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.”

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

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

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

As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA oversight and requirements under the May 2016 Deeming Rule for tobacco products. In Monday’s Federal Register, FDA issued a final rule to exclude products derived from tobacco from Federal regulation as “tobacco products,” if or when such products are intended for use as a drug, device, or combination product (the “Final Rule”). In other words, the Agency has formally clarified that even a product made or derived from tobacco may be regulated as a medical product if it is intended for use in a way that meets the legal definition of “drug” or “device.”

However, FDA’s attempt to apply further requirements and restrictions on tobacco-derived products comes amid intense government wrangling over how to regulate products like ENDS more generally. It also comes at the eleventh hour of the Obama Administration and in the face of a Republican-controlled Congress that has expressed an interest in repealing, or at least reviewing, a large proportion of Federal agency rulemakings completed in the past several months. So it is worth noting that although this Final Rule could have a profound effect on marketing schemes for tobacco products, drugs, and medical devices alike, Congress’s recent passage of the Midnight Rules Relief Act could eliminate the rule before it ever takes effect (set for February 8, 2017). Continue Reading FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress

We have had a huge election result, perhaps the most significant in our lifetime, potentially even exceeding what was called the Reagan Revolution.  It is critical, particularly for anybody from Washington DC, to have a great deal of modesty and humility in prognosticating the future under the Trump administration even in the CPSC world.  We assume, but really do not know, what the attitudes of the new Trump administration and the Republican-led Congress will be in our parochial, but critical, little product safety world.

We can understandably assume that within a year or less there will be a new CPSC Chairman and a new Republican majority on the Commission. We can also assume that this will change the direction and substance of many regulatory initiatives and maybe even some of the approaches to compliance and civil penalties.
Though we may be unsure about the future, I can say confidently that what we badly need from the outgoing Democratic majority and the yet to be defined incoming Republican majority is some perspective, restraint, and Aristotelian moderation.  I hope that the current majority commissioners will not take advantage of their present but fleeting power to push through ill-conceived regulatory or compliance and enforcement initiatives.  Such actions will be bitterly opposed and this Commission’s reign will end on a sour note and be subject to regulatory and congressional reversal.

vote-pins-CPSC-Post-Election On the other hand, all five of the current commissioners swore to uphold the Constitution and the laws of the United States.  Those laws absolutely include CPSIA and other governing statutes of the CPSC.  So the Commissioners need to, and I am confident that they will, continue to do their jobs.

There are some very important initiatives which will enhance safety and not be politically controversial.  For example, I welcome Chairman Kaye’s interest in a comprehensive and interagency review of the lithium ion battery problem.  We do not need to have any more spectacular safety problems to recognize that even without hoverboards and cell phones catching on fire, the increasing use and push-the-envelope application of products which use lithium ion batteries is causing lots of problems.

Indeed, the situation with respect to lithium ion batteries is even worse for smaller companies which don’t have vertical integration, don’t design batteries or battery packs, don’t have much control over their vendors, and basically have to take solutions off the shelf.  Everybody in the product safety community will benefit from figuring out what combination of standards, practices, and designs we need to protect the public and thousands of businesses.

Nevertheless, the business community and the future leaders of the CPSC need to show some restraint as well.  It would be a mistake to take advantage of the present politics to fundamentally reverse the key elements of the Consumer Product Safety Act, to strangle the agency with inadequate funding, or tie the agency up in knots so it cannot adequately function.  This is a formula for exponentially increasing an already problematic patchwork of state and local government regulation of consumer products.  It would also potentially allow for cheap, unsafe imports to flood our country and undermine significant product safety investments already made by U.S. companies.

This does not mean that nothing should be done or that the statute shouldn’t be revisited in some regards.  There are plenty of ways the business community can achieve meaningful regulatory improvements and burden relief that would not cause larger issues.

I do not support crippling the CPSC.  No members of industry that I have spoken with support such drastic action either.  It will not be in the long term benefit of the business community and it leaves American consumers, our families and friends, less protected.

I’ve been involved in the product safety world for 30-plus years and have seen the political pendulum swing on multiple occasions. One constant is that most reasonable, informed people, whether business executives or consumer advocates, agree that a well-functioning CPSC is a critical part of a vibrant economy for consumer products in this country.

 

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014).  More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation.  The HELP Committee also heard from experts in the cosmetics industry about product developments and health standards.

Witnesses in favor of the Personal Care Products Safety Act stated that the FDA has not done enough to ban endocrine-disrupting chemicals in cosmetic products and that industry-financed review programs should not substitute government regulatory programs in collecting chemical toxicity data.  They contrasted FDA’s inability to ban products unless they are “adulterated” with the more expansive authorities of similar regulatory agencies in Canada, Japan, and the European Union. Continue Reading Coming Soon to a Lawbook Near You – New Cosmetic Requirements

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in the media: does the U.S. Consumer Product Safety Commission (CPSC) have the authority to address the safety of amusement park rides and guns?

amusement-park-guns-cpscAmusement Park Rides.  Every time there is a tragedy on a ride at an amusement park, the nation turns its attention and scrutiny on the CPSC as the nation’s safe products regulator.  However, and crucially, the CPSC does not have jurisdiction over the safety of “fixed site” amusement park rides.  In 1981, the Congress stripped the CPSC of its jurisdiction over these rides through an amendment to the Consumer Product Safety Act (CPSA).  As a result, rides that are “permanently fixed to a site” (such as the ones at the Kansas and Tennessee parks) are subject to voluntary standards written by the ASTM F-24 Committee on Amusement Rides and Devices and state and local regulations.

The CPSC does have jurisdiction over “mobile” amusement rides (those transported from location to location).  The agency also acts as a clearinghouse for safety information on ride incidents identified by Commission investigators and state and local ride officials.  The following 2012 CPSC Directory of State Amusement Ride Safety Officials provides a helpful introductory overview of the CPSC’s activities with respect to amusement park rides and a directly of the relevant state and local officials dedicated to ride safety.

Read our previous post about this jurisdictional issue here.

Gun Safety.  Like fixed amusement park rides, firearms and ammunition are excluded from the definition of a “consumer product” in the CPSA.  As a result, the CPSC does not regulate the safety of guns, shells and cartridges (the Bureau of Alcohol, Tobacco, and Firearms does).

guns-amusement-park-cpscNote: CPSC Commissioner Marietta Robinson recently issued a thoughtful perspective describing how she believes the CPSC can make guns safer and help bring down the number of accidental incidents involving firearms.  According to Robinson, “guns should be defined as the consumer products they are so that we may do our job of protecting the American consumer.”

Despite its lack of jurisdiction to regulate the safety of guns and ammunition at present, the CPSC does have authority to regulate the safety of some products and accessories related to gun use.  For example, the CPSC has asserted its jurisdiction over separate firearm trigger locking devices.  Additionally, the CPSC has recalled previously gun storage boxes, handgun vaults, and gun holsters, thus all squarely falling within the regulatory authority of the agency.  In fact, as recently as 2013, the White House requested the CPSC to “review and enhance as warranted safety standards for gun locks and safes” as a measure to improve gun safety.

Without a further act of Congress, the CPSC’s activities with respect to fixed amusement park rides and gun safety will not likely change.

 

Yesterday, CPSC Chairman Elliot Kaye and Commissioner Robert Adler issued a lengthy joint statement vigorously defending the Commission’s current approach to civil penalties against various criticisms voiced by Commissioners Joe Mohorovic and Ann Marie Buerkle as well as stakeholders in the business community.  Their overarching message: such criticisms are without merit and are, in reality, a call for lesser penalties; there will be no change in the Commission’s current approach.

Over the past few months, we have written extensively about the Commission’s approach to seeking civil penalties against companies for failure to report violations—and the ongoing debate surrounding that process.  Chuck Samuels even testified on the subject last month at the CPSC’s Annual Priorities Hearing (watch here).

According to Kaye and Adler, “agency critics have urged an enormous undertaking by the Commission to prioritize exploring and redesigning its civil penalty system, effectively displacing work intended to save lives and prevent injuries.”  They expressed disappointment at the “distortion” of Chairman Kaye’s remarks at the ICPHSO conference last year, and pushed back at the idea that the Commission somehow operates without transparency when assessing civil penalties.  Specifically, Kaye and Adler assert the following points in their joint statement against the common civil penalty criticisms:

  • critics of the Commission’s current policy want more information shared related to the facts and factors that enter civil penalty valuations, but hamstring the agency in doing so by seeking (or supporting) stringent Section 6(b) confidentiality protections;
  • there is ample regulatory guidance to determine when to file a Section 15(b) report;
  • both the Commission and companies need flexibility when negotiating a civil penalty settlement, thus counseling against a matrix or formulaic approach to applying the civil penalty factors;
  • companies are afforded full due process protections and procedures when the Commission seeks civil penalties including the opportunity to be heard; and
  • the Commission carefully tracks the information available to firms at each and every step in time and does not rely on hindsight regarding companies’ obligation to file.

While many could find much to dispute in the joint statement, the Commission’s majority has made their view clear.

Companies should take a very close read of this policy statement.  It is now evident that the Commission will not change—or even revisit—its current approach to civil penalties in the coming fiscal year, as urged by some stakeholders in the product safety community.  Barring a change in CPSC personnel, Congressional action, or judicial involvement through the litigation process, the ongoing “debate” over civil penalties has effectively ended for now.

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods.  Already approved by the Senate last week, the bill is now expected to be signed into law by President Obama, according to a White House spokeswoman.

The bill directs the Department of Agriculture to set a standard within two years that would apply to all food labels in the U.S. The standard would permit three types of labels: a USDA-designed symbol; a written statement noting the presence of GE ingredients; and a QR code for smartphones to scan. The standard would preempt state law, including Vermont’s Act 120, which took effect July 1st. Continue Reading House Passes GE Labeling Bill; Obama Expected to Sign