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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 Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler 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. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler 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.

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