• Food Standards Australia New Zealand (FSANZ) has released its food recall statistics for 2019.  Recalls were down from 100 in 2018 to 87 in 2019.  The most common cause of recalls was undeclared allergens (32 recalls) and microbial contamination (30 recalls).
  • Australia and New Zealand are two of the three countries that have been recognized by U.S. FDA as having food safety systems that are comparable to the U.S.’s system.
  • Overall, undeclared milk allergen and Listeria monocytogenes were the most common bases for recalls, compared to other types of recalls.  These trends are very similar to recall statistics in the U.S. as well, where undeclared allergens and Listeria monocytogenes are primary bases for recalls.

 

 

  • As discussed here, the Food and Drug Administration (FDA) has been rolling out chapters, as they are completed, to provide guidance on complying with FDA’s Final Rule for Preventive Controls for Human Food.  These rules, found in 21 Code of Federal Regulations (CFR) part 117, implement the hazard analysis and risk-based preventive control (HARPC) provisions for human food under the FDA Food Safety Modernization Act (FSMA).  Most human food facilities were required to comply with the human HARPC rules by September 2016.
  • FDA’s Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food will provide a comprehensive resource for understanding how to comply with all requirements of the human HARPC rule.  With the October 4, 2019 announcement of the most recent guidance document, Chapter 14: Recall Plan, the multi-chapter draft guidance is about half-completed.  Previously released documents are Chapters 1 (The Food Safety Plan), 2 (Conducting a Hazard Analysis), 3 ( Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food), 4 (Preventive Controls), 5 (Application of Preventive Controls and Preventive Controls Management Components), 6 (Use of Heat Treatments), and 15 (Supply-Chain Program for Human Food Products), as well an Introduction and Appendices 1 (Potential Hazards for Foods and Processes), 2 (Food Safety Plan Forms), and 3 (Bacterial Pathogen Growth and Inactivation).
  • Additional draft guidance yet to be completed for the human HARPC rule are Chapters 7 (Use of Time/Temperature Control as a Process Control), 8 (Use of Formulation as a Process Control), 9 (Use of Dehydration/Drying as a Process Control), 10 (Sanitation Controls), 11 (Food Allergen Controls), 12 (Preventive Controls for Chemical Hazards), 13 (Preventive Controls for Physical Hazards), and 16 (Validation of a Process Control), and Appendix 4 (Sanitation and Hygiene Zoning).  FDA indicates the remaining chapters and appendix are “coming soon.”
  • The FDA Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees from (1) The responsible party for each domestic facility and the U.S. agent for each foreign facility subject to a reinspection, to cover reinspection related costs; (2) the responsible party for a domestic facility and an importer who does not comply with a recall order, to cover food recall activities associated with such order; and (3) each importer subject to a reinspection to cover reinspection-related costs.  See Sections 743(a)(1)(A), (B), and (D), respectively, of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Every year since Fiscal Year (FY) 2012, FDA has published the established rates for assessing fees for food facility reinspections, recall orders, and importer reinspections.  These FSMA authorized fees have not been collected, however, because guidelines mandated under Section 743(b)(2)(B)(iii) of the FD&C Act, for considering the burden of such fees on small businesses, are not yet available, and FDA is also still considering various issues associated with the assessment and collection of importer reinspection fees.  Additionally, guidance is also pending regarding the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement of the FD&C Act.  It is food safety related noncompliance issues that trigger a reinspection (subject to a fee assessment) to evaluate corrective actions.
  • In the July 25, 2019 Federal Register, FDA announced its FY 2020 rate of $240/hour, exclusive of travel, that will be assessed for FDA staff working on certain food facility reinspections, recall orders, and importer reinspections.  FDA’s rates where domestic travel or foreign travel are required are $258/hour and $301/hour, respectively, and are both increased as compared to the rates of $253/hour and $282/hour, respectively, for FY 2019, which ends September 30, 2019.  It does not appear as though any of these FSMA authorized fees will be collected for FY 2020 because FDA simultaneously announced (as it has in the past) that it does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees and that importer reinspection fee issues are still under consideration.
  • As previously reported by Food Industry Executive based on a report and press release from Stericycle Expert Solutions, recalls within the consumer products, automotive, pharmaceutical, medical device, and food and beverage industries were all down in the first quarter of 2019.  This is the first time since 2012 that recalls were down across all industries monitored by Stericycle.
  • Stericycle believes that the reduction in recalls “were largely due to reduced oversight from the government shutdown earlier this year which stopped or limited many government safety inspections.”  Though only a partial shutdown, routine inspections were impacted for all domestic food facilities (though roughly 150 staff were brought back to work mid-shutdown to perform routine inspections at high-risk food facilities) and this may well have impacted the number of violations observed and, consequently, the number of recalls.  For more on the shutdown, see the Daily Intake blog posts here, here, and here.
  • Also of interest from the Stericycle report:
    • One large recall accounted for 95.8% of all recalled FDA food units
    • Undeclared allergens was the top cause of FDA food recalls
    • Foreign material was the top cause of USDA food recalls
  • Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” applies to voluntary recalls of all products subject to FDA’s jurisdiction, including food, drug, and devices intended for human or animal use, any cosmetic and biological product intended for human use, any tobacco product intended for human use, and any item subject to a quarantine under 21 CFR Part 1240.
  • As mentioned in FDA’s press release, the draft guidance includes recommendations in three key areas:
    • Training – The draft guidance emphasizes the importance for firms in a product distribution chain to be “recall ready” to help minimize public exposure to products that are in violation of the Food, Drug, & Cosmetic Act and other laws administered by FDA.  The draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
    • Recordkeeping – The draft guidance discusses the need for thorough and organized distribution records, that should be maintained over a period of time. Further, the FDA states that products should have specific product coding, whether required by law or not. Product coding assists in facilitating effective recalls and may help a recalling firm accurately define and limit the scope of the recall effort.
    • Procedures – The draft guidance recommends that firms consider preparing and maintaining written recall initiation procedures to help minimize delays, ensure that necessary actions are not overlooked, and minimize the disruptive effect a recall can have on a business. FDA notes in the draft guidance that recall initiation procedures do not supersede any other specific recall plan requirements (e.g., HARPC written recall plans).
  • FDA believes the draft guidance effectuates an important step towards achieving the Agency’s goal of quickly executing recalls and reaching consumers with timely information to limit the impact of potentially dangerous products. Stakeholders may submit comments on the voluntary recall draft guidance until June 24, 2019.  Keller and Heckman attorneys are well-versed in recall procedures and are available to assist interested parties in preparing comments for submission to FDA.  For assistance, please email: fooddrug@khlaw.com
  • Following on recalls of dog food due to excess Vitamin D in late 2018, manufacturers are facing lawsuits by dog owners claiming their pets were injured by the products in question.
  • According to FDA, analysis of the recalled dog foods by state and private labs indicate that the dog food contained as much as 70 times the intended amount of vitamin D, and all eight brands that were subject to the recall had been produced by the same contract manufacturer.
  • In one class action suit, filed against Hill’s Pet Nutrition in the Eastern District of New York, plaintiffs are claiming that the company delayed warning consumers.  Specifically, the suit claims that consumer complaints started in February 2018, 11 months prior to the company recalling its products in late January 2019.  Similar suits have been filed in Florida and California, and there may be more to come.

 

  • As covered on this blog, FDA has worked to strengthen the recall process for food, drugs, medical devices, and cosmetics in response to a report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s recall process can be too slow and puts consumers at risk.  21 CFR Part 7, Subpart C provides guidance on policy, procedures, and industry responsibilities for recalls (including product corrections).
  • Final guidance issued February 7, 2019 further outlines the circumstances when a company should issue a public warning about a voluntary recall (i.e., where there is a serious health risk and other means for preventing the use of a recalled product appear inadequate), describes the general timeframe for companies to issue such a warning (i.e., generally within 24 hours of notification that FDA believes a public warning is appropriate), discusses what information should be included in a public warning (including how to identify the recalled product and characterize the reason for the recall), and describes situations where FDA may issue its own public warning if a company’s warning is deemed insufficient.  The final guidance also describes FDA’s policy for moving forward with posting recalls to FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA (including recalls that do not present serious hazards to health).  A recall may sometimes be posted to FDA’s Enforcement Report website before a final health hazard evaluation is completed.
  • FDA Commissioner Dr. Scott Gottlieb announced the final guidance on public warning and notification of recalls in a press release and also touted FDA’s other recent measures to protect consumers from health risks related to recalled products.  Such measures include draft guidance that describes situations where FDA will disclose retail information for recalled food products and mandatory recall guidance for foods, which was finalized in November 2018 and answers common questions about the mandatory food recall provisions.
  • Dr. Gottlieb further remarked on FDA’s implementation of the public warning and notification guidance last year while it was still in draft form, suggesting that FDA’s more prominent publicizing of recalls through social media and other routes may have given the impression that the number of recalls has increased when, in fact, the number of recalls in fiscal year 2018 (i.e., 7,420 recalls; 831 of which were classified as the highest risk) represents a five-year low.

 

  • On December 3, FDA issued an alert to pet owners and veterinary professionals about the recalls of several dry dog foods with potentially toxic levels of Vitamin D. Thus far, FDA believes the affected dog food has been produced by one contract manufacturer who makes dry dog food for several national brands. However, the name of the contract manufacturer has not yet been released. In order to ensure all affected dry dog food brands are accounted for, FDA is working with the contract manufacturer to generate a comprehensive list of the dry dog food brands that they work with.
  • The issue came to FDA’s attention after one brand notified FDA that it was recalling their dry dog food due to potentially toxic levels of Vitamin D. The reason for the recall arose after the brand had received complaints from customers that their dogs were experiencing symptoms of Vitamin D toxicity. It appears that shortly thereafter, other pet food brands who use the same contract manufacturer, followed suit and also instituted recalls. Thus far, eight brands have instituted recalls of products that were sold nationwide, however FDA notes that the issue is still developing and additional brands could also be recalled.
  • Testing conducted on the dry dog food samples found excessive, potentially toxic levels of Vitamin D. In some cases, the dry dog food contained as much as 70 times the intended amount of Vitamin D. While Vitamin D is an essential nutrient that regulates the calcium and phosphorus balance in a dog’s body, exposure to very high amounts can cause serious health problems, such as kidney failure or death.
  • FDA’s alert warned pet owners to discontinue feeding the recalled dry dog food products – a list of the affected brands, flavors, and lot numbers is provided by FDA on their website. Retailers have also been advised not to sell the recalled products and to contact consumers who have purchased such products, if possible. Additionally, FDA asked veterinarians who suspect that their patients have Vitamin D toxicity 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.
  • The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to the food will cause serious adverse health consequences or death to humans or animals (a Class I recall).
  • On November 5, 2018, FDA released a final guidance, in the form of questions and answers, on how the Agency will use its mandatory recall authority. (Also see: 83 Fed. Reg. 55551, November 6, 2018.) FDA issued a draft guidance on this topic in 2015 and requested comments at that time (see our May 7, 2015 blog for more information on the draft). The final guidance provides additional clarity, including some modifications based on comments received.
  • In addition to explaining the mandatory recall process, the final guidance identifies evidence that FDA “might” consider when making the decision to proceed with a mandatory recall, namely: 1) observations made during inspections, 2) results from sample analyses, 3) epidemiological data, 4) vulnerability of the populations that normally consumes the food, 5) nature of the product, 6)Reportable Food Registry data, 7) consumer and trade complaints, and 8) whether the responsible party has failed to initiate a voluntary recall. (See Q&A #8 in the final guidance.)
  • FDA has only issued a mandatory recall order of a food product once. (See our April 4, 2018, blog on FDA’s recall order for kratom products.). In two other instances, FDA began the process to initiate a mandatory recall authority under FSMA but the companies ultimately chose to voluntarily recall their product.