Photo of John Fuson

John Fuson is a partner in the firm's Health Care, Advertising & Product Risk Management (APRM), and White Collar and Regulatory Enforcement groups, focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters. He is also a member of the Steering Committee for the firm's APRM Group. Before joining Crowell & Moring, John served as associate chief counsel at the FDA, with broad law enforcement responsibilities, from 2007-2012. John has experience handling all types of major enforcement actions brought by the FDA, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases have involved drugs, devices, food, and veterinary drugs.

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 device security,
  • the FTC is holding a series of hearings on the transformative nature of the digital transformation on markets.
@GettyImages

What does all this activity in the United States mean for companies following the rapidly evolving regulations globally related to the safety and security of products?

This PLAC webinar will describe the current landscape at the federal agencies setting policy for product safety and security. With all the recent talk of regulatory humility in the face of great technological change, we’ll discuss whether regulators practice what they preach and if recent actions encourage or stifle innovation. Our session will compare and contrast activities across the federal government relevant to consumer products broadly defined with a particular focus on product safety and security.

Presenters:

Cheryl Falvey, Partner, Crowell & Moring, Washington, DC
John Fuson, Partner, Crowell & Moring, Washington, DC
Peter Miller, Senior CounselCrowell & Moring, Washington, DC

Please click here to register for this webinar.

© USDA

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 of developing peanut allergy by age five. The precise language FDA will allow reads:

For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. FDA has determined, however, that the evidence supporting this claim is limited to one study.

If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.

Qualified health claims must be supported by credible scientific evidence, a less rigorous standard than the “significant scientific agreement” requirement for authorized health claims. Here, FDA found support for the qualified claim in the same studies that moved the National Institute of Health to issue updated guidelines for the early introduction of peanut-containing foods in infants.

FDA’s decision is notable for several reasons. First, it was the first time the agency approved a health claim aimed at preventing a food allergy. FDA acknowledges that food allergies are an increasing and serious public health issue that requires the agency’s attention. This is one of many tools it has available to address the problem.

Second, it showed the FDA’s willingness to loosen restrictions on allowable disease prevention claims within its existing regulatory framework when presented with sound, scientific evidence demonstrates. In this case, the agency was responding to a manufacturer’s petition.

Third, it showed FDA Commissioner Scott Gottlieb’s willingness to step into the role of the nation’s doctor. FDA’s announcement was accompanied by a statement from Dr. Gottlieb, in which he addressed concerns about food allergies and possible prevention as both a parent and physician. He has spoken similarly on other public health issues, most recently on the opioid addiction crisis, and thus has demonstrated a willingness to encroach on questions traditionally in the realm of the practice of medicine, an area the agency typically avoids.

Achieving regulatory changes in the current political environment is challenging, but this decision demonstrates that FDA will respond to requests based on sound scientific evidence to relax rules that otherwise limit what manufacturers can say about their products. Manufacturers whose products show demonstrable health benefits may thus want to consider similar requests to secure greater marketing flexibility.

2017 continues to be the year of the Food Safety Modernization Act, as the U.S. Food and Drug Administration, having completed its roll-out of the major rules implementing this land-mark food safety legislation, moves in earnest with inspections to check on compliance.

© iStock

To help manufacturers prepare for this and other issues confronting the food industry, on Tuesday, June 13th, the American Bar Association Food & Supplements Subcommittee is hosting a Workshop in Hershey, Pennsylvania. One topic of discussion will be FSMA inspection preparedness as a panel of industry representatives will talk about what they’re seeing from the latest FDA inspections, and what manufacturers should expect when agency investigators come knocking this summer and fall.

In addition to talking about how to prepare for an FDA inspection, the panel plans to examine what FDA has said about its expectations during its first round of visits focused on FSMA compliance. It will also talk about how manufacturers can have their FSMA documents in order for investigator review, and how to prepare for the flurry of environmental samples FDA is likely to take. Crowell & Moring partner John Fuson will be presenting as part of the panel. Additionally, Laura Cordova will be speaking on a panel regarding ethical issues in parallel criminal and civil proceedings. Michelle Gillette is one of the program organizers for the workshop.

For more information, visit the ABA website.

iStock_000003906886Large_books
© iStock

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

First 100 Days Logo

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

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.”

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 proposals published earlier this year, which set standards for preventive controls and produce production at domestic food facilities.  [Read more . . .]

Content for this post provided by Crowell & Moring partners John Fuson and John B. Brew, and associate Michael L. Kuppersmith.

On Friday, August 2, 2013, the United States Food and Drug Administration (FDA) published a new regulation establishing standards for when a food product can claim to be “gluten-free.” According to the final rule, food bearing a “gluten-free” label, as well as foods claiming “no gluten,” “free of gluten” or “without gluten,” must not contain more than 20 parts per million of gluten.

Gluten is a naturally occurring protein in wheat, rye, barley, and various hybrids of those grains. According to the FDA the new rule will ensure uniformity in food product labeling and provide the approximately three million Americans who suffer from celiac disease the opportunity to make informed food purchasing decisions. Foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine in people with celiac disease, which can lead to very serious health conditions. Thus, people with celiac disease must maintain a strictly gluten-free diet.    

Food manufacturers will have until August 2014 to bring their labels into compliance with the new requirements.