• On March 12, 2021 the U.S. Food and Drug Administration (FDA) published Import Alert 54-18, which relates to the detention without physical examination (DWPE) of dietary supplements and bulk dietary ingredients that are or contain new dietary ingredients (NDIs), ingredients that were not marketed in the U.S. before October 15, 1994, that do not have an appropriate regulatory status.
  • Import Alert 54-18 prohibits two Chinese companies from importing their products that contain higenamine into the U.S.  Higenamine is a dietary ingredient found on FDA’s Dietary Supplement Ingredient Advisory List (“DSIA List”) and which FDA has determined to be adulterated under the Federal Food, Drug, and Cosmetic Act (“the Act”).  In Import Alert 54-18, FDA notes that there is inadequate information to “provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.”
  • By way of background, import alerts inform FDA’s field staff and the public that the Agency has enough evidence to allow for DWPE of products that have been determined to be in violation of the Act.  When a product and/or firm are the subject of an import alert, it will be added to the Red List found on FDA’s import alert, which identifies firms and products subject to DWPE.  To be removed from the Red List, information must be provided to the Agency to demonstrate that the firm has resolved the conditions that gave rise to the violation.
  • FDA has stated that it expects the Agency to use Import Alert 54-18 to identify and deny entry of non-compliant NDIs or products containing NDIs, such as higenamine.  Similar import alerts exist for supplements containing kratom and active pharmaceutical ingredients.
  • On March 16, the FDA released the results of its 2019 Food Safety and Nutrition Survey Report (FSANS) which assessed consumers’ awareness, knowledge, understanding, and reported behaviors relating to a variety of food safety and nutrition related topics. The results are intended to help the FDA make better informed regulatory, policy, education, and other risk-management decisions in order to promote and protect the public health.
  • The FSANS combines the Food Safety Survey (last conducted in 2016) and the Health and Diet Survey (last conducted in 2014). The survey was sent by mail to respondents who could submit online or by mail. Approximately 4,400 responses were collected between October and November 2019.
  • In their press release, the FDA highlighted the following key findings:
    • 87% of respondents have looked at the Nutrition Facts Panel on food packages and mainly look for calories, total sugar, sodium, and serving size.
    • 70% of respondents have seen menu labeling at restaurants. Of those, 53% reported using the calorie information when making food order decisions.
    • Over 80% of respondents have seen claims such as “no sugar added,” “whole grain,” “organic,” “gluten free,” “low fat,” “no artificial ingredients,” “low sugar,” and “no artificial colors.”
    • About 76% of consumers are likely to wash hands with soap after touching raw meat, whereas only 68% would wash hands before preparing food, and only 39% after cracking raw eggs.
    • 62% of respondents own a food thermometer. Usage among those who own food thermometers and cook the food ranges from 85% for whole chickens, 79% for beef, lamb, or pork roasts, to 40% for chicken parts, 36% for burgers, 23% for egg dishes, and 20% for frozen meals.
  • As we reported in 2019, a group of 600 Hawaiian coffee farmers sued a group of coffee sellers, including Walmart, Costco, Amazon, Safeway, Kroger, Cost Plus/World Market, and Bed Bath & Beyond for falsely advertising coffee as “Kona” that did not originate in the Kona region of Hawaii in violation of the Lanham Act. A sister class action was filed by consumers against the same coffee sellers under the same facts, alleging breaches of implied and express warranties, Common Law fraud and intentional misrepresentation. Both complaints centered on the allegation that true Kona-grown coffee is a premium product sought out by consumers for its distinct flavor profile.
  • While the consumer-brought case was voluntarily dismissed without prejudice in May 2019, the farmer-brought suit has reached settlement agreements with the defendants. Most recently, Costco, Marshalls, and Gold Coffee Roasters reached an agreement (Law360 subscription required) on March 9, 2021, approved by the U.S. District Court for the Western District of Washington. In addition to monetary compensation and attorney fees from some sellers, the settlement requires the defendant coffee sellers to follow new labeling guidelines and require vendors to go through a certification process when labeling their coffee as originating in the Kona region. The requirements would bring the sellers into compliance with Hawaii’s strict labeling laws specific to Hawaiian-grown coffee. Earlier this year, the same court approved preliminary settlements with other defendants totaling over $7 million.
  • Kona coffee has been at the center of other claims, most of which have also avoided trial. A March 2019 suit filed against L & K Coffee Co. alleged the defendant’s Magnum Exotics Kona Blend Coffee product could not be characterized as “Kona” because it did not contain enough Kona coffee (the suit was later voluntarily dismissed with prejudice for undisclosed reasons). An April 2020 suit filed against Hawaiian Isles Kona Coffee Company brought on behalf of consumers alleged that testing of the products showed they did not originate from Kona.
  • These claims further highlight the importance of reviewing your labels and advertising to ensure that you accurately portray the geographic origin of your food and ingredients so as to avoid misleading consumers and increasing risk of challenge, especially when the foods and ingredients are considered value-added. Keller and Heckman will continue to monitor and report on activity surrounding such claims.

Kellogg Buyers Say Revised $13M False Ad Deal Is Gr-r-reat! (subscription to Law360 required)

  • As previously covered on this blog, a plaintiffs’ class action lawsuit filed in 2016, and certified for three classes of consumers in 2018, alleges that statements such as “heart healthy” and “lightly sweetened” on various Kellogg cereals are false and misleading because the cereals contain 18 to 40 percent added sugar.  While the outcomes have been mixed in other lawsuits involving nutrition-related claims on breakfast cereals, as discussed here, the Kellogg class action appeared to be moving toward a settlement if the litigants could agree on terms that would be acceptable to the court.
  • On March 10, 2021, the plaintiffs asked the court to approve a revised settlement that they say addresses numerous concerns, including high administrative fees, an overly broad class of consumers, and provisions that would allow Kellogg to reclaim millions if consumers do not act immediately.  If approved, the revised settlement would establish a $13 million fund for payment of around $16.09 each to an estimated 16 million households who purchased the covered products between 2012 and May 1, 2020, as well as administrative fees.  Any unclaimed funds would go to a supplemental distribution to consumers or to the American Heart Association and the UCLA Resnick Center for Food Law and Policy, which were also named as cy pres recipients in a preliminarily approved $15 million settlement, discussed here, of similar claims involving Post breakfast cereals.  The revised settlement would also require that Kellogg refrain for at least one year from using claims such as “heart healthy,” which appears on various Raisin Bran and Smart Start cereals, and “lightly sweetened,” which appears on Frosted Mini-Wheat varieties of cereals.
  • Nutrition claims that could imply the product is healthy seem risky for foods with added sugars based on mixed results in recent litigation and uncertainty about when and how FDA will act on a citizens petition (discussed here) requesting a regulation to establish disqualifying levels of added sugar that would prohibit the use of a “healthy” claim.
  • Comments for the Food and Drug Administration’s (FDA) Request for Information (RFI) for labeling of foods made from cultured seafood cells became due on March 8, 2021. FDA posted the RFI in October 2020 and sought comments primarily on nomenclature concerns (we summarized the RFI here).
  • In addition to a handful of comments from consumers with varied views on cell-cultured meats, FDA received comments from stakeholders such as Memphis Meats, the Environmental Defense Fund, Finless Foods, Center for Science in the Public Interest (CSPI), and The Vegetarian Resource Group. Other comments not yet posted have been released from individual entities, including BlueNalu, Inc., Good Food Institute (GFI), and a joint comment from the Alliance for Meat Poultry and Seafood Innovation and the National Fisheries Institute. Some highlights from the comments are provided below.
    • Most comments encouraged FDA to encourage product identity statements that differentiate seafoods cultured from cells from traditional farmed or wild-caught products. Many industry comments indicated support for the term “cell-cultured” seafood or “cell-based” seafood, which many said signal to consumers that the product is not plant based and is distinct from “wild caught” or “farm raised” seafoods. Many of these comments cited two studies from Rutgers University on consumer perceptions of potential labeling terms of cell-cultured meats: Hallman & Hallman (2020) and Hallman & Hallman (2021) (both underwritten by BlueNalu, which provided a detailed summary of the studies in its comment).
    • Some comments noted that if a term such as “cell-cultured” were to be added to product identity statements, it should also appear in ingredient descriptions following the common or usual name of the ingredient (e.g., INGREDIENTS: Minced Pollock (cell-cultured seafood).
    • Other comments, including those from GFI and the Vegetarian Resource Group, suggested that descriptive phrases such as “grown from cells” or “engineered using cultured [fish species] cells” would be more effective at preventing consumer confusion given no term has yet leveraged common understanding in the new industry.
    • Some comments also suggested that FDA need not update The Seafood List, a nomenclature and labeling reference for seafood, as the term “cell-cultured” could be used in conjunction with the names on the list to form statements of identity.
  • As our readers know, FDA and the U.S. Department of Agriculture have a formal agreement that confirms that FDA has sole regulatory oversight over food derived from cultured seafood cells, other than cells from siluformes fish (i.e. catfish) that fall under USDA jurisdiction. While FDA is expected to release guidance informed by these comments, it has not released a established a timeline for doing so.
  • On March 9, 2021, the Center for Science in the Public Interest, Democracy Forward Foundation, American Lung Association, and other groups filed a lawsuit in the U.S. District Court for the Northern District of California against the U.S. Department of Health and Human Services (HHS) challenging the Agency’s “Securing Updated and Necessary Statutory Evaluations Timely” Rule (“SUNSET Rule”).
  • The SUNSET Rule mandates HHS to assess its regulations every ten years to determine whether they are subject to review under the Regulatory Flexibility Act (RFA).  If a given regulation is subject to the RFA, HHS must review the regulation to determine whether the regulation is still needed and whether it is having appropriate impacts.  Regulations will expire if the Agency does not assess and (if required) review them in a timely manner.  The complaint alleges that the rule exceeds the Agency’s authority and is arbitrary and capricious, as it obligates HHS to review regulations at a pace that the Agency will not be able to achieve, which will result in the elimination of regulations that structure the plaintiffs’ operations and businesses, delineate their obligations and rights, or protect their members and the populations they serve.
  • By way of background, the Trump Administration released notice of the proposed SUNSET rule the day after the 2020 election and scheduled it to take effect on March 22, 2021.  The lawsuit alleges that the Trump administration rushed the rule and did not provide the public with enough time to comment.
  • The Biden White House has called for a regulatory freeze on any last-minute regulations approved by the Trump Administration.  As a result, HHS has delayed several Agency rules so far.  Plaintiffs filed the lawsuit against HHS, as the Agency has not yet issued a stay in response to the White House’s announcement.  It is unclear whether the SUNSET Rule will be impacted by the Biden Administration’s regulatory freeze before it takes effect on March 22, 2021.
  • On March 3, the US Senate passed S.578, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021, which would add sesame to the list of 8 “major food allergens.” The bill would also require that the Secretary of Health and Human Services collect data on the prevalence of food allergies and make a report to Congress no later than 18 months after the date of enactment of the Act that outlines descriptions of ongoing federal activities related to the development of effective food allergy diagnostics, the prevention of food allergies, and the scientific criteria for defining a food or food ingredient as a “major food allergen,” among other requirements. The report would be made public on the Department of Health and Human Services’ website. If the bill becomes law, it would apply to any food introduced or delivered into interstate commerce on or after January 1, 2023.
  • In response to the bill, the food allergy advocacy group, FARE, commented that it “will save lives, provide transparency, eliminate fear and anxiety, and help reduce health care costs by eliminating some of the thousands of emergency room visits made each year by those suffering food allergies.”
  • S.578 was introduced in the Senate by Senators Tim Scott (R-SC) and Chris Murphy (D-CT). Its passage comes a week after Congresswoman Doris Matsui (D-CA-6) and Congressman Patrick McHenry (R-NC-10) introduced the same bill in the House. A summary of the House bill (H.R.1202) is available here. Although we cannot confirm the outcome, it seems likely the House bill will also pass, and the bill will be signed into law by President Biden.
  • Keller and Heckman will continue to monitor and report on any FASTER Act developments.
  • On March 3, 2021, the U.S. District Court for the Central District of California invoked the primary jurisdiction doctrine to stay a consumer class action asserting various causes of action against Infinite Product Company, LLC (Infinite) related to the allegedly improper sale of cannabidiol (CBD) products. (See order; law360 subscription required)
  • As we have previously covered in our blog, the federal regulatory framework for CBD remains uncertain. The FDA has taken the position that CBD is not a lawful dietary or food ingredient, even while the market is flooded by CBD products and individual states, such as New York, are forging ahead with their own regulatory frameworks. And while industry had hoped that draft CBD enforcement guidelines—which had been under review by the White House Office of Management and Budget (OMB) since July 2002—would provide clarity, the draft guidelines were withdrawn in January following the change in administration. No timetable for their release, or for any other FDA regulatory or Congressional action has been announced.
  • The class action had alleged that Infinite improperly and misleadingly marketed CBD products, including labeling of the products as dietary supplements when they were in fact (allegedly) misbranded drugs. The court found that it could not adjudicate the claims “given the lack of clarity as to which of Defendant’s CBD products are drugs, dietary supplements, or food products, and what standards apply to those Products.” Instead, the court held that the primary jurisdiction doctrine, which allows courts to stay cases pending resolution of an issue within the special competence of an administrative agency, was properly invoked because both FDA and Congress have expressed interest in regulating CBD and uniform regulation of CBD is necessary, especially given the potential safety concerns. Therefore, the case was ordered stayed “until the FDA completes its rulemaking and/or Congress passes legislation regarding the definitions, marketing, and labeling of CBD products.”
  • While the order states that the stay will be in effect until Congress or FDA act, it is likely that prolonged inaction might also result in a reversal of the stay. Many courts had initially stayed “natural” class actions pending FDA guidance on the definition of “natural,” but in light of continued FDA inaction, courts have reversed course and refused recent requests to stay. Keller and Heckman will continue to monitor the regulation of CBD products and class-actions relating to their sale.
  •  FDA published a response (discussed here) within two weeks of a Congressional report released on February 4, 2021 on the finding of heavy metals— including arsenic, lead, cadmium, and mercury—in baby foods in the U.S.  FDA’s initial response discussed the Agency’s programs for monitoring levels of toxic elements in baby foods (and other foods), the action levels set for inorganic arsenic in rice cereal for infants, multiple ongoing Import Alerts for toxic elements in food, and consumer education efforts regarding the importance of feeding infants a variety of foods.
  • On March 5, 2021, FDA announced new activities aimed at reducing the levels of toxic elements in baby food including:
    • A March 5, 2021 letter to baby and toddler food manufacturers and processors reminding the industry of their obligations to implement controls to significantly minimize or prevent any identified chemical hazards requiring a control.  FDA’s letter notes that some manufacturers may conduct verification activities like testing the final product for toxic elements.
    • Making a commitment “in the near term” to review current action levels, as well as develop additional action levels for contaminants in key foods, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.
    • Boosting sampling of foods for babies and young children and sharing the results.
    • Increasing inspections and, as appropriate, taking compliance and enforcement actions.
    • Holding a workshop “in the coming year” to bring together stakeholders to share knowledge on the variability of toxic element levels in different foods and the potential impacts, if any, of low exposures on childhood development, and discuss potential mitigation strategies.
  • Keller and Heckman will continue to monitor and report on FDA’s regulatory activities, as well as congressional investigation and litigation involving heavy metals in baby food.

 

  • Dietary supplement manufacturer Confidence USA Inc., located in Port Washington, New York, its president, and its general manager received a permanent injunction on March 4, 2021 from the U.S. District Court for the Eastern District of New York that prevents them from manufacturing, holding, or distributing dietary supplements until further notified by FDA. Confidence USA manufactures and distributes more than fifty dietary supplements under several brands, including Confidence USA, American Best, USA Natural, and the Herbal Store, through Amazon, Walmart, and its own online retail store.
  • The court found that Confidence USA had violated the Federal Food, Drug, and Cosmetic Act by failing to follow the Current Good Manufacturing Practices (CGMPs) for dietary supplements including repeat violations of rules requiring defendants to verify the identity of each dietary ingredient used in their products and verify that their products met certain purity, strength, composition, and contamination limits. To be able to continue their dietary supplement business, Confidence USA must hire an independent expert to assist in remedying the causes for the repeat violations, pass an inspection, and receive FDA’s specific approval to resume operations.
  • By way of background, FDA regulates the packaging and preparation of dietary supplements and their ingredients. The Dietary Supplement CGMPs include rules on quality control, sanitation, and product testing that ensure dietary supplements are processed in a sanitary and safe manner and meet quality standards. Keller and Heckman is experienced in assisting dietary supplement manufacturers with CGMP compliance.