Category: Regulatory

New York’s Beauty Justice Act: Sweeping Changes Proposed for Cosmetics and Personal Care Products

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New York lawmakers are advancing the Beauty Justice Act, one of the most comprehensive state-level efforts in the country to regulate cosmetics and personal care products. For in-house counsel at cosmetics and personal care companies, the bill is worth tracking now because it could affect product formulation, supplier oversight, labeling, and litigation risk well before any compliance deadline. The bill responds to growing concerns over consumer exposure to chemicals linked to cancer, hormone disruption, reproductive harm, allergies, and other health risks. Supporters argue that current federal law, including the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), does not go far enough. Framed as both a public health and environmental justice measure, the legislation aims to protect consumers in vulnerable communities disproportionately exposed to these products.

  1. Background

    The Beauty Justice Act remains pending before the New York Legislature; if enacted, its core product restrictions would apply beginning January 1, 2029. The bill would prohibit cosmetics and personal care products sold in New York from containing intentionally added chemicals on the bill’s restricted substances list. It would also require companies to evaluate whether ingredients listed as “fragrance,” “flavor,” “colorant,” or other functional classifications contain restricted chemicals, comply with contaminant thresholds such as lead limits, and monitor Department of Environmental Conservation (DEC) rulemaking that may add substances to the restricted list over time. The bill targets numerous chemicals that have already faced scrutiny in other jurisdictions and regulatory frameworks, including per- and polyfluoroalkyl substances (PFAS), parabens, phthalates, certain dyes, and preservatives.

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Transposing the EU’s New Product Liability Directive: A Member State Progress Report

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Even in the areas where the Product Liability Directive aims for full harmonisation, the EU member states’ early legislative activity reveals notable differences in implementation. Companies should continue to monitor national transposition closely and begin preparing for the new regime. Key steps include reviewing product safety documentation and post-market surveillance processes and ensuring that contractual arrangements with component suppliers and distributors adequately allocate responsibilities and risks under the revised framework.

Read the full article on the Faegre Drinker website

Significant Drug & Device Developments of 2025

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As we welcome the new year, it is time to reflect on some of the most significant legal developments in the drug and device space in 2025.

1. Navigating a New Skepticism in Science

Not long ago, the average American likely could not name the U.S. secretary of health and human services. Yet, following this year’s change in administration and major shakeup in the regulatory landscape, skepticism in science has become the elephant in the room for anyone working in the drug and device sphere. Practitioners should start thinking about how to present scientific evidence to juries in 2026 as the old norms may no longer apply.

Read the full article on the Faegre Drinker website.

Florida Courts of Appeal Scrutinizing Punitive Damages Claims

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It is not uncommon for a product liability plaintiff to base a claim for punitive damages on little more than the same allegations that undergird a strict liability or negligence claim, while adding that the defendant knew that the product was unsafe or that the warnings were inadequate and marketed the product regardless. While that approach has worked at times in the past, recent decisions from Florida’s Third and Fourth District Courts of Appeal remind us that Florida imposes a high bar on punitive damages claims. Specifically, these courts highlighted several key points related to claims of punitive damages in product liability cases: (1) Florida’s statutory requirements for punitive damages are more stringent than some other states (specifically, California) and, therefore, orders from other states awarding punitive damages are unpersuasive; (2) Florida law presumes a product is not defective if it complies with applicable government regulations; (3) the level of negligence required to plead punitive damages in Florida requires conduct equivalent to establishing criminal manslaughter; and (4) the Florida Supreme Court has all but eliminated punitive damage awards in product liability cases. These cases are discussed in further detail below.

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Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry Regulations

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On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes its name from a 1984 Supreme Court case, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc, 467 U.S. 837 (1984), which announced a bright-line rule governing whether a regulation promulgated by an executive branch agency, like FDA or USDA, was enforceable based on the scope of statutory authority Congress delegated to the agency. Chevron held that if a court concluded that a statute was silent or ambiguous as to an issue (Step One), then the court must defer to an agency’s permissible construction of the statute in the regulations it promulgated (Step Two). In overturning Chevron deference, Loper Bright announced that courts “must exercise their independent judgment in deciding whether an agency has acted within its statutory authority.”

To read the full article, visit the Faegre Drinker website.

Extended Producer Responsibility (EPR) is Here and It’s Time to Register With a Producer Responsibility Organization (PRO)

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As Extended Producer Responsibility (EPR) kicks off across the U.S., manufacturers should be mindful of sustainability claims, especially related to packaging materials and recycling. EPR reporting will generate significant, publicly available data, which could potentially be used in greenwashing claims against covered producers.

To read the full article, visit the Faegre Drinker website.