, was intended to address the infant formula shortage that resulted from the temporary shutdown of Abbot’s facility in Sturgis, Michigan due to positive test results in the facility for Cronobacter sakazakki and an outbreak of food-borne illness among infants who had been exposed to infant formula produced at the facility.
  • Last week FDA announced steps to facilitate the continued use of infant formula marketed under the enforcement discretion policy past its November 14, 2022 expiration date. Specifically, FDA announced that it would:
    • Provide a single technical assistance contact at FDA for companies aiming to enter the U.S. infant formula market.
    • Host meetings this summer with companies that import, sell, and/or distribute infant formula under the enforcement discretion policy to determine what additional steps would need to be taken to allow them to market infant formula in the U.S. long-term.
    • Issue guidance in September on the topic of how companies that are marketing infant formula under the enforcement discretion policy can continue to supply infant formula.
  • Although FDA emphasized that it would continue to apply “rigorous” standards to ensure that infant formula is safe and nutritious, FDA’s actions have been subject to scrutiny. Last month Congresswomen Rosa DeLauro sent a letter to the Department of Health and Human Services which requested a review of the enforcement discretion policy and voiced concern that the enforcement discretion was being provided too rapidly to ensure that the infant formula was safe and nutritious and that the decision-making process was opaque. We also note that the Abbot plant in Sturgis has only just restarted production. While it had initially restarted production in June after meeting the initial requirements mandated by the consent decree, it was forced to shut down later that month following storms and flooding.  Keller and Heckman will continue to monitor and report on the updates to the regulation of infant formula.

 9th Circ. Won’t Rethink Calif.’s In-State Foie Gras Sales Ban (Law360 Subscription Required)

  • As we reported earlier this year, plaintiffs who oppose a 2004 California law, which prohibits the force-feeding of birds to enlarge their livers and bans the in-state sale of foie gras products, indicated that they would request a rehearing en banc after a May 6, 2022 opinion by a split three-judge panel of the U.S. Court of Appeals for the Ninth Circuit upheld a 2020 district court ruling that California’s in-state sales ban of foie gras from force feeding is not preempted by federal law under the doctrine of impossibility preemption and does not violate the dormant Commerce Clause of the U.S. Constitution.
  • In an order filed July 1, 2022, the plaintiffs’ petition for panel rehearing and rehearing en banc was denied.  The same judge who accepted the plaintiff foie gras producer and restauranter’s impossibility arguments in the first appeal voted to grant a rehearing.  A majority of the appellate panel, however, voted to deny the plaintiff appellants’ petition for panel rehearing and no judge on the full court requested a vote for en banc consideration.
  • Barring a favorable ruling for the plaintiffs from the U.S. Supreme Court, in the event a writ of certiorari is requested and granted, it is now settled that individual California buyers can legally purchase foie gras from force fed birds only from out-of-state companies by internet, phone or fax.
  • Beginning on October 1, 2022, plant-based meat alternative products in France will face new labeling challenges. The decree (in French) prohibits manufacturers of plant-based products from using “sector-specific terminology traditionally associated with meat and fish.” Notably, this law applies exclusively to products made in France and not to imports.
  • Under this decree, terms like “steak,” “sausage,” or “chicken” will not be allowed to describe meatless, plant-based products. However, terms like “burger” will remain permissible because it does not specifically refer to meat.
  • France is the first country in Europe to ban this “meaty” language for plant-based foods; although, the European Union has prohibited plant-based products from using labels like “milk,” “cheese,” and “butter” if they do not include dairy ingredients. On an international scale, South Africa recently passed a similar restriction on the use of “meaty” language for plant-based products.  Keller and Heckman will continue to monitor changes in plant-based labeling requirements.
  • On July 6, 2022, FDA announced it had finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance aims to help food facilities develop a food safety plan to prevent or significantly minimize hazards in food for animals that could cause illness or injury to people or animals. Additionally, it provides detailed information to help animal food facilities anticipate possible food safety hazards, identify risk-based preventive controls to prevent or minimize those hazards, and create and implement a plan to keep unsafe animal food from entering the marketplace.
  • The document details:
    • How to recognize biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food;
    • Ways to identify and implement preventive controls for hazards that require preventive controls in animal food;
    • Components of preventive control management (e.g., monitoring, corrective actions, and verification (including validation); and
    • Recordkeeping requirements associated with the food safety plan and the implementation of the food safety plan.
  • By way of background, FDA released draft GFI #245, a draft of this guidance in January of 2018. One of the most notable changes in response to stakeholder feedback is the clarification that not all the hazard examples in the guidance are applicable to all animal food or all facilities.
  • Animal food facilities with questions about how this guidance applies to them can contact AskCVM@fda.hhs.gov for further assistance. Comments can be submitted here.
  • On June 10, 2022, the Food Safety and Standards Authority of India (FSSAI) issued a notification regarding the definition and regulation of vegan foods. Most notably, a food product cannot be considered “vegan” if the creation of the product required “animal testing for any purpose, including safety evaluation, unless provided by any Regulatory Authority.” This requirement also applies to food product imports that are labeled vegan and requires a certification by an appropriate authority of the exporting country.
  • The notification defines “vegan food” as “food or food ingredients” that are free from animal origin which means that “at no stage of production or processing” can ingredients of animal origin be used. Vegan food packaging must also display a logo indicating vegan compliance under the FSSAI regulations.
  • For comparison, the United States Food and Drug Administration (FDA) does not define or provide criteria for use of “vegan” claims on food labeling.  Rather, vegan claims are governed generally by the Federal Food, Drug, & Cosmetic Act § 403(a)(1).  This section requires that claims be truthful and not misleading.  Vegan certification claims on food products in the U.S. can be third-party certified, although this is not required by the FDA.  Keller and Heckman will continue to monitor and report on regulations regarding vegan foods.