regulation – Duane Morris Life Sciences Law

October 5, 2023 by Duane Morris

Federal Regulatory Laws Due Overhaul after MoCRA

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,

June 26, 2023 by Duane Morris

What Sunscreen Regulation Means for the Spa Industry

Kelly Bonner’s article for Well Spa 360 discusses recent sunscreen recalls, regulation and its impact on spa businesses.

“It’s hard to underestimate the importance of regularly wearing sunscreen to protect the skin from harmful ultraviolet rays. But recent reports suggest traces of benzene in sunscreens and a link to human health ailments have led to several voluntary recalls and consumer class litigation involving well-known brands. Concerns about whether certain sunscreens are actually “green,” “sustainable” or “reef-friendly” have left consumers in the dark about what those terms mean, while leaving brands vulnerable to consumer class action litigation.

“Here’s what spas need to know about the most recent controversies surrounding sunscreen.”

Read the full article at WellSpa360.com.

April 11, 2022 by Duane Morris

Rick Ball to Speak at FDLI’s Introduction to Drug Law and Regulation Event

Duane Morris partner Rick Ball will be a speaker at FDLI’s “Introduction to Drug Law and Regulation,” a virtual course to be held on April 28, 2022. Mr. Ball’s topic will be “Violations and Enforcement.”

About the Program

Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

To learn more about this program and register, please visit the FDLI website.

April 4, 2019 by Duane Morris

FDA Announces Its Next Steps for Cannabis Products

With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country. However, the U.S. Food and Drug Administration’s (FDA) press release issued that same day put a hold on the jubilation, stating that FDA considered any and all cannabis-containing or cannabis-derived products as drug products and not food or dietary supplements, regardless of whether the CBD was hemp-derived.

On April 2, 2019, departing FDA Commissioner Scott Gottlieb issued a statement about FDA’s next steps to advance a regulatory pathway for cannabis-containing and cannabis-derived products. At the same time FDA updated its cannabis-containing products and cannabis-derived products Q&A. It is clear that, at this point, FDA has not changed its position.

Read the full Alert on the Duane Morris LLP website.