On October 13, 2023 The FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information.
Continue Reading FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.
Continue Reading FDA Seeks Comments on COSMETICS Direct for MoCRA Facility Registration and Product Listing
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
A recent article published by MedTech, “Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern,” quotes a Crowell client alert and Crowell attorney, Robbie Jost, on this development. According to the client alert, “To the extent the FDA considers the SNOO a medical device based on its intended impact on infant sleep position, many
The Food and Drug Administration (“FDA”) recently issued guidance recommending that the term “milk” extend beyond dairy (cow) milk products to plant-based alternatives. Although not legally binding, the guidance indicates that nondairy milk alternatives can be labeled “milk” and need not be restricted as nondairy “beverages” or “drinks.” These plant-based alternatives should, however, include a statement on their product label describing how they are nutritionally different from milk (e.g., “contains a lower amount of potassium than milk”).
Continue Reading Plant-Based Milk Alternatives, Udderly Nutritious?
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
When diseases become newsworthy, advertisers may be tempted to profit, claiming that their products can help prevent, treat or cure the disease. Some advertisers did exactly that as the recent COVID-19 pandemic became a regular part of the news cycle.
In January 2020, GOJO Industries, Inc., the makers of hand sanitizer brand Purell, received a