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Consumer Product Matters

A product safety and consumer related regulation and litigation blog

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), U.S. Congress

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

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

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC), CPSC Civil Penalties

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

Seasoned Litigator Nominated to Replace Commissioner Robinson and Establish Republican Majority at CPSC

Posted in Consumer Product Safety, Consumer Product Safety Commission (CPSC)

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:

 

Food Identity Disputes Continue to Impose High-Profile Pressure on FDA

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

As we reported on previously (see here and here), FDA recently tussled with the manufacturer of an innovative vegan condiment called “Just Mayo” based on the existence of a Federal standard of identity for mayonnaise that requires the food product to incorporate eggs.

Similar disputes related to identity standards that don’t accommodate plant-based versions of foods, or that just don’t allow for new or innovative uses of traditional ingredients, seem to have increased in frequency and visibility over the past year. As a result, we expect that FDA is feeling pressure from diverse stakeholder groups to revisit some of its regulations and policies related to enforcing food standards of identity (SOI). This post highlights some of these emerging disputes and the trend of interested parties raising more challenges to long-standing (but potentially obsolete) food identity standards. Continue Reading

Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!

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

On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD). Continue Reading

California’s Prop 65: More Form Over Substance

Posted in Food and Beverage, Litigation, Prop 65, State Consumer Protection Laws, State Product Safety Laws, State Regulations, Supply Chain Risk Management, Uncategorized

California’s Safe Drinking Water & Toxic Enforcement Act of 1986 (affectionately known as “Proposition 65”) has long been the subject of discussion, both pro and con. Much of the conversation is on various issues surrounding the enforcement of Proposition 65 (for example, see a prior post here). In March 2017, a California trial court in  Monsanto Co. v. Office of Environmental Health Hazard Assessment (“OEHHA”), No. 16-CE CG 00183, addressed a much more basic issue: should a chemical – here Glyphosate, a key ingredient in Monsanto’s Round-Up® product – even be on Prop 65’s list of cancer-causing chemicals? Continue Reading

President Trump Nominates Acting Chairman Ann Marie Buerkle as Permanent Chairman of the CPSC

Posted in Consumer Product Safety Commission (CPSC)

Today, President Donald Trump officially announced his intent to nominate Acting Chairman Ann Marie Buerkle to be the permanent Chairman of the U.S. Consumer Product Safety Commission. Her new seven year term will begin on October 27, 2018 when her first term is set to expire. If confirmed, she will become the permanent Chairman immediately and her new term will end in October 2025.

The official announcement is copied below and was released by the White House Office of the Press Secretary just a few hours ago. Continue Reading

The Turn of the “Made in America” Claim Enforcement

Posted in Advertising, Consumer Product Safety, Federal Regulations, Federal Trade Commission (FTC), Importer Safety, Manufacturer Product Safety, Private Labeler Product Safety

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

CPSC to Host Recall Effectiveness Workshop; Commissioner Kaye Issues Recall Effectiveness Statement

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

On July 25, 2017 at 9:00 AM, the Consumer Product Safety Commission will be hosting a public workshop on Recall Effectiveness. The workshop, to be held in the Hearing Room at CPSC Headquarters in Bethesda, Maryland, is intended to allow consumer safety professionals and the CPSC staff to discuss ways to improve the effectiveness of recalls. Mintz Levin’s product safety team will be in attendance.

The agenda for the workshop includes: Continue Reading

Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

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

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products. Then last fall FDA released a new guidance document on what constitutes a “healthy” food and proper labeling of such foods, and the Agency simultaneously requested public input on a significant number of questions related to use of this particular claim.

Last week, FDA announced two actions that are intended to further advance this public consultation process for “healthy” label claims. First, it has extended the comment period that was initiated in October with the release of the draft guidance document until April 26, 2017. And it is convening a public meeting to discuss the use of the term “healthy” in the labeling of human food products, in part to further the feedback that may be received during this ongoing comment period. Continue Reading