In the wake of the COVID-19 pandemic, product manufacturers and distributors—many of whom have pivoted to create PPE-related products for the first time—are now faced with a veritable morass of guidelines and requirements to navigate from a variety of governmental agencies. Recent enforcement actions by federal agencies have only highlighted the importance of understanding exactly how a product must be produced, advertised, labeled, and sold.  This begs the important question: who is the regulator and what is the rule?

Our product risk management team has been speaking to several trade associations in September 2020 about how to navigate the alphabet soup of federal agencies supervising COVID-19 product distribution.  The biggest takeaway:  How a product is advertised for sale plays a critical role in how it is regulated and by which agency .  The regulatory profile can mean the difference between required manufacturing registration or specific requirements as to product labeling.

This article outlines a few of the major players involved in regulating products designed to mitigate or prevent COVID-19—specifically, the Food and Drug Administration (“FDA”), Federal Trade Commission (“FTC”), and Environmental Protection Agency (“EPA”)—and discusses high-level considerations for entities who find themselves caught up in the regulatory alphabet soup.


Continue Reading Who is the regulator? What is the rule?: Navigating the Alphabet Soup of COVID-19 Product Requirements       

Many universities and local governments have installed synthetic turf made with “crumb rubber” – ground up tires – on playing fields and playgrounds in recent years to obtain the advantages of all-season use and lower maintenance costs. In recent months, however, the media and a growing group of critics contend that the crumb rubber used

EPA has proposed a new rule to restrict the use of seven toluene diisocyanates (TDIs) in consumer products.  TDIs are commonly used in the production of polyurethanes found in foams, coatings, elastomers, adhesives and sealants used in consumer products.  Flexible foams (for cushioning) and rigid foams (for insulation) are the chief uses for TDI.

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By email dated December 14, 2012, the Environmental Protection Agency (EPA) withdrew its controversial direct final rule requiring the reporting of existing and unpublished health and safety data for cadmium and cadmium compounds used in consumer products pursuant to section 8(d) of the Toxic Substances Control Act (TSCA). In its email, EPA admitted that "there is significant confusion and uncertainty within certain industrial sectors concerning the rule." EPA went on to indicate that it "will withdraw the immediate final rule and will sign a Federal Register notice announcing this decision no later than the January 2, 2013, effective date of the immediate final." EPA will be considering the questions and concerns raised in response to the immediate final rule and next steps with regard to this rule.


Continue Reading EPA Reverses Course and Promises to Withdraw TSCA Section 8(d) Cadmium Rule