Happy New Year!  And now on to your regular Consumer Product Matters programming…

Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement priorities for over-the-counter homeopathic drug products. Although we will not re-cap the recent history of the industry here so we can keep this post a reasonable length, in late 2016 the Federal Trade Commission (FTC) announced its long-awaited policy for the advertising and marketing of OTC homeopathic drugs (see prior post here). The FTC’s action followed two public workshops convened in 2015 to deliberate a multitude of thorny legal and regulatory issues associated with consumer-directed homeopathy – one hosted by the FTC and the other hosted by the Food and Drug Administration (FDA). Written comments were also collected after both public meetings.

On December 18, 2017, FDA finally released a revised enforcement policy (in draft form) following this robust and comprehensive re-examination of the regulatory framework for homeopathic products. The enforcement policy applies only to human drugs labeled as homeopathic and sold without FDA premarket approval. Continue Reading FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about this uniquely-regulated class of consumer products.  Today, FTC released an Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs  (available here); a Staff Report on the discussions held during the September 2015 workshop (available here); and an FTC blog post summarizing these actions.

For readers who are not familiar with homeopathy, the practice dates back to the 1700s and posits that disease symptoms can be treated by tiny doses of substances that produce similar symptoms if given in larger doses to healthy people (“like cures like”).  Accordingly, modern-day homeopathic remedies that we find ubiquitously in drug stores today are highly diluted formulations, which some people consider to be no more effective than placebo.  The FTC Staff Report provides an excellent overview of how this OTC industry has grown over the past 50 years and the viewpoints presented by both supporters and skeptics of homeopathy.

 The upshot to the new FTC Enforcement Policy is this:
 “No convincing reasons have been advanced either in the comments or the workshop as to why efficacy and safety claims for OTC homeopathic drugs should not be held to the same truth-in-advertising standards as other products claiming health benefits.”

Continue Reading FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

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 Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

 

Last year, we wrote about a growing trend of local jurisdictions regulating children’s products, primarily toys and apparel. One such jurisdiction, Albany County, NY, enacted a far-reaching ordinance, “Local Law J of 2014,” that prohibited the sale of children’s products containing seven chemicals of “high concern” (see previous blog post here). At the time, we questioned the usefulness of this type of local legislation given the existing federal (and often state) product safety regulatory framework. Now, in the face of vocal opposition to the law from industry, which included the filing of a lawsuit in federal court, the Albany County Legislature has amended the law in an attempt to address industry concerns (see Local Law P of 2015). While the amendments are a step in the right direction, many concerns over potential adverse and unintended consequences remain.

Continue Reading Update: Albany County Legislature Amends Controversial Toxic Toys Law

RobotWebHas your business experienced difficulty identifying on the CPSC’s website which product safety regulations are potentially applicable to your products? In an effort to better guide industry, particularly new product makers and small businesses, through the maze of CPSC regulatory requirements and guidance, the CPSC rolled out earlier today a new self-help compliance tool—the Regulatory Robot (“Robot”)—intended to do just that.  Neal Cohen (no relation), the CPSC’s Small Business Ombudsman, and the Small Business Education team, spearheaded the development and launch of the Robot with the support of the Commission. Continue Reading CPSC Launches New Portal to Guide Companies through Regulatory Maze

shutterstock_252171946Over the past few months, numerous national media outlets have published stories about the potential health risks of a material commonly used on playground surfaces—crumb rubber.  Crumb rubber is a granule material typically made from recycled scrap tires that is used to provide a soft play surface for playgrounds (and infill for artificial turf fields).  Recently, some have questioned whether crumb rubber surfaces are safe for children to play on due to the materials’ potential toxicity.

From this debate, a narrower, more legally technical question has arisen over whether playgrounds—many of which use crumb rubber as a play surface—constitute “children’s products” under the Consumer Product Safety Act (“CPSA”).  A “children’s product” is defined under that law as a consumer product designed or intended primarily for children 12 years of age or younger and any children’s product must meet CPSC’s requirements for lead content, lead paint, third party testing and certification, tracking labels, and other regulations.  According to Public Employees for Environmental Responsibility (PEER), the U.S. Consumer Product Safety Commission (CPSC) has decided not to enforce the strict lead limits that apply to children’s products for playgrounds with crumb rubber play surfaces.

In a recent letter sent to CPSC Chairman Elliot Kaye about the crumb rubber issue, Senators Richard Blumenthal (D-CT) and Bill Nelson (D-FL) asked: Continue Reading Must Playground Equipment & Surfaces Comply with CPSC Lead Limits for Children’s Products?

CPSC and DOJ Stop Toy ImportsEarlier this week, the U.S. Department of Justice (“DOJ”)—at the behest of the CPSC—filed suit in California federal court against two companies and three individuals for importing products that violate the Federal Hazardous Substances Act (“FHSA”) and Consumer Product Safety Act (“CPSA”). The respective lawsuits can be accessed here and here.

The individuals and companies—Brightstar Group Inc. (“Brightstar”) and Unik Toyz Trading Inc. (“Unik Toyz”)—are accused of repeatedly importing children’s products and toys that contained high levels of lead, banned phthalates, small parts posing a choking hazard for young children. CPSC and DOJ also alleged that Unik Toyz and Brightstar continued these illegal activities despite receiving twenty-one and nine CPSC “letters of advice” (violation notices), respectively, over multiple years.

The companies and individuals have agreed to settle these charges by binding themselves to consent decrees (which can be accessed here and here). The consent decrees, which will go into force once entered by the court, are significant because they prohibit the companies and individuals from conducting any future business (selling, importing, or distributing) involving children’s products or toys until the CPSC verifies that certain far-reaching conditions are met—all of which relate to future compliance with CPSA and FHSA requirements.

The detailed and extensive conditions are set forth in the consent decrees and include, among other provisions: Continue Reading CPSC & DOJ Stop Two Companies from Future Importation of Children’s Products with Far-Reaching Consent Decrees

phil&teds civil penalty for failure to report defective clip on high chairsAt the very beginning of this year, we wrote that we expected the CPSC to remain active in bringing enforcement actions against companies for violations of the Consumer Product Safety Act (CPSA). About one month later, CPSC Chairman Elliot Kaye remarked at a product safety conference (ICPHSO 2015) that he was directing staff to seek significantly higher civil penalties against companies for such violations as provided for in the Consumer Product Safety Improvement Act. Since the beginning of the year, the CPSC has levied close to $25 million in total civil penalties against multiple companies for alleged reporting violations of product safety hazards—significantly more than any previous year.

Last week, the CPSC announced that phil&teds USA (“phil&teds”) agreed to pay $3.5 million to settle charges that it knowingly failed to report a product defect and unreasonable risk of serious injury to the Commission stemming from its “MeToo high chair.” Notably, in a rare occurrence and as part of the settlement agreement, the Commission agreed to temporarily suspend all but $200,000 of the $3.5 million civil penalty.

In doing so, the Commission relied upon phil&teds’ representations through financial statements that it has insufficient cash or other liquid assets to satisfy a civil penalty payment in excess of $200,000 without ceasing business operations. The company will be obligated to pay the suspended portion of the civil penalty if it fails to pay the non-suspended $200,000 payment or otherwise breaches its duties to implement an internal compliance plan and accurately report information to the Commission. Continue Reading CPSC Suspends Over 90% of $3.5 Million Civil Penalty Due to Company’s Inability to Pay; phil&teds USA to Pay $200,000

Law360[This article originally appeared on Law360.com on June 23, 2015.]

On June 2, 2015, the Suffolk County Legislature became the latest county legislature in New York to pass a “toxic-free toys” act. About a week later, the New York City Council got in on the action and introduced a similar bill. Since the beginning of the year, five county legislatures in New York (Albany, Suffolk, Westchester, Dutchess and Onondaga) and the New York City Council have either passed, or are in the process of considering, laws to supposedly stem the flow of unsafe children’s products onto local store shelves. The actions of these localities raise the fundamental legal and policy question: do local governments, such as county legislatures or town councils, have a legitimate role in regulating consumer products, a role typically reserved for the federal, and in some instances, state governments? Clearly, these local governments believe that they do, as do the consumer and environmental organizations behind the effort. Yet the answer is not as simple as it may seem.

Every so often, frequently in response to sensationalized media reports regarding the prevalence of allegedly unsafe products getting into the hands of children, counties decide to legislate on matters involving consumer product safety, and a trend, similar to the recent one in New York, begins. Unfortunately, these laws introduced and considered by localities tend to be more about politics and headlines than safety and have little effect on actually improving the safety of children’s products. Continue Reading Toy Safety Regulation Should Be Left To The Federal Government

Albany Toy SafetyEarlier this year, we wrote about a far-reaching product safety ordinance enacted into law in Albany County, NY (the “County”) entitled “The Toxic Free Toys Act.” At the time, we expressed our concern that numerous issues would arise in the local law’s implementation and enforcement, particularly with respect to those provisions in direct conflict with the federal Consumer Product Safety Improvement Act of 2008.  Not surprisingly, in mid-April, a coalition of consumer product associations filed a lawsuit in federal court to challenge the law.

The “Safe to Play Coalition” argued in its Complaint that the Albany County law is pre-empted by both the federal Consumer Product Safety Act (CPSA) and Federal Hazardous Substances Act (FHSA), which regulate the same children’s products that are covered by the ordinance. The coalition asserted that Congress enacted both of these federal laws to ensure nationwide, uniform standards would govern the safety of children’s products rather than a patchwork of state and local regulations.

Rather than answer or move to dismiss the Complaint, in mid-May, the County joined with Plaintiffs in seeking a stay from the court of the proceedings to allow the County time to promulgate regulations implementing the law. The County stated that it expected to complete the regulations by November 1, 2015, and the parties agreed not to litigate until Plaintiffs had a chance to review those regulations to determine whether they should continue with the lawsuit. In any event, the County agreed not to enforce the law (scheduled to take effect in January 2016) or any regulations implemented pursuant to it until six months after any court decision or order on the preemption issue or appellate order. On May 15, the Court granted the requested stay of the proceeding.

Despite this litigation and publicity surrounding the law, much of it negative, other New York counties including Suffolk, Duchess, and Onondaga continue to consider, and in the case of Westchester County enact, similar local “children’s product safety” laws. For the same reasons stated in our initial blog post on this subject, we believe that while the motive behind such laws is well-intentioned, these ordinances tend to create confusion and cause more harm than good, particularly adverse economic ramifications. Product safety regulation is best left to the federal government, and in some cases, state governments. Ironically, just a few months after Albany County had passed its ordinance, the New York State Assembly passed the “Child Safe Products Act” (A5612) which also seeks to regulate “toxic chemicals” in children’s products by requiring New York State to publish a list of toxic chemicals, require disclosure of their use in children’s products, and eventually ban their use. Should that state bill become law, the parties to the litigation may need to address that as well should the case proceed.