Hunton Retail Law Resource

The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products.  Subject matter may include the latest product recalls, major federal agency developments, and proposed or new federal rules.  The blog’s goal is to provide an overview, rather than a comprehensive report on every development that could potentially affect businesses or consumers.  Nothing herein constitutes legal advice.  If you have questions or comments about the blog, please reach out to the authors.

The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products. In lieu of the usual monthly recap, this post summarizes key events from 2021. Subject matter may include the latest product recalls, federal agency major developments, and proposed or new federal rules. The blog’s goal is to provide an overview, rather than a comprehensive report, on every development that could potentially affect businesses or consumers. Nothing herein constitutes legal advice. If you have questions or comments about the blog, please reach out to the authors.

The Recall Roundup is a monthly survey of regulatory activity affecting the manufacture, distribution, and sale of consumer products. Subject matter may include the latest product recalls, federal agency major developments, and proposed or new federal rules. The blog’s goal is to provide an overview, rather than a comprehensive report on every development that could potentially affect businesses or consumers. Nothing herein constitutes legal advice. If you have questions or comments about the blog, please reach out to the authors.

In a dramatic recent announcement, EPA suggested that if companies import, manufacture, or process a finished good for commercial sale, and that product is not a pesticide, not a firearm, not a tobacco product, and not a food, food additive, drug, cosmetic, or device, they will need to know all chemicals contained in those products. We explain more about this below.

The CPSC’s nine-year saga over magnet sets has finally concluded.  Magnet sets are clusters of small, separable, magnetic balls that a consumer can rearrange into countless shapes.  In 2012, a distributor refused to voluntarily recall the magnet sets, forcing the CPSC to file an administrative complaint alleging that the magnet sets were defective and presented a substantial ingestion hazard to young children.  In 2017, the CPSC concluded that the magnet sets posed a substantial product hazard that cannot be mitigated by package warnings and ordered the distributor to recall the magnet sets.  The distributor sued in federal court to block the CPSC’s order.  After multiple appeals, the Tenth Circuit Court of Appeals ultimately agreed with the CPSC.  Thus, this month the CPSC issued a rare mandatory recall of 10 million magnet sets.  The recall noted that two children who had ingested the magnets from the magnet sets required surgery to remove them and a 19-month-old child died after ingesting similar high-powered magnets.  The CPSC also issued a warning to consumers about the dangers of high-powered magnets, noting that from 2009 to 2018, there was an estimated 4,500 cases of children from 11 months old to 16 years old who were treated in US hospitals for ingestion of high-powered magnets.

As reported on the Hunton Insurance Recovery blog, Hunton product liability and mass tort attorneys Elizabeth Reese and Alexandra Brisky Cunningham and insurance attorney Latosha Ellis recently published an article in Risk Management discussing key lessons from Peloton’s Tread+ Recall.

The CPSC (by a 3-1 vote) recently filed an administrative complaint against Amazon.com, Inc. (“Amazon”) seeking to force the characterization of Amazon as a “distributor” of products under the Consumer Product Safety Act.  If the CPSC prevails on that characterization, Amazon would become responsible under the CPSA for recalling potentially hazard products sold via its “fulfilled by Amazon” program.   Although Amazon has engaged in recalls on what it has characterized as a voluntary basis, it has not conceded CPSC authority over it as a distributor.  The Amazon complaint that tees this issue up for judicial resolution involves carbon monoxide detectors that fail to alert, children’s pajamas that do not meet flammability requirements, and hair dryers without required water immersion protection devices.  Amazon has stopped selling some of these products, notified consumers who purchased the products about the potential hazards, and offered refunds via Amazon gift cards.  The CPSC views these steps as insufficient and aims to force Amazon to issue recalls and destroy the returned products.  Under the CPSA, a “distributor” is “a person to whom a consumer product is delivered or sold for purposes of distribution in commerce.”  15 U.S.C. § 2052(a)(8).  Under the “fulfilled by Amazon” program, merchants keep title to their products but store them at Amazon fulfillment centers, where Amazon packs and ships the products for a fee.  Although the CPSC views Amazon as a “distributor,” Amazon argues it is merely an intermediary for other retailers because it does not hold title to the products and therefore cannot be held liable for them.

The CPSC has recently focused its enforcement efforts on children’s products.  Fisher-Price recalled two of its infant sleep products—Rock ‘n Glide Soothers and Soothe ‘n Play Gliders—after four infant deaths were reported involving the first product.  All four infants were placed in the products unrestrained on their backs and were later found on their stomachs deceased.  This news comes after the CPSC’s actions last month to approve a new federal standard for infant sleep products and to recall two more products related to infant sleep.

In the world of consumer products, the month of May was all about infant sleep products. The CPSC recently approved a new federal standard for infant sleep products for infants up to five months of age since such inclined sleepers, bassinets, and in-bed sleepers that have been linked to multiple infant deaths. Beginning in June 2022, infant sleep products must meet a new federal safety standard. The new federal standard incorporates a voluntary ASTM safety standard with further modifications to strengthen it. If the products do not already meet the requirements of an existing CPSC standard, then the products must pass testing to confirm that the sleep angle surface is 10 degrees or lower and comply with the CPSC’s safety standard for bassinets and cradles.

The CPSC most commonly works with manufacturers, sellers, or those in the distribution chain to prompt them to issue warnings or recall notices to consumers. Recently, however, the CPSC has taken the far more unusual step of independently issuing its own warnings to consumers about dangerous products in three circumstances involving treadmills, youth ATVs, and bed rails.

The Consumer Product Safety Commission (CPSC) has proposed a Direct Final Rule implementing the new federal upholstered furniture flammability standard.  The Direct Final Rule, published by the CPSC on April 9, 2021, would codify California’s TB 117-2013 flammability standard as mandated by Congress, but with the following significant clarifications:

The Fifth Circuit recently issued an opinion concluding that the CPSC violated the APA when it issued a final rule in 2017 limiting phthalate content in children’s products. The Consumer Product Safety Improvement Act of 2008 (CPSIA) bans children’s toys and child care articles containing more than 0.1 percent of several phthalate chemicals because of concerns that ingestion can have harmful health effects on children. Phthalates are used to make soft and pliable plastics, such as vinyl. The CPSIA also directed the agency to promulgate a final rule regarding phthalates. In 2017, the CPSC issued a final rule expanding the list of phthalates covered by the ban.

The CPSC recently announced its first civil penalty of 2021.  Cybex International, Inc. (Cybex) agreed to pay $7.95 million after the workout equipment manufacturer allegedly failed to immediately report to the CPSC the defects in two of its products.

In response to industry and consumer demand created by the COVID-19 pandemic, ASTM International (ASTM) has released a new voluntary standard for the design, labeling, testing, and performance of face coverings.  The new standard, ASTM F3502-21, is the first voluntary standard directed at face coverings and “is intended to establish a national baseline” to allow consumers to make more informed decisions about the face covering products they use.

While the eleven January recalls are summarized below, this first “Roundup” focuses on the evolving use of cashierless technology and what role it may play in the context of product recalls.  Broadly speaking, cashierless technology refers to using technology at brick-and-mortar business locations that allows shoppers to enter the location and purchase consumer products without standing in a checkout line or interacting with a cashier.  Rather, cameras and sensors track the products selected and charge the shoppers upon exit.

After a hiatus from civil penalties, the CPSC recently announced a $12 million penalty.  In November 2017, Walter Kidde Portable Equipment Inc. (“Kiddie”) recalled fire extinguishers for two issues.  First, the fire extinguishers could become clogged or require excessive force to discharge.  Second, the nozzle of the fire extinguishers could detach.  These issues could result in a failure of the fire extinguishers to discharge during a fire emergency.  In fact, a 2014 death was reported involving a car fire after emergency responders could not get the fire extinguishers to work.  By November 2017, Kiddie had received 391 reports of defects, including one fatality, 16 injuries, and 91 episodes of property damage.

Congress has passed a law mandating nationwide compliance with California’s flammability standard for upholstered furniture.  The “COVID-19 Regulatory Relief and Work from Home Safety Act,” included in the massive appropriations bill passed by Congress and signed into law by the President on December 27, 2020, incorporates the provisions previously proposed in the Safer Occupancy Furniture Flammability Act (SOFFA), a bill widely supported by the furniture industry.

The CPSC recently posted guidance on its website for consumer products related to COVID-19, including personal protective equipment. The guidance covers four categories of products: (a) face coverings, (b) gowns, (c) gloves, and (d) disinfectant and cleaning products. The guidance emphasizes that personal protective equipment sold to consumers must comply with all CPSC regulations, which include testing, certification, labeling, and recordkeeping requirements. The guidance drew sharp criticism from CPSC Commissioner Dana Baiocco in a statement:

The CPSC took proactive steps in October to address recent concerns with infant sleep products that pose suffocation hazards and could lead to Sudden Infant Death (SID).  This month the agency made a rare proposal for a mandatory consumer product safety standard to address the risks associated with crib mattresses.  The safety standard would incorporate by reference the voluntary standard ASTM F2933-19 (Standard Consumer Safety Specification for Crib Mattresses) with modifications to make the standard even more stringent.  These modifications include increased product performance testing to cover crib mattress firmness, coil spring issues, and face-in-mattress scenarios.  The new rule would also update the product’s warning labels, instructions, and packaging to remove unnecessary wording and emphasize the importance of positioning infants on their backs to sleep.  For example, the proposal compares the voluntary standard’s warning label to the proposed mandatory standard’s warning label:

The Consumer Product Safety Commission (CPSC) has released COVID-19 guidance confirming that certain personal protective equipment (PPE) must comply with CPSC regulations, including testing, certification, labeling, and recordkeeping requirements.  The guidance, summarized below, also provides a concise overview of other federal regulations that may apply to these products.

The upcoming election offers opportunities for leadership changes at the CPSC.  The agency currently has four commissioners and one vacancy:

Even in a pandemic, some things do not change.  This month’s Recall Roundup finds the CPSC focusing on dangers that have been front and center for some time.  Specifically, the CPSC continues to focus its regulatory efforts on protecting consumers from product defects in all-terrain vehicles (ATV) and other recreational off-highway vehicles such as snowmobiles, golf carts, and utility vehicles.  The CPSC recently issued a warning to consumers about the risks associated with such products, especially as more consumers look for outdoor activities during the pandemic.  The warning cites to the CPSC’s Annual ATV Report of 2018, which identified almost 82,000 ATV-related injuries that required hospital treatment.  Nearly one-fourth of these injuries were sustained by children under 16 years old, the highest fraction of any age group.  There were also 264 ATV-related deaths in 2018, though this number is expected to rise as reporting is ongoing.  So far, the CPSC has issued 15 recalls for recreational off-highway vehicles in 2020.  In 2019, that figure was 20 recalls.

With the prevalent spread of COVID-19, hand sanitizers have become this spring and summer’s “fidget spinners,” cycling through the process from market shortage to glut in short order.  With such a rush to meet the drastic spike in demand, product missteps seem inevitable.  Although the Recall Roundup generally focuses on recalls under CPSC jurisdiction, the numerous FDA recalls involving hand sanitizers merits mention here.  Since June 27, 2020, there have been 15 recalls noted on the FDA’s “Recalls, Market Withdrawals, & Safety Alerts” website.  Retailers looking to meet market demand should keep an eye on this FDA web site relative to the hand sanitizers they may have stocked for sale.

At a June 16, 2020 hearing, the US Senate Committee on Commerce, Science and Transportation considered President Trump’s nomination of Nancy Beck to the CPSC.  In March, Trump announced his nomination of Dr. Beck to be Chairman and Commissioner of the CPSC.  The CPSC currently consists of two Republican appointees and two Democratic appointees with one of the Democratic appointees—Robert Adler—serving as Acting Chairman.  This month’s committee hearing included tough questions from Democrats and Republicans about how Dr. Beck would prevent unauthorized releases of confidential business information held by CPSC – a problem that has plagued the agency recently.  Dr. Beck was also quizzed about her prior experience as the Senior Director for Science Policy at the American Chemistry Council, which is a chemical industry lobbyist group.  Senate Democrats have expressed opposition to Dr. Beck’s confirmation as well as one Senate Republican on the committee – Shelley Moore Capito (R-WV).  If every Democrat on the committee plus Senator Capito oppose the nomination, then the committee’s vote count is at a 13-13 tie, signaling that the nomination may not proceed to a full Senate floor vote.

Should you have to pay to see CPSC’s adopted safety standards?  That is the question raised by a lawsuit filed in the Third Circuit this month, which challenges the CPSC’s adoption of mandatory safety standards for consumer products that are not available for free to the public.  The American Society for Testing and Materials (“ASTM”) is a well-recognized independent organization that develops consensus-based, voluntary standards for children’s products.  In 2019, ASTM updated its safety specifications for infant bath seats, which includes changes to labeling, product performance, and safety testing (ASTM F1967-19).  The CPSC later promulgated an agency rule adopting the updated ASTM standard as legally binding on infant bath seat manufacturers (16 C.F.R. § 1215).  On behalf of a new mother, a civil rights group filed a petition with the U.S. Court of Appeals for the Third Circuit pursuant to 15 U.S.C. § 2060 challenging the CPSC’s rule.  The mother claims that she asked the CPSC for a copy of the standard and the CPSC instead directed her to buy a copy from ASTM.  ASTM charges $56 for a copy of the standard—almost double the price of an infant bath seat.  The petition asks the Third Circuit to vacate the rule, order the CPSC to make any binding standard freely accessible to the public whenever the CPSC proposes to promulgate a new rule, and order the CPSC to make any binding standard freely accessible to the public permanently after the CPSC adopts it in a final rule.

A consumer recently filed a products liability lawsuit against Keurig regarding its mini plus brewing system—a coffee maker that Keurig recalled at the end of 2014. Keurig recalled the brewing system after receiving about 200 consumer reports, including 90 reports of burn-related injuries, regarding the brewing system’s pressurized water overheating and spraying out of the machine. The lawsuit alleges that Keurig waited too long to recall the brewing system and therefore failed to warn consumers of the product’s defects. This lawsuit serves as a reminder to manufacturers, distributors and retailers that actions or inactions prior to issuing a recall may be subject to scrutiny and litigation.

As reported on December 10, 2019 in Hunton’s environmental law blog, “The Nickel Report”, additive manufacturing, more commonly known as 3D printing, has already found commercial application in various industries and its use is on the rise. 3D printing converts 3D digital models created on a computer or with a scanner into physical objects, usually by successively adding material layer by layer. The process allows manufacturers to make complex designs, rapid prototypes and final products while offering the potential to limit process waste and reduce production costs.

3D ...