Earlier this year, we began a series of blog entries to update our readers on legislative efforts on Capitol Hill that affect stakeholders within the product safety arena. Over the summer, we updated you on an amendment to an appropriations bill passed in the House of Representatives that would halt the U.S. Consumer Product Safety Commission’s (CPSC) ongoing work on finalizing a rule on voluntary recalls. Since the summer, three additional pieces of legislation have been introduced on the Hill pertaining to product safety, which deserve our attention.
We do not typically take positions on product specific issues pending before the U.S. Consumer Product Safety Commission (“CPSC”), but the CPSC’s new safety standard for magnet sets demonstrates both why the agency exists and how it can use its regulatory authority to protect consumers. In enacting the safety standard, the agency did not eradicate what are commonly referred to as “rare earth magnets” from the marketplace. Instead, the CPSC set a minimum level of safety for certain types of magnet sets based on the data necessary to take such action under the Consumer Product Safety Act (CPSA), the CPSC’s organic statute.
The practical effect of the CPSC’s action will be to prohibit the sale of magnet sets composed of small but very powerful magnets that have proven both extremely attractive and hazardous to children. Although these types of magnet sets were marketed to adults to manipulate into various shapes for entertainment or stress relief, the individual magnets found their way into the hands, and ultimately, the mouths of children. When accidentally swallowed, the magnets can bond and become trapped within the digestive system in a manner that can cause severe internal damage.
This space has thoroughly explored the various forms of civil liability food companies face for the mislabeling and/or deceptive marketing of their products. Last week, a set of landmark convictions in a criminal food-safety prosecution potentially signal increased criminal liability for food companies when matters of public health and safety are at play…
On Friday, September 19, 2014, a federal jury convicted two former executives of a peanut-processing company of conspiracy and other charges in connection with a massive Salmonella outbreak in 2009, which killed nine people, sickened 700 others, and led to one of the largest U.S. recalls ever. Stewart Parnell, former owner of Peanut Corporation of America (PCA), and other former employees were convicted of conspiracy, mail, and wire fraud in violation of federal anti-fraud and conspiracy statutes, and the introduction of misbranded food into interstate commerce in violation of Sections 331(a) and 333(a)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA). Parnell alone was also convicted of the introduction of adulterated food into interstate commerce in violation of Sections 331(a) and 333(a)(2) of the FDCA; he could face more than three decades in prison. Continue Reading
A recent federal decision has made clear that court-ordered recalls can have real teeth, not just for manufacturers but also their officers—especially when the court has reason to suspect a company’s execs are deliberately dragging their feet.
On Tuesday, September 2, the Northern District of Georgia held the CEO and a senior vice president of Hi-Tech Pharmaceuticals in contempt for their repeated delays in carrying out a court-ordered recall. The court had issued the original recall order in May 2014, finding that Hi-Tech had run afoul of a long-standing injunction by continuing to make unsubstantiated weight loss claims about its dietary supplement products in violation of Sections 5 and 12 of the Federal Trade Commission Act. Months later—and with the recall far from complete—the court ordered the executives jailed as a sanction.
Expressing concern that the execs were not implementing the recall in good faith, the court emphasized several facts justifying the harsh penalty:
On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to generic drug development, and the FDA’s procedure for responding to such correspondence. The FDA issued this guidance as part of its implementation of the Generic Drug User Fee Amendments (“GDUFA”), which was signed into law in July 2012 with the intention of expediting the delivery of generic drugs to the public and reducing costs to the generic drug industry. The FDA’s draft guidance is subject to a 60 day comment period.
Under GDUFA, the FDA agreed to the following performance goals for responding to controlled correspondence from generic-drug manufacturers and will begin to work towards these goals in October 2014: Continue Reading
Although the final rule currently under consideration by the CPSC sets a performance standard for magnet sets, the practical effect of the new safety standard will be a ban on the future sale or distribution of powerful rare earth magnet sets like Buckyballs and Zen Magnets. During the height of their popularity, these types of magnet sets were commonly marketed to adults for purposes of entertainment, mental stimulation, and stress relief. The Commission will hold a public briefing on September 10th and is scheduled to vote on September 24th.
The briefing package states the risk of injury to consumers (primarily children) is internal damage caused when a person ingests more than one high-powered magnet from a magnet set and the magnets are attracted to each other within the digestive system. This results in intestinal tissue becoming trapped between the magnets and often requires surgery.
The briefing package outlined the following injury and cost/benefit data related to these types of magnet sets and the new safety standard: Continue Reading
Throughout the year, this space has periodically re-visited the topic of regulating the manufacture and labeling of foods with genetically modified ingredients (GMOs) at the state and federal level. This week, a lawsuit out of Kauai, Hawaii shed light on the fate of these regulations at the county level.
In the wake of the tragic drowning of Virginia Graeme Baker, the granddaughter of former Secretary of State James Baker, Congress passed and President Bush signed into law the Virginia Graeme Baker Pool and Spa Safety Act. The legislation was sponsored by Congresswoman Debbie Wasserman Schultz (D-FL) and it mandates safety requirements for pool drainage systems in all “public pools and spas.” The safety requirements are intended to prevent swimmers from being entrapped underwater by the powerful suction forces of pool drains – a relatively rare but serious hazard that led to the deaths and injuries of several children.
The law is enforced by the U.S. Consumer Product Safety Commission (CPSC) and has two primary requirements: the installation of drain covers that comply with the CPSC drain safety standard in all public pools and spas, and, for many public pools and spas, the installation of a “backup system” designed to automatically shut off drainage systems should a drain entrapment occur. The expense associated with installing these types of devices is not insignificant and the failure to comply with these federal or similar state requirements could lead to lawsuits, civil penalties, and potentially even criminal prosecution.
While one controversial (but decided) implementation issue centered on the agency’s reversal of an “unblockable drains” exemption from the backup system requirement, another more important issue to the proprietors of small bed and breakfast properties and people who occasionally rent out their homes still remains unresolved—do they have to comply with the VGB Pool and Spa Safety Act? Continue Reading
In June, we reported on a suit brought by the Grocery Manufacturers Association (“GMA”) seeking to rescind Vermont’s new GMO-labeling statute, Act 120. As we explained in that post, the GMA argues that Act 120 is doubly unconstitutional: not only does the law violate the Commerce and Supremacy Clauses (among others) of the U.S. Constitution by placing an undue burden on interstate commerce, it also runs afoul of the First Amendment by restricting the commercial speech rights of food companies to label their products. Those constitutional problems—combined with the pragmatic difficulty of meeting the law’s ambitious compliance deadline of July 1, 2016—renders Act 120 indefensible, according to the GMA’s complaint.
On August 8, the Vermont Attorney General’s Office responded to this opening salvo with its own, asking the district court to dismiss the GMA’s complaint in its entirety. Totaling 50 pages, the AG’s motion provides the first definitive look at the state’s arguments defending Act 120, shedding more light on the battle to come.
So what are Vermont’s responses to the criticisms levied by the GMA? Highlights from the AG’s argument below:
Two years ago, the U.S. Consumer Product Safety Commission (CPSC) took the uncommon step of filing administrative complaints against multiple rare-earth magnet companies who refused to voluntarily recall magnetic adult desk toy products deemed to be defective by CPSC staff. Specifically, the agency alleged that these companies sold products containing small, but high powered, rare-earth magnets, which pose a “substantial product hazard” to children.
To date, nearly all of the magnet companies have reached a settlement with the CPSC over the government’s claims regarding the magnetic products. In fact, earlier this year, we wrote about the settlement reached between the CPSC and the maker of Buckyballs and Buckycubes. However, there is one notable exception to those companies who have settled their litigation – Zen Magnets.