It has recently been reported that President Donald Trump is looking for ways to defend American-made products by certifying legitimate U.S. goods and aggressively going after imported products unfairly sporting the “Made in America” label, the White House said on July 18, 2017. President Trump announced that his administration would crack down on “predatory online sales of foreign goods” that are hurting U.S. retailers. According to a senior official, the United States loses about $300 billion a year to theft of intellectual property ranging from semiconductors to jeans. In March of this year, the President signed an executive order that gave customs officials more authority to stop pirated and counterfeit items.

This space has addressed the issues, both regulatory and litigation, relating to “Made in America” claims (see herehere, and here). Based on the Administration’s comments,  the White House plans to work with the private sector on the new certification and verification system rather than create new regulations or spend taxpayer money. Continue Reading The Turn of the “Made in America” Claim Enforcement

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the Act). The Final Rules on Foreign Supplier Verification Programs, produce safety, and accredited third-party certification were released by FDA in pre-publication format on November 13, and they will be published in the Federal Register on November 27, 2015.

That official publication date will be key for calculating individual compliance dates for businesses covered by the FSVP and produce safety rules, as those rules stagger compliance depending on business size and other factors, as do the final preventive controls for human and animal food. We blogged about those first two FSMA Final Rules back in mid-September, and the last two rules related to sanitary transportation and intentional contamination of food are expected to be finalized next year, in March and May, respectively.

Readers of this blog may be most interested in the FSVP and third-party certification rules, which are both designed under the Act to enhance the safety of imported food. Continue Reading Three More FSMA Rules Finalized As the Year Comes to a Close

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

consumer product toy safetyOn April 7, Renee Dudley of Bloomberg News authored an article entitled “The Cheap Toys You Buy Your Kid Are Rarely Inspected.”  The article has been republished by major news publications and gained some nationwide attention.  Ms. Dudley’s article uses the tragic death of a toddler to argue that the American consumer product safety system is flawed because not every product is inspected by the United States government.  This is an incorrect conclusion based on a failure to garner and evaluate relevant facts about the overall state of consumer product safety in the United States.

Naturally, this story is being disseminated broadly and creates an unfounded fear, particularly in the minds of parents, that their children are in constant and imminent peril from common consumer products, particularly children’s toys.  This is, in fact, not the case.  The consumer products “economy” is safer and more protective than ever.  The CPSC itself recently reported: Continue Reading Bloomberg Product Safety Article Misses the Mark; U.S. Product Safety Economy Safer Than Ever

In a recent post, we detailed lawsuits filed by corn exporters, farmers, and other stakeholders against Syngenta Corp. regarding its marketing of corn which contains genetically modified (“GMO”) traits that have not been approved for export to countries such as China.  On December 11, 2014, the Judicial Panel on Multidistrict Litigation agreed to consolidate multiple class actions and other suits filed against Syngenta by corn farmers, exporters, and others.  As the Panel described in its transfer order, “[a]ll actions involve common factual questions regarding Syngenta’s decision to commercialize the MIR 162 genetically modified corn trait in the absence of Chinese approval to import corn with that trait,” and thus these cases are to be consolidated in the District of Kansas before U.S. District Judge John Lungstrum, who has a depth of experience with complex litigation.   The case previously discussed in detail in this space, Archer Daniels Midland Co. v. Syngenta, was filed in Louisiana state court and has not yet been consolidated with the myriad federal actions in the District of Kansas.

Additionally, earlier this week, in a separate action that related to Syngenta’s marketing of its GMO corn, Syngenta ended its dispute with Bunge North America Inc. (“Bunge”) in which Syngenta alleged that Bunge had engaged in a false advertising campaign by posting signs at its receiving facilities that stated that Bunge would not accept Syngenta’s GMO corn because it has not been approved for export to China.  In their dismissal stipulation, the parties agreed to dismiss the case with prejudice without an award of fees or costs to any party.

Stay tuned to this space for further updates regarding Syngenta’s GMO corn litigation.

FDA Food Safety and Modernization ActLast month, Archer Daniels Midland Co. (“ADM”) joined a slew of corn exporters and other stakeholders who have sued Syngenta based on allegations that China rejected these exporters’ products because Syngenta’s genetically modified corn seed, which contains a trait that China has not yet approved for import, was not kept separate from the plaintiffs’ products.

Syngenta’s corn seed contains MIR 162, a patented genetically modified (“GMO”) trait that may protect corn crops from insect damage.  This corn is also known as “Viptera corn.”  The ADM suit against Syngenta, which was filed in Louisiana state court on November 19, alleges that Syngenta was negligent in marketing its GMO corn.

Continue Reading More GMO Woes: Another Corn Exporter Sues Syngenta for its Failure to Isolate its GMO Corn

Baja BikeOn October 28, 2014, the U.S. Consumer Product Safety Commission (CPSC) announced that Baja Inc., and its corporate affiliate, One World Technologies Inc., of Anderson, S.C., agreed to pay a $4.3 million civil penalty to resolve charges that it knowingly failed to immediately report certain defects and an unreasonable risk of serious injury involving some of the company’s mini-bikes and go-carts. To our knowledge, this is the largest civil penalty ever agreed to be paid by a company entering into a settlement agreement with the CPSC.

In this case, CPSC staff alleged that Baja failed to report immediately to the Commission that it had information which reasonably supported that certain of its mini-bikes and go-carts were equipped with: (1) gas caps which could leak or detach from the fuel tank, posing fire and burn hazards to consumers, and (2) a throttle that could stick due to an improperly positioned fuel line and throttle cable, posing a sudden acceleration hazard. CPSC staff also alleged that by the time Baja reported to the Commission, the firm had received four reports of fires from leaking gas caps and burn injuries to consumers, including a serious burn injury to a child, and two dozen reports of stuck throttles. Continue Reading CPSC Announces Largest Civil Penalty to Date for Alleged Failure to Timely Report

Starbucks and CERTIn April 2010, the Council for Education and Research on Toxics (CERT) sued Starbucks Corp. and other coffee sellers alleging they violated California’s Safe Drinking Water and Toxic Enforcement Act, passed by California voters in 1986 as Proposition 65, by failing to warn consumers about carcinogens in their products as required under the act.  In July 2013, Los Angeles Superior Court Judge Elihu M. Berle denied CERT’s motion for summary adjudication, saying the lawsuit would essentially boil down to a battle of experts.

Since then, the battle of the experts has continued to brew.  We are now a month into the bench trial that will culminate in Judge Berle’s ruling on the three affirmative defenses asserted by Starbucks and several other defendants: Continue Reading Battle of the Experts Still Brewin’ in Starbucks Trial

CPSC new and emerging risksOn October 14, the Government Accountability Office (GAO) published a report entitled “Consumer Product Safety Commission: Challenges and Options for Responding to New and Emerging Risks.”  The report analyzes the timeliness of the Consumer Product Safety Commission’s (CPSC) response to “new and emerging” safety risks from new or existing consumer products.  It is based upon a review of current product safety laws and regulations, related literature and studies, timeliness related to the regulation of specific consumer products, and interviews with CPSC officials, including current and former Commissioners, industry representatives, consumer groups and other subject-matter and legal experts.

According to the report, although the CPSC uses a multifaceted approach to reduce the risk of injury to consumers from immediate and future problems, the CPSC faces hurdles and challenges in responding timely to emerging risks because “the CPSC was established to respond to risks after products have been introduced into the market.”  The report concludes that the timeliness of the agency’s response to new and emerging risks is affected by factors such as:

Continue Reading GAO Releases Report on CPSC Response to New and Emerging Hazards

FDA Food Safety and Modernization Act On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many reported incidents of food-borne illness during the 2000s.

FSMA’s goal is to ensure that food in the United States is safe by shifting the focus of federal regulators from responding to contamination to preventing contamination from initially occurring.  The law has given FDA new authority to regulate the way foods in the United States are grown, harvested, and processed.  One means through which FDA exercises this authority is rulemaking.

The four rules for which FDA is proposing changes are: Continue Reading FDA Announces More Changes to FSMA Implementation Rules