‌ 

On Friday, Proctor & Gamble announced a voluntary recall of several of their aerosol dry shampoo and conditioner spray products due to the presence of Benzene. This voluntary recall was initiated because Benzene is classified as a human carcinogen, with exposure occurring by inhalation or orally and can result in certain cancers such as leukemia.[1] Proctor & Gamble states that although Benzene is not an ingredient in any of their products, testing showed that unexpected amounts were present in the propellant that facilitates spraying the product out of the can.

This recall highlights an important aspect when it comes to cosmetics and the role of the FDA. Although cosmetics are not regulated like medical devices or pharmaceuticals, they are still consumer products which subsequently results in the FDA having regulatory requirements to protect public health. Although significantly less stringent than medical devices or pharmaceuticals, good manufacturing practices (GMP) still play a critical role when it comes to cosmetics. As seen through the Proctor & Gamble example, unsafe products or manufacturing conditions for cosmetics can still result in a recall and other negative consequences on manufacturers.

The best thing cosmetic manufacturers can do is ensure that they fully understand what role GMP’s play in their products, and how to ensure that they are meeting all regulatory requirements. Additionally, it is of the utmost important to understand that even though most people think of medical devices or pharmaceuticals when they think of FDA oversight, cosmetics still fall within their jurisdiction and are regulated as such.

If you need assistance ensuring that your cosmetic product is compliant with the necessary regulations, EMMA International can help! With everything from developing a quality management system (QMS), to ensuring that your manufacturing operations are optimized to maximize both your business and compliance, you can count on EMMA International. Get in touch with our team of experts by calling 248-987-4497 or emailing info@emmainternational.com.

[1] FDA/P&G (Dec 2021) Company Announcement retrieved on 12/20/2021 from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pg-issues-voluntary-recall-aerosol-dry-conditioner-spray-products-and-aerosol-dry-shampoo-spray

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This