• The International Scientific Association for Probiotics and Prebiotics (ISAPP) published a consensus statement on May 4 providing clarity on the definition for “postbiotic” and its scope.  The statement proposed to define a postbiotic as a “preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” The statement clarifies that postbiotics are deliberately inactivated microbial cells that contribute to demonstrated health benefits, but that purified microbial metabolites and vaccines are not postbiotics. It also provides details on important processing factors in creating postbiotics, their proper characterization, and information on how postbiotics improve intestinal and systemic health.
  • ISAPP has previously published consensus statements on the definitions and scopes of the terms probiotics, prebiotics, synbiotics, and fermented foods as follows:
    • Probiotics: “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.”
    • Prebiotics: “substrate[s] that [are] selectively utilized by host microorganisms conferring a health benefit.”
    • Synbiotics: “mixture[s] comprising live microorganisms and substrate(s) selectively utilized by host microorganisms that confer a health benefit on the host.”
    • Fermented Foods: “foods made through desired microbial growth and enzymatic conversions of food components.”
  • Taken together, the consensus statements aim to provide stakeholders with a common understanding of these terms and avoid confusion between similar terms. For instance, its consensus statement on fermented foods aims to draw a line between fermented foods and probiotics by clarifying that fermented food products should only be labelled as “containing probiotics” when there is evidence that their live microbial components provide health benefits and the precise microbiological content is defined.
  • ISAPP underscores in each statement that implicit in each definition is the requirement that the subject be safe for its intended use and that any claims related to health benefits must be substantiated in the target host.
  • On May 10, Texas state lawmakers passed a bill that would prohibit plant-based, cell-based, or insect-based food products that do not contain meat from slaughtered animals from using terms like “meat,” “beef,” “pork,” or “poultry product” on food labels.
  • House Bill (HB) 316 states that a food advertised or labeled as a livestock or poultry product, analogue product, or cell-cultured product shall be considered misbranded if, among other requirements, it is an imitation of another food, unless its label bears the word “imitation” in prominent type. Meat and poultry analogue products and cell-based products are deemed misbranded unless they declare qualifying terms or disclaimers on the product label, such as “meatless,” “plant-based,” “made from plants,” “cell-cultured,” or other similar phrases that clearly communicate to the consumer the contents of the product.
  • HB 316 was introduced on November 9, 2020 by State Representative Brad Buckley (R), and was passed on May 10, 2021. There is a companion bill in the Senate, SB883, which was referred to the Senate Business & Commerce committee on March 11.
  • Of HB316, Rep. Buckley stated “[t]his is for those who choose to eat meat, but it’s also for those who choose to not eat meat” and that the goal “is to have clear and accurate labeling so the consumer has no doubt what they’re purchasing.” The bill gained support from the Texas & Southwestern Cattle Raisers Association, Texas Poultry Federation, Texas Pork Producers Association, and other livestock companies. However, the bill is opposed by organizations like the Plant Based Foods Association and the Alliance for Plant Based Inclusion. Several state lawmakers have also expressed concern. State Rep. Gene Wu (D) argued that the bill may cause Texas to be subject to unnecessary litigation and State Rep. Kyle Biedermann (R) stated “[t]here shouldn’t be a need to have to legislate more regulation of these other companies when it seems their packaging is pretty clear.”
  • Keller and Heckman will continue to monitor any developments.
  • Yesterday, on May 10, 2021, the FDA opened the FSVP Importer Portal for FSVP Records Submission (the Portal) for importers of human and animal food into the U.S.
  • By way of background, the Foreign Supplier Verification Program (FSVP) requires that importers verify that the food which they import provides the same level of public health protection as the preventive controls or produce safety regulations (as appropriate) in the U.S. and to ensure that supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
  • While the FDA typically conducts inspections of FSVP records at an importer’s place of business, the importer must provide the records electronically or through another means of prompt delivery if requested by the FDA. See 21 C.F.R. § 1.510(b)(3) (“How must I maintain records of my FSVP?”). The Portal now provides a streamlined means by which importers can provide FDA with FSVP records electronically.
  • The Portal can be accessed here and a user guide for the Portal is available here.

 

  •  Since launching in 2018, the FDA Nutrition Innovation Strategy (NIS) has included the possibility of FDA introducing a new symbol that could be used to convey the nutrient content claim “healthy” on packaged foods, as well as related plans to update the regulatory definition of “healthy” at 21 CFR 101.65(d).  Currently, the term may be used as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.  In the interim, while FDA works on the updated rule, as discussed here, FDA issued a guidance document stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
  • On May 7, 2021, FDA announced the availability of a procedural notice regarding plans to conduct three consecutive quantitative research studies—an experimental study and two surveys—to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  The first study will be a controlled, randomized experiment that will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel maintained by a contractor.  The second and third studies (surveys) will each utilize a 10-minute questionnaire to test sets of draft FOP symbols in a sample of 1,000 U.S. adult participants from an online consumer panel.
  • There is no news on any FDA progress in updating the regulatory definition of “Healthy.”  Comments on FDA’s proposed collection of information for the study, ‘‘Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘Healthy’ on Packaged Foods,” are due by July 6, 2021.  After public comments are received, FDA’s consumer research plans will be submitted for approval from the Office of Management and Budget (OMB).
  • On May 5, FDA released a report titled “Resiliency Roadmap for FDA Inspectional Oversight,” explaining how FDA adjusted its inspection program during the COVID-19 pandemic and providing details on its priorities moving forward. In March 2020, FDA responded to COVID-19 by postponing all domestic and foreign routine facility inspections, only resuming prioritized domestic inspections in July 2020.
  • The report explains that as FDA works to make up for lost time during the pandemic, it plans to continue to prioritize routine surveillance inspections for high-risk facilities and conduct inspections over a longer period of time.  As a result, certain lower-risk facilities may have an increased amount of time between inspections. The report proposes several different scenarios for a return to normal inspection schedules, considering best-case and worst-case scenarios.
  • The report also mentions FDA plans to begin a multi-year modernization plan for data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role, including remote approaches. FDA will review its approach to inspections with updated assessment programs and establish an agency-wide FDA Inspectional Affairs Council to plan and coordinate inspectional activities.
  • On May 6, 2021, the European Food Safety Authority (EFSA) updated its 2016 safety assessment of the food additive titanium dioxide (TiO2, E 171) and concluded that it can no longer be considered safe as a food additive despite EFSA’s findings in 2016 that E 171 did not raise a genotoxic concern.  Currently, TiO2 is authorized as a food additive in the European Union according to Annex II of Regulation (EC) No 1333/2008.
  • EFSA’s expert panel on Food Additives and Flavourings (Panel) stated that it reached this conclusion because of the food additive’s genotoxicity concerns when it is absorbed by the body.  The Panel concluded that, although the absorption of TiO2 particles is low, it has the potential to accumulate in the body, as the food additive contains at most 50% of particles in the nano range (i.e., less than 100 nanometers) to which consumers may be exposed.  EFSA noted that although the evidence for general toxic effects was not conclusive, the new data and strengthened methods did not allow the Agency to rule out a concern for genotoxicity.  By way of background, French authorities suspended the marketing of foods containing TiO2 in 2019, as there were gaps and uncertainties in the food additive’s safety data.
  • Based on EFSA’s opinion, the European Commission and the EU member states will meet to consider phasing out TiO2 from the EU legislation on food.  If the EU takes action in response to EFSA’s opinion, the decision would be notified to the World Trade Organization and would subsequently be considered by the Codex Alimentarius Commission.  It remains to be seen whether there will be ripple effects in other countries or on other products.
  • On May 4, the FDA published two Warning Letters for undeclared allergens and the “introduction or delivery for introduction into interstate commerce of any food that is misbranded” which is prohibited by section 301(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 331(a)).
  • In a March 26 letter sent to Hanover Foods Corporation, the FDA stated that its recalled Baked Rice Pudding and Cheddar Flavored Popcorn were misbranded within the meaning of section 403(w) of the FD&C Act because the labels failed to declare the major food allergens of milk and egg (Rice Pudding) and milk (Cheddar Flavored Popcorn). Specifically, the Rice Pudding was manufactured with milk and egg, but the label incorrectly declared an ingredient list for another product that did not contain milk or egg. Similarly, the Cheddar Flavored Popcorn incorrectly declared another product’s ingredient list, which did not contain milk.
  • On March 30, a separate letter was sent to George DeLallo Company Inc. for their recalled Holiday Cookie Platter and Provolini Antipasti products. FDA stated that the products were misbranded within the meaning of section 403(w) of the FD&C Act because the products did not declare the presence of pecans (tree nuts) and milk, respectively.
  • In comments to both Warning Letters, FDA noted that the manufacturing facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule). Thus, both Hanover and DeLallo are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) would be significantly minimized or prevented. In other words, the presence of the undeclared allergens may have been a result of the manufacturers’ inadequate prevention or failure to comply with CGMP and PCs.
  • As our readers know, food or ingredients that contain one of the now nine major allergens must be specifically labeled with the names of the allergen source. The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. These Warning Letters, in addition to the one sent to Whole Foods in December, reconfirm FDA’s attention and efforts to reduce the prevalence of undeclared allergens and allergen recalls.
  • Plaintiffs, on behalf of a proposed class of consumers, have filed a class-action against Baker Mills, Inc. and Kodiak Cakes, LLC, which alleges that the Defendants have deceptively labeled and marketed their Kodiak Cakes by overstating the products’ protein content and quality.
  • First, Plaintiffs allege that the amino acid testing that they conducted indicates that the products contain 17% less protein than the 14 grams of protein that is claimed (or 11.5 grams). Additionally, Plaintiffs allege that the products contain even less biologically available protein because they contain lower value wheat and pea protein. Furthermore, the nutrition panel does not include the percent daily value of protein as required by federal (and parallel state) regulations when a protein claim is made. See 21 CFR § 101.9(c)(7)(i). And, the percent daily value is required to take into account not only the amino acid content, but also its PDCAAS score, which is a method of evaluating protein quality based on human amino acid requirements and amino acid digestibility.
  • Plaintiffs also allege that Defendants’ website and other marketing materials, which make numerous protein claims, “confirm” Defendants’ intent to mislead consumers regarding the protein content of their products. For example, the website states that “Combining the nourishment of whole grains with the benefits of high-quality protein just makes sense” and describes the products as “Protein Packed.”
  • Although not directly at issue here, the case serves as a reminder that internet marketing materials may be considered to be labeling by the FDA, particularly where the marketing materials explain or supplement the product and appear on a company website where the product may be directly purchased by consumers. Keller and Heckman will continue to monitor this case and other food litigation news.
  •  We have reported on FDA’s guidance document, “Inorganic Arsenic in Rice Cereals for Infants: Action Level Guidance for Industry,” which was finalized in August 2020 and sets an action level of 100 parts per billion (ppb) as the threshold for considering whether infant rice cereal may be “adulterated” and enforcement action is warranted.  A February 4, 2021 Congressional report on the finding of heavy metals in baby foods in the U.S. raised questions regarding compliance with FDA’s action level and, among other things, recommended the possibility of “phasing out” ingredients such as rice, that are high in toxic heavy metals.  As discussed here, the “Baby Food Safety Act of 2021,” was later introduced, on March 25, 2021, and would impose a lower action level of 15 ppb for inorganic arsenic in infant and toddler cereal.
  • In an April 29, 2021 press release, New York Attorney General Letitia James announced a new investigation into whether infant rice cereal products that are sold in New York contain arsenic at levels exceeding the legal maximum under the law and whether the advertising and promotion of the products complies with New York’s consumer protection laws.  Gerber Products Co., Beech-Nut Nutrition Co., Nurture Inc., and Hain Celestial Group Inc. were identified as targets of the probe.  This action follows Attorney General James’ February 9 2021 request urging FDA to set federal standards for toxic metals in all baby food categories and require all baby food manufacturers to test their finished products for toxic metals rather than testing just individual ingredients.
  • The recently announced NY investigation and U.S. congressional activity, as well as recent litigation (discussed here), involve complicated and multifaceted issues.  As discussed in Closer to Zero, the new FDA action plan released on April 8, 2021 for reducing exposure to toxic elements from foods eaten by babies and young children to as low as possible, FDA is simultaneously focused on avoiding unintended consequences, such as eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one toxic element while increasing another.
  • On April 23, 2021, the Center for Science in the Public Interest (CSPI) announced that it had worked together with companies, including Sara Lee® and Thomas’®, to ensure that the companies provide additional information quantifying their products’ whole grain content.  CSPI notes that this disclosure will help consumers make informed decisions about the grains they consume and enable them to build a diet that meets the U.S. Department of Agriculture’s (USDA) 50% whole grain recommendation.  USDA’s recently published 2020-2025 Dietary Guidelines for Americans recommend Americans consume half of their grains from whole grain sources and the remainder from enriched grains.
  • CSPI and the companies agreed that “whole grain” claims will be accompanied by a prominent disclosure of the percentage of the grains that are whole grains.  For example, the companies will present their claims along with percentages as follows: “Sara Lee® White Made with Whole Grain Bread (32%),” “Thomas’® Plain Made with Whole Grain Bagels (25%),” and “Thomas’® Made with Whole Grain English Muffins (29%).”  Additionally, CSPI and the companies agreed that the words “made with” be more prominent (i.e., at least 75 percent as large as the words “whole grain”) when “made with whole grain” claims appear on the products.
  • In January 2021, CPSI also worked with Wonder Bread so that the company could provide additional information on its product labels that quantify the product’s whole grain content.