Vol. 1, Issue 6  ‣ October 2024

Table of Contents

In December of 2022, President Biden signed the MoCRA Act of 2022 into law, ushering in new regulations that significantly expanded the authority of the FDA over personal care companies. There have been years-long efforts to increase the FDA's oversight of the personal care and cosmetic industry, stemming from growing concerns regarding product safety. In 2018, there was 

an avalanche of lawsuits against Johnson & Johnson, alleging that the company's Baby Powder and other talc products were contaminated with asbestos. In November 2020, the Environmental Working Group (EWG) found asbestos in almost 15% of 21 powder-based cosmetic products, including make-up marketed to children.¹,²

New registration and listing requirements under MoCRA were enacted in July, and by the end of 2025, new Good Manufacturing Practices will become an FDA-mandated requirement.³ The FDA's cosmetics program will also receive significant funding increases. Previously operating under a limited budget of approximately 10M per year and with limited enforcement tools, MoCRA has authorized an increase in funding to the program, with nearly 26M allocated for 2024 and approximately 42M per year for 2025, 2026 and 2027.⁴ This funding will likely increase inspections and other enforcement activities by the FDA.

Considering these new changes, personal care companies should review their current manufacturing, marketing, and quality procedures to limit their risk of prompting unwanted FDA enforcement action. 

Hardy Diagnostics understands the unique challenges of personal care and cosmetics companies and specializes in regulatory compliance and microbial testing solutions. Check out our newly updated Personal Care and Cosmetics catalog to learn more.

References: 1, 2, 3, 4

Pharmaceutical professionals can now access free, self-guided training resources from the FDA, including a comprehensive course on cleanroom airflow management. This introductory 4-hour course covers key topics like cleanroom design, proper airflow control, and conducting smoke studies for airflow verification. Accredited for continuing education credits, it’s an excellent resource to enhance expertise in maintaining cleanroom environments. Sign up through TRAIN for full access.

TRIO.BAS™ MINI CD Kit, 100 Liters per minute,
CompactDry™, with charging cable

Specifically designed to hold CompactDry™ plates for efficient microbial air sampling.

More trusted solutions to ensure precision in
microbial detection and quality control

Burkholderia cepacia Selective Agar (BCSA), USP

A selective medium used for isolating Burkholderia cepacia from non-sterile samples. Its specific formulation ensures the detection of this contaminant, which is a significant concern for manufacturers.

HardyCHROM™ ECC (E. coli and Coliforms), Chromogenic Medium

This chromogenic medium is designed for the differentiation and enumeration of E. coli and coliforms. It’s essential for quality control to ensure the absence of these potential contaminants.

Tryptic Soy Agar (TSA), USP

A general-purpose medium used for the cultivation of a wide variety of microorganisms, making it ideal for environmental monitoring and microbial testing in products.

Ensure the highest standards of safety and cleanliness in your personal care products with our detailed brochure. Designed for microbiologists, it provides comprehensive insights into our diagnostic and testing solutions for detecting microbiological impurities and maintaining contaminant-free workspaces. Download now to enhance your quality control processes and safeguard your products.

A change to our Hungate-capped USP <71> tubes has been made. The change is designed to facilitate user disinfection procedures and workflow. The improvements are particularly suited to laboratories performing a high number of sterility tests, or for nuclear compounding technicians working with isolators aided by mechanical manipulators who, due to safety requirements, work at a greater distance from tubes when preparing radiopharmaceuticals.

The dual ports of the new cap will use two shapes: a circular port and a square port. The unique port shapes allow technicians to designate or identify ports for different purposes, such as sample inoculation, container venting for aerobic cultures, or sample withdrawal, or to avoid cross contamination of a single port with repeated inoculation, where indicated. Caps will be color coded by formulation: blue for Tryptic Soy Broth and red for Fluid Thioglycollate. This allows technicians to quickly identify media by cap color and help prevent workflow errors.

Joelle Brackeen

PHARMACEUTICAL PRODUCT MANAGER

Joelle Brackeen is the Pharmaceutical Product Manager at Hardy Diagnostics and has over a decade of experience in Marketing and Product Management. Before transitioning to the pharma sector, Joelle had the privilege of co-founding and helping to grow a business into a highly profitable, multinational enterprise. Her unique blend of entrepreneurial spirit and product management expertise contributes to her innovative approach and ability to drive successful products and strategic initiatives in the pharmaceutical industry. In her free time, she enjoys playing the piano and spending time at the beach.

Do you have a suggestion, comment, or question? Please contact Joelle here.

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