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.
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.
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:
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 Food Identity Disputes Continue to Impose High-Profile Pressure on FDA
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 Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!