Product Liability & Torts

Acting Chair Ann Marie Buerkle
Acting Chair Ann Marie Buerkle

This past Wednesday, in her first public remarks as Acting Chair of the U.S. Consumer Product Safety Commission (CPSC), Ann Marie Buerkle announced her top three priorities. As our readers know from our previous post, on February 9, then Commissioner Buerkle became Acting Chair of the CPSC after Commissioner Elliot Kaye stepped down as Chairman. Speaking to the annual conference of the International Consumer Product Health and Safety Organization (ICPHSO), Acting Chair Buerkle announced that her top three priorities include: (1) collaborating with all product safety stakeholders; (2) taking a balanced and reasonable approach to regulation; and (3) expanding product safety education and awareness for consumers.

The overarching theme of Chairman Buerkle’s remarks could not have been more clear: the core mission of product safety does not change with respect to who is in the White House—the focus needs to remain on safety, data, and science, and, to further that mission, all product safety stakeholders should remove their stereotypes of different groups within the community and work collaboratively and creatively to further a common goal.

To that end, Chairman Buerkle stated that she will continue to approach product safety as she has done since taking her seat on the Commission in 2013 in order to further the agency’s mission—she will strive for good governance, build relationships across the safety community, take advantage of available data and science, and rely upon the expertise available inside and outside of the Commission.

Acting Chair Buerkle’s top three priorities include:
Continue Reading CPSC Acting Chair Buerkle Announces Top Priorities at Product Safety Conference

On July 26, 2016, FDA issued an updated warning on beauty products, warning consumers to avoid certain “skin creams, beauty and antiseptic soaps, and lotions,” particularly those boasting “anti-aging” or “skin lightening” benefits, as potentially containing mercury.  While the dangers of mercury exposure are well-known, mercury’s ubiquity in certain beauty products is not.  Products that claim to “remove age spots, freckles, blemishes, and wrinkles,” including products targeting teenagers enduring acne, may contain mercury.  Checking the label can help—look out for words like “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or of course, “mercury”, but it’s not fool-proof.  As FDA points out, many of these beauty products are often made abroad and can be sold illegally in the U.S., without any labels. FDA continually monitors products like these, but is unable to catch all of them, especially due to their dubious channels of trade.  For those that FDA does catch, FDA sets up an import alert to prevent future influxes of such products.  Check here for all Consumer Updates from FDA.  Thus, retailers should do their due diligence to know what the chemical content is of the products they sell beyond the labels.

In its warning, FDA again mentioned one of its growing complaints levied against cosmetics – that the product may actually be an unapproved new drug under the law.
Continue Reading Beauty with a Side of Mercury?

Many universities and local governments have installed synthetic turf made with “crumb rubber” – ground up tires – on playing fields and playgrounds in recent years to obtain the advantages of all-season use and lower maintenance costs. In recent months, however, the media and a growing group of critics contend that the crumb rubber used

On December 3, 2015 in a unanimous decision, the California Supreme Court ruled that California state law claims for harms arising out of allegedly false “organic” labeling were not preempted by the federal Organic Foods Production Act of 1990.  With that decision, the Court reversed the lower court’s dismissal of Plaintiffs’ claims on the pleadings. 

On Tuesday, September 8, 2015, the House passed the E-Warranty Act of 2015, which, if enacted, would require the FTC to revise the Magnuson-Moss Warranty Act to allow manufacturers to satisfy the Act’s requirements by digitally posting consumer product warranties on their websites.

The E-Warranty Act would permit manufacturers to provide warranty information online

The FDA is cracking down on distributors of pure powdered caffeine. On Tuesday, the agency released a statement announcing that it fully intends to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” This is no empty threat. Warning letters were issued to five distributors of the product on August 27th. The FDA found the products to be adulterated within the meaning of the Food, Drug, and Cosmetic Act because they contain amounts of caffeine that could be lethal to consumers, and require the use of a precise scale to distinguish a “safe serving from a potentially lethal amount.” As a result, the agency concluded that the products present “a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”

Pure powdered caffeine products are 100% caffeine and a single teaspoon is the equivalent to approximately 25 cups of coffee.
Continue Reading The FDA Issues Warning Letters to Five Distributors of Pure Powdered Caffeine

On December 8 and 9, 2014, the Food and Drug Law Institute (FDLI) held its annual Enforcement, Litigation & Compliance Conference in Washington, D.C. Speakers from the U.S. Food and Drug Administration (FDA), Department of Justice (DOJ), and other federal agencies, as well as representatives from industry and the private bar, discussed recent activity and predictions for federal regulation of food, drugs, medical devices, cosmetics, dietary supplements, and tobacco in 2015.

  • Several speakers talked about FDA’s restructuring efforts and how that will change the way the agency functions.
    • Several FDA representatives explained that this is being driven in part to maximize resources and to re-align the various Centers with the Office of Regulatory Affairs (ORA), to build expertise, create sector-specific groups, and better coordinate inspection and enforcement efforts. It was predicted that generalist FDA inspectors will be a thing of the past and that there will be commodity-specific inspectors who have real time access to scientists during inspections. It was noted that this new approach may pose some challenges for FDA, which has traditionally functioned in silos.
    • Panelists expressed hope that the changes will lead to more uniformity in FDA’s inspections and enforcement and will, for example, result in less strategic port-shopping by importers.


Continue Reading Report from FDLI’s 2014 Enforcement, Litigation and Compliance Conference

As the storm of concussion-related litigation continues to churn, the Federal Trade Commission is once again wading into its turbulent waters. In August, the FTC sent warning letters to five undisclosed “major” retailers, expressing concerns that athletic mouthguards are being advertised deceptively on the retailers’ web sites as helping to prevent concussions. These FTC letters represent the convergence of two trends at the Commission: (1) a recent focus on advertising claims of concussion prevention/protection; and (2) sustained efforts to hold retailers accountable for advertising claims concerning the products on their shelves.

Retailers in the Crosshairs

The FTC’s letters mark the first time that the Commission has called retailers to account for allegedly deceptive concussion claims. They cite a 1977 FTC decision, Porter & Dietsch, Inc., for the proposition that retailers “can be liable for violating the FTC Act by disseminating false or unsubstantiated claims.” The FTC cited an example of a specific (and redacted) product, and recommended that the retailers review their web sites to ensure that they do not contain “concussion protection claims for which competent and reliable scientific evidence does not exist.” The FTC stated its intent to revisit the retailers’ web sites within 90 days, and implied that enforcement actions would be forthcoming if unsubstantiated claims were not removed.

FTC’s concussion warning letters continue a trend of the Commission using the threat of enforcement against retailers essentially to turn them into deputized enforcers of false advertising rules. This practice places a substantial burden on retailers to demand substantiation of potentially questionable claims from product manufacturers.

Continue Reading FTC Warns Retailers to Police Their Products’ Deceptive Concussion Prevention Claims

The American Conference Institute held its Second Annual Consumer Products Regulatory & Litigation conference on June 11-12, 2014, in Chicago, Illinois. Here is a list of the key takeaways from this year’s event:

On recent Commission activity:

  • While Commissioners at the Consumer Products Safety Commission (CPSC) may admit to having “erasers on their pencils” when it comes to looking at proposed rules, they need to see facts, science, and data—objectively presented—in order to be willing to use those erasers. The decision to postpone action on the pending 1110 rule and hold a stakeholder meeting shows the Commission’s willingness to be responsive when concerns are raised. Without hard data and compelling arguments, however, you may just be viewed as part of the din of the CPSC bar “echo chamber.”

On corporate compliance plans:

  • Tackling the question of whether a product presents a safety defect requires interdisciplinary product safety teams and robust communication to avoid information silos. Senior management oversight of the risk assessment necessary to determine whether a defect may present a substantial product hazard can help a company avoid making the wrong call as to whether a series of incidents or complaints should be reported to the CPSC.
  • The chain of authority and ultimate responsibility for decision-making on product safety defects need to be clearly delineated within your organization. Your product safety team must remain open to reassessing their prior decisions based on new or emerging information.
  • Don’t let the need to preserve attorney client privilege prevent you from telling your story at trial or in an agency penalty enforcement proceeding. Everyone—consumers, journalists, Congress, courts, and juries—will want to know what the record reflects in terms of corporate actions during an emerging product crisis. And courts have held that safety committee meeting minutes are not necessarily privileged even when an in-house lawyer participates as a committee member.


Continue Reading Highlights from ACI’s 2014 Consumer Products Regulatory & Litigation Program

A month in advance of its October 31, 2013 statutory deadline, California’s Department of Toxic Substances Control (DTSC) on September 26, 2013 released its preliminary lists of Candidate Chemicals under the state’s newly enacted Green Chemistry Initiative.  The Green Chemistry regulations, which officially took effect today, require certain “Priority Products” to go through a