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  • On January 26, FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert in an effort to stop violative products from entering the US market until the Agency is able to review the products’ safety. See FDA’s Press Release. Under the import alert, FDA may detain shipments of the alcohol-based hand sanitizers from Mexico, and as part of the entry review, FDA will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured in accordance with US current good manufacturing practices (cGMPs). This is the first time the FDA has issued a countrywide import alert for any category of drug product.
  • Over the course of the ongoing COVID pandemic, the FDA has seen an increase in hand sanitizer products from Mexico that were labeled to contain ethanol, but tested positive for methanol. Methanol, or wood alcohol, can be toxic when absorbed through the skin and life-threatening when ingested and is not an acceptable ingredient in hand sanitizer or other drugs. The FDA is aware of methanol-contaminated hand sanitizer adverse events, including blindness, cardiac effects, effects on the central nervous system, hospitalizations, and death.
  • From April to December 2020, the FDA analyzed alcohol-based hand sanitizers imported from Mexico and found that 84% of the samples were not in compliance with FDA regulations. More than half were found to contain toxic ingredients, including methanol and/or 1-propanol.
  • Methanol-contaminated hand sanitizers are a serious safety concern for the FDA, and the Agency has been proactively working with companies to recall products and encourage retailers to remove violative products. Further, since July 2020, the FDA has issued 14 warning letters to manufacturers for distributing hand sanitizers with undeclared methanol, inappropriate ethanol content, and misleading claims.
  • On December 22, the FDA issued a Warning Letter to Whole Foods Market “for a pattern of receiving and offering for sale misbranded food products necessitating a series of food recalls for allergens.” This is the first time the FDA has warned a retailer for engaging in such a pattern of selling misbranded food products containing undeclared allergens.
  • From October 2019 to November 2020, Whole Foods recalled 32 food products because the presence of major food allergens was not listed on the finished product labels. The FDA noticed similar patterns of recalls for undeclared allergens in previous years as well. The recalled products included a variety of foods sold under the Whole Foods in-house brand, although the foods were primarily from the deli and bakery sections of the store. For example, products were misbranded for failure to declare the presence of milk, eggs, and almonds, among other examples.
  • As our readers know, food or ingredients that contain one of the eight major allergens must be specifically labeled with the names of the allergen source. The eight major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. According to the FDA, undeclared food allergens have been the number one leading cause of Class I food recalls for at least the last three years. Thus, FDA has ongoing efforts to address undeclared allergens by analyzing patterns of recalls and have begun several initiatives to improve industry’s compliance with allergen labeling. For instance, in 2020, the FDA sent 8 warning letters to companies for issues related to undeclared allergens.
  • While the Warning Letter is unprecedented it reconfirms FDA’s attention and efforts to reduce the prevalence of allergen recalls. In an FDA press release, William A. Correll, Jr., Director of the Office of Compliance at CFSAN, stated that “[t]he entire food supply chain can and must do better to prevent exposing consumers to incorrectly labeled packaged food […] Manufacturers should also ensure they have controls in place to prevent unintentionally adding allergens during their manufacturing processes. When they fail to follow the law, we will take the necessary action.”

The next issue of The Daily Intake will publish on January 4, 2021. Keller and Heckman LLP wishes everyone a wonderful holiday season.

  • Our readers may recall a 2016 citizen’s petition filed by NuTek Food Science that requested FDA to permit “potassium salt” as a common or usual name for potassium chloride because of consumers’ negative associations with the word “chloride.”  While NuTek withdrew the petition following FDA’s release of a 2019 draft guidance authorizing the term “potassium chloride salt,” which FDA framed as a compromise, the case was made in numerous food industry comments, as discussed here, for removal of the word “chloride” as requested in NuTek’s petition.  Several health advocacy groups also supported this position.  Morton Salt, the manufacturer of salt (the common name for sodium chloride), was alone in urging FDA to permit only “potassium chloride” as a common name.
  • With a December 18, 2020 notice, FDA released its final guidance to advise food manufacturers of the Agency’s intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.”  In support of this change from the draft guidance, FDA cited consistency with activities to encourage manufacturers to reduce the sodium levels in food products and FDA’s Nutrition Innovation Strategy to reduce the burden of chronic disease in the United States through improved nutrition, by empowering consumers with information, and supporting and fostering industry innovation in developing and promoting healthfulness of food options.
  • Keller and Heckman will continue to follow a request, discussed here, for Health Canada to likewise allow “potassium salt” as an alternate name for “potassium chloride” in food labeling in Canada.

 

  • Our readers may recall that a lawsuit filed June 26, 2020 against The Hain Celestial Group, involving Organic Plus Vanilla Soy Milk, avoided some of the pleading issues that doomed some of the numerous class action lawsuits, filed mostly by a single firm, involving other products that are claimed to contain deceptive and misleading information on their labels regarding vanilla.  Plaintiffs alleged that the disclosure of “Vanilla Flavor With Other Natural Flavors” in the soy milk’s ingredient list indicated that the product contained non-vanilla flavor and that this non-vanilla flavor contained vanillin.  The plaintiffs also alleged that because vanilla is governed by standards of identity (see 21 CFR 169.175 (“Vanilla extract); 21 CFR 169.177 (“Vanilla flavoring”)), the general flavoring rules of 21 CFR 101.22, including the designation of “with other natural flavors,” do not apply and any non-vanilla flavor must be disclosed as an artificial flavor.
  • A November 23, 2020 memorandum filed in support of The Hain Celestial Group’s motion to dismiss, (subscription to Law360 required), characterizes the plaintiffs’ case as one of “over 91 other lawsuits their counsel have filed against producers of vanilla-containing products” and asserts they are attempting to “hold-up” food companies for expensive settlements based on what “they believe is a technical violation of FDA flavoring regulations.”  In addition to arguing that the plaintiffs’ false advertising claims are preempted to the extent they assert that the product labeling does not comply with the Federal Food, Drug, and Cosmetic Act’s (FDCA) food labeling requirements and is, therefore, automatically deceptive, the defendant’s memorandum directly attacks the plaintiffs’ conclusion that “vanilla” in the product name violates FDA’s food labeling regulations, arguing that under FDA’s regulations, the statement of identity in the product’s name is “Soymilk” and “Vanilla” is a flavor designation, not subject to the standards of identity cited by the plaintiffs.
  • It is yet to be seen whether the New York federal court hearing this case will reach the issue of whether the soy milk labeling complies with the FDCA and FDA’s characterizing flavor regulations.  FDA has not issued any warning letters that would clarify the matter of product labeling involving vanilla.  Keller & Heckman will continue to monitor and provide updates regarding vanilla products and other class-action litigation in the food industry.
  • On November 18, 2020, FDA released the Coordinated Outbreak Response and Evaluation (CORE) Investigation Table, a tool to publish early information on all foodborne outbreaks that the FDA is investigating.  While FDA issues public health advisories or recalls for any outbreak that results in specific, actionable steps for consumers to protect themselves against an unsafe food or product, this new table allows FDA to share information at the earliest phases of an investigation, before actionable steps have been identified.
  • In the press release announcing the table, FDA emphasized that releasing early information about investigations in their beginning stages does not mean FDA will announce early actions for consumers to take.  Rather, the table furthers FDA’s goal of improving transparency in outbreak investigations and complements its New Era of Smarter Food Safety initiative and implementation of the FDA Food Safety Modernization Act (FSMA).  The investigation table will be rolled out as a six-month pilot after which FDA may adjust the table per stakeholder feedback.
  • The table lists the outbreak investigation’s FDA Reference Number, the pathogen involved, the products linked to the outbreak, case count, investigation and outbreak status, and whether any additional steps have been initiated, including recall, traceback, on-site inspection, and sample collection and analysis.  The table is updated weekly with data from both the Center for Disease Control (CDC) and FDA’s CORE Response Teams and tracks outbreaks from beginning to end.  Upon its release, and as of the date of this post, the table listed seven ongoing investigations at various stages of development, including three recently announced investigations into ongoing E. coli O157:H7 outbreaks.  Keller and Heckman will continue to monitor and report on developments in foodborne illness outbreaks.

Kellogg Gets 2nd Win In Vanilla Flavor False Ad Suit (subscription to Law360 required)

  • As our readers may recall, a California federal judge dismissed a proposed class action on June 22, 2020 alleging that Kellogg Sales Company falsely and misleadingly labeled and advertised Bear Naked Granola V’nilla Almond as being flavored “with vanilla flavoring derived exclusively from vanilla beans when the ingredient list reveals otherwise.”  U.S. District Judge Roger T. Benitez found the lead plaintiff’s argument that Kellogg’s listing of “natural flavors” in the ingredient list, as opposed to “vanilla flavor” or “vanilla extract,” is acknowledgement that vanilla flavor or extract is not an ingredient in the product amounts to speculation rather than an allegation of sufficient facts.
  • On October 29, 2020, the California federal judge dismissed the case a second time, again finding an insufficient factual basis that the granola product was mislabeled.  While the judge agreed that a picture on the product label of a vanilla plant and the word “vanilla,” with no qualifier, would be deceptive if the product does not contain enough vanilla from vanilla beans to independently characterize the product as “vanilla,” the judge found the plaintiff has offered no proof that the flavoring in the product is not from vanilla beans, rejecting the argument that because vanilla is expensive, Kellogg would have included it in the ingredient statement if it were actually present.  Citing a recent decision in Sonner v. Premier Nutrition 971 F.3d 834 (9th Cir. 2020), the judge also dismissed the complaint, which seeks equitable relief, on the basis that the plaintiff failed to plead he lacks an adequate remedy at law.
  • Because the proposed class action was dismissed without prejudice, the plaintiff may amend the complaint a second time to cure the equitable pleading issue and attempt somehow to provide factual evidence of an inadequate level of vanilla from vanilla beans.
  • On October 1, 2020, the U.S. Food and Drug Administration (FDA) published the results of its sampling project on domestically manufactured dark chocolate bars and dark chocolate chips labeled with claims such as “dairy free.” FDA conducted the sampling assignment to better understand the extent to which these products contain potentially hazardous levels of milk and therefore may cause serious health consequences to consumers with an allergy to milk.
  • FDA’s sampling assignment focused on products that did not include milk as a disclosed ingredient; were manufactured in the U.S.; bore claims such as: “dairy free,” “milk free,” “100% milk free,” and “contains no milk,” on packaging or website (this sampling assignment did not target “lactose-free” or standalone “vegan” claims in the absence of “dairy free”-type claims); and consisted solely of dark chocolate, without other component ingredients such as fillings, candy shells, fruits, nuts, seeds, etc. From July 2018 to October 2019, FDA collected 119 samples (88 dark chocolate bars and 31 packages of dark chocolate chips), representing 52 products, at retail (including online).  FDA found that four of the products sampled (4 of 52 products; 12 of 119 samples) had milk levels ranging from 600-3,100 parts per million (ppm), and the potential to cause severe reactions in consumers with milk allergy.
  • Dark chocolate can be made with or without milk as an intentionally-added ingredient. Some dark chocolate is made without the addition of milk as an ingredient, but milk may nevertheless be found present in these products due to inadvertent cross-contact, or the fact that dark chocolate is often produced on equipment used to produce milk chocolate, and it can be very challenging to thoroughly clean the equipment between product runs.
  • Milk is one of the eight major allergens identified by FDA (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans), and manufacturers are required to label products that contain these ingredients and/or proteins accordingly. Undisclosed allergens are a leading cause of FDA requests for food recalls.  FDA believes milk is the most common undeclared food allergen, and that milk has been observed to be the leading cause of consumer adverse reactions to foods recalled due to undeclared allergens.  Based on consumer surveys, millions of people in the U.S. (estimated at approx. 2% of the population) are believed to experience symptoms of milk allergy, ranging from mild to severe (including hives, facial swelling, upset stomach, vomiting, wheezing, and anaphylaxis).
  • In response to the findings of the sampling project, all four products were recalled by the three manufacturers involved. The Agency will continue to monitor the issue, and will conduct additional sampling of domestic and imported dark chocolate.
  • As previously reported on this blog, a multi-state listeriosis outbreak in 2015 linked to Blue Bell Creameries LP’s ice cream products contaminated with Listeria monocytogenes led to recalls, state regulatory enforcement actions (discussed here), civil litigation (including shareholder lawsuits), and criminal prosecution of the company and its former president. According to the Centers for Disease Control and Prevention, at least 10 people were sickened with listeriosis and hospitalized in Arizona, Kansas, Oklahoma, and Texas, and three people in Kansas died.
  • Pursuant to a plea agreement filed in federal court in Austin, Texas, in May 2020, the company pled guilty to two misdemeanor counts under the Federal Food, Drug, and Cosmetic Act of distributing adulterated ice cream products through interstate commerce. After conviction, Blue Bell was recently sentenced to pay $17.25 million in criminal penalties ($9.35 million in criminal fines and $7.9 million in forfeiture). According to the U.S. Department of Justice (DOJ), this represents the largest-ever criminal penalty following a conviction in a food safety case.
  • Blue Bell also agreed to pay an additional $2.1 million to resolve civil False Claims Act allegations regarding ice cream products manufactured under insanitary conditions and sold to federal facilities. According to DOJ, the combined total of $19.35 million in fine, forfeiture, and civil settlement payments constitutes the second largest-ever amount paid in resolution of a food-safety matter (the largest to date is a $25 million fine paid by Chipotle Mexican Grill Inc. in connection with a three-year deferred prosecution agreement to avoid conviction through implementation of an improved food safety program). According to the U.S. Department of Justice’s (DOJ) press release announcing the Blue Bell plea agreement, since reopening its facilities in late 2015, Blue Bell has taken significant steps to enhance sanitation processes and enact a program to test products for listeria prior to shipment.
  • In a related federal action in the same court, Blue Bell’s former president, Paul Kruse, was charged with seven felony counts (including attempt and conspiracy to commit mail fraud, wire fraud, and attempted wire fraud) for his alleged efforts to conceal from customers what the company knew about the listeria contamination. Among other allegations, Kruse allegedly directed Blue Bell employees to remove potentially contaminated products from store freezers without notifying retailers or consumers about the real reason, directed employees to tell customers who inquired that there was an unspecified issue with a manufacturing machine instead of informing them that samples of the products had tested positive for listeria, and directed employees to conceal and destroy evidence. In July 2020, the court dismissed the felony charges for lack of subject-matter jurisdiction, after Kruse successfully argued that while prosecutors had filed an information to charge him, they had failed to properly secure the required indictment or, in the alternative, a waiver of the right of indictment.

 

  • The FDA’s Food Safety and the Coronavirus Disease Guidance  (the “Guidance”) is a resource for the food industry as it responds to the COVID-19 pandemic. On July 29, 2020, the FDA updated the page to include a section on considerations for U.S. exporters of FDA-regulated food products.
  • While cautioning that U.S. exporters are responsible for following the requirements of the countries to which they export (in addition to U.S. laws and regulations), the updated guidance reiterates that, despite the request from some countries for “commitments to provide information that food is free of the COVID-19 virus and/or has been produced under conditions that prevent contamination by the COVID-19 virus,”  there is no evidence of COVID-19 transmission in food or food packaging and that the FDA does not anticipate the need to recall food products because of COVID-19. (For media coverage of such requests from Chinese authorities, see here). In response to these requests, the guidance (1) states that the FDA is communicating its understanding of the science of COVID-19 transmission and food safety to foreign governments, (2) recommends that U.S. exporters distinguish between official food safety requirements and business requests, and (3) encourages exporters to use FDA’s COVID-19 resources when interacting with foreign countries.
  • The foreign country requests highlight the importance of following the COVID-19 best practices laid out in the Guidance (and linked documents), including frequently disinfecting surfaces, checking workers temperatures, and ensuring that workers are socially distanced.  Keller and Heckman will continue to monitor and report on COVID-19 related developments that impact the food industry.
  • On July 24, 2020, the US House of Representatives passed a four-bill minibus that set FDA’s fiscal year 2021 budget at $3.212 billion – a $40.8 million increase over last year’s allocation. The budget increase comes alongside a set of new policy priorities, detailed in the House Appropriations Committee’s minibus summary.
  • The bill would, for the first time ever, grant FDA mandatory recall power over prescription and over-the counter drugs. It also includes funding to develop a regulatory framework for cannabidiol (CBD), to increase medical product and food safety activities, and to investigate new influenza vaccine manufacturing technologies. The bill provides funding for an FDA program that would “identify, detain, and refuse the import of FDA-regulated products from a foreign establishment that did not allow physical access to FDA investigators.” It also contains “a strong focus” on combating foodborne illness and protecting the cybersecurity of medical devices.
  • Elsewhere, the bill allocates funds to USDA, including increased spending for nutritional programs, food safety and inspection programs, and agricultural research. The bill’s next stop is the US Senate, where action is needed by the start of the new fiscal year (October 20, 2020). If the Senate fails to pass the bill in time, these agencies will need to begin the fiscal year with funding from a Continuing Resolution. Keller and Heckman will continue to monitor developments on FDA and USDA funding.