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  • On August 3, the FDA announced that it will be hosting a free hybrid public meeting to discuss the modernization of FDA recalls on September 29. The session will provide an opportunity for interested parties to share information and feedback on topics related to FDA-regulated recalls, including the following:
    • General recall preparations / contingency planning
    • Creating successful recall strategies, including methods to reach underserved communities
    • Initiating a recall
    • Strategies for public warning, including press releases, social media, and other communication tools
    • Increasing efficiency and effectiveness of recall information exchange
    • Ensuring effective recalls
    • Terminating a recall
    • Strategies for reducing recall recurrence for similar situations
  • Interested parties must register for the event at this link. The session will take place on September 29, 2023 from 9AM-5PM, and will be held both in-person and virtually.
  • Stakeholders may submit comments on the modernization of recalls to www.regulations.gov, using Docket ID: FDA-2023-N-2393. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  •  As many of our readers (and fellow peanut butter consumers) are likely aware, on May 20th J.M. Smucker Co. issued a voluntary recall of its JIF peanut butter products due to potential Salmonella contamination linked to a manufacturing facility in Lexington, Kentucky.
  • Class-action lawyers wasted no time in holding J.M. Smucker accountable and at least two class-actions have been filed against the company alleging various causes of action, including negligence and breach of warranties, for actions resulting in the production of potentially contaminated product that was sold to plaintiffs and other similarly situated consumers. The law firm of Akim represents the Plaintiff in both lawsuits and the complaints are substantially similar to one another.
  • The recall is still being investigated by FDA, CDC, and other state partners. It presents a particularly interesting question of legal liability since the Salmonella strain associated with illness in the current outbreak is the same one which was found in an environmental sample during a 2010 FDA inspection. Keller and Heckman will continue to monitor this litigation and the results of the outbreak investigation.
  • 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.
  • As covered on this blog, on April 24, 2019 FDA announced a new, draft guidance on ways to help companies prepare to quickly and effectively remove from the market any violative food or other products subject to FDA’s jurisdiction.  The purpose of the guidance is to clarify FDA’s recommendations for industry and FDA staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.
  • On March 4, 2022, FDA published notice that its Final Guidance is available on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.  In addition to editorial changes made to improve clarity, changes from the draft to the final guidance include:
    • the addition of “correction” and “market withdrawal,” with these terms’ regulatory definitions, in the terminology section of the guidance;
    • the addition of language encouraging the use of electronic communications for conveying voluntary recall communications about FDA-regulated products; and
    • the deletion of section IV (‘‘References’’).

FDA did not respond to a comment that suggested replacing the word “should” with “may” as a way to provide more flexibility in recommendations that “a firm should consider establishing metrics appropriate to its recall plan” and “should implement procedures to identify indicators that there may be a problem with a distributed product that suggests it is in violation of the FD&C Act and other laws administered by the FDA.”

  • Prairie Wolf Spirits announced on June 21, 2021, that it is recalling all lots of Prairie Wolf Distillery hand sanitizer in two sizes (16.9 ounce and 20 ounce) due to their resemblance to consumer level water bottles.
  • The company’s announcement states that the product’s intended use is for topical use but that the product’s likeness to water bottles poses a risk of ingestion.
  • The recalled hand sanitizer products were distributed to selected customers and consumers nationwide via the manufacturer’s website, limited retail sales, and corporate donations.
  • The recall does not affect other Prairie Wolf Spirits hand sanitizer products, and as of publishing, Prairie Wolf Spirits has not received any reports of adverse reactions related to this recall.
  • Prairie Wolf Spirits, Inc. is an Oklahoma-based craft spirit distillery that produces a range of spirits, including vodka and gin, that use similar branding to their line of hand sanitizer.
  • Designed By Nature announced June 14, 2021 that it is recalling its Goat’s Milk Powder, Cow’s Milk Powder, and Base Milk Powder formulas with an expiration date between May 1, 2021 and June 11, 2022 because they are deficient in several nutrients required for infant formula.  Furthermore, the products were not tested for the presence of Cronobacter.
  • The current product label indicates the product was “developed for all life stages.”  However, the company will be changing its labeling to make clear that the products are not intended to be used for infants 12 months and younger.
  • Products marketed as infant formula must meet certain minimum nutrient requirements, and manufacturers must notify FDA prior to marketing a new formula.  According to the recall notice, Designed by Nature’s formulas were not approved by FDA.
  • On June 8, 2021, Beech-Nut Nutrition Company issued a voluntary recall for one lot of its Beech-Nut Stage 1, Single Grain Rice Cereal (“Cereal”). The rice flour used for the Cereal was tested and confirmed as being below the FDA guidance level, set at a 100 ppb or 100 µg/kg, for inorganic arsenic. However, a routine sampling program by Alaska found that Cereal samples tested above the guidance level for naturally occurring inorganic arsenic set by the FDA in August 2020.
  • As some of our readers may remember, Beech-Nut was named in a congressional report by the U.S. House of Representatives subcommittee on Economic and Consumer Policy with relation to the levels of heavy metals—including arsenic, lead, cadmium, and mercury—found in baby foods. Since that report, Beech-Nut has been involved in two class-action lawsuits for allegedly misrepresenting Beech-Nut baby foods are “real food for babies” and failing to disclose the presence of dangerous levels of heavy metals. Most recently in April 2021, the DC Attorney General filed a lawsuit against Beech-Nut for “misleading parent-consumers about the health and safety of its products.” The New York Attorney General similarly announced an investigation into arsenic levels in infant rice cereal products and the advertising and promotion of such products.
  • In addition to voluntarily recalling the Cereal, Beech-Nut has decided to exit the market for infant rice cereal products, citing concern over the ability to consistently obtain rice flour well-below the FDA guidance level and Beech-Nut specifications for naturally occurring inorganic arsenic.
  •  We previously discussed a December 30, 2020 alert from FDA regarding recalls by Midwestern Pet Food, Inc. of nine total lots of Sportmix pet food products following reports of death and illness in dogs after consuming the products.  As discussed in an updated alert, the recall was expanded on January 11, 2021 to include all pet food products containing corn (more than 1000 lot codes of dog food and cat food) that were made in the firm’s Oklahoma plant and that expire on or before July 9, 2022.  As of FDA’s updated, January 26, 2021 alert, more than 110 pets have died and more than 210 pets are sick after have consumed certain pet food manufactured by Midwestern Pet Foods.  Another recent recall of dog food (September 2, 2020 by Sunshine Mills, Inc.) was triggered by a finding of elevated levels of aflatoxin in routine sampling of a single 4-pound bag of one lot of product but has not been associated with any deaths or illness.
  • On January 28, 2021, a group of consumers with dogs that died or became ill after consuming the now-recalled product from Midwestern Pet Foods have filed a proposed class action lawsuit (subscription to Law360 required) in the U.S. District Court for the Southern District of Indiana on behalf of a nationwide class and a California state class of buyers of Midwestern Pet Foods’ cat and dog foods.  The plaintiffs, who allege negligent misrepresentation, fraud, and unjust enrichment, seek restitution and over $5 million in damages to be determined in a jury trial.
  • It is yet to be seen how Midwestern Pet Foods will respond.  In earlier litigation following a pet food recall in 2005-2006 associated with aflatoxin contamination and involving a large number of deaths in dogs, it was reported that Diamond Pet Foods, Inc. agreed to pay $3.1 million dollars in a settlement with pet owners.
  • On December 30, 2020, FDA issued an alert to pet owners and veterinary professionals about the recalls of certain Sportmix pet food products. Midwestern Pet Food, Inc. announced a recall of nine total lots of Sportmix pet food products after the reports of at least 28 dogs that have died and 8 that have fallen ill after consuming the products. The Missouri Department of Agriculture tested multiple product samples and found very high levels of aflatoxin. Aflatoxin is a toxin produced by the mold Aspergillus flavus and at high levels can cause illness and death in pets. The toxin can be present even if there is no visible mold.
  • According to the FDA, pets are highly susceptible to aflatoxin poisoning because they generally eat the same food continuously over extended periods of time. If a pet’s food contains aflatoxin, the toxin could accumulate in the pet’s system as they continue to eat the same food. Pets with aflatoxin poisoning may experience symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums or skin due to liver damage), and/or diarrhea. In some cases, this toxicity can cause long-term liver issues and/or death. Some pets suffer liver damage without showing any symptoms. There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, the FDA recommends that pet owners always wash their hands after handling pet food.
  • FDA’s alert warned pet owners to discontinue feeding the recalled pet food products – a list of the affected products is provided by FDA on their website. Retailers have also been advised not to sell or donate the recalled products and to contact consumers who have purchased such products, if possible. Additionally, FDA asked veterinarians who suspect that their patients have aflatoxin poisoning to report the events through a Safe Reporting Portal or by calling local FDA Consumer Complaint Coordinators. Pet owners are also encouraged to report suspected cases.
  • FDA is conducting follow-up activities at the manufacturing facility and notes that, as this is a developing situation, the Agency will update the alert with additional information as it becomes available.
  • As covered on this blog, FDA announced a new policy on September 26, 2018 and concurrently released draft guidance detailing the circumstances for publicizing retailer information (e.g., specific retail store name and address) when recalled human or animal food is not easily identified as being the subject of a recall from its retail packaging or lack thereof (e.g., deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually) and is likely to be available for consumption (i.e., given its shelf-life or perishability, it may still be in a consumer’s possession).  This policy is part of an overall effort to provide consumers with “actionable information” and followed the release a month earlier of draft guidance, subsequently finalized in February 2019, on the use, content, and circumstances for issuing public warnings for consumers in the event of a recall.
  • On November 23, 2020, FDA announced the Final Guidance on ‘‘Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.’’  Minor changes include a new statement that FDA intends to update the retail consignee lists as the information available to FDA develops and clarification that while this guidance is specific to retail consignees, FDA can disclose the names of restaurants and similar entities where appropriate.  FDA intends to post lists of retail consignees associated with a specific recall on FDA’s website.  Retailers that typically may be subject to public listing are grocery stores, pet food stores, convenience stores, and online food delivery services.  Food recalls at issue are those classified as Class I recalls, or recalls not yet classified that are likely to be classified as Class I, and some Class II food recalls, particularly where a public warning has been issued or there is an association with an outbreak of a foodborne illness.  Packaged food would not usually meet the criteria for posting information on the retailer of the recalled food, but FDA may in some cases determine that packaged food was distributed in a manner where identifying the retailer would help prompt consumers to consider whether they possess the recalled product.
  • FDA’s decision to publicly list retailers of recalled food in certain situations responds to Section 206 of the 2011 FDA Food Safety Modernization Act (FSMA), which directs FDA to consult the policy of the United States Department of Agriculture (USDA) for making publicly the available the names and locations of retail consignees of recalled meat or poultry products that USDA compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death (Class I recalls) and to consider the circumstances under which it would be appropriate for FDA to provide such a list to the public.  While identifying “retail consignees” is subject to restrictions under FDA’s regulations protecting confidential commercial information (CCI), FDA has the authority to make a public disclosure of CCI, including the revelation of confidential business relationships between suppliers and customers, to the extent necessary to effectuate a recall.