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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. To begin, we will discuss whether MoCRA applies to your product and, if so, which entity should serve as the responsible person for ongoing compliance.  

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Continue Reading MoCRA: Is my product a “cosmetic” and who is my “responsible person”?

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The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the most significant change to the regulation of cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. MoCRA is a seismic shift in the world of cosmetic regulation, bringing new authorities to the FDA that are similar to those that currently exist for food, drugs and medical devices, among other regulated products. MoCRA has sweeping implications for domestic and international cosmetics manufacturers that market products in the U.S.

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Continue Reading MoCRA: A New Era in the Regulation of Cosmetic Products

Heavy metals, such as arsenic, lead, cadmium, and mercury, are present in baby foods produced by U.S. baby food manufacturers according to a report released in February by the U.S. House of Representatives Subcommittee on Economic and Consumer Policy. Heavy metals are considered dangerous to human health and are especially concerning for children and babies, who are more susceptible to the neurological effects associated with exposure to heavy metals.
Continue Reading Heavy Metals in Baby Food – Congressional Report Unleashes a Flood of Litigation

healthcare technology iotThe influence of the Internet of Things (IoT) will undoubtedly be transformational with a total potential economic impact estimated to be $3.9 trillion to $11.1 trillion a year by 2025. In the race into the IoT marketplace, there are both known and unknown legal hurdles that will affect those who offer of goods and services during the proliferation of the Internet of Things.

Some of the current and potential legal hurdles related to the IoT are well known, some are not, and some are the result of the intersection between the physical and virtual worlds, and the collision between two intersecting major drivers of innovation in IoT. On one hand, there are the established manufacturers of products and consumer goods whose expertise in developing, testing and manufacturing products puts them in an advantageous position. On the other hand, there are the technology companies who are used to developing software and whose expertise lies in software development, data collection, and data processing.
Continue Reading Hurdles the Internet of Things Must Clear for Manufacturers and Providers

Product Liability Monitor

December 4, 2017
New Developments
Missouri Adopts Daubert: What It Means in Product Liability Cases
By Theresa Mullineaux

In March 2017, Missouri Governor Eric Greitens signed House Bill 153, which amended Mo. Rev. Stat. § 490.065, and effectively adopted Daubert standards for Missouri cases, effective in August 2017. As a result, Missouri now follows

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Product Liability Monitor

October 11, 2017
New Developments
America’s Opioid Epidemic: Who Will Be Held Accountable?
By Ally Schwab

In recent years America has seen an increasing number of opioid-involved deaths and is currently experiencing what the Center for Disease Control (“CDC”) describes as an “opioid epidemic.” This crisis has been devastating to many communities and individuals, and

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Product Liability Monitor

December 13, 2016
New Developments
Auto Manufacturers Partner with Nauto to Improve Driverless Car Technology
By Shannon Peters

One of the main obstacles to the autonomous vehicle industry is “infrastructure,” but not in the sense typically associated with the term. Since autonomous vehicles come in all shapes, sizes, and powertrain types (gasoline, electric, and hybrid),

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Product Liability Monitor

September 12, 2016
New Developments
FDA Requires Highest Level of Warning on Opioids & Benzodiazepines
By Jenna Marie Stupar

On August 31, 2016 the Food and Drug Administration (FDA) issued a new directive to include the “black box” label on approximately 400 opioid and benzodiazepine products. Opioids are powerful pain reducing medications including prescription oxycodone,

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3D Foot Bones Printing3D printing continues to transform the medical field. Recently, doctors in Spain produced the world’s first 3D-printed rib cage and sternum, which is made entirely of titanium. The doctors surgically implanted the metal rib cage and sternum in a cancer patient. Last month, the FDA approved the first 3D-printed drug. The drug, which Aprecia Pharmaceuticals has named Spritam, is for treating patients with epilepsy. Aprecia Pharmaceuticals’ ZipDose® Technology utilizes 3D printing that overlays multiple layers of powdered medication on top of one another until the correct dosage is reached. This type of technology can lead to easier-to-take medication that is individualized in nature with precise dosages based on a patient’s needs.
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Continue Reading Medical Advancements in 3D Printing