In 2022 new regulations were released that gave an expansion to the FDA’s authority to regulate cosmetics. [1] The new regulations are called the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), these regulations are now requiring that organizations that manufacture cosmetic products follow Good Manufacturing Practices (GMPs). This raises the question, why are GMPs important in cosmetics?
To answer this question, we first must understand what a cosmetic product is. The Federal Food, Drug & Cosmetic Act (FD&C Act) defines “cosmetic” in Section 201(i) as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” [2] On average people use 6 to 12 cosmetics products a day! [1]
Good Manufacturing Practices cover a lot of different things that relate to cosmetic products, for example Equipment, Personnel, and Raw Materials. These three examples are three strong reasons why GMPs are important in cosmetics. Equipment must be maintained in a clean and orderly condition, sanitized at appropriate times, and stored in a manner that protects against splash, dust, and other contaminants. [3] If all equipment is being maintained properly, it would help protect customers from contaminated products. Only authorized personnel should be allowed access into production, storage, and product control areas. [3] By only having authorized personnel in these areas it ensures that all personnel are trained for the task that they are performing. All raw materials should be sampled and tested for conformance with specifications and to ensure the absence of filth, microorganisms, and other adulterants prior to processing or usage. [3] Sampling and testing of raw materials ensure that there are no contaminants.
The three examples of Good Manufacturing Practices above are all focused on ensuring that the manufacturing practices being used keep the consumer safe. Safety is the main reason why GMPs are important in cosmetics. At EMMA international our team of experts can help ensure that your organization is compliant with the current Good Manufacturing Practices. Give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.
[1] Act of 2022 (MoCRA). https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
[2] Cosmetics & U.S. Law. (2024, May 2). Cosmetics & U.S. Law. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law
[3] Draft Guidance for Industry: Cosmetic Good Manufacturing Practices. (2023, May 3). Draft Guidance for Industry: Cosmetic Good Manufacturing Practices. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices
