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In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.

Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.…

Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper

CONSUMER PROTECTION CONCEPT

On March 30, 2023, the FDA authorized marketing of Happiest Baby’s SNOO Smart Sleeper, an over-the-counter infant sleep system intended to keep infants on their back throughout sleep. This marks the first time we are aware of that the FDA has given de novo marketing authorization to a product designed to keep sleeping babies positioned on their backs,[1] and signals a potential expansion of what the FDA considers to be a “medical device” within its regulatory purview.…

Continue Reading The FDA Appears to Expand Its Definition of a “Medical Device” to Include CPSC-Regulated Infant Sleep Products

Class actions following a product recall often focus on what the company allegedly knew before its products were taken off the market. But this is not always the case. A company can also come under fire for its actions after the recall and, specifically, what recourse it offers to consumers of recalled products.

On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) alerted the public of a manufacturing issue with certain lots of Ellume USA LLC’s (“Ellume”) COVID-19 Home Tests that had could lead to false positive results, and several weeks later, the FDA announced a Class I recall of these tests based on the higher-than-acceptable false positive test result. When it comes to COVID-19, a false positive could lead to delayed diagnosis and treatment of the actual cause of illness; further spread of COVID 19 when presumed positive people are grouped based on false test results; unnecessary COVID-19 treatment from health care providers, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects; disregard for the recommended precautions against COVID-19, including vaccination; and isolation, monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.
Continue Reading Recall Litigation Report: Consumers Bring Class Action Lawsuit Against Ellume Refusing to Refund Recalled COVID-19 Home Tests

The emergence of different COVID-19 variants and the corresponding surge in COVID-19 cases brings with it an increased demand for COVID-19 tests, particularly those that offer immediate results and can be done from the comfort of home. Unfortunately, like many other products on the market, at-home COVID tests are not immune to false claims or false results.

Earlier this month, the U.S. Food and Drug Administration (“FDA”) announced a Class I recall of at-home COVID-19 rapid antigen tests manufactured by E25Bio Inc. According to the FDA, E25Bio marketed and distributed its SARS-CoV-2 Antigen Test Kits (“E25Bio Tests”) to customers throughout the United States without authorization, clearance, or approval from the FDA and with insufficient data demonstrating that the E25Bio Tests performed accurately. Rapid antigen tests are designed to detect proteins called antigens from the SARS-CoV-2 virus in patient samples. And according to the FDA, the E25Bio Tests contained inaccurate claims and instructions, including a statement misrepresenting the test as FDA-authorized.
Continue Reading Recall Litigation Report: E25Bio Inc. COVID-19 Rapid Antigen Tests

The New York State legislature recently passed a bill (S2588A/A3354B), signed into law by Governor Cuomo on March 12, 2021, which amends the New York Labor Law and Civil Service Law to grant private and public employees paid leave time for the COVID-19 vaccination. The law is effective March 12, 2021 and will…

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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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

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.

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Continue Reading What Does The Future Hold For NHTSA?