Yesterday the U.S. Senate confirmed Dana Baiocco (pronounced “Bee Awe Co”) as a Commissioner for the U.S. Consumer Product Safety Commission with a term that runs through October of 2024. The confirmation took over eight months from Baiocco’s initial nomination last September and came over sixteen months into the Trump administration. Baiocco’s confirmation signals the shift to an eventual Republican majority at the CPSC for the first time since 2006.

Baiocco, a Republican, is replacing Democratic Commissioner Marti Robinson whose term expired in October of 2017. Robinson has remained on the Commission in a hold-over year but will roll off once Baiocco is sworn in as a Commissioner.

Once Baiocco is sworn in, the CPSC will be balanced equally with two Republicans and two Democrats. The Republicans will be Baiocco and Acting Chairman Ann Marie Buerkle. The two Democrats will be Commissioner, and former Chairman, Elliot Kaye and Commissioner Bob Adler.

The Senate is also still considering President Trump’s nomination of Acting Chairman Buerkle for the permanent Chairman position and a second term as Commissioner. Because Buerkle’s nomination has been pending since last July and she has been in the minority as Acting Chairman since last February, there has been growing unrest among and mounting pressure from major industry groups to swiftly push her nomination through the Senate.

The fifth Commissioner position, which became vacant after the departure of former Commissioner Joe Mohorovic last October, still remains open. President Trump is expected to nominate a new Republican Commissioner to fill this position soon. Once the fifth Commissioner is confirmed, the agency will have a Republican majority for the first time during Buerkle’s tenure as Chairman.

The CPSC issued a press release about Baiocco’s confirmation in which Acting Chairman Buerkle said “Ms. Baiocco brings to the Commission strategic experience in product safety, extensive knowledge of public policy with consumer products and a deep understanding of how companies can be proactive in improving the safety of their products.”

Baiocco also included a statement in the CPSC’s press release, stating:

I am honored to be joining an agency with an enduring and proud legacy of protecting consumers. At a time of ever more complex and technically advanced products coming to market, I look forward to working with the leadership of Acting Chairman Buerkle and the Commission to meet emerging challenges in product safety as well as ensuring that CPSC’s core mission of protecting the public is done in the most responsive manner.”

Anticipating Baiocco’s confirmation, Commissioner Robinson sent an agency wide email on Monday afternoon saying thank you to CPSC staff. Notably, the email did not say goodbye and, in her final blog post, she closed by saying: “Although my term as CPSC Commissioner is now coming to a close, I am not done advocating for safe consumer products. I look forward to continuing this conversation about safety and working with all stakeholders in the future.”

A recent Federal Court decision on the issue of whether to grant a preliminary injunction in the ongoing saga of the appropriateness of adding the pesticide Glyphosate to the CA Prop 65 list (see prior posts, here and here) has become the grist for the “Fake News” phenomenon. More specifically, Momsacrossamerica.org issued a press release on February 28, 2018 entitled “Judge Says Public Doesn’t Need Cancer Warning.”

However, a quick scan of the decision issued on February 26th reveals that the judge did no such thing. Continue Reading Prop 65 Preliminary Injunction and “Fake News”

On Friday, February 16, the U.S. Consumer Product Safety Commission (“CPSC”) announced that it had voted 3-1 (along party lines) to authorize CPSC staff to file an administrative complaint against Britax Child Safety, Inc., (“Britax”) a global manufacturer of car seats, strollers, and other juvenile products. In its Complaint, CPSC alleges certain models of Britax’s B.O.B. jogging strollers contain a design defect which results in stroller wheel detachments.  The Complaint seeks an order finding that the strollers present a substantial product hazard and directing Britax take action to recall the products, among other things.

One aspect of this case that’s especially noteworthy is that it was opposed by Republican Acting Chairman Ann Marie Buerkle, who is President Trump’s nominee for permanent Chairman. The three Commissioners who voted affirmatively are all Democratic Commissioners who, as a supermajority, still have control over many areas of the agency over one year into the Trump administration.

As we have written about previously, the Democratic Commissioners will continue to hold a majority until the confirmation of Republican Commissioner nominee Dana Baiocco. Of course, it is difficult to say how the composition of the Commission could have shaped the outcome of this vote, considering that the Zen Magnets litigation was only possible because a Republican Commissioner voted in favor of authorizing that Complaint while the Commission was composed of two Republicans and two Democrats in 2012. Continue Reading CPSC Sues Britax over Stroller Wheel Detachments

Much of the recent discussion regarding Prop 65 has been focused on the regulatory changes going into effect in August of 2018. And that makes sense since there will be significant changes to the warnings, responsibility, and labeling obligations on product websites. There is, however, other activity that may result in a more profound change as to which chemicals require Prop 65 warnings.  As we have discussed in the past (see prior post here), there has been litigation in California state court addressing the appropriateness of adding the pesticide ingredient Glyphosate to the Prop 65 list. Continue Reading A Federal Court Gets Opportunity to Weigh In on Prop 65 With a Little Help from Some Friends

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

As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future. In late October 2017, Senator Orrin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act,” which we will refer to as the “Hatch bill” for purposes of this post.

The proposed legislation would amend the Federal Food, Drug, and Cosmetic Act by introducing measures to regulate ingredients, monitor adverse reactions to cosmetics, and establish good manufacturing practices. Under the Hatch bill, FDA would receive authority to accredit third-party organizations in order to determine chemical safety. The Hatch bill also would preempt any state action on cosmetic chemical ingredients once FDA identifies a chemical for review. We summarize key sections of the Hatch bill below. Continue Reading A “Surprise” Cosmetic Reform Bill Appears in Congress; Bipartisan Compromise Continues to Be Legislators’ Goal

This morning at the CPSC’s public hearing Commissioner Joe Mohorovic announced that he would be resigning from his position as a Commissioner, effective Friday, October 20th. Mohorovic announced that he would be joining the law firm Dentons.

While Acting Chairman Buerkle remains at the helm of the agency, Mohorovic’s absence will mean an unprecedented Democratic 3-1 majority at the Commission with a Minority Chairman. While Mohorovic’s resignation allows President Trump to nominate a third CPSC Commissioner in as many months, it likely will take months to get all three nominees confirmed by the Senate. Continue Reading Breaking: Republican Commissioner Mohorovic Departing the CPSC; Acting Chairman Buerkle Now Sole Republican in 3-1 Democratic Majority

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held a public meeting to solicit stakeholder feedback on its ideas. Since that time the proposal to develop an OTC Monograph User Fee Program has matured and it is generating considerable steam. However, FDA cannot implement such a program to assess user fees against members of private industry unless and until it has statutory authorization from Congress to do so.

As the Agency explains it, “A user fee program for nonprescription monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.” General partisan gridlock in D.C. notwithstanding, it appears likely that Congress may enact the legislation necessary to create this new User Fee Program during its current session (2017-18). This post updates legislative and FDA activities in this area since our introductory discussion in 2016. Continue Reading OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

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