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John Fuson

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John Fuson is a partner in the firm's Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups, focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters.

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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       

When the U.S. Food & Drug Administration (FDA) issued 15 warning letters to companies selling CBD-infused products late last year, it more than doubled the number of warning letters directed to manufacturers of such products in 2019. The warning letters were announced in a November 25 press release in which FDA also stated that, at…

Join Us For A Complimentary Webinar – Thursday, October 25, 2018 – 12:00 – 1:00 PM ET

Two years into the Trump Administration and:

  • The Consumer Product Safety Commission finally has a Republican majority,
  • the Department of Transportation has released its 3.0 guidance on autonomous vehicles,
  • NIST has published a 375 page recommendation on medical

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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.

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

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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.

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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

On Friday, May 20, 2016, the U.S. Food and Drug Administration (FDA) announced a “refreshed” Nutrition Facts label, which, except for the addition of trans-fats in 2006, had gone largely untouched since 1994. Consumers will not only notice an updated design, which makes the label larger and bolder, but there are more substantive changes that, according to FDA, “are based on updated scientific information, new nutrition and public health research, more recent dietary recommendations from expert groups, and input from the public.”
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Continue Reading The FDA Unveils an Updated Nutrition Facts Label

On July 26, 2013, the U.S. Food and Drug Administration (FDA), continuing the process of implementing the 2011 Food Safety Modernization Act (FSMA), published two new proposed rules: one on foreign supplier verification programs for food importers and one on accreditation of third-party food safety auditors. These proposed rules are the foreign counterparts to two…