Consumer Product Safety

With Congress back in session, on January 8th President Trump was swift to re-nominate Acting Chairman Ann Marie Buerkle to be the permanent Chairman of the CPSC, along with a nomination for a second term as a Commissioner.  President Trump also re-nominated Dana Baiocco to be a Commissioner.

As we previously wrote, Chairman Buerkle was nominated by President Trump in in July of last year. After going through a Senate confirmation hearing in September that was contentious at times, Buerkle was approved by the Senate Committee on Commerce, Science, and Transportation for confirmation by the full Senate. Similarly, Ms. Baiocco was also awaiting full Senate confirmation after she was approved by the committee in November.

Both Buerkle and Baiocco were not confirmed by the Senate in December, at which time their nominations were returned to the President under Senate Standing Rule 31 along with almost 100 other nominees. Rule 31 provides that when a nominee is neither confirmed nor rejected prior to the end of the Congressional session, the nomination is returned to the President, and will not be reconsidered by the Senate unless they are re-nominated. Most often at the end of a calendar year, this rule is waived by the Senate. However, waiver of the rule requires unanimous consent, which was not provided for 100 nominees that were pending before the full Senate for confirmation in December.

Both Buerkle and Baiocco must again be approved by the committee. They will then again await full Senate confirmation.

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

Over the past few weeks, there have been many key goings-on related to the CPSC and its Commissioners.

Chairman Buerkle’s Confirmation Hearing and Committee Vote

First, on September 27, 2017, Acting Chairman Ann Marie Buerkle sat for a confirmation hearing before the Senate Committee on Commerce, Science, and Transportation. At the beginning of the hearing, Buerkle faced tough questions, particularly from ranking member, Senator Bill Nelson of Florida. In the wake of Hurricane Irma, and subsequent 11 deaths due to carbon monoxide poisoning from portable generators, Ms. Buerkle was repeatedly asked to defend her position that the CPSC should not undertake mandatory rulemaking on portable generator emissions. She explained that she believed the EPA has primary jurisdiction over carbon monoxide emissions from portable generators, but by working with industry on a voluntary standard involving an automatic shut-off mechanism within CPSC’s jurisdiction, it was her hope that a solution can be developed by the end of the year. Under CPSA, CPSC is required to rely on consensus standards instead of mandatory regulations where they are effective and compliance is widespread.

On October 4, 2017, the Committee cleared Chairman Buerkle’s nomination as Chair by voice vote but presumably because of the portable generators issue, her nomination for a second seven-year term as a CPSC Commissioner was not unanimous and voting followed party lines. Ms. Buerkle’s final hurdle will be a confirmation by the full Senate, which could take place quickly or take a couple of months depending on any further opposition to one or both of her nominations.

Continue Reading CPSC Round-Up: Buerkle Confirmation Hearing, Landmark Civil Penalty Ruling, and Partisan Action on Flame Retardants

Today, President Trump announced his nomination of Dana Baiocco to be a Republican Commissioner on the Consumer Product Safety Commission. If confirmed, Ms. Baiocco would take the seat of Commissioner Robinson, whose term expires on October 26, 2017.

Baiocco is a well-known litigator and partner at Jones Day in Boston, Massachusetts. She is also familiar with the world of product safety. Baiocco’s product safety experience includes extensive product-liability litigation, having defended many major consumer product companies. Ms. Baiocco’s biography can be found here.

The nomination is surely a welcome one for Acting Chairman Ann Marie Buerkle, who is currently operating with a Democratic majority and, until today, uncertainty surrounding when that would change. The nomination signals the White House’s intent to achieve a Republican majority at the CPSC and curtail the agency’s steady push of Democratic initiatives along 3-2 party line votes.

Notably, the nomination comes at the same time the Senate Committee on Commerce, Science, and Transportation announced that it will hold a confirmation hearing on September 27, 2017 for Acting Chairman Buerkle to become the permanent Chairman of the CPSC. If both Buerkle and Baiocco are confirmed, the agency would reflect the composition of the current executive and legislative landscape, with a Republican Chairman and a Republican majority of Commissioners.

Below is more information from the White House Press Release:

 

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

CommissionerBuerkle370x500This morning it was announced internally at the CPSC that Commissioner Ann Marie Buerkle has become the Acting Chairman of the agency. The CPSC has not yet released a statement concerning the transition of the chairmanship from Elliot Kaye to Ann Marie Buerkle, but we have confirmed the change in leadership with multiple sources inside the agency. In a move largely seen as a precursor to this change in leadership, the Commission recently voted to install Buerkle as the Vice Chairman of the agency — ensuring that she would become the Acting Chairman of the agency once Kaye vacated the Chairman’s office.

Continue Reading CPSC Begins Transition: Ann Marie Buerkle is Now the Acting Chairman of the Agency

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015 (H.R.4075).

Overall, the proposed legislation would amend the Federal Food, Drug, and Cosmetic Act with respect to FDA’s regulation of cosmetics by creating new requirements such as the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each marketed cosmetic. It also would require cosmetic manufacturers, packers, and distributors to report to FDA any serious and unexpected adverse events caused by a cosmetic product. Likewise, cosmetic labels would be required to include contact information for consumers to report such events to the manufacturer or distributor.

Below, we break down in detail pertinent sections of the Sessions bill, as it was introduced in the previous Congress (although reports indicate that the reintroduced version has not been altered significantly). Continue Reading Cosmetics Reform Activity Begins in the 115th Congress

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements.  Adverse events can be any negative reaction to a product, such as a serious illness or allergic reactions, or other complaints like packaging problems, that are received through FDA’s voluntary adverse event reporting systems for these classes of regulated products (except for in the case of dietary supplement manufacturers, who have mandatory reporting obligations).

The CFSAN Adverse Event Reporting System, called “CAERS,” includes data from reports submitted by consumers, medical professionals, and industry. The initial data file made public by the Agency contains CAERS data from January 2004 through September 2016. Continue Reading FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

We do not get many court decisions in the CPSC world, but yesterday we received one.  Last evening, a Wisconsin federal district court essentially held in the Government’s case against Spectrum Brands, Inc. (Spectrum) that (1) Spectrum failed to timely report defective coffee pots in violation of Section 15(b) of the Consumer Product Safety Act (CPSA) because they could create a substantial product hazard, and (2) the Government’s imposition of a civil penalty pursuant to the CPSA was not in violation of Spectrum’s statutory or constitutional due process rights.  In doing so, the Court rejected Spectrum’s procedural and substantive arguments, including that the CPSC’s claims were time barred and that the CPSA’s reporting requirements are unconstitutionally vague.

The Department of Justice and CPSC alleged that a company acquired by Spectrum (Applica Consumer Products) knowingly failed to timely report under Section 15(b) of the CPSA a hazardous defect relating to certain coffee pot handles.  The Complaint alleged that the Company had received approximately 1,600 consumer complaints over a four year period (2008-2012) related to the breakage of the pots’ handle resulting in coffee spillage and burns on consumers.

In response to the filing of the lawsuit, Spectrum asserted, among other arguments, that (1) the Commission’s claims against it were time barred under the so-called Gabelli doctrine; (2) the CPSA’s reporting requirements are unconstitutionally vague; (3) the CPSC failed to provide fair notice that a report was required in light of its finding that other Spectrum coffeemakers with similar issues did not present a substantial product hazard; (4) the CPSC’s late-reporting determination was arbitrary and capricious; (5) Spectrum had no duty to report because the CPSC had already been “adequately informed” of the handle failures and (6) the CPSA did not authorize the CPSC to seek certain forms of injunctive relief including the establishment of a compliance program and prospective liquidated damages in the event of noncompliance.

coffee-pot-cpscThe Court rejected all of these arguments and handed almost a total victory to the CPSC that may have future ramifications in the product safety community.  For example, the decision certainly lends new credence to the CPSC’s common refrain to regulated entities “when in doubt, report” when deciding whether a product defect could present a substantial product hazard.  The Court even went so far as to cite this common CPSC advice in the opinion.  It’s also noteworthy that the Court concluded that the CPSC does not need to articulate its reasoning for a civil penalty amount in writing and provide more transparency in the process generally­­­—a complaint often raised by industry defendants.

Continue Reading BREAKING: COURT RULES POSITIVELY FOR CPSC IN FEDERAL CIVIL PENALTY CASE AGAINST SPECTRUM BRANDS

On November 8, 2016, California voters approved Proposition 67, the statewide ban on carry-out plastic bags, by 52 percent. At the same time, California voters rejected Proposition 65 by 55 percent–a measure that would have sent the proceeds from sales of paper bags and reusable bags to environmental causes.

Plastic Bage Seagull

Main Provisions of Proposition 67

  • Prohibits most grocery stores, convenience stores, large pharmacies, and liquor stores from providing single-use plastic carry-out bags. The provision excludes plastic bags used for certain purposes, such as those used for unwrapped produce.
  • Creates new standards for the material content and durability of reusable plastic carryout bags. The California Department of Resources Recovery and Recycling (CalRecycle) would be responsible for ensuring that bag manufacturers meet these requirements. The measure also defines standards for other types of carryout bags.
  • Requires a store to charge at least 10 cents for any carryout bag that it provides to consumers at checkout. Certain low-income would not have to pay the charge.

Main Provisions of Proposition 65

  • Redirects carryout bag revenue to a new state environmental fund called the Environmental Protection and Enhancement Fund.
  • Allows funds to be used for grants to support programs and projects related to  (1) drought mitigation; (2) recycling; (3) clean drinking water supplies; (4) state, regional, and local parks; (5) beach cleanup; (6) litter removal; and (7) wildlife habitat restoration.
  • Takes effect only if both propositions pass and Proposition 65 gets more “yes” votes than Proposition 67.

Continue Reading With the passage of Proposition 67, the question is “Would you like paper or…paper?”