• In an April 29, 2022 order, the U.S. District Court for the Northern District of California rejected Defendant BA Sports Nutrition, LLC’s motion for summary judgment as to Plaintiffs’ claims that the labeling of BodyArmor (a sports drink sold by BA Sports Nutrition) deceptively enticed them to buy BodyArmor by suggesting that it contained real fruit and/or fruit juice, when in fact it only contained natural flavors. BodyArmor sports drinks were named with fruit names (e.g., BodyArmor Orange Mango) and were labeled with pictures of fruits.
  • In doing so, the Court rejected BA Sports Nutrition’s argument that the labeling claims were nutrient content claims that were preempted by FDA’s regulation at 21 CFR 101.13 because it found no evidence that the claims were express or implied claims regarding nutrient levels.
  • Interestingly, the Court found that the flavor labeling regulation (21 CFR 101.22) was not relevant to the proceedings because sports drinks are “not commonly expected to contain a characterizing food ingredient.” See 21 CFR 101.22(i)(1)(i).
  • However, the Court did grant summary judgment in favor of BA Sports Nutrition as to Plaintiffs’ claims that they were induced into purchasing BodyArmor based on labeling claims that falsely stated that BodyArmor offered superior hydration and health benefits. The Court found that Plaintiffs’ claims were belied by their own deposition testimony which indicated that they were aware that: (1) hydration was not an objective measurable attribute, (2) BodyArmor had a high sugar content, and (3) sugar can be unhealthy.
  • The case serves as a reminder that, in addition to challenging an action on the grounds that a “reasonable consumer” would not be misled by the labeling/advertising in question, Defendants can also challenge that the Plaintiffs in the particular action were misled.

FDA Issues the Accredited Third-Party Certification Program: Questions and Answers: Draft Guidance for Industry

  • As previously covered on this blog, on November 27, 2015, FDA finalized the rule, “Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications,” also referred to as the Third-Party Program (TPP).  As required under the Food Safety Modernization Act (FSMA), this rule established the framework for the accreditation of “third-party certification bodies” (CBs) to conduct food safety audits and issue facility and food certifications to eligible entities.  Upon recognition by FDA, “Accreditation bodies” (ABs) may assess and accredit CBs that meet the TPP program requirements.  Accredited CBs may conduct consultative and/or regulatory food safety audits of eligible entities that produce food for humans or animals.
  • On April 28, 2022, FDA made available a new draft guidance titled, “The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry.”  When finalized, this draft guidance will answer frequently asked questions (FAQs) about the requirements of the Accredited Third-Party Certification Program as follows:
    • Definitions of terms: consultative audits, regulatory audits, audit agent, and days;
    • Circumstances requiring certification: (1) “Facility certification” is required for eligible entities to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), and (2) “Food certification” is required by FDA under certain circumstances to provide assurance that the food meets applicable food safety requirements;
    • Requirements for ABs seeking recognition from FDA: (1) Eligibility, (2) How to Apply, (3) the 11 Scopes of Recognition (Acidified Foods, Dietary Supplements, Infant Formula, Juice Hazard Analysis and Critical Control Points (HACCP), Low-Acid Canned Foods (LACF), Medicated Feed Current Good Manufacturing Practices (CGMPs), Preventive Controls for Animal Food, Preventive Controls for Human Food, Produce Safety, Seafood HACCP, and Shell Eggs), and (4) how the scopes of recognition correspond with legal and regulatory food safety requirements;
    • Requirements for recognized ABs: (1) Information for developing criteria for evaluating food safety audits, (2) Factors to consider in determining the appropriate number of onsite audits to observe prior to accrediting a CB, (3) Reports and notifications that must be submitted to FDA, (4) Application to FDA for recognition of additional scopes of recognition, (5) Conditions for accepting payment from a CB for accreditation services, (6) Conflict of interest protections and documentation requirements involving an AB employee serving as an audit agent for a CB that the AB has accredited under the TPP, (7) Consideration of financial interests of spouses and children of a recognized AB’s officers, employees, and agents involved in accreditation activities, (8) Records to be maintained for fee payments and reimbursement of direct costs, and (9) Notification by FDA to a recognized AB of FDA’s response when a CB accredited by the AB requests a waiver for the 13-month limit for audit agents conducting regulatory audits.
    • Requirements for CBs seeking accreditation from recognized ABs: (1) Eligibility, (2) How to apply, (3) the 11 Scopes of accreditation, (4) how the scopes of accreditation correspond with legal and regulatory food safety requirements (including a table describing the scopes of recognition and accreditation), (5) Further information on audit criteria for CBs (including the possibility of additional food safety requirements beyond those for which FDA has developed templates), (6) How a CB could demonstrate capability to meet the requirements for accreditation if the CB has not previously issued certifications based on food safety programs, and (7) Explanation that onsite audits conducted prior to the CB’s accreditation cannot serve as the basis for issuing a food or facility certification;
    • Requirements for accredited CBs conducting observed onsite audits and food safety audits: (1) Restrictions on the same CB conducting both consultative audits and regulatory audits for the same eligible entity, (2) Conduct of a regulatory audit without announcement during an identified 30-day timeframe; (3) Auditing and certifying eligible entities outside the countries of the CB, (4) Who makes the determination and issues certificates, (5) Determining what to assess as part of a food safety audit, (6) Circumstances for issuing a certificate for food that was not directly observed during the onsite examination of a regulatory audit, (7) Prohibition on providing a certificate for a scope that is not part of the CB’s accreditation, and (8) Evaluation for a new scope while the accredited CB’s AB is onsite conducting monitoring activities for an already-accredited scope;
    • Reports and notifications that an accredited CB must submit to FDA: (1) Regulatory Audit Report (RAR), Self-assessments, serious risk to public health, and withdrawing or suspending a food or facility certification, (2) Name(s) that must appear in food or facility certificate information submitted to FDA, (3) Timing for submission of a RAR and when FDA considers the RAR to be complete, (4) Required data elements for a RAR, (5) Change of address for an eligible entity, (6) Adequate information about observed processes and foods, (7) Role of FDA product codes provided to FDA in the certification information in FDA’s Unified Registration and Listing System (FURLS), and (8) Notification when a condition of public health significance is identified during a non-TPP audit;
    • Conflict of interest requirements for accredited CBs: A written program to protect against conflicts related to the financial interests of spouses and children younger than 18;
    • Requirements for eligible entities: (1) Certification of an eligible entity (such as a farm) that is not required to register as a food facility, and (2) Non-issuance of certificates to eligible entities that are not in compliance with applicable U.S. food safety requirements including FDA’s food facility registration requirements.
    • General requirements for the TPP: (1) Public registries of the recognized ABs and accredited CBs, (2) User fees for participation, and (3) Inclusion of a logo or mark of conformity to indicate certification and restations on use of FDA’s name;
    • TPP and other FSMA requirements: (1) Relation to VQIP, (2) Use of TPP audits to meet requirements of the Foreign Supplier Verification Program (FSVP) and Preventive Controls regulations, and (3) Conflict of interest requirements when an FDA-recognized AB is also a FSVP importer.
  • FDA has requested that comments on the new TPP guidance be submitted to Docket No. FDA-2022-D-0370 by July 28, 2022.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com if you are interested in submitting comments on the new draft guidance or if you have any questions about FSMA or the Accredited Third-Party Certification Program.

  • On April 27, 2022, FDA issued a draft guidance providing draft action levels for lead in single-strength apple juice and other single-strength juices. FDA states that the new levels are intended to reduce the potential for negative health effects associated with dietary exposure to lead. The action supports FDA’s Closer to Zero action plan which intends to reduce exposure to toxic elements in foods.
  • The guidance provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and 20 ppb for lead in all other single-strength juice types. As noted by FDA, the draft action levels in the guidance were determined using FDA’s interim reference level (IRL) for lead. Using this measurement, FDA estimates that a 10 ppb action level in apple juice could result in an estimated 46% reduction in exposure to lead from apple juice in children. For all other juices, an action level of 20 ppb is estimated to result in a reduction of 19% in exposure to lead from the juices in children. The Agency noted that it chose to issue lower draft action levels for apple juice because it is the most consumed juice by young children.
  • FDA is accepting comments on the draft guidance. Comments may be submitted by mail or electronically at Regulations.gov using Docket No. FDA-2019-D-5609.
  • On April 27, 2022, FDA issued updated guidance on the requirement, under the Foreign Supplier Verification Programs for Food Importers (FSVP) regulation, for food importers to ensure that each entry line of food offered for importation to the U.S. has an acceptable unique facility identifier (UFI) that is provided electronically when filing entry with the U.S. Customers and Border Protection. FDA has recognized the Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as acceptable for this purpose.
  • Previously, FDA issued a guidance that provided for the temporary use of the entity role code “UNK” (unknown) in place of a DUNS number. The policy was intended to be temporary, as FDA acknowledged that it was a new requirement and that some factors may have prevented importers from providing their UFI. This new guidance intends to update the previous one by removing the temporary policy that allowed for the use of the “UNK” code.
  • FDA now provides that importers have had “ample time” to familiarize themselves with the UFI requirements. As such, beginning on July 24, 2022, FSVP importers will no longer be permitted to use the code “UNK” and must instead ensure that a valid DUNS number is provided.
  • On April 25, a New Jersey federal judge dismissed a putative class action lawsuit against baby food producer Sprout Foods, Inc. finding that the alleged harm was “simply speculative” (subscription to Law360 required). The lawsuit alleged that Sprout’s baby food products contained dangerous levels of heavy metals and were misleadingly advertised as “clean,” “healthy,” “wholesome,” and “organic.” This lawsuit came in the wake of last year’s Congressional report on heavy metals in baby food. Summaries of the report and subsequent events are available here and here.
  • U.S. District Judge Stanley R. Chesler held that the proposed class action sufficiently alleged that there were heavy metals in the Sprout baby food products and that elevated levels of heavy metals can be unsafe and dangerous. However, the proposed class did not connect those two allegations by establishing that the levels of heavy metals in the Sprout baby food products were unsafe. In support of the dismissal, Judge Chesler quoted the FDA’s March 2021 letter to industry, which stated that “at the levels we have found through our testing….children are not at an immediate health risk from exposure to toxic elements in foods.” Judge Chesler wrote “[a]t the very least, this statement weakens the inference that the amount of heavy metals in the Baby Food Products creates a substantial risk of danger to children.”
  • The case was dismissed without prejudice, which allows the plaintiffs the ability to refile. Keller and Heckman will continue to monitor and report on any developments with this case or other heavy metal baby food-related lawsuits.
  • The Association of Food and Drug Officials (AFDO)— a nonprofit organization made up of regulators, industry representatives, and other stakeholders— released a white paper in which it outlined problems in FDA’s recall activities and proposed solutions to the identified issues.
  • The report identified two broad ongoing problems effecting FDA regulated food product recalls: (1) consumers continue to get sick after the issuance of a recall announcement and (2) the recall is typically issued and communicated too late to prevent additional illness. The report details each stage of the food recall process as well as specific issues that were identified at each step including:
    • Lack of consistency on how and when a recall is triggered;
    • Long delays and misclassification of recalls;
    • Lack of urgency in notifying states of pending recalls;
    • Lack of training on what to expect from regulators during a recall;
    • Lack of adherence to timeframes for assigning recall audit checks;
    • Lack of communication between state authorities and FDA; and
    • Lack of clear lessons learned after recall termination.
  • To rectify these problems, AFDO recommends that FDA make changes to:
    • Policy, including creating clear timelines for recall classification, hazard analysis, alerts to state partners, and issuance of recall audit checks.
    • Training, including increased training on recall activities for both industry and regulators.
    • Communication, including improved communications between all stakeholders, and leveraging artificial intelligence and other technology-based solutions.
    • Recall Management, including streamlining recall decisions by rethinking FDA’s organization structure and measuring if existing timeframes are being met.
    • Culture, including creation of a culture in which recalls are treated as public health emergencies and changing federal statutes to allow for more free distribution of information.
  • We will monitor and report on any changes that FDA makes to its recall policies and procedures.

 Kellogg Says ‘Veggie’ Means ‘No Meat,’ Not ‘Vegetables’ (Law360 Subscription Required)

  • The judge in a proposed class action lawsuit before the Northern District of California dismissed the plaintiff’s initial complaint alleging the term “Veggie” on Kellogg’s Morningstar Farms brand products, such as Veggie Burgers, Veggie Dogs, and Veggie Chik’n, is misleading.  The January 19, 2022 order explains that the claim that reasonable consumers interpret “Veggie” to mean that the products are made exclusively or primarily of vegetables is simply not plausible where the dictionary definition demonstrates the term “Veggie” can be used to describe a vegetarian product or the presence of vegetables and there is no allegation that the packaging or marketing otherwise conveyed the presence of vegetables in the products.
  • In an April 20, 2022 motion to dismiss with prejudice the plaintiff’s first amended complaint, Kellogg addresses new allegations as follows:
    • Kellogg asserts that a new survey commissioned by the plaintiff’s attorneys constructs a false dichotomy by asking consumers to categorize Morningstar Farms products as either “Vegetable-based” ingredients “made of actual vegetables such as carrots, cauliflower, or potatoes,” or “Other Plant-based” ingredients “made of other non-vegetables such as grains or oils,” rather than asking respondents how they interpret the term “veggie” or to define a “veggie” product.
    • As for the plaintiff’s allegation that the term “veggie” is a “call-out” understood by reasonable consumers to signal that Morningstar Farms products are “primarily made of vegetables rather than other non-vegetable plant-based ingredients,” Kellogg asserts this theory of deception has already been rejected as inconsistent with the established understanding of “veggie.”
    • Regarding the plaintiff’s citations to several trademark applications describing Morningstar Farms products as “vegetable protein food patties,” “textured vegetable protein,” “vegetable-based meat substitutes,” and “preserved, processed, dried, frozen and cooked vegetables,” Kellogg notes the plaintiff does not allege to have seen or relied upon these trademark applications and argues they have no bearing on how consumers understand the term “veggie” on the product labeling.
    • Kellogg additionally argues that plaintiff does not allege to have seen or relied upon June 2000 website copy, which claimed Morningstar Farms products were “[m]ade with sun-ripened vegetable goodness” and no longer appears on Kellogg’s website and is absent from product labels.
    • Rather than suggesting Morningstar Farms Grillers are made with vegetables, Kellogg asserts that the phrase “veggies look good with grill marks,” which appears, in an advertisement, next to an image of veggie burgers and vegetable skewers cooking on a barbecue, confirms that they are a meatless substitute for hamburgers, as it emphasizes that “they are burgers” and that they are “lower in cholesterol and fat than a beef burger,” thus proving that the defining feature of a “veggie” product is the fact that it is vegetarian—not that it is made from vegetables.
    • Kellogg also characterizes website copy from a retailer (referring to Morningstar Farms Veggie Chik’n Nuggets as “Vegetable Nuggets”) and a restaurant menu (referring to a “Morningstar Farms Vegetable Patty”) as isolated examples that do not displace consumers’ prevailing understanding that the term “veggie,” as used to describe a vegetarian meat substitute, refers to the absence of meat rather than the presence of vegetables

In addition to the above arguments, Kellogg asserts that even if the term “veggie” could arguably be considered ambiguous as to each product’s ingredient content, the labeling resolves that ambiguity by stating all of the product’s ingredients in order of predominance, and the plaintiff’s first amended complaint should be dismissed with prejudice under this reasoning.  To preempt any possible argument based on a Ninth Circuit ruling that an ingredient list cannot be used to correct a misleading claim on the front of the package, Kellogg notes that there is “no deceptive act to be dispelled” for Morningstar Farms products, which do not include any pictures or other representations of the specific plant-based ingredients present in each product.

  • Although there are no direct parallels with laws enacted in several states, such as Missouri’s law, discussed here, which prohibit marketing a product as “meat” if it is not derived from livestock or poultry, since there is no alleged confusion about whether the Morningstar Farms products are made from meat or poultry, Kellogg’s motion to dismiss may have been strengthened by a discussion of  how “veggie burger” and similar terms have been used to describe plant-based products generally in recent battles over “fake meat” labeling laws.
  • On April 21, 2022 FDA announced the issuance of draft guidance on FDA’s policy regarding dietary supplements containing N-acetyl cysteine (NAC). The guidance details the agency’s intent to exercise enforcement discretion on the sale and distribution of such products.
  • In 2020 FDA sent warning letters to several companies regarding the use of NAC in dietary supplements. In the letters, FDA warned against the use of drug claims, but also noted that NAC could not be marketed as a dietary supplement because there was no evidence that NAC had been marketed as a food or dietary supplement prior to its approval as a drug in 1963. More recently, we reported that FDA had confirmed in response to citizen petitions that NAC is excluded from the definition of a dietary supplement. FDA had not yet reached a decision, however, regarding a petitioner’s request to issue a regulation that would permit the use of NAC in dietary supplements.
  • FDA is still considering whether to issue such a rule. In the meantime, it has published this draft guidance with the acknowledgment that NAC has been sold as a dietary supplement for over 30 years and that consumers seek access to such products. FDA notes that while its full safety review is ongoing, there are no safety concerns at this point with respect to the use of NAC as an ingredient or dietary supplement. Thus, the draft guidance explains that unless safety-related concerns are identified, the agency intends to exercise enforcement discretion until either 1) the agency completes notice-and-comment rulemaking to allow NAC in or as a dietary supplement, or 2) FDA decides to deny the request for rulemaking.
  • FDA is accepting comments on the draft guidance. Comments may be submitted by mail or electronically at Regulations.gov using Docket No. FDA-2022-D-0490.
  • As previously reported, FDA recently released a draft guidance regarding the agency’s approach to evaluating the public health risks of allergens other than the nine major food allergens. On the same day, the Center for Science in the Public Interest (CSPI) issued a statement regarding the guidance, arguing that FDA’s approach fails to provide consumers adequate protections.
  • Specifically, CSPI stated that, while the guidance provides a potentially useful framework, it does not indicate when the agency would act to take further action on an allergen if deemed to be a priority. Further, CSPI criticizes the agency for not proactively considering new allergens for prioritization and instead allowing “its allergen agenda be driven piecemeal by petitions from the public.”
  • CSPI highlights that it first petitioned FDA to require sesame to be labeled as a priority allergen in 2014 and that the agency did not respond until 2020, after Congress had mandated it.  CSPI encourages Congress to “direct FDA to create a more clear and efficient path towards adding new major allergens.”
  • On April 20, the FDA published a final rule for added fluoride levels in bottled water. The final rule amends the quality standard, and specifies that domestically packaged and imported bottled water to which fluoride has been added may not contain fluoride in excess of 0.7 mg/L. The final rule revises the current allowable levels, which range from 0.8 – 1.7 mg/L.
  • The revised maximum added fluoride level is consistent with the current recommendation by the US Public Health Service (PHS) for the fluoride concentration in community water systems that add fluoride to their water. The chosen maximum level balances the issues of tooth decay prevention and the risk of fluoride overexposure.
  • The final rule reiterates that fluoride added to bottled water must be declared in the ingredient list. In other words, bottled water with added fluoride is a multi-ingredient food. In addition, the terms “fluoridated,” “fluoride added,” or “with added fluoride” may be used on the label or in labeling of bottled water that contains added fluoride.
  • Notably, the final rule does not impact bottled water that contains only naturally occurring fluoride. The FDA decided not to revise the allowable levels for fluoride in bottled water that was not added by the manufacturer because the PHS recommendation does not affect community water systems with naturally occurring fluoride in water at concentrations greater than 0.7 mg/L. The final rule becomes effective on June 19, 2022, and compliance is required by October 17, 2022.