On March 30, 2023, the FDA authorized marketing of Happiest Baby’s SNOO Smart Sleeper, an over-the-counter infant sleep system intended to keep infants on their back throughout sleep. This marks the first time we are aware of that the FDA has given de novo marketing authorization to a product designed to keep sleeping babies positioned on their backs,[1] and signals a potential expansion of what the FDA considers to be a “medical device” within its regulatory purview.
Last Thursday, April 6, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) sued SunSetter Products LP (SunSetter) in a Massachusetts federal court in a rare civil penalty lawsuit. SunSetter manufactures motorized retractable awnings for outdoor use. The Government alleges in its complaint that SunSetter knowingly failed to timely report under Section 15(b) of the Consumer Product Safety Act (CPSA) a hazardous defect related to vinyl covers for its retractable awnings. The complaint seeks permanent injunctive relief, including a third-party monitorship over the company, and civil penalties.
Continue Reading CPSC Seeks Civil Penalty Against SunSetter in Rare Federal Court Action
Button cell and coin batteries are ubiquitous. They power countless products that consumers use on a daily basis: key fobs, remote controls, bathroom scales, electronic watches and jewelry, decorative ornaments, flameless candles, and even musical greeting cards. But button cell and coin batteries also pose a unique hazard.
Continue Reading Reese’s Law to Impact Wide Range of Consumer Products
On Wednesday afternoon, CPSC Chairman Alexander Hoehn-Saric addressed the annual conference of the International Consumer Product Health and Safety Organization (ICPHSO) for the second time as chairman. In his remarks, Hoehn-Saric looked back on his first year as chairman, including the recent controversy over gas stoves, and shared some of the agency’s priorities moving forward. But the central theme of Hoehn-Saric’s remarks could not have been clearer— consumers are first in everything the agency does.
Continue Reading CPSC Chairman Addresses Gas Stoves and Other Issues at ICPHSO Conference
Companies take note: over the past month or so, the U.S. Consumer Product Safety Commission (CPSC) has issued four unilateral press releases instructing consumers to stop using a product. Since May of this year, that number rises to seven. If that number does not seem high, consider this: between 2011 and 2019—a nine-year period—the agency issued two. So, what exactly is a “unilateral press release” and what does the agency’s issuance of four over recent weeks mean for you?
Continue Reading CPSC Enforcement Trend: Unilateral Press Releases
Despite imposing onerous new compliance terms, the recently announced Vornado civil penalty was criticized by three commissioners as too low amid their urgent calls for larger penalties in the future. On July 7, the U.S. Consumer Product Safety Commission (CPSC) announced a $7.5 million civil penalty settlement with manufacturer of air circulation products, Vornado Air (Vornado). Vornado agreed to pay the civil penalty to resolve charges that the Company knowingly failed to immediately report allegedly defective electric space heaters to the CPSC under Section 15(b) of the Consumer Product Safety Act (CPSA). The Commission voted 4-0-1 to provisionally accept the settlement. Notably, three of the agency’s five commissioners published individual statements alongside the agency’s announcement of the penalty, which is atypical. The statements provide product safety stakeholders with insights on how the “new” Commission views civil penalties and its enforcement authority.
On Wednesday, the U.S. Senate confirmed Mary Boyle to serve as a commissioner of the U.S. Consumer Product Safety Commission (“CPSC”) by a vote of 50-48. For the first time since late October 2019, when then-Acting Chairman Ann Marie Buerkle departed the agency, the Commission will have a full complement of five commissioners. And, most notably, for the first time since May 2018, the Democrats will hold a voting majority.
As soon as Ms. Boyle is sworn in, she will join Democratic Commissioners Alexander Hoehn-Saric and Richard Trumka Jr. and Republicans Dana Baiocco and Peter Feldman. As we wrote last July when President Biden announced her nomination, Ms. Boyle is well known to the product safety community. She knows the inner-workings of the CPSC as well as anybody as she has served most recently as the agency’s Executive Director. She has also served as the agency’s acting General Counsel. Interestingly, Ms. Boyle is the second Executive Director of the agency recently nominated for the Commission, as President Obama nominated then-Executive Director Elliot Kaye to be Chairman.
Continue Reading Senate Confirms Mary Boyle to CPSC; Democrats Reclaim Majority
Earlier this week, President Biden signed the Safe Sleep for Babies Act into law. The new statute does two things. First, it bans infant inclined sleepers with an inclined sleep surface greater than ten degrees that are intended for infants up to age one. Second, it bans crib bumpers. When the Act takes effect in November, both products will be considered “banned hazardous products” under Section 8 of the Consumer Product Safety Act.
These infant products have also been the subject of recent rulemaking activity by the U.S. Consumer Product Safety Commission (CPSC). This sets up at least one potential conflict of law. Where the Safe Sleep for Babies Act bans infant inclined sleepers intended for infants up to age one, the CPSC rule affected only sleepers intended for infants up to 5 months old.
Continue Reading President Biden Signs Safe Sleep Act, Banning Infant Inclined Sleepers and Crib Bumpers
This afternoon, CPSC Chairman Alexander Hoehn-Saric gave remarks to the annual conference of the International Consumer Product Health and Safety Organization (ICPHSO). As many of our readers know, the Senate confirmed Mr. Hoehn-Saric on October 7, 2021 to a six-year term. This was Hoehn-Saric’s first year addressing the annual ICPHSO conference.
Notably, Chairman Hoehn-Saric picked up right where then-Acting Chairman Robert Adler left off at the 2021 annual conference—the need for the agency to approach product safety from a variety of diverse viewpoints. The Chairman cited startling statistics concerning the significantly higher rates at which African Americans drown in swimming pools and minorities suffer from CO exposure from portable generators than their White counterparts. The Chairman stated that targeting underserved, often minority, communities would be a priority for the Commission in the months and years ahead.
Continue Reading Live from ICPHSO – New CPSC Chairman Hoehn-Saric Addresses Annual Conference
Here’s a brief review of key developments concerning the U.S. Consumer Product Safety Commission (“CPSC”) from last month. We look forward to seeing many friends at the Annual Meeting and Training Symposium of ICPHSO in two weeks. For those who are unable to make the conference, our team plans to share daily insights so stay tuned for more important product safety updates!
Decisional Meeting on Clothing Storage Units Addresses “Tip-Over” Issue. On January 19, the CPSC adopted, by a 4-0 vote, staff’s recommendation to issue a Notice of Proposed Rulemaking for Clothing Storage Units (CSUs) to address the “tip-over” issue. Notably, the Commission adopted two amendments to the proposed rule, both offered by Commissioner Richard Trumka Jr.
The first amendment pertained to the rule’s stockpiling provision. The rule presented by staff “prohibited manufacturers and importers of CSUs from manufacturing or importing CSUs that do not comply with the requirements of the proposed rule in any 12-month period between the date a rule is promulgated and the effective date of the rule at a rate that is greater than 120 percent of the rate at which they manufactured or imported CSUs during the base period for the manufacturer.” Trumka’s amendment defines the “base period” as one month out of the last 13 months with the median import or manufacture volume, and changes the percentage increase that is allowed under that base period from 120% to 105% in each month between the final rule and the effective date. It is intended to reduce the risk of stockpiling products. The Commission adopted the amendment by a vote of 4-0.
Continue Reading CPSC Insights – January 2022