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Consumer Product Matters

A product safety and consumer related regulation and litigation blog

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

Consumer Product JurisdictionAs our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the jurisdiction of the Consumer Product Safety Commission (CPSC).

But when is a so-called consumer product not regulated by the CPSC? Or, when does the CPSC have coterminous jurisdiction with another federal agency over a consumer product, or even jurisdiction over some aspect or a component of that consumer product?

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U.S. House Passes GMO Labeling Legislation

Posted in Advertising, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Class Actions, Product Liability

GMO Legislation

Today the Safe and Accurate Food Labeling Act of 2015 passed the House, in a vote of 275 to 150 (more information here). Still a hot-button issue, opposition to the Act is emotionally charged, with those opposed to the bill calling it the “DARK” Act (Denying Americans the Right to Know Act). Supporters of the bill, including farm, biotech, food, and beverage companies, argue mandatory labels would be expensive for companies and confusing for consumers.

H.R. 1599 stops states from mandating food labels on GMO products. The bill also calls for the creation of a voluntary USDA certification process for GMO-free foods and for FDA to regulate “natural” claims used on food labels. Groups advocating for labeling maintain that people should know what is in their food; since FDA already requires labeling of over 3,000 ingredients, additives, and food processes, GMOs should be no different. Supporters of Representative Pompeo’s (R-KS) bill, however, point to the dearth of any credible evidence showing foods produced with biotechnology pose any risks to health or safety.

The Associated Press reports that Senator Hoeven (R-ND) will introduce a companion to the Pompeo bill following the August recess. The Senate bill would put emphasis on amending federal agriculture laws, not food safety laws, to preempt state labeling efforts on GMOs. It will also emphasize a USDA GMO-free certification program and delineate how USDA’s Agriculture Marketing Service would oversee this effort, preempting any labeling by states that do not follow the same rules. Given the controversy surrounding GMOs, especially partisan divisions on state pre-emption and the “dangers” of genetic engineering, it remains to be seen if such legislation will be able to pass.  As always, we will keep an eye on the situation.

Shifting CPSC Recall Landscape? Agency Announces Major “Repair Program” that is not Labeled a “Recall”

Posted in Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Federal Regulations, Voluntary Recalls

Ikea Product IssueYesterday the CPSC and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip over posed by 27 million chests and dressers sold by the company. The repair program offers free wall anchoring repair kits so consumers can secure the chests and dressers to the wall to reduce the likelihood of a tip-over incident (more background on furniture tip over and wall-anchoring here).

If you weren’t looking for it, then you could have easily missed that the announcement did not contain the word “recall.” Nor was it included in the CPSC’s recall announcement list (though it is currently listed as a “recall” on saferproducts.gov).

So why is this significant? Continue Reading

The Patchwork Solidifies: GMO Bill Moves Forward in the House

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Product Class Actions, State Consumer Protection Laws, U.S. Congress

GMA lawsuit GMO labeling VermontThe proposed Federal regulation of GMOs is proceeding. Following the White House’s recent action on GMOs, Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) was passed by the House Agriculture Committee on July 14.

The Pompeo bill is an attempt to preempt a patchwork of state regulations on GMOs. More specifically, the legislation: Continue Reading

Hidden Costs of Common Beauty Treatments?

Posted in Consumer Product Safety, Drugs & Cosmetics, Food & Drug Administration (FDA), Litigation, Manufacturer Product Safety, Product Class Actions, Product Liability, Retailer Product Safety, State Consumer Protection Laws

Nail Salon ProductsThe “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions stemming from their daily use of nail products, many of which contain potentially harmful chemicals. A New York Times exposé on the health conditions affecting nail salon workers has thrust this issue, which exists largely outside FDA’s authority, into the regulatory spotlight.

The toxic trio refers to the following three chemicals:  Continue Reading

GMOs in the Hotseat: White House to Overhaul Regulatory Framework on Biotechnology

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

Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation.

In a statement released July 2, OSTP noted that the current regulatory system for “biotechnology products” (defined for this purpose as products created through genetic engineering of plants, animals, and microbes), governed by the Coordinated Framework for the Regulation of Biotechnology (CF), creates “unnecessary costs and burdens.”  It also is difficult for laypeople to understand, thus undermining public confidence in the safety of such products.  The White House science advisors are calling for an “update of the CF […] to facilitate the appropriate Federal oversight by the regulatory system and increase transparency, while continuing to provide a framework for advancing innovation.”

Under the current Framework, USDA, EPA, and FDA rely on their traditional statutory authorities and roles to regulate biotechnology products: USDA has authority to approve all releases of GMOs to ensure they don’t create an environmental hazard; EPA must approve all crops that contain insect-killing genes; and FDA is responsible for evaluating whether GMOs are safe to eat.  In some cases the jurisdictional lines have been unclear, and new technological advancements are making possible developments that were not conceived when the original CF was issued in 1986 (or revised in 1992).

To begin improving predictability, increasing efficiency, and reducing uncertainty in the regulation of biotechnology products, OSTP’s memo laid out the following one-year objectives for a new Biotechnology Working Group:

  1. Develop an updated CF to clarify the roles and responsibilities of USDA, EPA, and FDA in regulating biotechnology products;
  2. Formulate a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens; and
  3. Commission an external, independent analysis of the future landscape of biotechnology products (to be undertaken by the National Academies).

The Biotechnology Working Group will consist of representatives from the three affected Federal agencies and the Office of the President.  The recent memo also announced three public listening sessions, starting with one in Washington, D.C., in the Fall of 2015, to seek input on the best ways to clarify the current roles and responsibilities of the USDA, EPA, and FDA in the regulatory process. The updated CF will also undergo public notice and comment before it is finalized.

Meanwhile, the tide of GMO legislation at the Federal and State continues, with Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) continuing to gain momentum in the House and a companion bill expected shortly in the Senate.

What is CPSC’s Fast Track Recall Program and When Should Companies Utilize It?

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Product Recalls, Manufacturer Product Safety, Private Labeler Product Safety, Product Liability, Retailer Product Safety, Supply Chain Risk Management, Voluntary Recalls

US CPSC Fast Track Recall ProgramSo what is the CPSC’s “fast track recall” program and what is the benefit of participating in it? What is a “stop sale notice” and why does the CPSC generally request it for fast track recalls? What else is required by the CPSC in order to participate in the program and what are the potential downsides? When should a company utilize fast track? These are common questions for companies who believe they could have a product safety issue and are already seriously considering a voluntary recall.

What is the CPSC “Fast Track Recall” Program?

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Toy Safety Regulation Should Be Left To The Federal Government

Posted in Children's Products, Consumer Product Safety, Consumer Product Safety Commission (CPSC), Consumer Product Safety Improvement Act (CPSIA), Litigation, Product Liability, State Consumer Protection Laws, State Product Safety Laws, State Regulations, U.S. Congress

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

CPSC Files Suit for Second Time in Three Months against a Company for Alleged Failure to Timely Report Defective Product

Posted in Consumer Product Safety Commission (CPSC), CPSC Civil Penalties, CPSC Enforcement Actions, Litigation, Product Liability

DOJ Failure to Timely ReportOn Wednesday of last week, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) announced that a complaint has been filed in federal court against Spectrum Brands, Inc. (Spectrum).  Notably, this is the second case in the past three months brought by the government in federal court against a company for an alleged failure to timely report (see our earlier post on the Michaels Stores litigation).  These cases are not typical because most companies settle civil penalty claims rather than litigate against the government.  As a result, there is precious little case law precedent as to how these lawsuits might play out in court, and close attention is being paid to them in the product safety community.

In this case, the government alleges that Spectrum and a former subsidiary (Applica Consumer Products) failed to timely report under Section 15(b) of the Consumer Product Safety Act (CPSA) a hazardous defect relating to certain Black and Decker brand SpaceMaker coffee pot handles.  Specifically, the Complaint claims that the companies knowingly violated the reporting requirements of the CPSA with respect to allegedly defective carafe handles that could detach and cause hot coffee to spill onto consumers and burn them.  According to the government, over a three year period, hundreds of consumers reported incidents involving the detached handle to the CPSC before the companies notified the agency of the potential problem and later recalled the product.  The Complaint alleges that the companies themselves received approximately 1,600 consumer complaints regarding the same issue over the three year period (early 2009 through April 2012).  The Complaint further alleges that the companies distributed a small number of the allegedly defective coffee pots to retailers even after the recall was announced, which is also prohibited by the CPSA.

The government is seeking an undisclosed monetary civil penalty under Section 20 of the CPSA and injunctive relief, including the enactment of a stringent compliance program to ensure future compliance with CPSC reporting obligations.

Notably, in response to the filing of the complaint, Spectrum Brands has stated, in part, that “the Commission is taking a position that is inconsistent and irreconcilable with its conclusions concerning the nature and degree of risk associated with similar products and similar quality issues” and that it is “compelled to defend its conduct in court” in the face of the Commission’s “inconsistent positions and arbitrary civil penalty demand.”  The Company further stated that that it “has a long history of proactive communications with the [CPSC]” including in this case after “Spectrum Brands determined that it had distributed a small number of recalled coffeemakers…”

As we have previously commented, we expect the Commission to remain active in brining enforcement actions against companies for violations of Section 15(b) of the CPSA and other provisions of the CPSA (and statutes enforced by the Commission).  We will continue to follow this litigation, and the Michaels Stores case, and update our readers on notable latest developments given the importance of these recent cases.

 

FDA Determines Artificial Trans Fat Are No Longer “Generally Recognized as Safe”; Must Be Removed From Human Food By June 2018

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

Trans Fats No Longer Generally Recognized As Safe

Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over the next three years. PHOs in ready-to-eat foods like baked goods, snack foods, and frozen foods represent Americans’ major dietary source of industrially produced trans fat, which studies have found to be associated with coronary heart disease and other adverse health outcomes. Artificial PHOs have been used in human food since the 1950s to increase the shelf life and enhance the flavor stability of food products. Trans fats also are naturally occurring in meat and dairy products, and FDA’s action does not apply to naturally occurring trans fats. The action also does not apply to fully hydrogenated oils (FHOs), which contain no trans fat and in essence become saturated fats, or to PHOs that may be added to animal foods.

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