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

The International Campaign Against Microbeads in Cosmetics is most likely celebrating this week, following the California State Legislature’s passage of a bill that would prohibit the use of plastic microbeads in personal care products after January 1, 2020.  The bill, AB 888, now heads to Governor Jerry Brown’s desk for his signature.  Although several states already have similar legislation on the books (Maryland, for example), California of course is the largest and most economically significant of those jurisdictions to legislate a ban on microplastics in personal consumer products.

Microbeads, usually made from non-biodegradable polyethylene, are used in personal care products such as body wash and facial scrubs to add exfoliating properties.  In recent years, as the potential for adverse environmental, wildlife, and health consequences of microplastics has become more clear (the beads are too small to be filtered out by wastewater treatment plants, so they end up being discharged into lakes, rivers, and oceans), some manufacturers have begun voluntarily removing the ingredient from their personal care products.  The impetus for industry action came after Unilever announced in December 2012 that it would phase out plastic in all of its products worldwide by 2015; since that time Colgate-Palmolive and Johnson & Johnson have joined the pledge, along with many smaller companies.  The pledge to remove these microplastics also has been taken up by private-label manufacturers and distributors of certain personal care products, including Target and others.

In addition to state policymakers and legislators, the U.S. Congress is taking note of the emerging science and environmental advocacy in this area.  The bipartisan Microbead-Free Waters Act of 2015 (H.R. 1321) was introduced this year by Chairman and Ranking Member of the House Energy and Commerce Committee, Reps. Fred Upton (R-Mich.)  and Frank Pallone (D-N.J.), respectively, and it is currently listed as having 34 cosponsors.  Companion legislation has also been introduced in the Senate by Kirsten Gillibrand (D-N.Y.); that identical bill (S. 1424) is currently listed as having 7 cosponsors.  The Microbead-Free Waters Act would effectively ban microplastics from personal care products after January 1, 2018, by deeming any cosmetic that contains them to be adulterated under the Federal Food, Drug, and Cosmetic Act.  The Personal Care Products Council, the industry’s primary trade association, noted in May testimony to the House E&C Committee that a uniform federal standard would be preferable to state-by-state action and that non-prescription drugs that contain microbeads should be included along with cosmetics in any such legislation.

We will update our readers of any developments related to federal action to remove plastic microbeads from the marketplace.

shutterstock_160344110Another potentially meaningful development in legislation affecting consumer products companies: on February 25, a California legislator introduced a bill, AB 708, that would require manufacturers, distributors and retailers to disclose all “chemical” ingredients for designated consumer products “manufactured from chemicals or chemical compounds.” The bill designates a broad swath of consumer goods for disclosure, from cleaning products and floor polishes to air fresheners and car wax. Covered products include:

Continue Reading A Clean Slate? California Bill Is Latest Attempt to Legislate Labeling Requirements for Cleaning Products

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed the Safe and Accurate Food Labeling Act (H.R. 4432), this bill would give FDA exclusive authority to regulate the labeling of products containing GMOs, effectively preempting state legislation in this field.

This past Wednesday, the House Energy and Commerce Committee held a hearing to consider that bill as well as the broader question of whether and how the federal government should regulate GMO labeling. Members of the Committee heard testimony from six witnesses on both sides of the debate over the course of three hours.

On the side against GMO labeling, perhaps the most influential witnesses were Michael Landa, the director of FDA’s Center for Food Safety and Applied Nutrition, and Tom Dempsey, the President and CEO of the Snack Food Association. The most notable voice on the other side: Representative Kate Webb of Vermont, the only state to have passed a GMO labeling law that does not depend on other states to act before going into effect. The contrasting testimony from these witnesses vividly illustrates the poles of this debate, and the questions posed by the Committee give a meaningful glimpse into the factors that may motivate Congressional action.

More highlights from the hearing below:

Continue Reading Vermont Doubles Down: Representative Testifies Before Congress Against Federal GMO Labeling Bill

Airbnb Pool and Spa SafetyIn the wake of the tragic drowning of Virginia Graeme Baker, the granddaughter of former Secretary of State James Baker, Congress passed and President Bush signed into law the Virginia Graeme Baker Pool and Spa Safety Act. The legislation was sponsored by Congresswoman Debbie Wasserman Schultz (D-FL) and it mandates safety requirements for pool drainage systems in all “public pools and spas.” The safety requirements are intended to prevent swimmers from being entrapped underwater by the powerful suction forces of pool drains – a relatively rare but serious hazard that led to the deaths and injuries of several children.

The law is enforced by the U.S. Consumer Product Safety Commission (CPSC) and has two primary requirements: the installation of drain covers that comply with the CPSC drain safety standard in all public pools and spas, and, for many public pools and spas, the installation of a “backup system” designed to automatically shut off drainage systems should a drain entrapment occur. The expense associated with installing these types of devices is not insignificant and the failure to comply with these federal or similar state requirements could lead to lawsuits, civil penalties, and potentially even criminal prosecution.

While one controversial (but decided) implementation issue centered on the agency’s reversal of an “unblockable drains” exemption from the backup system requirement, another more important issue to the proprietors of small bed and breakfast properties and people who occasionally rent out their homes still remains unresolved—do they have to comply with the VGB Pool and Spa Safety Act? Continue Reading Are Airbnb Hosts Regulated by the CPSC? Short-Term Rental Properties May Require Compliance with Pool & Spa Safety Laws

In January and April, this space took a look at the growing patchwork of state proposals for regulating the labeling of foods with genetically modified ingredients (GMOs). As posited here in April, the recent surge in such bills raises a serious question as to whether any individual state—especially one, like Vermont, that accounts for less than 0.01% of the total US population—”should be in a position to regulate labels” of foods sold in interstate commerce. Against this backdrop of potentially thorny constitutional issues, the US House of Representatives is considering a bill that answers: “They shouldn’t.”

On April 10, 2014, representatives from both parties joined to introduce the Safe and Accurate Food Labeling Act (H.R. 4432), a bill that would preempt state legislation by giving the FDA exclusive authority to regulate GMO labeling. The proposed bill would:

Continue Reading Will Feds Step Onto the GMO Playing Field?