Food and Drug Administration

© 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

The regulation of e-cigarettes and other electronic nicotine delivery systems (“ENDS”) presents complex regulatory and scientific challenges. Two key federal agencies with product safety mandates and overlapping jurisdiction – the Consumer Product Safety Commission and the Food and Drug Administration – have turned their attention onto the specific area of e-cigarette battery-related fires and explosions in the last few months.

In August 2016, the Food and Drug Administration finalized its so-called Deeming Rule to bring e-cigarettes and ENDS, as well as their components and parts such as batteries, under its authority to regulate tobacco products. Under this newly granted authority to regulate e-cigarettes and ENDS, FDA held a public workshop in April on “Battery Safety Concerns in Electronic Nicotine Delivery Systems.” Through the workshop and also through other channels, FDA is seeking data and other information on explosions, fires, and overheating of e-cigarettes. FDA also has initiated a public safety campaign of “Tips to Help Avoid Vape Battery Explosions.”


Continue Reading

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

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

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

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