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       

As more organizations incorporate technology in newfound ways to increase efficiency and effectiveness, government agencies have done the same. Take, for instance, the CPSC’s new recall app, which makes recall information more accessible to consumers on their mobile devices. Now government agencies are looking towards companies to apply the latest technologies to protecting consumer

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Earlier this month, the U.S. Food and Drug Administration announced that it would allow infant food manufacturers to use a qualified health claim on their labeling to characterize the relationship between consumption of ground peanuts by infants beginning between 4 and 10 months of age and a reduced risk

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The Food Safety Modernization Act, which was signed into law by President Obama on January 4, 2011, promised sweeping reform of food safety practices from farm to fork, and shifted FDA’s regulatory posture from reacting to food contamination to proactively preventing it. While the Trump administration has vowed to eliminate two regulations for every new regulation, at this year’s Food and Drug Law Institute’s Annual meeting, Dr. Susan Mayne, the Director of FDA’s Center for Food Safety and Applied Nutrition, made clear that FSMA is the law of the land and FDA fully intends to continue its implementation and enforcement of it.


Continue Reading The Devil is in the Details: Recordkeeping a Central Focus in FSMA Inspections

iStock_000005544549_FullOn March 30, 2017, Crowell & Moring’s Advertising & Product Risk Management Group hosted a webinar in which we discussed likely changes on the horizon at the Food & Drug Administration, Consumer Product Safety Commission, and the National Highway Traffic Safety Administration. We also discussed the relationship between these agencies and the Department of Justice,

Cars on highwayMore than two months after President Donald Trump’s inauguration, the automotive industry continues to face substantial uncertainty regarding the direction and priorities of the National Highway Traffic Safety Administration (NHTSA) over the next few years. For now, we can only guess.  The new Transportation Secretary, Elaine Chao, was confirmed January 31.  She takes over a NHTSA that had been working hard to keep up with emerging technologies – while acting increasingly muscular in its fines and other punishments under the prior administration.

For some safety agencies, it is much easier to read the tea leaves under the new administration. For example, at the Consumer Product Safety Commission, for example, we know that there is a new Republican Acting Chair (Ann Marie Buerkle), and that the five commissioners will remain 3-2 in favor of Democrats until at least October 2017 when Democratic Commissioner Marietta Robinson’s term on the Commission expires.  See prior article here.  And, following Acting Chair Buerkle’s public remarks last month at the annual conference of the International Consumer Product Health and Safety Organization (ICPHSO), we know that her top three priorities include: (1) collaborating with all product safety stakeholders; (2) taking a balanced and reasonable approach to regulation; and (3) expanding product safety education and awareness for consumers.  See prior article here.


Continue Reading What Does The Future Hold For NHTSA?

First 100 Days LogoThursday, March 30, 2017 1:00 – 2:00 p.m. Eastern

Aggressive enforcement, massive recalls and proactive safety agendas left an indelible impression on the product safety world under the Obama administration. Product safety is no longer a bipartisan affair. But what will the Trump administration mean for your regulatory compliance programs? What changes will we see

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Historically, as administrations change at the safety agencies, new priorities and shifting judgments on risk-based hazard assessment drive regulatory burdens up or down. The effect of President Trump’s executive order requiring the repeal of two rules for every one promulgated is yet to be seen when it comes to rulemaking at consumer facing safety agencies such as the National Highway Traffic Safety Administration, Food and Drug Administration, and Consumer Product Safety Commission.

The CPSC, as an independent agency, could take the position that the E.O. simply does not apply to them.  The White House agrees.  But the reality is that very few $100 million rules have been issued by the CPSC over the entire life of the agency.  That is because its enabling statute favors voluntary industry standards over mandatory rules.  Indeed, many of the CPSC rules affecting product performance have been mandated by Congress and could not be repealed by the agency absent an act of Congress.  Still others may require some APA process before they can be legally repealed or changed.


Continue Reading Safety Agencies after Trump’s “2 for 1” Executive Order: What it May Mean for Regulating the Safety of IoT and other Emerging Technologies

First 100 Days LogoJoin Us for a Webinar – Thursday, March 30, 2017 1:00 – 2:00 p.m. Eastern

Aggressive enforcement, massive recalls and proactive safety agendas left an indelible impression on the product safety world under the Obama administration. Product safety is no longer a bipartisan affair. But what will the Trump administration mean for your regulatory compliance programs? What changes will we see and how will they affect your safety program?

Join us for a roundtable discussion of what the regulated community can expect under the new administration at the Food & Drug Administration, Consumer Product Safety Commission and the National Highway Safety Administration. We’ll help you to forecast where policy shifts on by focusing on topical discussions of emerging products such as autonomous cars, drones, miniaturized cameras and e-cigarettes, and emerging issues including fire and lithium ion batteries, as well as hacking concerns on interconnected products.

Please click here to register for this webinar, or click here to view the event on Crowell.com.

Key topics to be discussed:
Continue Reading Webinar: The Safety Agencies in Transition – What to Expect at FDA, CPSC and NHTSA in the First 100 Days