• On July 26, 2022, FDA announced that it would hold a webinar for stakeholders to discuss Food Facility Registration, Biennial Renewal, and obtaining an acceptable Unique Facility Identifier.
  • As previously reported, under FDA’s Food Safety Modernization Act, Food Facility Registration is required for U.S. and foreign human and animal food facilities. Facilities that are registered must renew their registration between October 1, 2022, and December 31, 2022. The webinar will discuss who needs to register or renew and how to do so, as well as how to obtain a unique facility identifier and the benefits of food facility registration.
  • The webinar will take place on August 11, 2022, at 1:00 pm EST. Registration is required by August 10 to attend the webinar.
  • On July 22, the FDA published a draft guidance on conducting Remote Regulatory Assessments. Remote Regulatory Assessments (RRAs) were originally developed during the COVID-19 health emergency and are a set of tools to help the Agency conduct oversight, mitigate risk, and meet critical public health needs with respect to certain FDA-regulated products.
  • Currently, requests for records or other information from drug establishments under section 704(a)(4) of the FD&C Act, and requests for FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), are RRAs that FDA conducts for which participation is mandatory. RRAs that are not conducted under statutory or regulatory authority are voluntary, meaning that an establishment can decline to participate, in which case the Agency would consider other tools for evaluating compliance with FDA requirements.
  • The draft guidance describes the FDA’s current thinking on its use of RRAs and is intended to increase the industry’s understanding of RRAs and the FDA’s process for conducting RRAs. The draft guidance provides answers to frequently asked questions about what RRAs are, when and why FDA may use them, and how they are conducted, among other FAQs.
  • Stakeholders may submit comments on the draft guidance until September 23. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • A class action lawsuit which asserted various false advertisement claims related to the vegetable oil content of Costco’s chocolate almond dipped vanilla ice cream bars (the “product”) has been dismissed.
  • The Plaintiff alleged that the product was misleadingly advertised as chocolate because the product’s coating contained more vegetable oils than chocolate and the inclusion of vegetable oil was not “prominently disclosed on the product’s front label” as required by 21 CFR 163.155(c). Plaintiff also alleged that the vegetable oil content reduced the chocolate’s quality. In support of his claims, Plaintiff cited to a study which found that 64% of the 6400 respondents who viewed the product label “expected that it would contain more cacao bean ingredients than it did and would not be made with chocolate substitutes.”
  • The Court rejected each of these arguments. It found that the product label did not claim that the coating was made of mostly or entirely cacao bean ingredients and that any alleged violation of FDA regulations was largely irrelevant because there was no evidence that consumers were “aware of the nuances of the FDA’s regulations.” Furthermore, it found that sugar and milk should be considered in the calculation of the proportion of chocolate in the product’s coating, and that when considering these ingredients, the product’s coating contained more chocolate than vegetable oil.  The Court found the cited study similarly unpersuasive because it did not answer the precise question at issue and the complaint was devoid of important details such as the questions asked and the methodology used. Finally, the Court found that there were insufficient allegations to support the claim that the chocolate was of an inferior quality.
  • This case is the latest in a string of recent dismissals of similar lawsuits. Notably, in this case, the court took the unusual step of dismissing with prejudice (i.e., without leave to amend) because “Plaintiff alleged an unreasonable interpretation of what ‘chocolate’ includes, and no set of alleged facts could change the Court’s ruling.”
  •  As covered on this blog, on July 24, 2020, the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) recommended the addition of a new crop, ‘‘Sugarcane (insect-resistant),’’ to the List of Bioengineered Foods (the List).  AMS also recommended amending the existing listing for “squash (summer)” to “squash (summer, virus-resistant),” and sought information about bioengineered (BE) versions of cowpea and rice.  As of January 1, 2022, the date when all regulated entities were required to comply with the National Bioengineered Food Disclosure Standard (NBFDS; discussed here), the use of a listed food or ingredient produced from an item on the List would require a BE food disclosure unless a regulated entity has records demonstrating that the food or ingredient they are using is not BE.  When a crop is not on the List (as is currently the case for sugarcane), a BE disclosure is required only if the entity has actual knowledge that a food or food ingredient that it uses is BE.
  • On July 21, 2022, AMS announced a proposed rule that would update the List to add “sugarcane (Bt insect-resistant varieties)” and amend “squash (summer)” to “squash (summer, mosaic virus-resistant varieties).”  Both proposed listings would contain more precise language than previously recommended.  AMS noted in the July 22, 2022 Federal Register notice of the proposed rule that it did not receive any comments on cowpea or rice and is not proposing any action related to those two crops at this time, and addressed comments opposed to the previously recommended updates on sugarcane or wanting additional changes to the amendment for squash (summer) as follows:
    • On a comment acknowledging that BE sugarcane is authorized in Brazil, but arguing that sugarcane (Bt insect-resistant varieties) should not be added to the List because the BE sugarcane is in production in Brazil primarily for seedling bulk up, and not for human consumption, AMS found that sugarcane (Bt insect-resistant varieties) could be used for human food and requested data or evidence that would support or refute the conclusion that seedling bulk up is the only current use for sugarcane (Bt insect-resistant varieties).
    • In answer to a comment that BE sugarcane produced in Brazil is unlikely to end up in the United States, AMS noted that the List reflects production of BE foods on a global level and does not consider whether such foods are likely to end up in the U.S.
    • As for comments that sugar produced from BE sugarcane is not a BE food because it is highly refined and does not contain detectable modified genetic material, AMS noted that the BE presumption established by listing applies here because the BE sugarcane meets the only two applicable criteria for inclusion (i.e., it is authorized for commercial production and currently in legal commercial production somewhere in the world), and that the presumption could potentially be rebutted, and the associated BE disclosure requirement could be avoided, by demonstrating that modified genetic material is not detectable in sugar.
    • AMS declined to add a trade name to the more specific listing for “squash (summer, mosaic virus-resistant varieties),” in response to comments suggesting this would help distinguish BE versions from their non-BE counterparts, because there is more than one variety of squash (summer) that meets the listing criteria and it is an AMS policy to list crops generically where there is more than one BE variety being marketed.
  • As we noted previously when AMS recommended adding ‘‘Sugarcane (insect-resistant)’’ to the List, the addition of “Sugarcane (Bt insect-resistant varieties)” may complicate the strategy of regulated entities wishing to alleviate NBFDS burdens by avoiding “Sugarbeet,” which is currently listed generically based on availability of more than one BE version.  Comments on the proposed rule are due by September 20, 2022.

 

  • Following an Advance Notice of Proposed Rulemaking (ANPR) for labeling cell-based meat products issued in September, the issue has been placed on the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service’s (FSIS) list of “long-term actions” – meaning the agency does not intend to have a regulatory action within the next 12 months.
  • This is despite food tech companies’ eagerness to bring cell-cultured meat to the market. A California-based company recently developed what it claims to be a significantly less expensive method to produce edible beef cells and anticipates lowering that cost further at scale.
  • Through the ANPR, FSIS received more than 1,200 comments on an array of questions, including whether labeling should differentiate cell-cultured products from products made from traditionally slaughtered animals.
  • Keller and Heckman will continue to monitor FSIS’s plans regarding regulating cell-based meat products.
  • On July 19, 2022, FDA Commissioner Robert Califf published a statement regarding FDA’s evaluation of agency activities. In his statement, Califf acknowledged that the agency has recently confronted challenges that have tested its regulatory frameworks. As a result, Califf commissioned external agency experts to conduct evaluations for the agency’s Human Foods Program and Center for Tobacco Products.
  • The evaluation of the Human Foods Program will include the Office of Food Response and Policy (OFPR), Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). Califf noted that the program has been stressed by complexity of the nation’s food systems and supply chain, and that fundamental questions regarding the structure, funding and leadership of the program must be addressed. The evaluation of the Center for Tobacco Products (CTP) will focus on how the agency will address policy issues and enforcement activities for an increasing number of novel products.
  • The Reagan-Udall Foundation, an independent partner organization for FDA, will work with the external group of experts on the evaluation and will report its findings to FDA within 60 days of initiation. Califf stated that he was committed to addressing the findings and communicating them to the public and believes that the evaluation will support the agency in addressing immediate and future public health matters.
  • On July 13, Chair of the House Appropriations Committee Rosa DeLauro (D-CT-03) and Senator Dick Durbin (D-IL) introduced the Food Safety Administration Act, which is legislation that would establish the Food Safety Administration, a single food safety agency that would incorporate FDA’s food safety and veterinary medicine centers and the Office of Regulatory Affairs’ food operations. The Food Safety Administration would be led by a Senate-confirmed food safety expert.
  • In a Fact Sheet about the bill, DeLauro and Durbin state that, because most FDA commissioners have been medical specialists, the food program “has second-class status within FDA and we have not had sufficient strategic leadership and management accountability for the programs that regulate our food supply.” Further, DeLauro and Durbin state that “[i]n addition to bringing focused leadership and more accountability, a unified structure and full-time senior leader will strengthen oversight of the food supply and enhance the industry’s ability to operate effectively.”
  • DeLauro, Durbin, and other lawmakers have tried to establish a new food safety administration numerous times over the past 20 years. For instance, lawmakers have repeatedly introduced the Safe Food Act which is aimed at transferring and consolidating food safety authorities for inspections, enforcement, and labelling into a single food safety agency. In 2015, the White House’s fiscal 2016 budget proposed consolidating FDA food inspections and enforcement functions and the USDA’s FSIS into a single new food agency within HHS. Of note, DeLauro and Durbin’s current legislation would not apply to the USDA and would only affect FDA.
  • Keller and Heckman will continue to monitor the status of the legislation and provide updates.
  • 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.