Kelly Bonner – Duane Morris Life Sciences Law

November 8, 2023 by Duane Morris

FDA Pushes Back Enforcement Deadline for MoCRA Facility Registration and Product Listing Requirements

Today, FDA announced updated guidance regarding its MoCRA rollout.

FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.

To read the full text of this post by Kelly Bonner, please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.

October 20, 2023October 24, 2023 by Duane Morris

MoCRA featured on the Class Action Weekly Wire Podcast with Guest Kelly Bonner

In Episode 35 of the Class Action Weekly Wire podcast, host Jerry Maatman interviews Duane Morris associate Kelly Bonner about the Modernization of Cosmetics Regulation Act (MoCRA). Watch the episode below:

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,

September 6, 2023 by Duane Morris

FDA’s Second Warning Letter of the Year Deals with Potentially Misleading Efficacy Claims About Inhaler

On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a warning letter to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure for its Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate) inhalation aerosol contained false or misleading claims regarding the drug’s efficacy.

In view of the warning letter—only the second of the year issued by the Office of Prescription Drug Promotion (OPDP)—companies should review their promotional materials to confirm that any efficacy claims are clearly supported by cited data and do not give rise to misleading impressions and regulatory scrutiny—even where such materials are intended for patients.

Read the full Alert on the Duane Morris LLP website.

July 5, 2023 by Duane Morris

Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq.,
in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, 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.

March 6, 2023 by Duane Morris

US FDA Looks to Move Cosmetics Work

Duane Morris attorney Kelly Bonner was quoted in an article in Chemical Watch on March 3.

“The US Food and Drug Administration has started its search for a deputy commissioner for its new human foods programme, and plans to move certain cosmetics functions to another part of the agency to advance oversight of the products. […]

The inclusion of cosmetics in the proposed restructuring is “very significant”, said Kelly Bonner, associate with law firm Duane Morris.

The move will allow the FDA to implement MoCRA more efficiently and effectively, she told Chemical Watch. To this end, the agency “anticipates closer collaboration between cosmetics and other FDA subject matter experts” in the Center for Drug Evaluation and Research and the Office of Women’s Health, she said.”

To read the full text of this article, please visit the Chemical Watch website (subscription required).

February 22, 2023February 23, 2023 by Duane Morris

Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment

On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.

Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.

To read the full text of this article by Duane Morris attorneys Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.