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Consumer Product Matters

A product safety and consumer related regulation and litigation blog

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014).  More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation.  The HELP Committee also heard from experts in the cosmetics industry about product developments and health standards.

Witnesses in favor of the Personal Care Products Safety Act stated that the FDA has not done enough to ban endocrine-disrupting chemicals in cosmetic products and that industry-financed review programs should not substitute government regulatory programs in collecting chemical toxicity data.  They contrasted FDA’s inability to ban products unless they are “adulterated” with the more expansive authorities of similar regulatory agencies in Canada, Japan, and the European Union. Continue Reading

Stuck in the Middle with the FTC

Posted in Advertising, Federal Regulations, Federal Trade Commission (FTC), Litigation, State Consumer Protection Laws, State Unfair Competition Laws, Supply Chain Risk Management

“…Clowns to the right of me, jokers to the left, here I am…”

-Stealers Wheel (1972)

Legal actions regarding “Made in the USA” claims, whether prosecuted by the Federal Trade Commission (FTC) or through various state unfair trade practices acts, often settle early in the proceedings.  For example, in 2014, the FTC issued 16 “closing letters” wherein the target company agreed to revise its “Made in the USA”  claim to clarify that its products, even those assembled in the United States, included imported components. In 2015, the FTC issued 28 such “closing letters”; and in 2016, to date, the FTC has issued 18.

Earlier this month, Chemence, Inc., the Ohio maker of Kwikfix, Hammer-Tite and Flash Glue, entered into a settlement with the FTC.  Chemence was the third glue company that has resolved its claims issues with the FTC since 2015.   Toagosei America, Inc., makers of the Crazy Glue brand, and Gorilla Glue both previously reached agreement with the FTC, with FTC issuing closing letters after both companies agreed to make clear that their products included some imported materials.

Chemence’s path to resolution with the FTC was different.  Continue Reading

Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Posted in Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past six years (since a 2010 consumer alert about certain ingredients in the same products).  The Agency is warning parents and caregivers to seek medical care immediately if an infant or child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels. It is also advising consumers to dispose of any such products they may have in their possession. Continue Reading

Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling.  In addition, while the process is underway, the Agency intends to exercise enforcement discretion for (meaning it will not take action against) foods labeled with the term “healthy” as long as they meet the conditions in the regulatory definition at  21 CFR 101.65(d) and other criteria laid out in a newly issued guidance document.

FDA explained in announcing this initiative late last month that:   Continue Reading

California Prop 65: More Unintended Consequences

Posted in Litigation, Prop 65, State Consumer Protection Laws, State Product Safety Laws, State Regulations, Supply Chain Risk Management

Last month, the California Office of Environmental Health Hazard Assessment (“OEHHA”) adopted new Proposition 65 warning regulations.  Much of the discussions regarding these new regulations have centered on the warning requirements that become effective, after an approximately two-year phase-in period, in August 2018.

There were, however, amendments to Prop 65 settlement terms, penalty amounts and attorney’s fees in civil actions filed by private persons that became effective on October 1, 2016.  These amendments have “flown under the radar” but actually may be more problematic than the proposed new warnings.

Proposition 65 permits private citizens (known by the plaintiff’s bar as “citizen enforcers”) to initiate enforcement actions, and, when they do, they are entitled to 25% of any penalties assessed by the courts and attorney’s fees.  Continue Reading

CPSC Sends Another Shot Across the Bow of Retailers with $3.8 Million Civil Penalty Against Best Buy for the Sale of Recalled Products

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Retailer Product Safety, Supply Chain Risk Management

On Tuesday, the U.S. Consumer Product Safety Commission (CPSC) announced that Best Buy Co., Inc. entered into a settlement agreement with the CPSC to pay a $3.8 million civil penalty to resolve allegations that it “knowingly sold, offered for sale, and distributed in commerce recalled consumer products.”  This civil penalty is significant because the alleged violation of the Consumer Product Safety Act (CPSA) had nothing to do with timely reporting under Section 15(b)—the usual suspect in civil penalty cases.  Rather, the allegation against Best Buy is that it violated CPSA Section 19, which prohibits the sale, distribution, or importation of any product that has been recalled.

This penalty is just the second such penalty in recent years (see Meijer 2014 civil penalty).  In a tweet commenting on the penalty and noting the reason for it, CPSC spokesman Scott Wolfson said “[The] challenge is great enough to get recalled products out of homes.  We need retailers to keep them out of their stores.”


The CPSC alleged here that Best Buy knowingly sold and distributed sixteen different recalled products between 2010 and 2015, including washing machines and dryers, ovens, televisions, surge protectors, computers and other electronics.  Notably, according to the CPSC’s allegations, sales of recalled products continued even after Best Buy had told the Commission that measures were put in place to catch such products and reduce the risk of sales of recalled products.

Importantly, the CPSC imposed the penalty and highlighted in its press release that internal logistics issues caused the sale of the recalled products. Specifically, the CPSC alleged “Best Buy, in some cases, failed to permanently block product codes due to inaccurate information that signaled that the recalled product was not in inventory.  At other times, the blocked codes were reactivated prematurely, and in a few cases, overridden.”

In a complicated and massive supply chain, these issues are not unheard of.  However, where such issues lead to the sale of recalled products, the CPSC is clearly not accepting them as excuses or defenses, and will not hesitate imposing a hefty civil penalty.

In response to the civil penalty announcement, Best Buy stated the following: “We regret that any products within the scope of a recall were not removed entirely from our shelves and online channels.  While the number of items accidentally sold was small, even one was too many.  We have taken steps—in cooperation with the CPSC—to help prevent these issues from reoccurring.”

Along with paying the $3.8 million civil penalty, Best Buy has agreed to maintain a product safety compliance program with the common program elements we have seen in recent timeliness penalties to ensure that the Company complies with product safety standards and regulations enforced by the Commission.  Not surprisingly, the compliance program also contains elements related to the “appropriate disposition of recalled goods,” and management and oversight of that program.

As we frequently advise, companies in the consumer products arena should remain mindful of and attentive to their obligations under the Consumer Product Safety Act—not just Section 15(b) reporting (as that, deservedly, receives a lot of attention)—but also to the CPSA’s many other requirements and prohibitions, including the prohibition on the resale of recalled products.

This civil penalty is a good reminder that companies, large or small, must have robust procedures in place to identify and set aside recalled products whether on the shelves, in inventory, or otherwise, and to control all supply channels to prevent this from happening.




Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Uncategorized

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks.  The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and it also completed work on a National Strategy for Modernizing the Regulatory System for Biotechnology Products. Together, these documents clarify the authority that Federal administrative agencies have to regulate certain products of biotechnology and they establish goals to ensure the proper use of those authorities in the future.

First, the Working Group’s proposed Update to the Coordinated Framework outlines the specific roles that FDA, USDA, and EPA serve to regulate biotechnology-derived products and the ways in which the agencies work together when those roles overlap. The Coordinated Framework, as noted in the Administration’s corresponding blog post, presents this information in three forms:

  • “graphics that illustrate agency-specific overviews of regulatory roles;
  • case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • a comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.”

The Administration is soliciting public comment on its proposed Update. The deadline for submitting comments will be forty days after the Update is published in the Federal Register.

Second, the Working Group’s National Strategy dovetails with the Coordinated Framework, by listing a number of objectives related to the agencies’ use of their regulatory authorities. It groups these objectives under three overarching goals: “increasing transparency, increasing predictability and efficiency, and supporting the science that underpins the regulatory system.”

EPA, FDA, and USDA have agreed to report annually to the White House on their progress in meeting these three goals for at least the next five years. In addition, sometime soon, the Working Group plans to release a study on the future of biotechnology, the one item remaining on the group’s to-do list announced at its inception last year.

Consumer Product Matters will continue to follow the waning days of the Obama Administration and the transition to the next Administration – when the updated Coordinated Framework and the National Strategy ultimately will be put to the test.

Hot CPSC Jurisdictional Issues: Does the CPSC Have Regulatory Authority Over Amusement Park Rides and Guns?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Federal Regulations, State Product Safety Laws, State Regulations, U.S. Congress

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in the media: does the U.S. Consumer Product Safety Commission (CPSC) have the authority to address the safety of amusement park rides and guns?

amusement-park-guns-cpscAmusement Park Rides.  Every time there is a tragedy on a ride at an amusement park, the nation turns its attention and scrutiny on the CPSC as the nation’s safe products regulator.  However, and crucially, the CPSC does not have jurisdiction over the safety of “fixed site” amusement park rides.  In 1981, the Congress stripped the CPSC of its jurisdiction over these rides through an amendment to the Consumer Product Safety Act (CPSA).  As a result, rides that are “permanently fixed to a site” (such as the ones at the Kansas and Tennessee parks) are subject to voluntary standards written by the ASTM F-24 Committee on Amusement Rides and Devices and state and local regulations.

The CPSC does have jurisdiction over “mobile” amusement rides (those transported from location to location).  The agency also acts as a clearinghouse for safety information on ride incidents identified by Commission investigators and state and local ride officials.  The following 2012 CPSC Directory of State Amusement Ride Safety Officials provides a helpful introductory overview of the CPSC’s activities with respect to amusement park rides and a directly of the relevant state and local officials dedicated to ride safety.

Read our previous post about this jurisdictional issue here.

Gun Safety.  Like fixed amusement park rides, firearms and ammunition are excluded from the definition of a “consumer product” in the CPSA.  As a result, the CPSC does not regulate the safety of guns, shells and cartridges (the Bureau of Alcohol, Tobacco, and Firearms does).

guns-amusement-park-cpscNote: CPSC Commissioner Marietta Robinson recently issued a thoughtful perspective describing how she believes the CPSC can make guns safer and help bring down the number of accidental incidents involving firearms.  According to Robinson, “guns should be defined as the consumer products they are so that we may do our job of protecting the American consumer.”

Despite its lack of jurisdiction to regulate the safety of guns and ammunition at present, the CPSC does have authority to regulate the safety of some products and accessories related to gun use.  For example, the CPSC has asserted its jurisdiction over separate firearm trigger locking devices.  Additionally, the CPSC has recalled previously gun storage boxes, handgun vaults, and gun holsters, thus all squarely falling within the regulatory authority of the agency.  In fact, as recently as 2013, the White House requested the CPSC to “review and enhance as warranted safety standards for gun locks and safes” as a measure to improve gun safety.

Without a further act of Congress, the CPSC’s activities with respect to fixed amusement park rides and gun safety will not likely change.


E-Cigarette Makers Contending with New CPSC and FDA Regulations

Posted in Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Federal Regulations, Food & Drug Administration (FDA)

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries.  Newly enacted Federal requirements for ENDS and their components and parts show that such scrutiny sometimes leads to legislative or administrative actions.  Indeed, Summer 2016 could down in infamy for manufacturers, distributors, and retailers of this category of consumer products due to its confluence of new regulations from two major Federal agencies – CPSC and FDA.

We previously reported on the  Child Nicotine Poisoning Prevention Act of 2015, introduced last year by Senator Bill Nelson (D-Fla.) and signed into law in January.  It requires liquid nicotine to be packaged in accordance with the Poison Prevention Packaging Act and CPSC’s standards child-resistant packaging and containers (children are those under age five).   Continue Reading

CPSC Chairman Kaye and Commissioner Adler: Current Civil Penalties Approach Works

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Federal Regulations, Litigation, U.S. Congress

Yesterday, CPSC Chairman Elliot Kaye and Commissioner Robert Adler issued a lengthy joint statement vigorously defending the Commission’s current approach to civil penalties against various criticisms voiced by Commissioners Joe Mohorovic and Ann Marie Buerkle as well as stakeholders in the business community.  Their overarching message: such criticisms are without merit and are, in reality, a call for lesser penalties; there will be no change in the Commission’s current approach.

Over the past few months, we have written extensively about the Commission’s approach to seeking civil penalties against companies for failure to report violations—and the ongoing debate surrounding that process.  Chuck Samuels even testified on the subject last month at the CPSC’s Annual Priorities Hearing (watch here).

According to Kaye and Adler, “agency critics have urged an enormous undertaking by the Commission to prioritize exploring and redesigning its civil penalty system, effectively displacing work intended to save lives and prevent injuries.”  They expressed disappointment at the “distortion” of Chairman Kaye’s remarks at the ICPHSO conference last year, and pushed back at the idea that the Commission somehow operates without transparency when assessing civil penalties.  Specifically, Kaye and Adler assert the following points in their joint statement against the common civil penalty criticisms:

  • critics of the Commission’s current policy want more information shared related to the facts and factors that enter civil penalty valuations, but hamstring the agency in doing so by seeking (or supporting) stringent Section 6(b) confidentiality protections;
  • there is ample regulatory guidance to determine when to file a Section 15(b) report;
  • both the Commission and companies need flexibility when negotiating a civil penalty settlement, thus counseling against a matrix or formulaic approach to applying the civil penalty factors;
  • companies are afforded full due process protections and procedures when the Commission seeks civil penalties including the opportunity to be heard; and
  • the Commission carefully tracks the information available to firms at each and every step in time and does not rely on hindsight regarding companies’ obligation to file.

While many could find much to dispute in the joint statement, the Commission’s majority has made their view clear.

Companies should take a very close read of this policy statement.  It is now evident that the Commission will not change—or even revisit—its current approach to civil penalties in the coming fiscal year, as urged by some stakeholders in the product safety community.  Barring a change in CPSC personnel, Congressional action, or judicial involvement through the litigation process, the ongoing “debate” over civil penalties has effectively ended for now.