Duane Morris attorneys Rick Ball and Coleen Hill will be speakers at MassMEDIC’s Regulatory Roundup, to be held on November 15, 2023 from 8:00 a.m. to 4:15 p.m. Rick and Coleen will present “When Things Go Wrong: Navigating Enforcement When the FDA, SEC, and DOJ Are All Involved.” For more information and to register for this hybrid event, please visit the MassMEDIC website.
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.
Rick Ball and Coleen Hill to Speak at MassMedic Regulatory Roundup Event
Duane Morris attorneys Rick Ball and Coleen Hill will speak at the MassMedic Regulatory Roundup Event webinar on February 16, 2023, starting at 9 a.m. Their presentation is titled “Recent Developments on the ‘Fraud on the FDA’ Theory of False Claim Liability” at 10:45 a.m.
This program is designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts.
For more information or to register, please visit the MassMedic website.
FDA Final Guidance on Initiating Voluntary Recalls: Be “Recall Ready”
On March 4, 2022, FDA issued a final guidance to industry and FDA staff regarding the initiation of voluntary recalls under 21 CFR part 7, subpart C. The guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any:
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- Food, drug and device (human or animal use);
- Cosmetic and biological product (human use);
- Tobacco product;
- Item subject to a quarantine regulation under 21 CFR part 1240; and
- Devices that are electronic products regulated as radiology devices (subject to 21 CFR part 892) but not electronic products subject to 21 CFR parts 1003 and 1004.
In short, the final guidance clarifies FDA’s recommendations on how a firm should be prepared to facilitate the timely initiation of voluntary recalls, steps a firm should take if there is an indication of a problem with a distributed product and how to initiate voluntary recalls. The final guidance also explains how FDA works with firms to initiate a voluntary recall.
To read the full text of this Duane Morris Alert, please visit the firm website.