In the wake of the COVID-19 pandemic, product manufacturers and distributors—many of whom have pivoted to create PPE-related products for the first time—are now faced with a veritable morass of guidelines and requirements to navigate from a variety of governmental agencies. Recent enforcement actions by federal agencies have only highlighted the importance of understanding exactly how a product must be produced, advertised, labeled, and sold.  This begs the important question: who is the regulator and what is the rule?

Our product risk management team has been speaking to several trade associations in September 2020 about how to navigate the alphabet soup of federal agencies supervising COVID-19 product distribution.  The biggest takeaway:  How a product is advertised for sale plays a critical role in how it is regulated and by which agency .  The regulatory profile can mean the difference between required manufacturing registration or specific requirements as to product labeling.

This article outlines a few of the major players involved in regulating products designed to mitigate or prevent COVID-19—specifically, the Food and Drug Administration (“FDA”), Federal Trade Commission (“FTC”), and Environmental Protection Agency (“EPA”)—and discusses high-level considerations for entities who find themselves caught up in the regulatory alphabet soup.Continue Reading Who is the regulator? What is the rule?: Navigating the Alphabet Soup of COVID-19 Product Requirements       

Recalls in Review: A monthly spotlight on trending regulatory enforcement issues at the CPSC.

Electric scooters have taken American cities by storm as micromobility companies expand to meet consumer demand for more convenient transportation options. As with bicycles, scooters have become a go-to option for consumers who are seeking socially distant activities and modes of transportation amid the COVID-19 pandemic.

The regulation landscape for powered scooters is still being charted. Although a federal safety standard which addresses electrical systems and lithium-ion batteries in personal e-mobility devices (ANSI/CAN/UL 2272) exists, there is no corresponding safety standard for regulating the overall operational, mechanical, or electrical safety aspects of powered scooters. Additional standards may be promulgated in the near future, however. The American Society for Testing and Materials (ASTM) Consumer Products Subcommittee on Powered Scooters and Skateboards (F15.58) has begun developing a proposed standard intended to minimize the common hazards associated with use of commercial electric-powered scooters by adults.

Given the lack of a mandatory federal safety standard for powered scooters, it is unsurprising that recalls of powered scooters were infrequent in in the first two decades that the products were on the market. The Commission has conducted 34 total recalls of powered scooters. Only nine of the recalls occurred between 1996 and 2015. The small enforcement “spike” in 2005 corresponds with CPSC efforts to track emergency-room visits related to powered scooters. At least 10,015 emergency room-treated injuries occurring between July 2003 and June 2004 were related to powered scooters. Recalls increased dramatically as hoverboards (also referred to as “self-balancing” electric scooters) were introduced to the market. Fourteen recalls of powered scooters were conducted in 2016 alone, closely followed by another ten recalls in 2017.

Continue Reading Recalls in Review: Electric- and Gas-Powered Scooters

Mopeds fall within NHTSA’s jurisdiction when they can go over 20 mph and are meant to be used primarily on roads.  They’re considered “motor-drive cycles,” which are a subset of motorcycles.  In NHTSA’s world, a motorcycle is “a motor vehicle with motive power having a seat or saddle for the use of the rider and designed to travel on not more than three wheels in contact with the ground.”[1]  A motor-drive cycle is “a motorcycle with a motor that produces 5–brake horsepower or less.”[2]  Since these mopeds are regulated by NHTSA, they cannot be imported into or sold in the United States without complying with the FMVSS.[3]

Since NHTSA is focused on vehicles meant for road use, one might wonder whether the use of bike paths changes NHTSA’s jurisdiction over mopeds.  Ultimately, though, NHTSA is focused on speed.  According to NHTSA’s published interpretations of its regulations, the agency “believe[s] that vehicles with speeds of over 20 mph are capable of on-road operation,” and therefore fall within their purview.  NHTSA makes classifications for vehicles in interstate commerce.  The classifications are meant to be as applicable in California as they are in Tennessee or Maine.  Some cities may have ample bike lanes such that it would be reasonable for the bikes to never be used on roads, but most do not. NHTSA’s classifications will not change from location to location.Continue Reading NHTSA versus CPSC Jurisdiction Over Certain Micromobility Products

Recalls in Review: A monthly spotlight on trending regulatory enforcement issues at the CPSC.

As bicycles become a go-to social distancing option for consumers, we turn our attention in this Recalls in Review segment to an associated (and also closely regulated) product—bicycle helmets.  The CPSC mandates that all bicycle helmets manufactured or imported since March 17, 1995 meet the standard set forth in 16 CFR Part 1203.1(c).  This mandatory standard covers bicycle helmets and multipurpose helmets that can be used when riding a bicycle.  The standard does not cover helmets marketed for exclusive use in another designated activity, such as baseball or skateboarding.  (16 CFR Part 1203.4(b)).

The Commission has conducted 26 bicycle helmet recalls, with the first occurring in 1995 and the latest just last week.  CPSC attention to helmets remains fairly steady over time, with at least one recall most years, and no significant enforcement “spikes” at any point.

Continue Reading Recalls in Review: Bicycle Helmets

As alluded to in last week’s post, Product Safety Regulations for Electric Bicycles and Scooters, micromobility products, such as e-bikes and scooters, fall at the intersection of jurisdiction between two distinct federal agencies: the Consumer Product Safety Commission (CPSC) and National Highway Traffic Safety Administration (NHTSA).

The CPSC is charged with protecting the public from unreasonable risks of injury or death associated with “consumer products.”  “Consumer products” broadly defined includes any product for use in or around residences, schools and in recreation.  CPSC’s jurisdiction expressly excludes “motor vehicles.”[1]

NHTSA, which is charged with ensuring safety on public road ways, has jurisdiction over “motor vehicles.”  “Motor vehicles” are “vehicle[s] driven or drawn by mechanical power manufactured primarily for use on public streets, roads, and highways, but does not include a vehicle operated only on a rail line.”[2]

There is no hard-and-fast rule as to what constitutes a “motor vehicle” subject to NHTSA’s jurisdiction.  Thus in determining whether a product is a “motor vehicle,” NHTSA typically considers such factors as:

  • the product’s intended use;
  • the product’s use of the public roadways and how incidental or predominant that use tends to be;
  • how the product is marketed;
  • the kinds of dealers that sell the product;
  • how or whether dealers may certify or register the product; and
  • the product’s speed.

Continue Reading 20 Miles Per Hour Divides NHTSA and CPSC Jurisdiction Over Micromobility Products

Rideshare bicycles and scooters have become increasingly ubiquitous in cities across the United States over the past few years.  While many rideshare bicycles are conventional, others feature pedal-assist technology and are commonly referred to as “electric bicycles” or “e-bikes.”  As for scooters, electric versions are offered to consumers by rapidly growing micromobility companies such as Lime and Bird.  Given the increasing popularity and expansion of these rideshare vehicles across the country, we provide a brief overview of the regulatory landscape that ensures the safety of these products.

Bicycles

In 1972, the Congress established the U.S. Consumer Product Safety Commission (CPSC) to regulate the safety of consumer products at the federal level.  One of the first products to be regulated by the Commission was bicycles.  In 1978, the CPSC promulgated its first rules regulating traditional human powered bicycles (16 CFR part 1512) with the goal of establishing requirements for their assembly, braking, and structural integrity.  It was not until twenty-five years later, in 2003, that the Commission, pursuant to an act of Congress, updated the federal safety standard for bicycles to include low-speed electric bicycles.  Thus, electric bicycles, including most of those used for ridesharing purposes, are regulated by the CPSC and must comply with the mandatory federal safety standard for bicycles at 16 CFR part 1512.Continue Reading Product Safety Regulations for Electric Bikes and Scooters

Recalls in Review: A monthly spotlight on trending regulatory enforcement issues at the CPSC.

As we launch into the third quarter of 2020, we are taking a look at the trends from the CPSC’s recalls through the first half of the year.  The Commission has conducted 145 total recalls so far this year.  As is usually the case, the types of products recalled have varied widely, including ceiling fans, cleaning products, furniture, inclined sleepers, portable generators, pajamas, and strollers.  But some product categories have appeared multiple times, including: Dressers and Drawer Chests, Essential Oils, and Recreational Vehicles such as ATVs, UTVs, and Golf Carts.

In 2020 so far, Dressers, Drawer Chests, and Essential Oils have seen an increase in number of recalls as compared to recent years. Recreational Vehicles have historically been highly regulated, however, and the rate of recalls conducted in 2020 is comparatively similar to past years.

Continue Reading Recalls in Review: Recall Trends in 2020

Blockchain is a digital, decentralized, distributed ledger that provides a way for information to be recorded, shared and maintained by a community. Below we review the impact blockchain can have on increasing product safety, reducing recall expense, combatting counterfeits and otherwise assisting retailers in managing risk and protecting customers. By allowing for near real time, immutable tracking that is easily accessible to suppliers, manufacturers and government entities, blockchain technology has the capacity to revolutionize the retail industry.

Key features of the blockchain include:

  • Near real time – enables almost instant settlement of recorded transactions, removing friction and reducing risk.
  • Reliable and available – as multiple participants share a blockchain, it has no single point of failure and is resilient in the face of outages and attacks.
  • Transparent – transactions are visible to all participants, with identical copies maintained on multiple computer systems, increasing the ability to audit and trust the information held.
  • Irreversible – it is possible to make transactions irreversible, which can increase the accuracy of records and simplify back-office processes.
  • Immutable – it is nearly impossible to make changes to a blockchain without detection, increasing confidence in the information it carries and reducing the opportunities for fraud.

Helping Product Safety, Reducing Recall Costs and Protecting Brands
Continue Reading Blockchain & the Retail Industry: Product Safety and Counterfeiting Use Cases

Recalls in Review: A monthly spotlight on trending regulatory enforcement issues at the CPSC.

In the past year, the Commission has significantly ramped up its monitoring of products for compliance with special packaging safety standards (16 CFR § 1700), resulting in a jump in recalls for failure to meet those standards.  The CPSC has conducted