STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
STATE OF THE
  NATION 2021
   PRODUCT RECALL
   UNITED STATES EDITION

DATA , T R E N D S & PR ED I C T I O N S FO R U S I N D U S T R I E S   brand protection
STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
brand protection

                   The Sedgwick Brand Protection Recall Index remains an essential reference for
                   manufacturers and retailers seeking impartial and reliable perspective on past, present,
                   and future recall data and product safety trends.

                   The Index collects and analyzes data from the Consumer Product Safety Commission
                   (CPSC), the Food and Drug Administration (FDA), the National Highway Traffic Safety
                   Administration (NHTSA), and the U.S. Department of Agriculture (USDA), providing
                   businesses with insights and guidance they cannot find elsewhere.

                   This 2021 State of the Nation Recall Index goes beyond          We trust you will find our analysis and predictions
                   our traditional quarterly reviews, bringing you not only        insightful. Whether you read it cover-to-cover or focus
                   information about the latest quarter, but also offering a       on sections of particular importance to your company or
                   year-in-review look at recall data and trends from 2020.        industry, you’re sure to learn a great deal about what is
                   In addition, we provide a glimpse into January recall           happening today and what is likely to happen next that
                   numbers.                                                        will impact your business.

                   Our analysis and predictions let you know what to               One final note: this 2021 State of the Nation Recall Index
                   expect in 2021 as regulators and business leaders alike         focuses on U.S. recall data and regulatory developments.
                   look ahead to a post-pandemic world and a continuation          If your business also includes operations outside the
                   of what has been one of the most turbulent eras in U.S.         United States, we encourage you to review our European
                   government history.                                             Edition. Like this report, our European Edition shares
                                                                                   recall data from global regulatory agencies and offers
                   Insights from some of our strategic partners at leading         expert analysis on product safety and regulatory changes
                   law firms, insurance companies, and communications              impacting global companies.
                   firms offer further expert analysis to help you prepare for
                   the changes and trends in the regulation of food, drugs,        European edition available here: LINK
                   consumer products, medical devices, and automobiles.

                   As U.S. lawmakers increasingly question whether
                                                                                   In an increasingly complex and regulated world, being
                   regulators are effectively protecting consumers and the
                                                                                   prepared for risks is essential, having the capabilities
                   number of new products grows every day, there has
                                                                                   to act quickly and effectively is critical. To find out
                   never been a more important time for companies at
                                                                                   more about our product recall capabilities, contact us
                   every level in the supply chain to be primed and ready
                                                                                   today: LINK
                   for recalls and related threats to their livelihood.

brand protection                                                                 STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   3
STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
CONTENTS
                                            3
                           INTRODUCTION

                                            6
                                  SUMMARY

                                            8
                    CONSUMER PRODUCTS

                                          22
                         MEDICAL DEVICE

                                          34
                       PHARMACEUTICAL

                                          48
                    FOOD AND BEVERAGE

                                          60
                             AUTOMOTIVE

                                          74
                             CONCLUSION

                                          75
                                      ABOUT

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
SUMMARY

2020 was full of risk and great uncertainty for companies      Arguably more important than regulatory collaboration,     Litigation risks are increasing and evolving. The courts        Regulatory inspections and enforcement will be
across all industries. While a year for the history books is   however, is the fact that regulatory actions are           may have moved more deliberately during the pandemic,           fast and furious in the immediate post-COVID-19
now behind us, don’t expect much to change in 2021. In         increasingly public, particularly for products regulated   but new lawsuits haven’t slowed as the plaintiffs’ bar          future. The pandemic will continue to limit regulatory
fact, expect COVID-19 to continue impacting regulatory         by the CPSC and the FDA. We discuss this further within    has remained persistent in finding and filing new cases.        inspections, especially those that would typically include
oversight and enforcement activities for at least the first    our industry commentary in the pages that follow.          We’re seeing a high volume of typical civil claims, but         on-site audits, product sampling, and environmental
half of the year.                                                                                                         we’re starting to see a surge in lawsuits related to            swabbing. But by mid-year, expect to see FDA inspectors
                                                               National regulators have a global impact. While the        COVID-19. The Products Liability Litigation team at             back on the road.
We may see regulators shift their priorities or                degree of regulatory scrutiny and resources devoted        Faegre Drinker offered this list of claims companies are
approach to rulemaking and regulation under the                to product safety vary around the world, actions by        already facing:                                                 Companies allegedly making counterfeit or fraudulent
Biden administration, but these changes take time. In          the FDA, Health Canada, and regulators throughout                                                                          products will be a priority, as will any manufacturers
                                                                                                                          •   Failing to warn about the presence of COVID-19 in a
the meantime, there are five regulatory and business           the European Union and United Kingdom have a global                                                                        with spotty recordkeeping or past violations. With those
                                                                                                                              manufacturing or distribution facility.
considerations that companies across industries, and up        impact. Expect this trend to continue as regulators                                                                        inspections we expect an increase in warning letters,
and down the supply chain, need to plan for if they are to     around the world make agreements to share more
                                                                                                                          •   Sanitizers, protective gear, and disinfectants that         pressure for recalls, regulatory sanctions, and negative
emerge as leaders in 2021 and long into the future.            records and detailed reports from on-site audits and           misrepresent the protection against viruses, germs,         publicity.
                                                               investigations. With this approach, violations may             and bacteria.

The regulatory agencies watching you are numerous.             ultimately impact your business beyond the borders of      •   Products falsely claiming to protect against COVID-19.      Product safety is the responsibility of the entire
An increasing number of companies are finding the              the primary regulatory jurisdiction.                       •   Dietary supplements and other foods that allegedly          supply chain. It is well understood that manufacturers
products they manufacture subject to oversight by                                                                             cure, treat, or mitigate COVID-19 and its symptoms.         bear the brunt of product liability claims and regulatory
more than one regulatory agency. Not to mention their          In fact, even if an enforcement action is based on one                                                                     enforcement. But retailers and supply chain partners are
                                                                                                                          •   Drugs and vaccines claiming to treat COVID-19 or
business operations are under constant scrutiny by the         country’s investigation, it now often has an effect in                                                                     increasingly implicated in product safety matters. As a
                                                                                                                              lessen its impact.
Federal Trade Commission (FTC) and the Department of           multiple countries. We saw this with the discovery of                                                                      result, these organizations are starting to take matters
                                                                                                                          •   Testing claiming to detect COVID-19 or related
Justice (DOJ). Consider these examples:                        ineffective and contaminated hand sanitizer products.                                                                      into their own hands.
                                                                                                                              antibodies.
                                                               In this particular case, the FDA was a leading force
•   CPSC, FDA, and FTC may all have a hand in regulating       with their efforts to protect consumers from dangerous     •   Products claiming to boost immune systems.                  Take Amazon for example. After scrutiny from the
    face masks used to protect against the transmission of     sanitizer products, recalling or placing them under        •   Exposure to COVID-19 from contaminated devices or           CPSC and FDA, Amazon began imposing quality-control
    coronavirus.                                               import alert. Public warnings were even placed on              packaging.                                                  requirements on firms selling supplements on its site. If
                                                               products that the agency had no record of ever reaching                                                                    a seller cannot demonstrate the product it sells complies
•   NHTSA and FDA both regulate automakers that                                                                           •   Failing to warn about potential side effects or impacts
                                                               U.S. consumers. While Health Canada and regulators                                                                         with FDA regulations for labeling and cGMPs, the
    shifted resources to produce medical devices.                                                                             caused by drugs or devices.
                                                               across the EU took a similar approach, these products                                                                      product will be removed. The mammoth e-commerce site
•   U.S. Department of Transportation, NHTSA, and CPSC                                                                    Drugs, medical devices, and food products are named
                                                               remained available on store shelves throughout Mexico.                                                                     is seeking similar documentation for products regulated
    have regulatory enforcement authority on products                                                                     explicitly in this list, but similar claims may apply to        by the CPSC.
    such as lithium-ion batteries and micro mobility                                                                      automotive and consumer product companies. While
                                                               FDA then took the precautionary step of issuing a
    products.                                                                                                             the Public Readiness and Emergency Preparedness Act
                                                               country-wide import alert on all hand sanitizers from                                                                      With these broad observations in mind, let’s take a
•   U.S. Environmental Protection Agency (EPA) is putting      Mexico – the first time such a drastic step was taken.     (PREP Act) aims to provide immunity from liability to,          look at our predictions and recall data specific to each
    its own stake in the ground on products traditionally      Companies should be aware that this action is likely to    among others, “entities and individuals involved in             industry.
    regulated by FDA, including hand-sanitizer wipes and       happen again, and next time, the CPSC could flex its       the development, manufacture, testing, distribution,
    cosmetic products containing talc.                         regulatory muscle as well.                                 administration, and use of such countermeasures,” expect
•   Customs and Border Patrol supports FDA and CPSC                                                                       those protections to be tested by the plaintiffs’ bar.
    on regulatory enforcement, investigating, holding, or
    denying imported products at the ports.

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
CONSUMER
PRODUCTS
As we look at what 2021 has in store for CPSC
and the consumer product industry, much will
rest on the fact that the Biden administration has
an opportunity to secure a Democratic majority
within the agency. With that is likely to come an
increase in enforcement efforts, stricter safety
standards, and a shift from voluntary guidance to
mandatory standards.

The following pages outline what we see as the
top issues on the CPSC’s priority list.

                                                     CPSC estimates an annual average of
                                                     25,500 emergency department-treated
                                                     injuries (2017–2019) and 571 fatalities
                                                     that occurred between 2000 and 2019.”

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
Home Furnishings and Décor in the Spotlight
The Home Furnishings Association recently warned members
that the CPSC would be seeking to address issues related to
upholstered furniture flammability, furniture stability (including
tip-over risks), and formaldehyde emissions from composite
wood products in 2021. It would be no surprise to us since this
category is almost always the most impacted by recalls on a
quarterly basis.

It would also be a logical follow on from the CPSC’s recently published “Product
Instability or Tip-Over Injuries and Fatalities Associated with Televisions, Furniture,
and Appliances: 2020 Report.” In the report, CPSC estimates an “annual average of
25,500 emergency department (ED)-treated injuries (2017–2019)” and 571 fatalities
that occurred between 2000 and 2019. Those are staggering numbers. In response,
CPSC continues its consumer education campaigns as a parallel track to regulatory
enforcement. Now it looks like retailers and manufacturers are seeking ways to
educate consumers while limiting their own liability.

In late January 2021, a leading home furnishing brand announced it would require
U.S. shoppers to acknowledge and accept tip-over risks associated with certain
furniture and the recommendation they attach the furniture to the wall. In doing so,               CPSC continues its consumer
consumers would provide their name and email address as personal identifiers.                      education campaigns as a
Nancy Cowles, executive director for Kids in Danger, said the move was “a good
                                                                                                   parallel track to regulatory
step” because ensuring consumers are made aware of the safety risks is important.                  enforcement. Retailers and
But she also warned that her organization, Kids in Danger, is really focused on                    manufacturers are now seeking
making furniture more stable.
                                                                                                   ways to educate consumers while
As it pertains to recalls, could the solution actually spur a new generation of                    limiting their own liability.”
product registration cards?

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
Battery-Related Risks, Oversight, and Enforcement                                                                           New Phase of Oversight is                                     Ecommerce in the Crosshairs
Continue to Evolve                                                                                                          Coming for Internet of Things                                 Over the course of 2020 we examined how Amazon
                                                                                                                            (“IoT”) Products                                              ended up in the crosshairs of consumer product safety
Lithium-ion batteries have become ubiquitous to household devices,                                                                                                                        issues and product liability claims, and what it would
                                                                                                                            Before leaving office, former President Donald Trump
automobiles, toys, and gadgets of all kinds. Companies around the world turn                                                signed the Internet of Things (IoT) Cybersecurity
                                                                                                                                                                                          mean for the industry. While we don’t yet have clarity
                                                                                                                                                                                          on when or how the legal and regulatory landscape will
to lithium-based solutions to power products despite significant risks. We                                                  Improvement Act into law. The ultimate result will be
                                                                                                                                                                                          change for ecommerce companies like Amazon, Alibaba,
                                                                                                                            the first federal regulations for IoT devices, which will
know the CPSC has long been concerned about safety issues associated with                                                                                                                 and others, we do expect it to happen.
                                                                                                                            include security requirements, as well as guidelines
these products, but its latest warning was meant for consumers rather than                                                  for managing disclosures about those devices’ security
manufacturers.                                                                                                              vulnerabilities. It’s a signal that traditional product       In fact, it’s clear that Amazon is feeling the heat. Third-
                                                                                                                            safety regulations and the world of data and privacy          party Amazon sellers are reportedly receiving a flurry
                                                                                                                            have finally collided. Companies should expect the            of requests for regulatory compliance documents
The CPSC recently urged consumers “not to buy or            This warning is the latest phase in a product component
                                                                                                                            regulatory environment to continue evolving under a           for the products they sell. It could be due to court
use loose 18650 lithium-ion battery cells” typically        at the heart of safety issues for many product categories.
                                                                                                                            Biden administration, with more IoT product-related           decisions or in an attempt to pre-empt an imminent
manufactured as part of larger battery packs. The           From smartphones and laptops to hoverboards and
                                                                                                                            regulations on their way over the next four years.            regulatory crackdown. Either way, third-party seller and
cells, which are intended for individual sale, are          electric cars, lithium-ion batteries are notorious for
being separated, rewrapped, and sold individually           fire risk. They have caused household devices, cars, and                                                                      ecommerce businesses would be wise to catch up with
on e-commerce websites. The battery cells may have          even homes to catch fire, resulting in numerous life-                                                                         any regulatory record-keeping and ensuring the products
exposed metal positive and negative terminals that can      threatening injuries. Recalls nearly always follow. One                                                                       they sell are authentic, legal, compliant with regulations,
overheat, short-circuit, and ultimately result in “fires,   Q4 2020 example was LG Chem Ltd.’s recall of home                                                                             and safe for consumers.
explosions, serious injuries and even death.”               energy storage batteries that could overheat and start fires.

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
Increased Publicity of                                2020 BY THE NUMBERS
                   Enforcement Actions
                   Product safety advocate groups have long
                   criticized the CPSC for a perceived lack of           The CPSC announced 66 recalls in the fourth quarter               packaging violations. It is worth noting, however, that
                   regulatory oversight and enforcement. Whether         of 2020, bringing the annual total to 257 recalls. While          despite this 241.7% increase in the number of Personal
                   or not those criticisms were fair, it was clear by    this represents a 7% decrease in recalls quarter-over-            Care product recalls from 2019 to 2020, the number of
                   late 2020 that CPSC leadership became more            quarter, the real story is in the annual numbers. Despite         impacted units increased by only 21.1% from about 1.1
                   aggressive and vocal in its enforcement actions.      the far-reaching and long-lasting impact of the global            million units to 1.3 million units.
                                                                         pandemic, we saw a 7% year-over-year increase in
                                                                         recalls from 2019 to 2020. This level of recall activity          Injury risk was the top cause of 2020 recalls at 50
                   For example, Acting Chairman Robert Adler
                                                                         maintained an average five consumer-product recalls               events, with fire and childproof packaging violations
                   announced in mid-November that the CPSC
                                                                         every week in 2020.                                               close behind at 47 and 42 events respectively. Injury and
                   was referring to the U.S. Justice Department
                   a case for prosecution of a civil penalty. The                                                                          fire risks have been the top two causes for recalls for
                   Department of Justice later disclosed that a          Recalls in 2020 impacted just over 20 million units. Only         the past three years. Not surprisingly, the vast majority
                   federal judge had ordered Walter Kidde Portable       one event impacted more than 1 million units: a recall of         of injury and fire-related recalls impacted Sports and
                   Equipment Inc. to pay a $12 million civil penalty     5.7 million children’s water bottles. Setting that singular       Recreation and Home Furnishings and Décor products.
                   in connection with allegations that the company       recall aside, six recalls impacted more than 500,000
                   failed to timely inform the CPSC about problems       units and an additional 27 recalls impacted between
                   with fire extinguishers it manufactured. While        100,000 and 500,000 units.
                   the process followed its normal course, the                                                                                            JANUARY 2021 INSIGHT
                   CPSC’s announcement was an unusual publicity          Looking more closely at the number of units impacted
                   ploy perceived by some as the regulator trying to     by recalls, we saw a 116% increase in the fourth quarter,
                   take credit for the case.                             with an average recall impacting about 94,000 units.
                                                                         That’s more than twice as large as the average third-                           The CPSC announced 10 consumer product
                                                                         quarter 2020 recall. Overall, the average recall in 2020                        recalls in January 2021, compared to a monthly
                   Consider a second example. The CPSC, along with
                                                                         impacted 78,000 units compared to 90,000 units in                               average of 21 recalls in 2020. If recalls maintain
                   U.S. Customs and Border Protection, announced
                                                                         2019.                                                                           this pace for the remainder of the first quarter
                   in January the seizure of nearly 600 imported
                                                                                                                                                         of 2021, we will see less than half of the
                   girl’s bicycles that violated lead paint standards.
                                                                                                                                                         quarterly average number of recalls logged
                   Again, while the seizure is not unusual, a public     The product category most often impacted by recalls in
                                                                                                                                                         since at least 1998.
                   announcement for some 600 units seems to              2020 was Home Furnishings and Décor with 57 recalls.
                   be, particularly when you compare it with other       Close behind was Sports and Recreation products with
                   government releases issued around the same            54 recalls and Personal Care products with 41 recalls. Sports                   January 2021 recalls impacted just shy of
                   time for seizures of liquid meth, cocaine, and        and Recreation and Home Furnishings and Décor products                          200,000 units, compared to a monthly average
                   counterfeit masks for use in protecting against       have been the top two product categories impacted by                            of 1.7 million units impacted in 2020.
                   COVID-19.                                             recalls for at least the last nine years (since 2012).
                                                                                                                                                         Sports and Recreation products led with three
                   Regardless of your position in the supply chain       Personal Care products, on the other hand, are typically                        recalls, followed by Home Furnishings and
                   and the type of products you manufacture,             responsible for a small number of recall events each                            Décor with 2 recalls. Fall and fire risks were the
                   distribute, or sell, it’s likely that under a         year. In 2019, there were just 12 recalls of Personal Care                      leading causes of recalls, each accounting for
                   Democratic majority CPSC will become even             products. This anomalous activity in 2020 was largely                           three recalls.
                   more aggressive in publicizing its efforts to         due to a significant number of essential oil recalls and
                   protect consumers. Now is the time to double-         other personal products – all the result of childproof
                   check your records, and enhance your product
                   safety processes and procedures, before the
                   agency is granted more power – and greater
                   leeway in using that power – to protect consumers.

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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
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STATE OF THE NATION 2021 - UNITED STATES EDITION PRODUCT RECALL - Sedgwick
BOAZ GREEN, OF COUNSEL,
NEAL COHEN LAW

WELCOME TO A NEW ERA OF REGULATORY ENFORCEMENT

Expect 2021 to be the start of a new era for the Consumer Product Safety
Commission (CPSC). With the opportunity to nominate a Chair and at least two
additional Commissioners over the next four years, the Biden administration has                                           But when oversight of a supply chain is limited, there is        CPSC-related items into broader bills. For example, tucked
                                                                                                                          significant benefit to a discreet batching system.               into the “COVID-19 Regulatory Relief and Work from Home
the power to influence the direction of the CPSC beyond a single presidential term.
                                                                                                                                                                                           Safety Act” was a provision that instructs the CPSC to
                                                                                                                          For example, instead of one week of production, pare the         adopt the California upholstered furniture flammability
                                                                                                                          batch down to one day. When sourcing a component from            standard TB 117-2013. As part of this mandate, the Act
To begin, it is very likely that the Biden administration’s   While some of the traditional proactive methods for                                                                          requires manufacturers to apply a label to furniture that
                                                                                                                          multiple partners, change batch numbers when switching
first nominee to fill the vacancy for CPSC Chair will be      mitigating product safety and quality issues may be less                                                                     asserts compliance with this new standard. This label
                                                                                                                          suppliers or lots. Change SKUs following changes in
someone with consumer advocacy experience. With such          effective during the pandemic, other options abound.                                                                         requirement makes enforcement not just attractive for the
                                                                                                                          components or product redesign. This type of carefully
an appointment, an era of more active enforcement and                                                                                                                                      CPSC, but easy. Once the law takes effect, expect the CPSC
                                                                                                                          designed protocol ultimately has the power to minimize
rulemaking can be expected.                                   When other safeguards fail, remember customers can                                                                           to launch an enforcement program utilizing both port and
                                                                                                                          recall exposure when a quality or safety issue is identified.
                                                              serve as an important warning system. By listening and                                                                       retailer inspections to identify non-compliant products,
Where will increased scrutiny and enforcement come            being responsive to the concerns raised, deciding when                                                                       and either stop them at the ports or pressure companies to
from?                                                         to take action to prevent possible future incidents and     Increased Presence at the Ports                                  announce recalls.
                                                              mitigate the risk of enforcement action becomes easier.
                                                                                                                          Even before we see makeup of the CPSC change, the agency
                                                                                                                                                                                           Now is the time to get the house in order, before facing
Risks Created by a Strained                                   Be more proactive when monitoring and responding to
                                                                                                                          is pushing for increased resources and expanded authority.
                                                                                                                          That includes a stronger presence at the ports, a concept        double trouble: complete destruction of product shipments
Supply Chain                                                  consumer concerns.                                                                                                           at the ports combined with regulatory enforcement actions
                                                                                                                          already endorsed by Congress.
Consumer preferences and demand have evolved                                                                                                                                               by the CPSC, Customs and Border Protection, and possibly
significantly in 2020, driven in large part by the            If you are not in the practice of monitoring social                                                                          others.
                                                                                                                          Importers must be aware of these impending changes. A
COVID-19 pandemic. As manufacturers work to respond           media, product reviews, third-party seller sites,
                                                                                                                          stopped shipment at the port translates directly to delays,
to these changes, sourcing high-quality raw materials         and conversations with retail partners, now is the
                                                              time to start. Lower your threshold for launching an
                                                                                                                          but the impact doesn’t stop there. There are legal and           Intellectual Property and Product
and components in the quantity needed is challenging.                                                                     regulatory enforcement risks.
                                                              investigation based on the number or seriousness                                                                             Safety Will Collide
                                                              of complaints. Ensure your teams are proactively
Complicating matters, detecting quality and safety                                                                        When CPSC’s increased enforcement at ports first begins,         Manufacturers and traditional brick-and-mortar retailers
                                                              identifying potential risks and issues, and escalating
issues stemming from suppliers is not happening in                                                                        the agency may show some flexibility, allowing companies         alike are growing increasingly concerned about Intellectual
                                                              quickly. These steps will allow you to identify and then
the traditional fashion, in the form of in-person audits,                                                                 to correct technical violations such as a missing tracking       Property (IP) issues, particularly when it comes to the
                                                              address potential issues earlier. Taking these steps also
inspections, and product reviews. With suppliers facing                                                                   label or Certificate of Conformity. But after that first         potential for fraudulent products to find a way into
                                                              demonstrates a commitment to safety which could help
only a fraction of the scrutiny experienced previously,                                                                   violation, it is safe (and wise) to assume the agency will       consumers’ hands. These industries are joining forces to
                                                              avoid the perception of a delay in CPSC reporting and
there is more incentive for them to cut corners to meet                                                                   take a harsher future stance. Soon, companies should be          pressure legislators and regulators to address concerns
                                                              the related enforcement risks.
new demands and accelerated delivery expectations.                                                                        prepared for shipments to be held, and even destroyed, at        over IP violations, especially as they relate to e-commerce
                                                                                                                          higher rates when compared to what was experienced 2019          and platform sellers. Legislators and regulators have taken
                                                              While these steps are focused on consumer interaction,
It is critical that companies take additional proactive and                                                               and 2020.                                                        notice. At the CPSC, Commissioner Dana Baiocco, for one,
                                                              there are also ways to limit potential exposure on the
precautionary steps to mitigate the risks created by their                                                                                                                                 is very interested in curtailing the online sale of counterfeit
                                                              manufacturing side by improving traceability. Consider,
stressed supply chains.                                                                                                   We should also expect CPSC to exercise its muscle in areas       and fraudulent products by leveraging an increased
                                                              for example, how batching is handled. The definition of a
                                                                                                                          where it has gained new authority. Lawmakers also tucked         presence at the ports.
                                                              “batch” varies greatly across the manufacturing industry.

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IP is traditionally outside the scope of the CPSC’s jurisdiction. When      Now is the time to get the house in order, before
it comes to the import of fraudulent, counterfeit products, regulation
falls more squarely under the purview of U.S. Customs and Border
                                                                            facing double trouble: complete destruction of product
Protection.                                                                 shipments at the ports combined with regulatory
                                                                            enforcement actions by the CPSC, Customs and Border
But regulators understand that, when a product is fraudulent or
                                                                            Protection, and possibly others.”
counterfeit, the violations often go beyond IP laws. For example,
counterfeit products likely do not meet relevant safety standards, and
were probably not tested by third-party laboratories. As the agencies
collaborate more frequently at the ports, increased enforcement is
a likely result. If Customs and Border Protection stops a shipment of
product for IP concerns, inspectors may also call CPSC to evaluate the
product for safety issues.

Surgical Approach to Legislation,
Enforcement will Broaden
Expect the CPSC’s approach to rulemaking and enforcement to be far
more impactful in the months and years to come.

Under the Trump administration, attempts at legislation were narrowly
focused. Most legislation was focused on specific hazards or products,
like furniture stability or portable fuel containers.

With both houses under Democratic control, there is greater appetite
for a comprehensive review of the CPSC and its statute (the Consumer
Product Safety Improvement Act). Key changes would likely include an
increase on the CPSC’s penalty authority, removing the controversial
Section 6(b) requirements limiting the CPSC’s ability to disclose product
safety information, and removing barriers to CPSC’s ability to pass new
mandatory safety standards.

Until then, recent announcements by the CPSC should serve as a
reminder that the agency will likely want to show that we are in a new
era. In the Commission’s mind, the bigger the announcement, the
better. Think enforcement activities like major recalls, sweeping port
inspections, and financial penalties. These are the types of activities
that will ultimately help the agency counter the perception that it
isn’t doing enough to protect consumers, and especially vulnerable
populations like children.

              brand protection                                                              STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   21
Talk to your legal counsel now about
whether you have the regulatory
approvals needed to continue production
once EUAs are rescinded. If not, be
prepared to shut down production.”

                                          MEDICAL DEVICE
                                          As we look ahead, here’s what medical device
                                          companies need to think about in 2021 and beyond.

                                          Emergency Use Authorizations (EUAs) Will
                                          Come to an End
                                          The time will come, possibly as early as mid to late 2021, that the FDA
                                          will begin revoking EUAs, reverting to unapproved status medical
                                          devices that were not approved by traditional means. From that
                                          moment forward, legal protections currently offered to the companies
                                          manufacturing or distributing these products will likely be non-
                                          existent.

                                          What that means for future product liability cases, class action
                                          litigation, and regulatory enforcement may very well depend on
                                          your ability to demonstrate a strong safety record and a history of
                                          appropriate marketing activity (in other words, you did not commit
                                          COVID-19 fraud). You should also be talking to your legal counsel now
                                          about whether you have the regulatory approvals needed to continue
                                          production once EUAs are rescinded. If not, be prepared to shut
                                          down production of those unapproved medical devices and withdraw
                                          devices from the market the moment the EUA is revoked.

     brand protection                                     STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   23
COVID-19 Fraud will Draw Scrutiny                           It is critical that companies in this space work closely

From the FDA and DOJ
                                                            with FDA to the extent they are able. After all, software
                                                                                                                                          Company records can be used
                                                            is, and will continue to be, a primary reason for medical
Suspected COVID-19 fraud will be a hot-button issue         device recalls.                                                               as an indicator of a firm’s
across industries, and the medical device sector is                                                                                       compliance and may allow
no exception. In a “COVID-19 Product Regulation
                                                            Virtual Inspections will Inform                                               us [FDA] to focus and limit
Enforcement Roadmap” recently authored by the team at
Morrison Foerster, legal experts warn that companies can    Future Inspections and Regulatory                                             time needed on an on-site
expect enforcement activities such as warning letters or    Enforcement                                                                   inspection, or in advance of
product recalls for products claiming to:
                                                            It is well-known that the number of on-site inspections
                                                                                                                                          an inspection to later occur.”
•   Provide any type of COVID-19 testing.                   of medical device facilities plummeted in 2020 as a
•   “Treat” or “fight” COVID-19 or “inhibit” the virus.     result of the COVID-19 pandemic. In response, FDA
                                                            has been seeking ways to remotely evaluate regulatory
•   “Prevent” or “reduce the risk” of contracting
                                                            compliance. That process is no doubt going to involve
    COVID-19; or
                                                            requests for various records and video meetings aiming
•   Treat or reverse bodily symptoms caused by COVID-19.    to evaluate a company’s due diligence and quality
But these risks go beyond allegations of product efficacy   management systems.
and patient safety.
                                                            When speaking about the progress being made, FDA
If you need a specific example for just how damaging        Assistant Commissioner for Medical Products Elizabeth
an accusation like this could be, consider the recent       Miller explained that company records can be “used as
indictment of Decision Diagnostics Corp. (DECN) CEO         an indicator of a firm’s compliance and may allow us to
Keith Berman. According to a Justice Department             focus and limit time needed on an on-site inspection,
announcement, Berman was “indicted by a federal grand       or in advance of an inspection to later occur.” In other
jury in connection with an alleged scheme to defraud        words, proving you are running a tight ship could
investors by making false and misleading statements         delay future scrutiny. Otherwise, be prepared to be
about the purported development of a new COVID-19           among the first companies receiving an unannounced
test, leading to millions of dollars in investor losses.”   visit when FDA inspectors get back on the road. If this
                                                            approach proves to be beneficial to the agency, expect
                                                            these more detailed virtual inspections to be a long-
FDA Action on Artificial                                    standing part of the regulatory oversight process.
Intelligence-Enabled Software
The FDA’s Focus Areas of Regulatory Science (FARS)          Regulatory Enforcement will be a
highlighted several priorities related to medical device    Collaborative Effort
safety, including the agency’s focus on improving the way
it conducts product safety surveillance.                    International collaboration will also be critical to
                                                            ensuring the safety of the global drug supply. We
                                                            know that many regulatory bodies are working out
As the FDA went deeper, the agency released a plan for
                                                            processes for sharing findings of remote and in-person
how it will develop and evolve the regulatory framework
                                                            inspections to better protect consumers worldwide.
by which it will oversee artificial intelligence/machine
                                                            Companies should plan for the inevitable fact that
learning (AI/ML)-based software as a medical device
                                                            any inspectors, regardless of the regulatory body they
(SaMD). While the framework offers helpful insight and
                                                            officially represent, will be sharing the information
direction from the FDA, it will be constantly evolving as
                                                            they collect with their counterparts around the world.
the agency learns more and the technology behind the
                                                            Whether it is findings from an on-site inspection or
software and devices progresses.
                                                            results of remote sampling, expect regulators to freely
                                                            share the information to protect consumers across
                                                            their borders.

               brand protection                                                                                         STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   25
2020 BY THE NUMBERS

Recalls decreased slightly to 235 incidents in the fourth quarter,
down just 2.9% from 242 recalls in the third quarter and resulting
in a seven-quarter low. Despite this decline, we saw a total of 1,078
recalls in 2020, just short of our predicted 1,100 recalls for the year.
By comparison, 2019 saw a total of 884 recalls.

In a similar fashion, we saw a year-over-year increase in impacted
units. 2020 recalls impacted a total of about 467 million units, the
most units impacted by recalls since at least 2012. In 2019, recalls
impacted just over 430 million units. This record was in part due to
a quarterly record-high number of units impacted in the first quarter
of 2020, resulting from a single anomalous event impacting more
than 314 million units.

At 169 recalls, software issues were the top reason for recalls for the
18th time in the last 19 quarters, and the leading cause of recalls for
2020. But this does not carry over as the leading cause of recalls in
terms of impacted units. While 43 fourth quarter recalls, or 18% of
fourth quarter events, were the result of software issues, these 43
recalls impacted a mere 640,000 units, or just 1% of recalled units.

Other leading causes of recalls in 2020 were quality concerns and
mislabeling issues, accounting for 148 and 124 recalls respectively. By
comparison, software led 2019 recalls with 184 events, with quality
and mislabeling issues also among leading causes, triggering 117 and
105 events respectively.
                                                                           JANUARY 2021 INSIGHT
The leading cause of fourth quarter recalls in terms of impacted
units was mislabeling, accounting for 22 million units. Mislabeling
was followed by quality issues impacting about 18 million units.           The FDA disclosed 63 medical device recalls in January 2021,
                                                                           compared to a monthly average of 90 recalls in 2020.
When we look at activity over the duration of 2020, 67.4% of
recalled units were the result of a product being manufactured             January recalls impacted about 6.8 million units, with one event
outside of specifications. Nearly all of these units were involved in      accounting for 63.7% of all affected units. Adjusting for that
the anomalous recall referenced above. In 2019, the leading cause of       anomalous recall, the average January 2021 recall impacted
recalls by units was quality concerns, impacting 273 million units. In     just under 40,000 units. By comparison, the average recall
2018, manufacturing defects were the leading cause, impacting 196          size for a 2020 recall was 433,000 units. In further evidence of
million units.                                                             the smaller size of January medical device recalls, 58 recalls in
                                                                           January 2021 impacted fewer than 10,000 units.
Of fourth-quarter recalls, 84.3% impacted products distributed
nationwide. In terms of the global impact of recalls, 46.5% of             Software issues were the leading cause of January 2021 recalls
U.S. FDA recalls impacted products distributed to international            at 15 events, followed by Quality concerns with 12 recalls.
customers.

               brand protection                                                 STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   27
brand protection   STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   29
KATE W. HARDEY, PARTNER,
MCGUIREWOODS

CONSEQUENCES OF A PANDEMIC-DRIVEN
DEVICE INDUSTRY

As companies and regulators around the world navigate a global pandemic,
nearly everything known about supply and demand or regulatory oversight
activities has been turned upside down.

The medical device industry is experiencing new             make corrections. Much of this on the COVID-19 side
market entrants sparked purely by an increase in            of things, but it is not limited to pandemic response
demand for COVID-19 devices such as diagnostic tests,       products. This online research could also serve as an
ventilators, and personal protective equipment (PPE).       indicator of where the FDA should focus its efforts even
Simultaneously the Food and Drug Administration             when on-site inspections and other traditional oversight
(FDA) needed to find new ways to conduct oversight          activities resume.
and enforcement activities in a remote or virtual fashion                                                               The biggest challenges will be for companies that,             first products addressed through the EUA process, only
– all while prioritizing its support of the nation’s                                                                    often unknowingly, go too far in trying to capitalize          for the recommendations to change a few months later
coronavirus response.                                       Opportunistic Marketing that Turns                          on pandemic-inspired consumer demand. These are                as agency thinking and understanding of potential risks
                                                            into Fraud                                                  companies that, for whatever reason, want to get into          also evolved. Those types of changes are a challenge
Through this process, there have been a few COVID-19                                                                    the COVID-19 market, and start making claims about the         for businesses to follow and adapt in the normal course
                                                            When it comes to manufacturing-related risks, the
inspired consequences that the medical device industry                                                                  efficacy of products in preventing transmission of the         of business, let alone during a time of supply chain
                                                            supply chain continues be a concern for medical device
should expect to remain even when the pandemic is over.                                                                 coronavirus, testing for infections (or antibodies), or        disruptions, increased demand, and product shortages.
                                                            companies. In some cases, component manufacturers
                                                                                                                        treating someone who has contracted the virus. There are
                                                            are making false or exaggerated claims, often related
                                                                                                                        several companies that realized too late that the moment       The impact of EUAs is also likely last far longer than
Creative Approaches to Regulatory                           to COVID-19. There have been many missteps here,
                                                                                                                        a medical-related claim was made, they entered the world       the pandemic. The longer EUAs stick around, the more
                                                            particularly among companies that have the mindset
Oversight                                                   that claims may be made since only a component of
                                                                                                                        of medical devices. At that moment, FDA regulatory             long-term the effects on the composition of the medical
                                                                                                                        oversight and enforcement actions became a reality.            device industry. Many companies that benefited from
With inspections at record low levels over the last year,   a product is provided and the claims provide ideas or
                                                                                                                                                                                       EUAs are currently evaluating whether to take the next
the FDA is becoming more creative in how it approaches      suggestions for end use. This is absolutely not the case,
                                                                                                                                                                                       step of filing a 510(k) before the EUAs expire in order
regulatory oversight. For one, it is widely known that      however, opening these component manufacturers up to        Evolution of Emergency Use                                     to be a medical device company for the long-haul.
                                                            scrutiny that could have been avoided.
the agency is utilizing virtual inspections where it can.                                                               Authorizations                                                 The reasons could vary – from viewing the move as a
Less discussed is that the FDA, in lieu of in-person
                                                                                                                                                                                       survival tactic that will help the company emerge from
inspections and traditional record reviews, is taking to    These matters have the potential to worsen if a             As long as the country is in a state of declared pandemic,
                                                                                                                                                                                       the pandemic to a strong desire to be a medical device
Google for insight on potential enforcement actions.        manufacturer of a finished product adopts a claim,          Emergency Use Authorizations (EUAs) will remain a
                                                                                                                                                                                       company long-term.
                                                            putting both companies at risk of regulatory enforcement    critical component of regulatory guidance, oversight,
FDA staff are reviewing publicly available information      actions. Violations to this end, however, have been rare    and enforcement. Further, the process and protections
                                                                                                                        will likely continue to evolve.                                Either way, the medical device industry is more likely
on the Internet for discrepancies or violations in the      and will likely stay that way. Manufacturers of end-use
                                                                                                                                                                                       to maintain something more similar to its current
marketing or positioning of a product. When something       devices generally have a greater understanding of the
                                                                                                                                                                                       competitive composition than revert to its pre-COVID-19
runs afoul, instead of issuing warning letters, for less    regulatory environment, specifically the guidance for       In fact, changes in the EUA process have been one of the
                                                                                                                                                                                       business landscape.
egregious issues or concerns regulators are picking up      making product-related claims.                              biggest challenges facing medical device manufacturers.
the phone or sending emails and telling companies to                                                                    Consider the case of face masks and PPE – some of the

             brand protection                                                                                                                                                        STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   31
Recalls are Driving Litigation                                As companies consider potential legal risk, keep in
                                                              mind COVID-19 products may benefit from some of the
Separate and apart from the pandemic response,                indemnity provisions within the Public Readiness and
but still very much relevant to COVID-19 products,            Emergency Preparedness (PREP) Act, these protections
medical device companies must understand the legal            are not likely to be the blanket indemnification some
ramifications of enforcement actions – and specifically       may think. There is always the risk that a plaintiff’s
product recalls.                                              attorney tries to apply state law theories, pursue medical
                                                              negligence or malpractice claims, or even test the PREP
Increasingly, plaintiff consumer litigation law firms         Act indemnity directly. Companies must prepare for this
are monitoring the FDA website for recall activity as         eventuality, because even if the lawsuit ultimately goes
inspiration for lawsuits. In fact, it is almost inevitable    away, it will have a lasting impact in the form of a costly
that a recalling firm will face at least one lawsuit as a     legal expense, an operational distraction, and, the longer
direct result of the recall announcement. A lawsuit could     it plays out, potentially, a damaged reputation.
come in several shapes and forms (or even a combination
of the following):                                            To sum these consequences up with one overarching
                                                              piece of advice: be sure to think big and broad about risk
•   Class action product liability,
                                                              and exposure within the medical device industry. While
•   Unfair trade practices,                                   regulatory safety issues should be a top priority, public
•   State law violations (e.g., Prop 65 in California), and   and private companies need to think holistically about
•   Securities class action, to name a few.                   the risks faced in terms of state and international laws,
                                                              rules, statutes, and litigation. Too narrow of a focus on
                                                              any one of these will likely serve to increase your risk
Companies need to be careful about what is said
                                                              exposure somewhere else.
about the recall and underlying issues, and how it is
communicated. While there will be specific information
the FDA requires as part of the recall, be very careful
how the issue and actions are characterized beyond the
FDA process. Just one wrong word has the potential to
increase legal exposure.

               brand protection                                                                                             STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   33
PHARMACEUTICAL
As we look ahead, here’s what pharmaceutical companies
need to think about in 2021 and beyond.

Drug Quality and Current Good Manufacturing
Practices (cGMP) are Top Recall Enforcement
Priorities
Whether we look at prescription drugs or over-the-counter medications,
the leading causes of recalls and enforcement actions are typically the
same. From a recall perspective, we know that violations in Current Good
Manufacturing Practice (cGMP) regulations and quality issues are routinely
the top reasons for recalls.

Expect the FDA to have a continued focus on cGMP, especially when it
comes to foreign Active Pharmaceutical Ingredient (API) manufacturers.
It is critical for manufacturers, especially during a global pandemic, to be
even more diligent with ensuring suppliers are meeting standards and
quality requirements. Regardless of when it happens, companies need to
be prepared if the agency takes enforcement action or requires a recall that
reaches as far back as the last inspection or start of the pandemic.               It is critical for manufacturers,
                                                                                   especially during a global
                                                                                   pandemic, to be even more diligent
                                                                                   with ensuring suppliers are
                                                                                   meeting standards and quality
                                                                                   requirements.”

             brand protection                                                  STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   35
NDMA Continues to Trigger Recalls, Litigation                                                                                COVID-19 Products Remain in
Valisure’s 2019 discovery of likely carcinogen N-Nitrosodimethylamine (NDMA)
                                                                                                                             the Spotlight
                                                                                                                             Remember that the definition of COVID-19 products
in heartburn and diabetes medications is having long-lasting ramifications.
                                                                                                                             is broad. It includes products recommended by health
                                                                                                                             officials to prevent the transmission of the coronavirus,
We continue to see a regular stream of NDMA-related            blood pressure drug manufacturers that allegedly sold
                                                                                                                             as well as treatments and vaccines. Hand sanitizers is
recalls through 2020 and into 2021. We saw nine recalls        the products they knew were contaminated with NDMA.
                                                                                                                             one product category scrutinized by the FDA. Dietary
due to NDMA in the fourth quarter of 2020 alone,
                                                                                                                             supplements making COVID-19 claims is another.
bringing the total to 36 for the year. By comparison, just     On top of that, Valisure recently published a study
                                                                                                                             Safety of these products is a primary concern, but
12 recalls were announced for NDMA contamination               in the Journal of the American Medical Association
                                                                                                                             suspected fraud is another hot-button issue.
in 2019. We suspect this story is far from over. Recalls       (JAMA) Network Open which suggests ranitidine drugs
are likely to continue as regulators and pharmaceutical        can cause NDMA to form under a range of conditions,
                                                                                                                             As of mid-November 2020, more than 1,200 fraudulent
companies grapple with understanding how and when              including in the human body, thus increasing cancer risk.
                                                                                                                             products were identified by FDA. As at-home COVID-19
the contamination occurs.                                      In fact, if you do an Internet search for ‘ranitidine,’ you
                                                                                                                             testing kits become more available, and consumers
                                                               may see ads from plaintiff law firms atop the results,
                                                                                                                             continue to look for ways to protect themselves or
In fact, it is very likely about to get worse. U.S. District   along with links to multiple studies citing the drug’s link
                                                                                                                             recover from the coronavirus, fraud will remain a top
Judge Robert Kugler in New Jersey allowed fraud                to cancer. We expect an increase in litigation in light of
                                                                                                                             priority. As long as COVID-19 remains a concern, these
allegations to proceed against several generic valsartan       these findings.
                                                                                                                             products will stay in the spotlight.

                                                                                                                             The team at law firm Morrison Foerster recently
Regulatory Enforcement is Now a Collaborative Effort among                                                                   published a “COVID-19 Product Regulation
Global Agencies and Independent Organizations                                                                                Enforcement Roadmap” in which the authors offer the
                                                                                                                             below list of product claims most likely to spark FDA
The impact of Valisure’s 2019 discovery of NDMA                In addition, collaboration among regulators worldwide
                                                                                                                             scrutiny. Expect enforcement activities such as warning
contamination sparked a string of product recalls,             is proving even more critical to ensuring the safety of
                                                                                                                             letters or product recalls for products claiming to:
influential consumer protection efforts, and stricter          the global drug supply. We know that many regulatory
regulatory enforcement. As a result, independent               bodies are working out processes for sharing findings         •   Provide any type of COVID-19 testing.
organizations have seen how they, like Valisure, can have a    of remote and in-person inspections to better protect         •   “Treat” or “fight” COVID-19 or “inhibit” the virus.
public role in protecting patients, and they are jumping on    consumers worldwide.
                                                                                                                             •   “Prevent” or “reduce the risk” of contracting
board to proactively monitoring drug quality and safety.
                                                                                                                                 COVID-19; or
                                                               Companies should plan for the inevitable fact that
                                                                                                                             •   Treat or reverse bodily symptoms caused by
From pharmacies to academic institutions, these                any inspectors, regardless of the regulatory body they
                                                                                                                                 COVID-19.
organizations are conducting their own investigations,         officially represent, will be sharing the information they
testing, and publicizing any findings that call the safety     collect with their counterparts around the world. Whether     But it is not just the FDA that’s worried about the
of products into question. These efforts increased             it is findings from an on-site inspection or results of       dangers these products may pose to people and the
as COVID-19 kept the FDA from conducting on-site               remote sampling, expect regulators to freely share the        environment. The U.S. Environmental Protection
inspections. One example we shared in the Third Edition        information to protect consumers across their borders.        Agency (EPA) has taken action indicating that it sees
of the Recall Index was the petition from University                                                                         certain products, like hand sanitizer wipes, falling
of Kentucky researchers to FDA, requesting a recall of                                                                       under its regulatory purview. The EPA has called on at
Mylan and Hikma versions of an injectable diuretic after                                                                     least one hand-wipe manufacturer to submit a recall
finding high impurity levels.                                                                                                plan, saying the product is regulated under the Federal
                                                                                                                             Insecticide, Fungicide, and Rodenticide Act. This is
                                                                                                                             not surprising given the all-hands-on-deck approach
                                                                                                                             to product regulation and safety during the pandemic,
                                                                                                                             and companies should only expect to see more of this
                                                                                                                             type of regulatory overlap and even collaboration.

               brand protection                                                                                                                                                          STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   37
Regardless of the type of
pharmaceutical product you
manufacture or its intended use,
now is the time to prepare for
increased regulatory oversight and   Return Focus on Longstanding Priorities
enforcement in 2021 and beyond.”
                                     The FDA’s Focus Areas of Regulatory Science (FARS)
                                     highlights several issues that are directly related to product
                                     safety, including a focus on the quality of compounded
                                     drugs, technologies to reduce pathogen contamination, and
                                     leveraging data to improve product safety surveillance.

                                     Likewise, we know product safety risks impacting hot-button issues such as API
                                     safety, opioids, cannabis, and vaping products haven’t fallen entirely off FDA’s
                                     radar, but they have taken a back seat to pandemic response. Don’t expect
                                     that to last forever. In fact, the tide may already be changing at the federal and
                                     state level.

                                     On September 10, 2020, the FDA announced the issuance of warning letters
                                     to 17 website operators in China, Iceland, India, New Zealand, Pakistan, and
                                     the United States involved in the illegal importation and sale of unapproved
                                     and misbranded opioids. These letters are a reminder that the FDA will pursue
                                     companies throughout the supply chain, making it even more important the
                                     companies understand their risks up and downstream.

                                     Meanwhile, Oregon cannabis regulators recently banned several additives that
                                     potentially could harm marijuana vape users. Depending on the path the FDA
                                     ultimately takes with cannabis and Cannabidiol products, growers, producers,
                                     manufacturers, and retailers must all be prepared for increased regulatory
                                     scrutiny, warning letters, and ultimately enforcement action at the state and
                                     federal level.

                                     Regardless of the type of pharmaceutical product you manufacture or its
                                     intended use, now is the time to prepare for increased regulatory oversight and
                                     enforcement in 2021 and beyond.

      brand protection                                     STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   39
2020 BY THE NUMBERS

                   About halfway through 2020, we predicted that
                   it would still be feasible for the drug industry to
                   experience a similar level of recall activity to 2019
                   – before COVID-19 response changed the way
                   businesses and regulators operate. Our prediction
                   became reality.

                   Even with minimal inspection and regulatory enforcement activity, we
                   saw 344 pharmaceutical recalls in 2020, representing a 2.4% increase
                   compared to 2019. While this is a small increase in the number of
                   events, 2020 recalls impacted nearly 133 million units, or 50.6% more
                   units than were impacted by 2019 recalls.

                   Fourth-quarter recalls impacted 84 recalls compared with 100 recalls
                   announced in the third quarter. This is a 16% decrease in recall
                   events quarter-over-quarter. These recalls impacted 30 million units,
                   representing a 11.1% decrease compared to the third quarter.

                   cGMP deviations and failed specifications were tied as the leading
                   cause of fourth-quarter recalls, each leading to 24 events. It marks
                   the sixth time in the last seven quarters that cGMP deviations were a
                   leading cause of recalls. Not surprisingly, it secured cGMP deviations
                   as the top cause of recalls in 2020.                                     JANUARY 2021 INSIGHT

                   For perspective, cGMP deviations were the leading cause of recalls
                   in 2019, and the second-leading cause in 2018 followed by failed         The FDA logged 23 pharmaceutical recalls in January 2021, with
                   specifications.                                                          just one of these events receiving the FDA’s Class I designation. By
                                                                                            comparison, the FDA announced 33 recalls in January 2020 and a
                   cGMP deviations were the top cause in terms of units in the fourth       monthly average 29 recalls for the year.
                   quarter, impacting more than 24 million units or 81% of all recalled
                   units. Similarly, cGMP deviations were the leading cause of units        January 2021 recalls impacted about 4.9 million units. That equates
                   recalled for the entirety of 2020, accounting for 63 million or 47% of   to an average recall size of about 214,000 units. By comparison, an
                   recalled units.                                                          average 11 million units were recalled each month in 2020. The average
                                                                                            size of a pharmaceutical recall in 2020 was about 386,000 units.
                   Among fourth-quarter recalls, 64 impacted products distributed
                   nationwide, while just 5 affected products sent internationally. When    Failed specifications, cGMP deviations, and sterility issues were the
                   we look at activity over the course of the year, 273 recalls impacted    leading causes of recalls at five events each.
                   products nationwide, and 18 impacted products sent internationally.

brand protection                                                                                                                                           STATE OF THE NATION 2021 | Product Recall Data, Trends and Predictions for US Industries   41
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